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8 years ago

At war with my skin and joints

HealthPad
Directory:
Rheumatology
Tags:
arthritis
autoimmune conditions
commentary
inflammatory bowel disease
iritis
joint inflammation
joint swelling
psoriasis
Psoriatic Arthritis
rheumatoid arthritis
 
  • Psoriasis is a serious chronic inflammatory disorder of the immune system
  • It affects more than 90m people worldwide: 1.2m in Britain, 7.5m in the US
  • The condition runs in families
  • Symptoms include red patches of skin covered with silvery scales that itch and burn
  • 30 to 40% of people with psoriasis may experience psoriatic arthritis, which may lead to chronic pain, disability and sometimes; mutilating joint disease
  • New drugs are changing the prospects for people with psoriasis and psoriatic arthritis
  • Dr. Sonya Abraham, Imperial College London, and British Psoriatic Arthritis Consortium describes some of the causes of psoriasis, and prospects for future therapies
 
At war with my skin and joints
 
The novelists John Updike and Vladimir Nabokov, among others, suffered from psoriasis, which significantly influenced and shaped their respective lives.
 
Psoriasis affects more than 100m people worldwide: 1.2m in Britain, and 7.5m in the US. 30 to 40% of these can experience psoriatic arthritis. In 2014, the WHO recognized psoriasis as a serious chronic non-communicable disease, and suggested that people with the condition suffer needlessly because of, “incorrect or delayed diagnosis, inadequate treatment options and insufficient access to care, and because of social stigmatization”.

Therapies for psoriasis include a range of topical and systemic medications as well as phototherapy. Many of the systemic therapies can also reduce the pain and disability from arthritis and other manifestations of the condition.
 
Health professionals have been somewhat constrained by the limited therapies specifically for psoriasis, but this is beginning to change. New treatments are improving the prospects for people with psoriasis, and psoriatic arthritis. “The outlook is good for the millions of people with the conditions”, says Dr. Sonya Abraham of Imperial College London, and a member of the British Psoriatic Arthritis Consortium (Brit-PACT):
 
 
Psoriasis

Psoriasis is a serious chronic inflammatory disorder triggered by an immune systems fault that causes the over production of skin cells. It runs in families, and has an unpredictable course of symptoms. It mainly presents in adults, usually before the age of 35.

Psoriasis mostly affects the skin and joints, and usually occurs on the scalp, knees, elbows, hands and feet. It also may affect the fingernails, the toenails, the soft tissues of the genitals and the inside of the mouth. The condition is characterized as ‘mild’, ‘moderate’, and ‘severe’ according to the amount of body surface area (BSA) affected and the severity of redness, thickness, and scaling of the skin. Approximately 80% of those affected have mild to moderate disease, while 20% have moderate to severe psoriasis affecting more than 5% of the body surface area. The most common form of psoriasis affecting about 80 to 90% of psoriasis patients, is ‘plaque psoriasis’, which is characterized by patches of raised, reddish skin covered with silvery-white scale. There are other forms of psoriasis, including inverse, erythrodermic, pustular, guttate and nail disease. 
 
Psoriatic arthritis and associated conditions

Below Sonya Abraham describes some of the causes of psoriatic arthritis and the effects that the condition may have on various organs of the body. Up to 40% of people with psoriasis experience joint inflammation that produces symptoms of arthritis. Psoriatic arthritis can lead to chronic pain and change in physical appearance. Patients suffering from psoriatic arthritis have reduced physical fitness, compared to psoriasis patients without arthritis. Typically, psoriatic arthritis occurs in conjunction with longstanding skin lesions, but it can occur in the absence of psoriasis.

Psoriasis and psoriatic arthritis may be associated with other diseases and conditions. The incidence of Crohn’s disease and ulcerative colitis, two types of inflammatory bowel disease, is 3.8 to 7.5 times greater in psoriasis patients than in the general population. Patients with psoriasis also have an increased incidence of lymphoma, heart disease, obesity, type-2 diabetes and metabolic syndrome. Depression and suicide, smoking, and alcohol consumption are also more common in psoriasis patients.
 
 
Causes of psoriatic arthritis

What does psoriatic arthritis do to the body?

Living with psoriasis

Updike was affected by psoriasis throughout his whole life, and his writings provide a vivid insight into the significant physical and psychological challenges that sufferers face. In his book Self Consciousness he devotes a chapter to the condition, and in 1985 he wrote a personal history of his psoriasis for The New Yorker entitled, “At War with My Skin”.
 
Updike says that he became a writer because of his psoriasis: “writers do not have to be presentable”. He married young because he found a person “who forgave” his skin, and moved to a small town in Massachusetts near a beach where he could swim and sunbath to relieve his symptoms. During the cold New England winters Updike moved to the Caribbean where he could continue to swim and sunbathe. The stress of leaving his wife in 1974 aggravated his condition, which resulted in a failure of his salt water and sun therapy. Consequentially, he enrolled in what was then an experimental light therapy, which, together with some systemic medication cleared his skin.
 
Nabokov was deeply disturbed by his psoriasis, which he tried to conceal, except to people close to him.  In 1937, after suffering a bad attack, he wrote to his wife describing his agony, "I continue with the radiation treatments every day, and am pretty much cured. You know, now I can tell you frankly, the indescribable torments I endured before these treatments, drove me to the border of suicide; a border I was not authorised to cross because I had you in my luggage”.
 
Treatment options for psoriasis

Updike and Nabokov’s descriptions provide insights of the devastating impact that psoriasis can have on the quality of life. Until recently, there has been few drugs specifically targeted for psoriasis, but this is beginning to change and the outlook for people with psoriasis and psoriatic arthritis looks promising. Here we describe some of the new medications that have recently come to market. But before doing so, we briefly describe current therapies.
  
Mild to moderate psoriasis
 
Mild to moderate psoriasis is managed with topical therapies, which are not very effective. These include coal tar, emollients, salicylic acid, topical retinoids and corticosteroids, and forms of vitamin D, which can sometimes be used together with other medications.
 
People with moderate to severe psoriasis may be treated with traditional systemic medications, phototherapy or biologic agents. In cases of more extensive psoriasis, topical agents may be used in combination with phototherapy, or traditional systemic or biologic medications. Phototherapy includes narrowband and broadband ultraviolet B (UVB), and furocoumarins plus UVA (PUVA), which have to be used sparingly because light therapies may increase the risk of skin cancer.
 
Psoriatic arthritis therapies
 
In the video below, Sonya Abraham describes some of the conventional therapies for psoriatic arthritis. Medical treatment regimens for the condition include the use of non-steroidal anti-inflammatory drugs (NSAIDs), and disease-modifying anti-rheumatic drugs (DMARDs). Conventional therapy usually consists of NSAIDs and local corticosteroid injections, with DMARDs being reserved for NSAID-resistant cases. However, because 40% of patients may develop erosive and deforming arthritis the early use of more aggressive treatment with DMARDs may be warranted.
 
DMARDs include methotrexate, sulfasalazine, cyclosporine, and leflunomide, as well as biologic agents, such as monoclonal antibodies targeting tumour necrosis factor therapies (TNF) - alpha, interleukin-12/23 (IL-12), IL-17, or IL-23.
 
In September 2013, the US Food and Drug Administration (FDA) approved ustekinumab, an IL-12/23 inhibitor, for the treatment of active psoriatic arthritis in adults who have not responded adequately to previous treatment with non-biologic DMARDs. The drug was already approved in Europe and the US for treatment of moderate to severe psoriasis plaques in adults.
 
 
Monoclonal antibodies
 
A monoclonal antibody is an antibody produced by a single clone of cells, and is therefore a single pure type of antibody. Monoclonal antibodies can be made in large quantities in a laboratory, and are a cornerstone of immunology, and increasingly are being introduced as therapeutic agents. The anti-Tumour necrosis Factor Therapies, (anti-TNF) monoclonal antibody biologics include adalimumab, certolizumab, golimumab, infliximab, and the fusion protein, etanercept. All have FDA and EU approvals. Immunology is a branch of biomedical science that covers the study of all aspects of the immune system in all organisms.
 
New drugs
 
Secukinumab
 
Secukinumab is an immunosuppressant that reduces the effects of a chemical substance in the body that can cause inflammation. It works by blocking a certain natural protein in your body (interleukin-17A) that may cause inflammation and swelling. Marketed by Novartis as Cosentyx®, it is the first drug to target psoriatic arthritis, and could help those who suffer from the worst effects of the condition. The therapy is self-administered by a monthly injection, and is aimed at the parts of the immune system known to make proteins called interleukins, which are believed to be faulty in the amounts of serum they release. Up to 84% of psoriatic arthritis patients treated with Cosentyx® at two years had no radiographic progression in their joints. Clinical studies found 80% of patients saw a 75% improvement after using the drug for 12 weeks. 70% saw a 90% improvement by week 16. 405 found their symptoms disappeared completely.
 
Mark Tomlinson, from Novartis, the drug manufacturer, said: “In those without psoriasis, the immune system is like an orchestra; each section perfectly balanced and working harmoniously together. When a person has psoriasis, it is like one violinist in the orchestra playing out of tune. It dominates the sound and rhythm. IL-17A is like a maverick violinist”.
 
Apremilast
 
Apremilast is a recently licenced oral drug for psoriasis and psoriatic arthritis, which inhibits the phosphodiesterase enzyme, which in turn has affects on regulating pro and anti-inflammatory cytokines and proteins such and TNF and IL-17. In randomised control studies, Apremilast has shown improvement in psoriasis skin and arthritis disease activity assessments.
 
Ixekizumab
 
Another new anti-IL-17 drug, ixekizumab a cloned antibody, has been approved for treating adult patients with moderate to severe plaque psoriasis (covering 10% or more of the body) who are candidates for phototherapy or medications that are absorbed into the blood stream (systemic therapy). Ixekizumab has been shown to clear symptoms in 80% of people. Research published in the New England Journal of Medicine in 2016, suggests that Ixekizumab neutralises the inflammatory effects of an interleukin, a protein in the skin that carries signals to cells.
 
To test the drug's efficacy over time, three studies enrolled 3,736 adult patients at more than 100 study sites across 21 countries. Researchers assessed whether the drug reduced the severity of the symptoms of psoriasis compared to a placebo, and evaluated its safety by monitoring any side effects. By 12 weeks, 76 to 82% of people in the study had their condition classified as 'clear' or 'minimal'; compared to 3.2% of patients in the placebo. By 60 weeks, 69 to 78% showed their improved condition had been maintained. Kenneth Gordon, professor of dermatology at Northwestern University, and the first author of the study, said: 'Based on these findings, we expect that 80% of patients will have an extremely high response rate to ixekizumab, and about 40% will be completely cleared of psoriasis.”
 
Takeaway 

None of these new drugs represent a magic bullet, but they do appear to provide significant relief for a substantial percentage of sufferers of psoriasis and psoriatic arthritis.
 
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5 years, 3 months ago

A new comprehensive gene-based breast cancer prediction device

HealthPad
Directory:
Cancer
Tags:
BRCA genes
breast cancer
cancer genetics
cancer prediction
commentary
genome sequencing
mammography
  • CanRisk is a new online gene-based health-risk evaluation algorithm for detecting breast cancer
  • It identifies people with different levels of risk of breast cancer, not just those at high risk
  • As the infotech and biotech revolutions merge expect authority in medicine to be transferred to algorithms
  • CanRisk has the potential to provide a cheap, rapid, non-invasive, highly sensitive and accurate diagnosis before symptoms present
  • Breast cancer is the most common cancer in women worldwide and is the 5th most common cause of death from cancer in women
  • Currently mammography screening, which has a sensitivity between 72% and 87%, is the gold standard for preventing and controlling breast cancer
  • For every death from breast cancer that is prevented by screening, it is estimated there will be three false-positive cases that are detected and treated unnecessarily
  • Lack of resources do not support breast cancer screening in many regions of the world where the incidence rates of the disease are rapidly increasing
  • In the near-term expect interest in the CanRisk algorithm to increase
 
 A new comprehensive gene-based breast cancer prediction device

 
A new online gene-based health-risk evaluation device called CanRisk has the potential to identify women with different levels of risk of breast cancer; not just women who are at high risk. Predicated on a comprehensive algorithm, CanRisk is one of several innovations currently in development, which include novel methods for predicting the recurrence of breast cancer, a new class of molecules that aim to halt or destroy breast cancer, and liquid biopsies, which determine the presence and recurrent risk of the disease through the detection of tumour cells in peoples’ blood.
 
Although over the past two decades there have been significant improvements in the detection and treatment of breast cancer, the disease remains the most common cancer in women worldwide, with some 1.7m new cases diagnosed each year, which account for about 25% of all cancers in women and it is the fifth most common cause of death from cancer in women, with over 0.52m deaths each year.
 
Game changer for breast cancer
 
Findings of CanRisk were reported in the January 2019 edition of Genetics in Medicine. Findings of a less comprehensive version of the device’s algorithm were published in the July 2016 edition of the same journal. Commenting on the 2019 study, Antonis Antoniou, Professor of Cancer Risk Prediction at the University of Cambridge and lead author of the two studies said: "This is the first time that anyone has combined so many elements into one breast cancer prediction tool. It could be a game changer for breast cancer and help doctors to tailor the care they provide depending on their patients' level of risk”.
 
When fully developed and approved, CanRisk will be well positioned to provide a cheap, rapid, non-invasive, highly sensitive and accurate diagnostic test to detect breast cancer early in people with diverse levels of risk. This might be expected to provide an alternative to the current gold standard population-based mammography screening and assist in making a significant dent in the vast and escalating global burden of the disease.
 
In this Commentary
 
This Commentary describes the algorithm that drives CanRisk, which benefits from the increasing availability of vast and growing amounts of genomic and other personal data and significant advances in genomic sequencing technologies. The confluence of these two phenomena facilitates and enhances the quality and speed of data analysis and drives the development of new and innovative diagnostic and prognostic cancer technologies. The fact that CanRisk is based on UK data and its algorithm is available to researchers globally, presents a potential  opportunity for medical research organizations in emerging regions of the world where the burden of breast cancer is increasing. The Commentary briefly describes the heterogeneous nature of breast cancer and highlights some of its complexities and risk factors. Originally perceived as a Western disease, breast cancer is growing rapidly in Asia and other regions of the world where it tends to be detected late and managed less effectively. Developed economies prevent and manage breast cancer through well-established population-based mammography screening programs. Because of  the lack of resources,  such screening programs are not widely available in low to middle income countries (LMIC). As the infotech and biotech revolutions merge expect authority in medicine to be transferred to Big Data algorithms such as CanRisk. This not only could provide an alternative to gold standard mammography screening, but also provide a cheap and effective device for use in developing nations where the burden of breast cancer is significant and increasing.
 
CanRisk: a world first
 
CanRisk, developed by members of the Centre for Cancer Genetic Epidemiology at the University of Cambridge, UK, takes advantage of discoveries in both cancer genomics and epidemiology and aims to become a popular device used by primary care physicians, in consultation with their patients, to effectively assess patients’ diverse levels of risk of developing breast cancer. The device is predicated on an algorithm called BOADICEA (the Breast and Ovarian Analysis of Disease Incidence and Carrier Estimation Algorithm). This is the world’s first polygenic breast cancer risk model and the only one to-date, which is available to the international research community. Also, it is the first breast cancer risk model to incorporate pathology data and population-specific cancer incidences in risk calculations. The algorithm accounts for over 300 genetic risk factors, including BRCA1, [BReast CAncer gene] BRCA2, PALB2, CHEK2, and ATM, which are genes that have been found to impact a person’s chances of developing breast cancer. The device uses a Polygenic Risk Score (PRS) based on 313 single-nucleotide polymorphisms (SNPs), [SNPs, pronounced ‘snips’, are the most common types of genetic variation in people. Each SNP represents a difference in a single DNA building block and is called a nucleotide] which explains 20% of breast cancer polygenic variance. CanRisk also includes a residual polygenic component, which accounts for other genetic/familial effects; known lifestyle/hormonal/reproductive risk factors and mammographic density [Dense breast tissue can make it harder to evaluate mammographic results and may also be associated with an increased risk of breast cancer].

 

Authority increasingly being transferred to algorithms
 
Over the past two decades we have increasingly learnt to accept the authority of Big Data algorithms. For example, without question we expect algorithms to give us directions, tell us what movies to watch, who to date, what clothes to wear, where to go on holiday, what flight to take, what hotel to stay in and where to eat. We are  comfortable with algorithms assigning us our credit rating, limiting our overdraft and capping our payments. Furthermore, we are beginning to accept the authority of algorithms in medicine. For example, we are gradually replacing the authority of primary care doctors with algorithms that can diagnose common diseases more accurately and more cost effectively.


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China’s rising MedTech industry and the dilemma facing Western companies
In December 2018, for the first time in history, the US FDA approved an algorithm to diagnose patients without a doctor’s interpretation. The algorithm, called IDx-DR, detects diabetic retinopathy by analysing images of the back of the eye. Indeed, we are living on the cusp of history when the twin revolutions of information technology and biotechnology are merging and providing the basis for us to transfer authority in medicine to algorithms. In the next two decades, it seems reasonable to assume that it will become common practice to accept the authority of algorithms such as CanRisk, which will inform us that we are suffering from a medical condition long before we present any signs or symptoms.
 
Increasing supply of data
 
CanRisk takes advantage of the fact that genetic and other risk factor data are becoming more easily available in clinical practice through electronic health records, biometric sensors that convert biological processes into electronic information, which computers can store and analyse, cost-effective high speed, high capacity genomic sequencing technologies, and efforts such as the 100,000 Genomes Project. A UK Government sponsored initiative completed in December 2018, which collected, stored and analysed data from the genomes and medical records of 85,000 NHS England patients affected by cancer or rare disease. Genomics England, which is wholly owned by the UK’s Department of Health, was set up in 2003 to deliver the project. Because CanRisk solely is based on UK population data, its findings are likely to be more applicable to similarly developed Western populations, and less so to populations in other regions of the world. This provides a potential opportunity for international organizations interested in early breast cancer diagnosis. 
 
International sequencing projects
 
The UK’s genomes project is part of a much larger rapidly growing and dynamic global genomics market comprised of data and gene sequencing technologies. 100,000 genomes have been the goal of several other nations interested in improving their healthcare - and lowering costs  - by carrying out precision medicine based on insights from sequencing data. Currently the global genomics market is estimated to be about US$19bn and projected to reach US$41bn by 2025. The market is driven by increasing government funding, the consequent rise  in the number of genomics projects, decreasing gene sequencing costs, growing application areas of genomics and the entry and fast growth of commercial players.

China has become the world’s leader in genomic sequencing. In 2010, the Beijing Genomics Institute (BGI) in Shenzhen was understood to be hosting a higher sequencing capacity than that of the entire US. While most government projects aim to sequence 100,000 genomes, China’s sequencing program is set to sequence 1m human genomes, which include subgroups of 50,000 people, each with specific conditions such as cancer or metabolic disease. The data will also include cohorts from different regions of China, which will facilitate “the analysis of different genetic backgrounds of subpopulations”.
 
Revolution in genome sequencing
 
The first human genome project began in 1990, took 13 years and about US$1bn to complete. The last two decades have seen a revolution in genome sequencing with dramatic increases in its speed and efficiency coupled with massive reductions in cost. Genomic sequencing has proved its usefulness as a diagnostic and prognostic tool. Today it is possible to get your genome sequenced for around US$1,000 in a few days and delivered by  post from firms such as Dante Labs and 24 Genetics in Europe, and Veritas Genetics and Sure Genomics in the US.
 
Breast cancer
 
Returning to breast cancer. It is important to note that the disease is not one, but  a group of conditions that manifest themselves with maladies in the same organ. Breasts are comprised of three main parts: lobules, which produce milk; ducts, which carry milk to the nipples; and fibrous and fatty connective tissue, which hold everything together. The type of breast cancer depends on which cells in the breast mutate, but most breast cancers begin in the ducts or lobules. Some mutated cells in the breast may never spread, however, most breast cancers tend to be invasive and may present with a number of different characteristics in terms of hardness and shape, which can provide some indication of their likely progression. Breast cancer can spread outside the breast through blood and lymph vessels. Further, there are significant differences in breast cancer at the genetic level. A study published in the April 2012 edition of Nature compared the genetic makeup of breast cancer tumour samples with their other characteristics for some 2,000 women, for whom information about the tumour characteristics had been meticulously recorded; and identified at least 10 distinct sub-types of breast cancer, each with its own unique characteristics. Although the study contributed to how breast cancer is diagnosed, classified and treated, in practice certain characteristics of these tumours were already known and tested for: most notably cellular receptors for estrogen, and progesterone, which are the two most significant steroid hormones responsible for various female characteristics. Their presence or absence generally suggests the potential utility of additional medication to accompany surgery, radiotherapy and chemotherapy.
 
Despite population screening and advanced therapies breast cancer remains a killer disease
 
Let us briefly consider breast cancer in the world’s most advanced and wealthiest nation: the US. Although there have been significant improvements in the detection and treatment of breast cancer in the US; still about 1 in 8 American women will develop an invasive type of the disease over the course of her lifetime. In 2019, an estimated 268,600 new cases of invasive breast cancer are expected to be diagnosed in the US, along with 62,930 new cases of non-invasive (in situ) breast cancer. Breast cancer death rates for women in the US are higher than those for any other cancer, besides lung cancer. As of January 2019, there were more than 3.1m women with a history of breast cancer in the US. Although breast cancer death rates in the US have been decreasing over the past three decades and women under 50 have experienced larger decreases, still some 41,760 are expected to die in 2019 from the disease. About 2,670 new cases of invasive breast cancer are expected to be diagnosed in men in the US in 2019 where a man’s lifetime risk of breast cancer is about 1 in 883.
 
Breast cancer challenges in Singapore
 
There are also breast cancer challenges in wealthy non-Western developed economies such as Singapore. Over the past four decades, the incidence of breast cancer in Singapore has more than doubled: from 25 to 65 per 100,000 women. Breast cancer is not just the most common cancer for Singaporean women, accounting for one in three cancers in women, but it is also the top killer. Data reported in the country’s Cancer Registry showed that 2,105 women died of the disease between 2011 and 2015. Notwithstanding, Singapore has extensive awareness-raising programs; population-wide mammography screening; excellent, multi-disciplinary primary and long-term care and improving palliative care, which have contributed to a significant increase in the survival rates of breast cancer patients. However, a substantial proportion of Singaporean women still appear to have a patchy knowledge of aspects of the disease, which leads to comparatively low participation rates in the nation’s breast cancer screening services, and this contributes to late presentation of the disease when it is more difficult to cure and more challenging to treat.

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Breast cancer growing rapidly in Asia
 
Breast cancer was once largely confined to developed Western countries and Australasia, but it has now become the most common cancer in Asia. Although Asian data on breast cancer are patchy, an Economist Intelligence Unit report, suggests that, “since the 1990s, increases in the incidence of breast cancer in Asia, as measured by age-standardised rates (ASRs), is four to eight times that of the global average”. Indeed, as younger cohorts of Asian women age and adopt Western diets and lifestyles (particularly fertility patterns, such as later first childbirth and shorter breast feeding), breast cancer incidence rates in Asia look set to converge with the much higher ones in the West. Further, in LMIC breast cancer is increasing at a more rapid rate than in the West and has become a significant healthcare challenge: 50% of breast cancer cases and 58% of deaths from the disease occur in LMIC.
 The significance of early detection
 
The good news is that if caught in its early stages, breast cancer can be treated effectively, with high survival rates. The average 5-year survival rate for women with invasive breast cancer is 90%. The average 10-year survival rate is 83%. If the cancer is located only in the breast, the 5-year survival rate of women with breast cancer is 99%. In all types of the disease early detection is the cornerstone of breast cancer control.
 
 Gold standard breast cancer mammography screening
 
The current gold standard for preventing and controlling breast cancer is population-based mammography screening. This is a non-invasive process that uses an x-ray of the breast to look for disease in women who do not have symptoms. The method has reasonable sensitivity (72%–87%) that increases with age and allows for the early detection of breast cancer, which helps increase survival, especially in women between 50 and 70. Notwithstanding, mammograms are not pleasant as the breast is squashed between two metal plates and further some women may find mammograms embarrassing.
 
Success of population-based mammography screening
 
Following a landmark Swedish study that began in 1977 mammography screening has been adopted in more than 26 developed countries worldwide. Findings of the study, reported in a 1989 edition of the Journal of Epidemiology and Community Health, suggested that mortality from breast cancer dropped 31% after screening of women aged 39 to 74. More recent findings of the UK screening program published in the June 2013 edition of the British Journal of Cancer, suggested mortality rates from breast cancer were reduced by 20% in the screened group compared to the unscreened group across all age groups. A study published in 2018 in Cancer, which tracked 52,438 Swedish women aged 40-69 from 1977 to 2015, suggested that regular mammograms contributed to a 60% decrease in breast cancer death during the first 10-years of diagnosis, and a 47% reduced risk within 20-years. Research has shown that mammography has relatively little benefit for women under 50.
 
Diverging views about mammography screening
 
Despite evidence to support the benefits of population-based mammography screening, there are diverging views among healthcare professionals about the impact of several decades of high levels of screening. Some argue that traditional mammography screening stretches finite resources and is not cost-effective because the majority of people who undergo screening do not have cancer and may never go on to develop it. Others suggest that there are significant uncertainties about the magnitude of the harms from mammography screening especially associated with false positives (a test result, which wrongly indicates that breast cancer is present).

Challenges of mammography screening
 
The sensitivity of mammography is between 72% and 87%, but is higher in women over 50 and in women with fatty rather than dense breasts. Dense breast tissue can make it harder to evaluate results of a mammogram. According to the Marmot review, for every death from breast cancer that is prevented by screening, it is estimated there will be three over-diagnosed or false-positive cases that are detected and treated unnecessarily. The chance of having a false positive result after one mammogram ranges from 7% to 12%, depending on age (younger women are more likely to have false positive results). After 10 yearly mammograms, the chance of having a false positive is about 50-60%. The more mammograms a woman has, the more likely it is she will have a false positive result. This makes it difficult for doctors to weigh and communicate the benefits and risks of mammography screening programs and fuels interest in innovations such as CanRisk.
 
Takeaways
 
Mammography screening for breast cancer is not 100% accurate. Further, knowhow, trained healthcare professionals and significant resources are required to effectively implement and manage a well-organized and sustainable breast cancer screening program that targets the right population group and ensures effective coordination and quality of actions across the whole continuum of care. These attributes tend to exist only in developed wealthy countries. CanRisk, and other innovative breast cancer early diagnostic devices under development, offer the potential for cheap, rapid, reliable and exquisitely accurate diagnosis that can be easily used in primary care settings throughout the world. In time, as authority in medicine passes to algorithms, expect these new and innovative devices to replace mammography screening in wealthy countries and quickly become devices of choice in developing economies and significantly dent the vast and rapidly growing global burden of breast cancer.
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2 years, 6 months ago

Should MedTechs follow surgeons or patients?

HealthPad
Directory:
Medical Technology
Tags:
Artificial Intelligence
commentary
medical devices
patient groups
  • The traditional strategy of the medical devices industry has been to maximise the experience of the surgeon
  • This has resulted in paying little attention to the demands of patients
  • Surgeon populations are shrinking while the general population is growing, aging, becoming ill and demanding care
  • This creates care gaps, which are challenging to reconcile, prolong unnecessary suffering and cause unnecessary deaths
  • Reconciling the shrinking supply of health professionals with the increasing healthcare demands has given more weight to patient demands
  • MedTechs will be obliged to recalibrate their approach to patients principally because regulators are involving them in the approval process of medical devices
  • Patient centric digital therapeutic solutions help to reduce care gaps
  • However, developing such digital therapeutics and involving patients will not come easy to traditional MedTechs because of their lack of capabilities and organizational culture
  • Notwithstanding, to be relevant in the future, MedTechs will need to continue to improve their ties with surgeons while increasing their focus on the large and rapidly growing patient demands
 
Should MedTechs follow surgeons or patients?
 
 
Traditional MedTech business models are overwhelmingly focussed on manufacturing physical devices for surgeons to use in episodic, hospital-based, interventions. Over decades, a symbiotic relationship between surgeons and medical device manufactures has been established and led to significant commercial success for both parties. This has meant that MedTechs have not paid the attention they should have to the growing demands of patients, which include primary prevention and screening through diagnosis and staging to treatment, rehabilitation, and the subsequent management of a condition. Should medical device companies double-down on their business models to follow surgeons, or should they change approach and follow patients?
 
In this Commentary

This Commentary has 2 sections: (i) Follow surgeons, and (ii) Follow patients. Section1 suggests that medical device companies will need to continue their mutually beneficial relationships with physicians but tighten their governance ties. Further, leaders might consider some aspects of surgeon populations, which could impact their business model. These include: (i) the increasing shortages and aging of surgical populations, (ii) burnout among surgeons that prompts early retirement, and (iii) the prevalence of unnecessary surgeries. Section 2 considers the business model of MedTechs following patients and suggests that this is likely to become more relevant in the future as regulators are encouraging patient participation in the approval process for medical devices. Further, patient demands are supported by advancing technologies and smart platforms such as PatientsLikeMe. Patient centric solutions tend to be digital therapeutics, based on software rather than hardware. Solutions that address patient care pathways require scarce digital, data management and artificial intelligence (AI) capabilities, which MedTechs tend not to have. To stand a chance of attracting these, MedTechs will need to develop non-hierarchical, agile working cultures with the capacity to innovate at speed. The significance of business models that improve patients’ care pathways is illustrated by two recent, transformative MedTech deals. Takeaways suggest MedTechs should continue following surgeons, albeit under enhanced governance principles and involve patients in the development of devices and increase their capabilities to provide patient centric digital solutions.
 
 
SECTION 1
Follow surgeons
 
The medical devices industry is “big business”. In 2021, the US devoted ~US$199bn (~5.2%) of annual national health expenditures to medical devices. Over the past four decades mutually beneficial relationships between surgeons and medical device companies have been built, and this forms the basis of a dominant industry business model to “follow surgeons”.
 
Surgeons play a crucial role in the conceptualization, development, and enhancement of medical devices; they influence hospital purchasing decisions, and are compensated for providing these services. Further, they are remunerated for representing MedTechs at conferences, giving speeches on behalf of corporations, and playing a critical role in training physicians to use devices because their efficacy is often associated with a specific use technique that needs to be taught. Further, surgeons may receive research grants from MedTechs and be promoted because of their association with a successful innovation. More recently, with the rise of medical device start-ups, the financial incentives to surgeons have included equity stakes in lieu of cash for various contributions. This means that significant financial ties between medical device companies and surgeons are relatively common, which can be the basis for potential conflicts of interest.
 
MedTechs code of conduct

AdvaMed, a US medical device trade association, based in Washington, DC, is aware of such conflicts and suggests that physicians should be compensated at fair market rates for work they perform. The Association is against equity compensation and says that there should be no link between the commercial success of a medical device and a physician. AdvaMed encourages voluntary, ethical interactions and advises member organizations and physicians to disclose all potential conflicts of interest, which include consulting arrangements, training, support of third-party educational conferences, participation in sales and promotional meetings, gifts, grants, and charitable donations.
 
Despite AdvaMed’s best efforts its suggested code of conduct does not appear to work. A bibliometric analysis of 100 clinicians receiving compensation from 10 large MedTechs and published in the November 2018 edition of JAMA Surgery found that conflicts of interest were not declared in 63% of 225 research projects that resulted in publications. Given the increasing significance of environmental, social, and governance (ESG) criteria among socially conscious investors to screen potential investments, it seems reasonable to suggest that MedTechs might consider regularly disclosing all their financial ties with surgeons and health professionals.
More issues to consider

In addition to the increasing significance of ESG issues, there are some further questions associated with MedTech business models that follow surgeons, which corporate leaders might wish to reflect upon. These include: (i) the surgeon population is aging and shrinking, (ii) surgeons have a higher propensity to burnout than other medical specialities, and (iii) surgeons are responsible for a substantial number of unnecessary operations. Let us describe these in a little more detail.
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Shrinking surgeon populations

Throughout the world, populations of surgeons and health professionals are shrinking. Findings of a 2016 US Department of Health and Human Services report suggest that by 2025, there will be shortages in 9 out of 10 surgical specialties in America, with the greatest reduction in ophthalmology, orthopaedics, urology, and general surgery. Research prepared for the Association of American Medical Colleges (AAMC) by the healthcare consulting firm IHS Markit and published in June 2020, suggests that, by 2032, the US could lack ~23,000 surgeons. Although the US has a higher number of total hospital employees than most countries, nearly half of that workforce is comprised of non-clinical staff who are not directly involved in delivering care. For instance, compared to Italy and Spain, America has fewer practicing physicians per capita: 2.6 per 1,000 inhabitants, compared to 4 in Italy and 3.9 in Spain. According to the World Health Organization (WHO), the global shortage of health workers is projected to reach 13m by 2033.
 
Care gaps

One reason for this projected shrinkage is that a large percentage of surgeons are nearing traditional retirement age. For instance, more than 2 in 5 currently active American doctors will be ≥65 years within the next decade. Further, people are living longer, and a substantial percentage are not staying healthy and need care. According to the US Census Bureau the number of Americans ≥65 is expected to reach ~84m by 2050, which is ~2X the 2012 level of 43m. Among this older population there is a large and growing prevalence of chronic lifetime diseases such as cancer, diabetes, heart conditions, respiratory diseases, and mental illness. In the US there are ~150m people with such conditions and ~40% of these are living with ≥2 chronic diseases. According to the US Centers for Disease Control and Prevention, ~90% of the US$4.1trn annual medical spend (~20% of the country's GDP) is attributable to chronic disorders. Such trends magnify the vast and growing pressure on a shrinking pool of health professionals, and this creates challenging care gaps.
 
Digital therapeutics

Care gaps will not be reduced by medical schools training more physicians and nurses. This takes too long to have an impact on the size of the problem. The UK has attempted to reduce care gaps by importing physicians: ~190,000 of the 1.35m NHS staff in England report a non-British nationality, and ~27% of NHS staff in London report a nationality other than British. This policy raises some ethical issues as most are imported from developing economies with underdeveloped healthcare systems and a scarcity of health professionals. The option to import physicians is not open to the US because its immigration policies make it difficult for international health professionals to work in America. Recently, many advanced industrial economies have sought to reduce their care gaps by developing digital therapeutic solutions for patients, which extend the reach of physicians by overcoming time, place and personal constraints that limit care delivery.
 
Surgeon burnout

Findings of a research study published in the June 2018 edition of the Journal of the American College of Surgeons suggest that the prevalence of burnout among surgeons has increased over time. The research references the 2015 Medscape Physician Lifestyle Report, which argues that burnout among surgeons is on the rise and documents burnout rates among various specialisms ranging ~37% to ~53%, with general surgeons nearing the top of the list at 50%. Research on the impact of the COVID-19 crisis on healthcare professionals published in the December 2021 edition of the Mayo Clinic Proceedings, found that ~1 in 3 US physicians expressed a clear intention to reduce their work hours, and ~1 in 4 intended to leave their practice altogether. Such trends are concerning considering the aging of the US population and the subsequent increased pressure this puts on healthcare systems.
 
Many factors contribute to surgeon burnout. Common causes among American surgeons include long work hours, delayed gratification, challenges with work-home balance, and issues associated with patient care in a changing healthcare ecosystem. According to the WHO’s International Classification of Diseases, (ICD-11) burnout results from “chronic workplace stress that has not been successfully managed”. It is characterised by being emotionally exhausted, feelings of cynicism and loss of empathy and a sense of low personal accomplishment with respect to one’s work. A meta-analysis of the prevalence of burnout published in the March 2019 edition of the International Journal of Environmental Research and Public Health  suggests that surgeons experience elevated rates of depression and psychiatric distress and posits that burnout among junior surgeons is at an epidemic level, which affects patient safety, quality of care and patient satisfaction.
 
Unnecessary surgeries

Another issue for medical device leaders to consider is the incidence rates of unnecessary surgeries. These are any intervention, which is not needed, not indicated, or not in the patient’s best interest when weighed against other available options.  Unnecessary surgeries are not a recent phenomenon: they are a significant reality that continue to expose patients to unjustified surgical risks. In 1976, the American Medical Association (AMA) called for a congressional hearing to address the issue, claiming that each year there are “2.4m unnecessary operations performed on Americans at a cost of US$3.9bn and that 11,900 patients had died from unneeded operations”.  Across the US, the phenomenon is patchy. A cross-sectional study of five US metropolitan areas and published in the January 2022 edition of the Journal of the American Medical Association found significant differences in physician treatment recommendations across a range of specialisms.

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If spine surgery fails to relieve low back pain why is it increasing?
Most common unnecessary surgeries

The incidence rates of unnecessary surgeries appear more prevalent in spinal, gynaecological and some orthopaedic procedures. Clinical trials have shown that a significant percentage of spinal fusions for back pain do not lead to improved long-term patient outcomes when compared to non-operative treatment modalities, including physical therapy and core strengthening exercises. Despite these findings, spinal fusion rates continue to increase significantly in the US.
Further, women are at high risk of unnecessary hysterectomies and caesarean sections. Although these rates are moderating, a study for the American College of Obstetricians and Gynecologists, suggested that hysterectomies were improperly recommended in ~70% of cases, even though there were non-surgical alternatives. Hysterectomies can lead to bladder and bowel dysfunction, prolapse, and incontinence,  as well as a 4-fold increased risk of pelvic organ fistula surgery. A study in Health Affairs found that caesarean rates varied significantly (from 2.4% to 36.5%) in hospitals across the US, even among those with low-risk pregnancies.
 
Another study published in Health Affairs suggests that after patients received information on alternatives to joint replacement surgeries, ~26% had fewer hip replacements and ~38% had fewer knee replacements. Each year in the US, >1m total hip and total knee replacement procedures are performed.
 
 
SECTION 2
Follow patients
 
It is not uncommon for MedTech leaders to say that they put “patients first” when developing devices. However, although things are changing, which we describe below, this is more rhetorical that factual. MedTech R&D teams tend to be relatively remote, inwardly focussed, and, particularly in the US, patient voices are generally ignored and not perceived as an integral part of the process.
 
However, the healthcare ecosystem is changing and “following surgeons” cannot constitute an entire strategy for MedTechs. In the future, MedTech business models that follow patients will be driven by patients’ knowledge and their increasing demands to participate in their healthcare decisions, the movement towards personalized care, and regulators’ mandates to incorporate patient perspectives into the development of medical devices and approval processes (see below). Earlier, we suggested that, when surgeons engage with medical device corporations there are competing interests, which often are not disclosed. By contrast, patients are primarily driven by their own safety and wellbeing, which, contrary to surgeons, are grounds for promoting mutual accountability and understanding with healthcare providers.
 
To remain relevant, MedTechs will need to incorporate patient perspectives and patient data into their business models, not least because patients are co-producers of their health and represent a consistent factor, probably the only consistent factor, throughout the care pathway. Further, patients, empowered by digital therapeutics and health information from wearables, hold invaluable personal data, which are often critical to improving care pathways, and outcomes.
 
PatientsLikeMe
 
Patient voices were loud and influential long before MedTechs recognised the significance of engaging patients in development processes. Consider PatientsLikeMe, a digital platform founded in 2004, with a mission to improve the lives of patients by sharing knowledge, experiences, and outcomes. The company quickly grew to become the world’s largest integrated community, health management, and real-world data platform. Via the site, users can document and share their experiences, track their conditions, and communicate with others living with similar disease states. Data generated by patients who use the site are systemically collected and quantified by the company, while providing users with an environment for peer support and learning. Today, PatientsLikeMe has >0.8bn users representing >2,900 conditions. The company makes money by selling the information patients share in de-identified, aggregated, and individual formats. In 2019, the platform was acquired by the UnitedHealth Group, an American multinational healthcare and insurance company, after former President Trump’s administration forced it to seek a buyer because its majority owner was China-based iCarbonX.
 
Increasing patient input in approval processes for medical devices

What will make MedTechs wake up to the significance of patient perspectives in the development of medical devices are initiatives and demands made by regulators. For the past decade, European regulators through the European Medicine’s Agency (EMA). have solicited patient inputs into their approval process for medical devices. In 2014, the FDA and the EMA created a joint working group to share knowledge and information on patient engagements. In 2007, the Clinical Trials Transformation Initiative (CTTI), a public-private partnership was co-founded by the US Food and Drug Administration (FDA) and Duke University and modelled on the EMA Patients’ and Consumers’ Working Party. CTTI’s mission is to develop and drive patient involvement in the development and approval of devices, which is expected to increase the quality and efficiency of clinical trials. Since its foundation, the CTTI has become a leader in evolving and advancing clinical trials, making them more efficient, and patient focused.
 
In December 2017, a nationwide request in the US was made for patients and patient advocate groups to join the CTTI and become more involved in healthcare product development and in the FDA product reviews. This call came ~1 year after the 21st Century Cures Act became law in December 2016. The Act’s intention is to expedite the process by which new medical devices and drugs are approved by easing the requirements put on companies seeking FDA approval for new products and indications. Under Section 3001 of the Act, the FDA is required to report any patient experience data that were used to support an approval process and to publicly provide aggregate reports on agency use of those data at five-year intervals. This suggests that MedTechs wanting new FDA approvals will need to provide patient-driven data.
 
These initiatives are driven by an ever-improving consumer-controlled social and health data ecosystem, advancements in personal genetic understanding, and increased healthcare cost-sharing. Patient-driven changes are systematically beginning to inject more than token patient participation and viewpoints into all stages of device and drug development.
 
A cultural shift

Improving patient engagement in the development process of medical devices will be challenging for MedTechs that have focussed their business models mainly on manufacturing physical devices and building relationships with surgeons, rather than developing digital assets for patients. The latter requires scarce data management and AI capabilities, which do not thrive in conservative hierarchical organizations. Rather, they require a culture, which promotes innovation at speed and agile ways of working. A recent survey of European executives by The Economist Intelligence Unit, found that poor collaboration between a company’s IT function and its business units slows progress in a firms’ digital objectives. MedTechs that are slow to develop digital capabilities that address patient needs and integrate these into their business models risk not being a party to decisions shaping the emerging healthcare ecosystem.
 
The increasing significance of scarce AI talent

Digital therapeutics predicated upon AI techniques, which are growing in significance with healthcare systems, require large amounts of data collected from electronic health records (EHR), medical images, and information from patients’ wearables. Key areas where AI techniques can improve the delivery of care include: (i) diagnoses, (ii) managing patient journeys, and (iii) improving patient engagement. Streamlining these three areas can ease administrative burdens on healthcare systems, optimize physicians’ time, improve patient outcomes, and lower costs. However, a significant challenge for MedTechs is the scarcity of essential capabilities to develop digital strategies. A 2020 research report by Deloitte Insights suggested that there are significant shortages of “AI developers and engineers, AI researchers, and data scientists”. Corporate leaders might consider bolstering their chances of attracting digital and AI talent by: (i) leveraging their company’s unique value and purpose, (ii) prioritizing and offering best-in-class training over recruiting, (ii) prioritizing diversity, and (iv) engaging with universities.
 
Transformative MedTech deals
 
The significant shift in MedTech strategies towards patients is demonstrated by two recent transformative deals: Teledoc’s 2020 acquisition of Livongo and Siemens Healthineers AG’s 2021 acquisition of Varian Medical Systems Inc. Both combinations emphasise the significance of digitalization and demonstrate the strategic shift towards patients. 
 
The US telehealth giant Teledoc’s acquisition of Livongo for US$18.5bn was the largest digital healthcare deal in history, which valued the combined company at US$38bn. Livongo, founded in 2014, provides digital therapeutic solutions to improve patient health outcomes for a range of chronic conditions including diabetes, and hypertension. The other transformative MedTech digitalization deal was the German health imaging giant Siemens Healthineers AG’s acquisition of cancer device and software specialist Varian in April 2021 for US$16.4bn. Siemens Healthineers is the leading supplier of medical imaging solutions used to support the planning and delivery of radiotherapy. Varian was the leading supplier of radiotherapy solutions. Both deals were substantially larger than Amazon’s US$0.75bn 2019 acquisition of PillPack, and Google’s US$2.1bn 2021 acquisition of Fitbit, and they signal a new and permanent path for MedTech companies towards a digital-first future.
 
Takeaways

To remain relevant MedTechs will need to continue their symbiotic relationships with surgeons albeit in a modified form, while becoming significantly more patient centric and digitally savvy. However, a bigger challenge Western MedTechs will have to face in the next five years is whether they can develop digital therapeutic solutions for patients fast enough to compete with the looming threat from China’s large and rapidly growing capacity to develop and market medical robotics for surgeons and innovative digital therapeutics for patients. This will be the subject of a forthcoming Commentary.
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1 year, 1 month ago

Healthcare 2040

HealthPad
Directory:
Medical Technology
Tags:
AI
commentary
genomics
Internet of Things
Machine Learning
Medical Technology
robotics
telemedicine
  • Since 2000 healthcare has been transformed by genomics, AI, the internet, robotics, and data-driven solutions
  • Traditional providers, anchored in outdated technologies, struggle to keep pace with the evolving healthcare landscape
  • Over the next two decades anticipate another seismic shift, bringing further disruptions to medical technology and healthcare delivery
  • In the face of this imminent transformation, risk-averse leaders may cling to outdated portfolios, showing little interest in adapting to a 2040 healthcare ecosystem
  • Providers must decide; embrace change now and thrive in a transformed healthcare landscape, or stick to the status quo and risk losing value and competitiveness
 
Healthcare 2040
 
Abstract

By 2040, the landscape of healthcare will have undergone a seismic shift, discarding antiquated models in favour of cutting-edge AI-genomic-data-driven approaches that will radically change both medical technology and healthcare delivery. This transformation signifies a departure from the conventional one-size-fits-all system, ushering in an era of targeted therapies grounded in molecular-level insights that challenge entrenched healthcare paradigms. The evolving healthcare narrative emphasises prevention, wellbeing, personalised care, and heightened accessibility. This departure from the norm is not a trend but a significant reconfiguration, where the fusion of biomedical science, technology, and expansive datasets merge to facilitate early detection and proactive interventions. This not only deepens our comprehension of diseases but also elevates the efficacy of therapies. At the core of this transformation is the empowerment of individuals within a framework that champions choice and fosters virtual communities. Genetic advancements, far from just addressing hereditary conditions, play an important role in enhancing diagnostic accuracy, optimising patient outcomes, and fundamentally shifting the focus from reactive diagnosis and treatment to a proactive commitment to prevention and holistic wellbeing. The indispensable roles played by genomics and AI-driven care in reshaping healthcare are not isolated occurrences; they will catalyse the emergence of new data-intensive R&D enterprises, which are poised to redefine the healthcare landscape against a backdrop of multifaceted influencing factors. Successfully navigating this transformative period necessitates a distinct set of capabilities and strategic alignment with an envisioned 2040 healthcare environment.

Providers find themselves at a crossroads, confronted with a choice: adapt and thrive or risk losing value and competitiveness in a rapidly evolving landscape. Recognising potential resistance to change and the scarcity of pertinent capabilities, leaders of traditional enterprises must acknowledge that immediate strategic action is not just beneficial but a prerequisite for success in the redefined healthcare ecosystem of 2040. The urgency of this call to action cannot be overstated, as the window of opportunity for adaptation narrows with each passing moment.
 
In this Commentary

This Commentary aims to help healthcare professionals to strategically reposition their organizations for success in the next two decades. Leaders must evaluate their strengths and weaknesses in the context of an envisioned future and implement strategies to align their organisations with the demands of a rapidly changing health ecosystem. Failure to do so will dent enterprises’ competitiveness and threaten their survival. Leaders should anticipate and address resistance to change among executives with a preference for the status quo. The Commentary has two sections: Part 1, Looking Back 20 Years, describes the scale and pace of change since 2000 and emphasises how genomics, the internet, AI, digitalization, data-driven solutions, robotics, telehealth, outpatient services, personalised care, ubiquitous communications, and strategic responses to demographic shifts have transformed medical technology and healthcare delivery. Part 2, Looking Forward 20 Years, seeks to stimulate discussions about the future of healthcare. While we highlight a range of factors positioned to impact medical technology and healthcare deliver in the future, we emphasise the significance of genomics, varied and vast datasets, and AI. We suggest the emergence of specialised agile, AI-driven research boutiques with capabilities to leverage untapped genomic, personal, and medical data. The proliferation of such entities will oblige traditional healthcare enterprises to reduce their R&D activities and concentrate on manufacturing. Over the next 20 years, anticipate an accelerated shift towards patient-centric, cell-based prevention and wellbeing care modalities, large hospitals replaced with smaller hubs of medical excellence, the rapid growth of outpatient centres, and the acceleration of home care and care-enabled virtual communities. The future dynamic healthcare ecosystem necessitates stakeholders to change immediately if they are to survive and prosper. Takeaways posit a choice for healthcare leaders: either stick to the status quo and risk losing value and competitiveness or embrace change and stay relevant.
 
Part 1
 
Looking Back 20 Years

Reflecting on the past two decades shows the rapid evolution and interplay of factors shaping medical technology and healthcare delivery. Appreciating the speed and scale of change helps to envision the future. Factors such as genomics, the Internet, AI, robotics, digitalisation, data-driven health solutions, telehealth, outpatient services, home care, personalised wellbeing, ubiquitous personal telephony, and strategic responses to demographic shifts have all influenced medical technology and healthcare delivery and will continue to do so in the future. Here we describe a few of these factors.

The completion of the Human Genome Project in 2003 was a pivotal moment in the direction of medical advancement, laying the foundations for the emergence of genomics. Genomics, encapsulating the mapping, sequencing, and analysis of DNA, is a pivotal tool for unravelling molecular information, variations, and their implications in both traits and diseases. This achievement not only transformed biomedical research but also changed healthcare, shifting it from a generic one-size-fits-all approach to finely tuned care tailored to the unique genetic makeup of individuals.

Over the past two decades, the decoding of the human genetic blueprint has provided unprecedented insights into diseases at the molecular level, triggering a paradigm shift in medicine. This ushered in an era of personalised and precision approaches to diagnoses, treatments, and prevention. From the advent of targeted therapies to the implementation of genetic screening, genomic research has had a transformative influence and is positioned to continue its impact on healthcare.

Indeed, genomic testing has become a standard practice, and US Food and Drug Administration (FDA)-approved genomic care modalities have advanced medicine. For example, pharmacogenonics tailors drug treatments to individual patients by utilising genetic information, with FDA-approved tests for specific biomarkers that predict medication responses. Hereditary assessments evaluate an individual's cancer risk based on genetic makeup, such as identifying BRCA gene mutations linked to elevated risks of breast and ovarian cancers. Gene expression profiling analyses a patient's tumour genetics to guide targeted cancer therapies, with FDA-approved companion diagnostic tests for specific cancer treatments. Carrier testing identifies genetic mutations that could be passed on to children, which contribute to family planning and prenatal care. Pharmacodiagnostic tests help pinpoint patients that would benefit from specific drug treatments, predicting responses, especially in cancer therapies.

In 2012, the UK government inaugurated Genomics England, an initiative designed to spearhead the 100,000 Genomes Project, which aimed to sequence the genomes of 100,000 patients with infectious diseases and specific cancers. The project’s goals included the enhancement of our understanding of various genetic factors in diseases, the facilitation of targeted treatments and establishing a framework for the integration of genomics into everyday clinical practice. The successful completion of the project in 2018, provided a basis for genomic medicine and a deeper understanding of the genetic framework influencing health and disease.

In addition to genomic data, since 2000, there has been a significant increase in health-related data, driven by the proliferation of electronic health records (EHRs), developments in information management technologies, initiatives to improve healthcare efficiency, and enhanced communications among stakeholders. The growth in data has, in turn, created opportunities for the utilisation of AI and machine learning (ML) algorithms. Over the last two decades, AI has changed medical technology and healthcare delivery by enhancing diagnostics, personalising treatment plans, streamlining administrative tasks, and facilitating research through efficient data analysis, which has improved patient outcomes, and advanced the field. As of January 2023, the FDA has approved >520 AI and ML algorithms for medical use, which are primarily related to the analysis of medical images and videos. Indeed, the rise of algorithms has transformed healthcare, with many of them focusing on predictions using EHRs that do not require FDA approval.

In addition to EHRs there has been the evolution of wearable technologies like the Apple Watch and Fitbit, which have transformed personal health. Initially focusing on fitness tracking, these devices have expanded to monitor an array of health metrics. Over the years, they have amassed vast amounts of personalised data, ranging from activity levels to heart rate patterns. These data reservoirs are a goldmine for healthcare and wellbeing strategies, enabling individuals, healthcare professionals and providers to gain unprecedented insights into health trends, customised care routines, and the early detection of health issues. This combination of technology and health data has created opportunities for proactive healthcare management and personalised wellbeing interventions.

Targeted medicine not only benefitted from AI but also from personalised telephony, which experienced a significant boost in the early 2000s by the widespread internet access in households across the globe. The period was marked by the introduction of the iPad in 2001, closely followed by the launch of the iPhone. These innovations triggered widespread smartphone use and accessible internet connectivity, laying the foundations for the emergence of telehealth and telemedicine. In the early 2000s, global cell phone subscriptions numbered ~740m. Today, the figure is >8bn, surpassing the world's population. This increase was driven by the proliferation of broadband, the evolution of mobile technologies and the rise of social media, all contributing to the ubiquitous presence of the internet. By the 2010s, the internet had integrated into the daily lives of a substantial portion of the global population. Initially, in 2000, ~7% of the world’s population had access online. Contrastingly, today, >50% enjoy internet connectivity. In a similar vein, broadband access in American homes has surged from ~50% in 2000 to >90% in the present day. Personal telephony has evolved into an omnipresent force, and has become an integral part of billions of lives, actively enhancing health and wellbeing on a global scale. After 2010, patient-centric wellbeing evolved and later was helped by Covid-19 pandemic lockdowns, with telehealth and telemedicine offering remote consultations and treatments, empowering patients, and emphasising shared decision-making between healthcare providers and patients.

On a more prosaic level, consider how robotics has changed surgery over the past two decades by offering enhanced precision, reduced invasiveness, and improved recovery times. The use of robotic systems, like the da Vinci Surgical System, which gained FDA-approval in 2000, has allowed surgeons to perform complex procedures with greater accuracy. Between 2012 and 2022, the percentage of surgical procedures using robotic systems rose from 1.8% to 17%. Robotic surgery is becoming increasingly popular, with an annual growth rate of ~15%. In 2020, its global volume was 1.24m, with the US accounting for >70% of all robotic surgeries.

The shifting demographics over the past few decades, marked by decreasing birth rates, prolonged life expectancy, and immigration, has transformed prosperous industrial economies, resulting in a substantial rise in the proportion of the elderly population. For instance, in the US in 2000, there were ~35m citizens ≥65; today, this figure has risen to ~56m, ~17% of the population. Concurrently, there has been an increase of chronic lifetime illnesses such as heart disease, diabetes, cancer, and respiratory disorders. In 2000, ~125m Americans suffered from at least one chronic condition. Today, this figure has increased to ~133m - ~50% of the population. Simultaneously, there is a shrinking pool of health professionals. Research suggests that by 2030, there will be ~5m fewer physicians than society will require. This, together with ageing populations, the growing burden of chronic diseases and rising costs of healthcare globally are challenging governments, payers, regulators, and providers to innovate and transform medical technology and healthcare delivery.
 
Part 2
 
Looking Forward 20 Years

This section aims to encourage healthcare professionals to envision the future. Over the next two decades, medical technology and healthcare delivery are likely to be affected by numerous interconnected factors, which include: (i) continued progress in AI and ML, internet of things (IoT), robotics, nanotechnology, and biotechnology, (ii) advances in genomics, (iii) increasing availability of multi-modal data (genomics, economic, demographic, clinical and phenotypic) coupled with technology innovations, (iv) accelerated adoption of telemedicine and virtual monitoring technologies, (v) changes in healthcare regulations, (vi) an increase of patient-cantered care and greater patient involvement in decision-making, (vii) emerging infectious diseases, antimicrobial resistance, and other global health issues, (viii) Investments in healthcare infrastructure, both physical and digital, (ix) an evolving and shrinking healthcare workforce, including the further integration of AI technologies and changes in roles, (x) economic conditions and healthcare funding, (xi) the ethical use of technology, privacy concerns, and societal attitudes towards healthcare innovations, and (xii) environmental changes and their impact on health and wellbeing. Such factors and their interconnectivity are expected to drive significant healthcare transformation over the next two decades. Healthcare systems throughout the world are tasked with: (i) improving population health, (ii) enhancing patients’ therapeutic journeys and outcomes, (iii) strengthening caregivers’ experience and (iv) reducing the rising cost of care. There appears to be unanimous agreement among healthcare leaders that these goals will not be achieved by business as usual.
 
In November 2023, BTIG, a leading global financial services firm, organised its Digital Health Forum, bringing together >30 healthcare companies that offer a diverse range of products and services. During the event, executives discussed business models, reimbursement, and commercial strategies, and unanimously agreed that: "The market is primed for the mainstream integration of digital diagnostics and therapeutics."  Here we focus on the anticipated accelerated convergence of genomics and AI technologies, and foresee the emergence of agile, AI-driven R&D boutiques as key players in reshaping medical technology and healthcare delivery.
 
These dynamic research entities thrive on the power of data. Currently, ~79% of the hospital data generated annually goes untapped, and medical information is doubling every 73 days. This emphasises the vast latent potential within these repositories. Traditional enterprises and healthcare professionals, constrained by a dearth of data management capabilities, have struggled to unlock the full potential inherent in these vast stores of information. By contrast, the adept data processing capabilities of these new innovative enterprises position them strategically to harness untapped data sources, extracting valuable insights into disease states and refining treatment modalities. Moreover, they boast advanced technology stacks, seamless connections between semiconductors, software, and systems, and are well-prepared to leverage specialised generative AI applications as they emerge in the market. Armed with cutting-edge technology and extensive datasets, they stand ready to enhance diagnostic precision, streamline treatment approaches, and reduce overall healthcare costs. Private equity firms will be eager to invest in these disruptive AI start-ups, anticipating M&A activities focused on specific therapeutic areas that will make them appealing to public markets.

These innovative entities are set to expedite the introduction of disruptive solutions, improve patients' therapeutic journeys, and optimise outcomes while driving operational efficiencies. Anticipate them to overshadow their traditional counterparts, many of which have outdated legacy offerings and historically have treated R&D as small adjustments to existing portfolios. Given that many conventional healthcare enterprises have: (i) failed to keep pace with technological developments, (ii) a dearth of in-house data-handling capabilities, and (iii) no experience in data-heavy disruptive R&D, it seems reasonable to suggest that they will most likely retreat into their core manufacturing activities, relinquish their R&D roles and lose value.

In the forefront of seismic change, the integration of digitalisation, AI, and cutting-edge decision support tools propels the emerging agile, data-driven R&D enterprises into a pivotal role within the landscape of well-informed, personalised healthcare. Meticulously safeguarding sensitive information, these enterprises not only adhere to the highest standards of privacy but also elevate security measures through state-of-the-art encryption techniques and decentralised storage solutions. As staunch guardians of privacy, they go beyond conventional approaches, crafting data repositories that not only shield confidential information but also facilitate the seamless flow of critical insights crucial for advancing medical technology and elevating care delivery. The seamless synergy between vast genomic, economic, demographic, clinical, and phenotypic data repositories and advanced AI techniques is poised to radically change healthcare R&D, redirecting it away from refining traditional products towards disruptive endeavours. Moreover, these agile research entities are anticipated to encourage widespread industry cooperation, harnessing the power of diverse data sources to innovate health solutions and services that transcend boundaries, thereby playing an important role in shaping a borderless health and wellbeing ecosystem.

In the regulatory arena, a transformation is anticipated by 2040. Regulators are likely to evolve from enforcers to stewards of progress, collaborating with industry stakeholders to promote a consumer-centric healthcare. Advocating transparency, patients' rights, and ethical innovation, regulators will become influential drivers of progress, contributing to a shared and equitable healthcare future. This collaborative effort is expected to contribute to a data-driven healthcare ecosystem that prioritises individual wellbeing, innovation, and accessibility in equal measure.

By 2040, expect healthcare payers to have undergone a transformative change, fuelled by a seismic shift in medical technology and healthcare delivery. New payment models will prioritise individualised therapies and patient outcomes, leveraging real-time health data for customised coverage. AI will streamline administration, reduce costs, and enhance overall healthcare efficiency. Increased patient engagement and collaboration among payers, providers, and patients will drive a holistic, patient-centred approach, ultimately improving the quality and accessibility of healthcare services.

This section has emphasised the transformative forces of genomics and AI shaping a personalised healthcare ecosystem. While traditional medical technology and healthcare delivery may be predicated upon physical devices and a one-size-fits-all approach, the future lies in the fusion of data and smart software to accelerate targeted care, which marks a significant departure from the conventional.
 
Takeaways

The shift towards genomic-driven healthcare marks a transformation in the medical landscape expected by 2040. Moving away from outdated models, the trend towards personalised care, rooted in molecular insights, necessitates a revaluation from health professionals. This shift, facilitated by the fusion of biomedical science, advanced technologies, and vast amounts of varied data, foresees a future where prevention, individualised wellbeing, and improved accessibility become the new norm. The convergence of genomics and AI not only improves diagnostics and treatments but also points to prevention and overall wellness. This Commentary has highlighted the transformative impact of genomics and AI-driven healthcare at the cellular level, making way for data-intensive R&D enterprises that will shape the future of medical technology and healthcare delivery. The path to 2040 demands a departure from conventional norms of the past, requiring strategic realignment and specific capabilities. Traditional providers find themselves at a juncture: those that adapt to an envisioned care environment of 2040 are more likely to succeed, while those that resist risk becoming obsolete. By acknowledging potential obstacles to change and the scarcity of relevant capabilities, leaders are encouraged to recognise the urgency of strategic action as a prerequisite for success in the redefined healthcare landscape of 2040. The future is imminent, and the time for transformative readiness is now.
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3 weeks, 2 days ago

MedTech Market Access for a Digital Era

HealthPad
Directory:
Medical Technology
Tags:
commentary
digital health
MedTech
predictive analytics
value-based healthcare
  • Traditional, high-touch sales approaches fail to meet the demands of today’s healthcare systems
  • Value-based care, digital health, AI and increased patient voices are reshaping purchasing priorities and market dynamics
  • Marketing success lies in outcome-based partnerships, AI-driven insights, and integrated digital solutions
  • MedTech leaders must become digitally fluent, foster innovation, and prioritise long-term value

MedTech Market Access for a Digital Era

In the late 20th century, the MedTech industry thrived, powered by a sales-driven approach that prioritised the relationship between sales representatives and healthcare providers. These strategies, built on personal trust and labour-intensive engagement, played a pivotal role in bringing transformative technologies to patients. However, the healthcare landscape of the 21st century is evolving rapidly. The traditional relationship-centric sales model, once a cornerstone of success, is now at odds with the demands of modern healthcare ecosystems.

The rise of value-based healthcare, digital health platforms, and AI-driven personalised therapies has redefined how healthcare is delivered and measured. Providers and healthcare systems are seeking solutions and services that demonstrate tangible clinical and economic value, integrate into digital workflows, and support data-driven decision-making. This shift requires MedTech companies to transcend traditional sales policies and embrace innovative, technology-enabled approaches to market access. Success in this rapidly changing era demands not just products but also partnerships, where digital tools, real-world evidence, and collaborative strategies drive sustainable outcomes. It is time to rethink how MedTech engages with the healthcare sector in a world shaped by data, efficiency, and value.
 
In this Commentary

This Commentary explores the decline of the traditional MedTech sales model, once built on personal relationships and high-touch engagement, in an era dominated by value-based care, digital health, and AI-driven healthcare solutions and services. It highlights the misalignment of traditional strategies with modern healthcare needs and suggests ideas for reimagining market access. By embracing outcome-based partnerships, leveraging AI, and embedding digital services, MedTech companies can position themselves as leaders in the evolving healthcare landscape.
 
The Rise and Resilience of the Traditional MedTech Sales Model

The traditional sales-driven model in MedTech emerged as a natural response to the needs of both the industry and the healthcare ecosystem. Sales representatives were more than transactional intermediaries; they played multifaceted roles as educators, advocates, and trusted advisors. Their expertise bridged the gap between cutting-edge medical technologies and the overburdened physicians tasked with delivering care. Often, these representatives worked directly alongside clinicians, providing support in operating rooms during surgeries, or guiding optimal device use, ensuring that complex products achieved their intended outcomes.

This model thrived during a time when clinicians held significant autonomy in selecting tools and technologies. Purchasing decisions were often personal, based on trust and familiarity, which made relationship-building important. MedTech companies responded by assembling well-trained, specialised salesforces adept at navigating these nuanced dynamics. Firms like Johnson & Johnson, Abbott, and Medtronic solidified their market dominance - the combined 3 companies account for ~16% of the global MedTech market - by cultivating deep customer loyalty through this hands-on approach, reinforcing their reputations as partners in care rather than just vendors.

Even as healthcare evolves, the resilience of this model is evident. Its foundational emphasis on trust, expertise, and collaboration remains a cornerstone, albeit one facing new challenges in an era of value-based care and centralised purchasing decisions.
 
Why Traditional MedTechs Cling to Old Ways

Despite significant changes in healthcare delivery, many MedTech companies remain tethered to this traditional sales model. There are several reasons for this inertia.

1. Cultural Legacy of Sales Dominance
Senior leadership teams in many traditional MedTech firms are frequently comprised of executives who built their careers in sales, fostering a deep-rooted belief that success is driven by high-touch, relationship-oriented selling. This perspective often aligns with the sector’s historical reliance on personal connections to drive growth. Shifting such entrenched mindsets can be a challenge, particularly in organisations with a legacy of success using these approaches. It requires not only cultural transformation but also demonstrating the value of alternative strategies.

2. Misaligned Incentives
Many MedTechs continue to incentivise their commercial teams using metrics focused on short-term sales performance, such as quarterly revenue targets or the volume of devices sold. While effective for driving immediate results, these incentives create a strong disincentive to explore alternative strategies that may better serve long-term objectives. By prioritising near-term gains, companies risk stifling innovation and missing opportunities to align more closely with evolving customer needs, ultimately limiting their potential for sustainable growth.

3. Lack of Digital Fluency at the Top
Traditional MedTech leaders frequently lack the digital fluency needed to fully understand and embrace the transformative potential of tools such as AI, predictive analytics, and digital service layers. This gap in knowhow and experience can encourage scepticism about the value and efficacy of digital-first strategies, often leading to hesitation or underinvestment in these innovations. Without a clear appreciation of how such technologies can drive competitive advantage, organisations risk falling behind in an increasingly tech-driven healthcare landscape.

4. Complexity of Healthcare Systems
Selling to healthcare providers, payers, and integrated delivery systems is more complex than engaging with individual clinicians. These broader stakeholders demand value propositions that go beyond individual product benefits, requiring an understanding of system-wide outcomes, cost-effectiveness, and interoperability. Despite this shift in the healthcare environment, many MedTech companies remain hesitant to move beyond their traditional clinician-focused sales strategies. Such reluctance stems from a preference for familiar approaches and a lack of confidence in navigating system-based selling challenges.

5. Resistance to Risk
The MedTech industry operates within a highly regulated ecosystem, where strict compliance standards and patient safety are paramount. As a result, companies tend to be inherently risk-averse, with leadership often cautious about pursuing change. This hesitation is driven by concerns that innovation or new strategies could inadvertently compromise regulatory compliance, disrupt established customer relationships, or threaten existing revenue streams. While this caution is understandable, it can sometimes hinder the agility needed to adapt to evolving market demands.
 
Why the Traditional Sales Model No Longer Works

The healthcare industry’s transition to value-based healthcare, alongside the rapid rise of digital health solutions, has rendered the traditional sales model increasingly obsolete. Here’s why:
 
1. Shift to Value-Based Care

Under value-based care, healthcare providers are incentivised to deliver superior patient outcomes while controlling costs. This shift moves away from traditional fee-for-service models, where clinicians had discretion to select high-cost devices, toward systems emphasising cost-effectiveness and real world evidence-based results. MedTech companies must adapt by demonstrating their devices provide measurable, impactful value through robust data and clinical evidence, rather than relying on persuasive sales tactics or legacy relationships to drive adoption.
 
2. Consolidation of Decision-Making
 
Purchasing decisions in healthcare have shifted from individual clinicians to procurement committees, group purchasing organisations (GPOs), and hospital executives, who now drive the process. These stakeholders prioritise data-driven evidence that demonstrates both clinical efficacy and economic value, leaving little room for decisions influenced by personal relationships. This transition emphasises the growing significance of robust metrics and compelling outcomes in shaping purchasing strategies and aligning with institutional priorities.
 
3. Digital Health and AI Disruption
 
The rapid proliferation of digital health solutions and services has heightened expectations for seamless integration, real-time data sharing, and personalised user experiences. As a result, legacy MedTech devices that lack advanced digital capabilities are increasingly perceived as outdated and less competitive. This shift is obliging companies to rethink their product strategies and marketing approaches, emphasising innovation, connectivity, and alignment with evolving healthcare ecosystems to remain relevant and meet the demands of modern stakeholders.
 
4. Rising Patient Empowerment

The healthcare landscape is undergoing a transformative shift as patients take an active, informed role in their care decisions, driven by digital tools and unprecedented access to information. As highlighted in Choice Matters by Gordon Moore et al, empowered patients influence health outcomes and reshape healthcare expectations, demanding transparency, personalisation, and value. For MedTech companies, adapting to this paradigm requires prioritising patient-centric strategies, fostering collaboration, and delivering tailored solutions to remain relevant and trusted in an era of heightened patient agency.
 
Reimagining Market Access: Ideas for the Digital-First Era

To thrive in this digital era, MedTech companies must embrace changes to how they market and distribute their products. Here are three strategies for rethinking market access:

Outcome-Based Partnerships
The traditional fee-for-product sales model in MedTech needs to evolve into outcome-based partnerships that align the incentives of MedTech companies with those of healthcare providers. Such partnerships can include innovative risk-sharing agreements where payment is directly linked to the device's performance in delivering measurable clinical outcomes.

For instance, rather than selling a surgical robot outright, a MedTech company might partner with a hospital to deploy the technology while sharing in the cost savings generated by fewer surgical complications and improved patient recovery rates. Similarly, companies specialising in wearable health devices could base their pricing on tangible metrics, such as increased patient adherence to prescribed treatment plans or significant reductions in hospital readmissions, ensuring mutual value creation.

Challenges and Solution
Challenge Establishing robust data and metrics to measure outcomes.
Solution Adapt existing products to generate data and work collaboratively with healthcare providers to define clear, evidence-based performance indicators. Leverage real-world evidence to validate outcomes over time.

Leveraging AI and Predictive Analytics
AI and predictive analytics are poised to transform how MedTech companies demonstrate value to payers and healthcare systems. By leveraging data from clinical trials, real-world usage, and digital health platforms, companies can build predictive models that quantify the long-term clinical and economic benefits of their devices.

For example, a MedTech company specialising in cardiac implants could use predictive analytics to highlight how its products reduce lifetime healthcare costs by reducing hospitalisations and improving patient outcomes. Additionally, AI-driven insights can help tailor value propositions to address the unique priorities of each healthcare provider, such as reducing readmission rates or improving operational efficiency, ultimately strengthening sales strategies, and fostering more meaningful partnerships.

Challenges and Solutions
Challenge Accessing high-quality, longitudinal data.
Solution Partner with healthcare providers, payers, and academic institutions to co-develop data-sharing agreements that ensure mutual benefit.
 
Embedding Digital Service Layers
MedTech companies must shift from a hardware-focused sales approach to delivering integrated solutions that combine devices with advanced digital service layers. These layers might include features like: (i) remote monitoring for continuous patient care, (ii) predictive maintenance alerts to optimise the uptime of surgical equipment, and (iii) AI-powered decision support tools that assist clinicians in making more accurate and timely interventions.

For instance, a company selling glucose monitors could enhance its offering by integrating them with a digital health platform that provides patients with personalised insights and actionable recommendations for managing their diabetes. These digital services not only foster long-term engagement with patients and healthcare providers but also create recurring revenue streams, reinforce brand loyalty, and position MedTech companies as indispensable partners in the care continuum.

Challenges and Solutions
Challenge Developing and maintaining high-quality software capabilities.
Solution Invest in in-house digital talent or pursue strategic acquisitions of digital health start-ups.
 
Case Study

DePuy Synthes, a Johnson & Johnson company and a global leader in orthopaedics, exemplifies how traditional corporations can transform sales strategies to thrive in the 21st century. By leveraging digital tools, data-driven insights, and personalised customer engagement, DePuy Synthes has set a new industry benchmark.

Central to this transformation is the adoption of Salesforce, a powerful customer relationship management platform. By centralising customer data and enabling real-time sales tracking, Salesforce empowers DePuy Synthes to make data-driven decisions and respond swiftly to customer needs. Complementing this, the company has incorporated Virtual Reality and Augmented Reality into its sales processes. These immersive technologies facilitate product demonstrations and surgical simulations, providing healthcare professionals with risk-free, hands-on experiences that build trust and confidence in complex orthopaedic solutions.

DePuy Synthes also employs targeted digital marketing strategies, including content marketing, social media engagement, and personalised email campaigns, to expand its reach and foster brand awareness. Through these channels, the company communicates with both healthcare professionals and patients, driving lead generation in a competitive market.

Data and predictive analytics, plays a role in refining sales strategies. DePuy Synthes leverages analytics to identify market trends, predict customer needs, and tailor offerings to specific segments. Predictive analytics further enhances inventory management and positions the company to seize emerging opportunities.

Remote collaboration tools, such as virtual meetings and webinars, enable DePuy Synthes to engage healthcare professionals globally, sharing product knowledge and maintaining client relationships without geographical constraints. This commitment to accessibility and innovation is emphasised by personalised customer experiences, where tailored recommendations and dedicated support teams foster loyalty and trust.

DePuy Synthes’ transformation underscores the need for MedTech companies to modernise their sales strategies. By embracing digital innovation, data-driven insights, and customer-centric approaches, DePuy Synthes has enhanced efficiency and secured its competitive edge, serving as a model for industry evolution.
 
Call to Action: A New Vision for MedTech Leadership

The transition to a digital-first era demands not only new strategies but also a shift in leadership mindset. MedTech executives must champion digital fluency and cultivate a culture of innovation and experimentation across their organisations. Key steps could include: (i) establishing dedicated innovation teams to pilot transformative market access and value-based care models, (ii) integrating chief digital officers into the executive leadership teams to drive digital transformation, and (iii) aligning incentive structures to prioritise long-term value creation over short-term revenue goals. By embracing these changes, MedTech companies can break free from legacy limitations.
 
Takeaways

The traditional MedTech sales model, while effective in its time, has reached its limits in today’s rapidly evolving healthcare landscape. In an era shaped by value-based care, digital health integration, and AI-driven personalisation, adhering to outdated approaches risks diminishing relevance. The future belongs to companies bold enough to reimagine how their solutions are marketed, adopted, and integrated into the broader healthcare ecosystem.

By shifting to outcome-based partnerships, MedTech firms can align their success with measurable clinical improvements and cost savings for providers. Leveraging AI and predictive analytics empowers companies to demonstrate the long-term value of their products while tailoring offerings to the specific needs of healthcare systems. Embedding digital service layers not only enhances product functionality but also fosters long-term relationships and recurring revenue streams.

This is not the end of MedTech’s growth potential but a pivotal moment to transform. By embracing these changes, companies can redefine their role as essential partners in delivering smarter, more sustainable healthcare.
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8 years, 11 months ago

Will Devi Shetty have a major influence on global healthcare?

HealthPad
Directory:
Health Policy
Tags:
affordable quality healthcare
Cayman Island
commentary
Devi Shetty
healthcare costs
medical insurance
medical tourism
Narayana Health
NHS
  • Narayana Hrudayalaya (NH) is an innovative Indian healthcare provider
  • In just 15 years NH has become one of India’s leading hospital groups
  • Founded by Dr Devi Shetty, a heart surgeon, NH treats nearly 2m patients a year
  • NH has built an international reputation for affordable quality healthcare
  • A number of large institutional investors are betting that NH can grow
  • Is NH’s model of affordable quality healthcare replicable outside of India?

Will Devi Shetty have a major influence on global healthcare?
 
 
PART 1
 
Dr. Devi Shetty, founder and chairman of Narayana Hrudayalaya (NH), an innovative Indian healthcare provider, wants to transform the way healthcare is delivered across the world. Can he do it?
 
This Commentary is in three parts. Part 1 is a general introduction to NH and its 2015 initial public offering. It describes some of NH’s internal challenges and suggests that it is reasonable to assume that these will be overcome given its position within a buoyant Indian healthcare market. Part 2 describes some key aspects of NH’s model for affordable quality healthcare. In particular, it shows how Shetty has embraced information technology and some aspects of scientific management to create mega hospitals in India that delivers sustainable high-volume affordable quality care. Part 3 discusses some of the challenges associated with replicating the NH model outside of India. It briefly describes Shetty’s initiative to create a medical city in the Cayman Islands to capture share from the North and South American healthcare markets. It discusses some of the barriers to replicating the model in the UK and other developed markets and suggests that besides India; Africa, - despite its complexities and challenges - might offer NH growth opportunities. It also suggests that NH could play a leading role in training a new generation of healthcare professionals specifically attuned to the vast and escalating healthcare needs of developing economies, and this could be commercially valuable.
 
London-based financial institution CDC and a number of others think Shetty can provide the world with a new model of affirdable healthcare. In December 2015 the CDC Group, owned by the British government, with an investment portfolio valued at £2.8bn, backed NH’s initial public offering (IPO) with an investment of US$48m. The IPO valued NH at US$1bn. The issue was 8.6 times oversubscribed, with most of the demand coming from foreign institutional investors. Beside CDC, other anchor investors included the government of Singapore, Morgan Stanley, Nomura, BlackRock, and Prudential.
 
Dharmesh Mehta, former managing director and CEO of Axis Capital, one of the bankers to the issue, said:  “We got one of the best anchor books, with several long-term investors supporting it. Investors are bullish about the Indian healthcare space, especially hospitals, and Narayana Hrudayalaya has a unique business model, and the backing of good quality management.”
 
In the video below Shetty argues that, “Healthcare of the future will not be an extension of the past.” Shetty has a good understanding about how technology is revolutionizing the way healthcare is delivered and changing its structure and organization to such an extent that the future of healthcare will be dramatically different from what it is today. Healthcare is moving beyond the hospital towards patient self-knowledge and empowerment. Home-healthcare services facilitate enhanced doctor-patient connectivity where it had not been previously possible.
 
 
(click to play the video)
 
Narayana Hrudayalaya
 
Shetty, who has more than three decades of experience as a cardiac surgeon both in the UK and India, founded NH in 2000. Since then, it has become one of India’s leading healthcare service providers; with a network of 23 multi-specialty, primary and tertiary healthcare facilities, eight heart centers, and 25 primary care facilities, across 32 cities, towns and villages in India. Currently, NH has 5,600 operational beds, which it intends to increase to 30,000 by 2020. NH employs some 12,500 people, including 818 doctors, 5,400 nurses and about 1,660 visiting consultants.

In fiscal year 2015, Narayana provided care to nearly two million patients and undertook more than 51,456 cardiology procedures, 14,000 cardiac surgeries - which accounted for 10% of the national figure - and 184,443 dialysis procedures. Narayana posted revenues of US$219m for fiscal year 2015 and profit after tax of $2m. For the four fiscal years that ended March 31, 2015, the company’s revenues grew at a compounded annual rate of 30%.
 
Access to healthcare for millions of poor people
 
NH has one of the world’s largest telemedicine networks with 150 centers including 50 in Africa, where Shetty sees further expansion opportunities for NH. The service is free-of-charge and enhances the connectivity between remote health facilities and consultants at Narayana. Shetty, a vocal advocate of affordable healthcare, helped design the Karnataka State government Yeshasvini scheme, which is one of the largest self-funded micro healthcare insurance programs in India. It covers about 2 million people who previously did not have access to healthcare. Participants pay US$1.40 per year, which provides them with free access to over 800 surgical procedures in 400 hospitals. In the past 10 years, 85,000 peasant farmers have used the insurance to have surgery.
 
Challenges

NH faces some challenges. Its profit margins are low and its revenues are mainly derived from three of its largest hospitals, which concentrate on cardiac care and cardiology. As of March 2015, the company’s recent acquisitions and expansion into the Cayman Islands, where it opened a 130-bed tertiary hospital, were making losses.

However, NH’s acquisitions and expansion are strategic and their pay-offs are expected to accrue over the next four years. Also, higher yields from value-added therapies such as oncology, neurology and gastroenterology are anticipated to improve Narayana’s average revenue per operating bed (ARPOB). The company’s strategy to focus on the mid-income segment of the market is predicted to increase its utilization, given that this is a large, rapidly growing and immediately addressable market. Narayana is also advantaged by its history of efficient use of capital: it has a debt-equity ratio of only about 0.3. 
 
Market drivers

In 2015 investors might have been influenced by the falling gold, oil and real estate markets and the relative attraction of the Indian healthcare sector, buoyed by changing demographics, rising incomes and a large and expanding middle class, greater health awareness, changes in disease profiles and a rising penetration of health insurance. By 2020 India is expected to be the world’s third largest middleclass consumer market behind China and the US. By 2030 India is projected to surpass both countries with an aggregated consumer spend of some US$13 trillion. A 2019 study by the McKinsey Global Institute (MGI) suggests that if India continues to grow at her current pace, average household incomes will triple over the next two decades, making the country the world’s fifth-largest consumer economy by 2025, up from the current 12th position.

While recognizing the challenges for India’s healthcare sector, investors must have thought that NH is well positioned to take advantage of the expected explosion in India’s middleclass consumer market. Narayana has a strong brand name and it is one of India’s leading healthcare companies, with significant revenue growth over the past four years. Its services appear cheaper than those of its competitors, such as Chennai’s Apollo Hospitals Limited, which has about four times the revenues of NH and Delhi’s Fortis Healthcare, which is about three times bigger in revenue terms. This suggests that NH has scope for substantial growth. 

 
PART 2
 
International attention
 
Healthcare systems worldwide consume a large and escalating share of national incomes and costs and quality of care are the two most hotly debated issues among healthcare professionals. Does Shetty have an answer?
 
For many years, Shetty has attracted international attention. For example, in 2010 a UK prime ministerial delegation visited NH’s Medical City in Bengaluru. Vince Cable, then the UK’s Business Secretary, said: “What we're trying to do in the UK is to get more for less. Dr Shetty has shown us a model by which we do not need to accept inferior healthcare because there's less money, but actually how to get more out of the system for less resource,” Cable described his visit as “inspirational” and went on to say, "I just found it overwhelming. NH combines what we always see in a good health system, which is humane humanitarian behaviour, with sound economics."
 
The Henry Ford of heart surgery
 
Worldwide, the demand for healthcare services is rising faster than its supply. By focusing on an endeavour to make doctors more effective, NH has demonstrated that it can deliver what healthcare systems need: enhanced patient outcomes for less money.  “We have invested in infrastructure. Similar infrastructure in the UK and the US is used for about eight to nine hours a day. Ours is used for 14 to 15 hours a day, which allows us to perform the high volume of procedures,” says Shetty. In 2009 the Wall Street Journal referred to him as “the Henry Ford of Heart Surgery”.
 
In a similar way Henry Ford used large factories and mass-production techniques to manufacture a large number of quality cars, which many ordinary people could afford; so, Shetty developed large hospitals and a significant skill base, which he used to improve the quality of surgical procedures and reduce costs. This enabled him to offer large numbers of people access to affordable high-quality healthcare. 
 
NH doctors, who are on fixed salaries, work in teams. Each team comprises a specialist, a number of junior doctors, trainees, nurses and paramedics. A bypass surgery typically takes about five hours. The actual grafting, which is the critical part, takes only an hour and is performed by an experienced specialist surgeon, while harvesting of the veins/arteries, opening and closing of the chest, suturing and other procedures are carried out by junior doctors. Nurses and paramedics handle the preparation and the aftercare of the patient. This Henry Ford-type process leaves the specialist free to perform more surgeries. As the volume of surgeries increase, outcomes improve, and costs are reduced. A heart surgery at NH costs less than US$2,000 per operation.
 
NH’s lower costs have not come at the expense of quality. Narayana’s mortality rate for coronary artery bypass procedures is 1.27% and its infection rate 1%, which are as good as that of US hospitals. Incidence of bedsores after cardiac surgery is anywhere between 8% and 40% globally, whereas at NH it has been almost zero in the last four years.
 
It can’t be done!
 
“When we started our journey, we were discouraged by people saying that, ‘there is no such thing as low-cost high-quality healthcare’, and that ‘healthcare is expensive and will always be expensive’. Only when people become wealthy, they can afford quality healthcare . . . . . When I grew up, I looked at some of the richest countries in the world, struggling to offer healthcare to its citizens and quickly realized that even if India became a rich country, it still would not be able to guarantee healthcare to everyone. We had to change the way we were doing things and this is what we’ve done,” says Shetty.
 
Socializing the P&L
 
UK doctors and health providers often talk about reducing the costs of healthcare, but, says Shetty, “doctors usually have no idea how much they are spending”.  In contrast, at noon every day all NH doctors receive an text with NH’s previous day’s revenue, expenses and EBIDTA (earnings before interest, depreciation, taxation and amortization). According to Dr. Ashutosh Raghuvanshi, NH’s CEO, “When you look at financials at the end of the month, it’s a post-mortem. When you look at them daily, you can do something to change things”. The daily data doctors receive describes their operations, and the various levels of reimbursement. “It’s not just a cheap process, it’s effective,” says Raghuvanshi.
 
In the video below Shetty suggests that a key factor for the future success of NHS England will be its ability to re-invent itself, increase its focus on costs and outcomes, benchmark key functions with successful international comparators and instil strict financial discipline in doctors, “because they represent the biggest spend in healthcare systems,” says Shetty.
 
      
 (click to play the video)   
 
Information technology
 
Healthcare systems require radical change at every level in order to reduce the vast and upward trajectory of unsustainable costs, improve patient experiences and outcomes, speed the translation of research into therapies and make healthcare accessible to everyone. Information technology helps in these regards. NH regularly mines data to raise the quality of care and patient outcomes. Its business intelligence activities manage real-time data on 30 different parameters that track and support efficiency improvements. Those related to clinical outcomes are then reviewed at a weekly meeting, where all major clinical procedures are discussed among doctors and best practices shared. This way NH maps the cost effectiveness of each doctor.
 
PART 3
 
Affordable quality healthcare outside India
 
An example of Shetty’s model of affordable quality healthcare working effectively outside of India is Narayana Health Cayman Islands. The Cayman government has given Shetty a 200-acre site and New York investors have backed him to develop and operate a Health City. In 2014 NH opened its first phase, a 130-bed tertiary hospital targeting the elective surgery markets of North and South America. “Narayana Health City Cayman will demonstrate how over-priced and inefficient US hospitals actually are and show that lower costs and better outcomes can be achieved outside of India just as well as in Bengaluru,” says Shetty.
 
The UK
 
There are numerous barriers to adopting the Shetty model in the UK and in other developed economies. NHS England has its innovators and there are efforts to roll-out innovations nationally, but they have limited success, mainly because innovations tend to be isolated and local and not widely known across different NHS functions or beyond sector boundaries. The lack of centralised expertise in NHS England skews perspectives and limits resources. This presents a significant obstacle to the adoption of compelling healthcare innovations, such as those demonstrated by Narayana.
 
Further, there is doctor-resistance to innovations in the UK. Doctors are trained to identify and implement proven and recommended treatment protocols for various disease states. To deviate from this is to run the risk of litigation. Further, health professionals in the UK are increasingly time-pressed, with the result that acquiring and adopting new and innovative pathways of care takes a back seat. See, Meeting the challenges of affordable quality healthcare. and, The end of doctors.
 
Medical tourism
 
"Medical tourism" refers to traveling to another country for medical care. The world population is aging and becoming more affluent at rates that surpass the availability of quality healthcare resources. In addition, out-of-pocket medical costs of critical and elective procedures continue to rise, while nations offering universal care, such as the UK, are faced with ever-increasing resource burdens. These drivers are forcing patients to pursue cross-border healthcare options either to save money or to avoid long waits for treatment.

In 2015 it was estimated that the worldwide medical tourism market was between US$50bn and US$65bn and growing at an annual rate of between 15%-25%. In 2015 some 1.5 million US residents travelled abroad for care, up from 0.5 million in 2007. Two of their top destinations were Costa Rica and India. Costa Rica can yield savings on standard surgical procedures of between 45% and 65%, and India, between 65% and 90%.

Beyond the US, the OECD estimates that there are up to 50 million medical tourists worldwide annually. The most common procedures that people undergo on medical tourism trips include heart surgery, dentistry and cosmetic procedures. People are attracted to well-known, internationally accredited hospitals, which have a flow of medical tourists, internationally trained experienced health professionals, a sustained reputation for clinical excellence and a history of healthcare innovation and achievement.

Already, NH attracts medical tourists from over 50 countries, it has an international reputation for excellence, many of its top health professionals have been trained and have gained clinical experience in the US and Europe and it has a significant track record in high demand areas, particularly heart surgery. This suggests that NH is well positioned to take advantage in the future growth of medical tourism and this is probably something taken into account by NH’s anchor investors. 
 
Africa
 
Because of entrenched obstacles to change in the healthcare systems of developed economies, Shetty has indicated an interest in Africa. In the past, private healthcare providers have neglected African healthcare; it has been underserved by governments, and mostly reliant on irregular help from abroad. However, this is about to change, and there is some evidence to suggest that healthcare reform in Africa is beginning. A 2016 African Healthcare Summit suggested that African healthcare spending is expected to grow to 6.4% of GDP in 2016, making it the second highest category of government investment. A Report from the International Finance Corporation (IFC) of the World Bank suggests that, over the next 10 years, there will be, “considerable African demand” for investment in hospitals, medicines and health professionals and meeting this demand, “can deliver strong financial returns.”
 
Healthcare providers also can take heart that a number of African countries are trying to establish or widen social insurance programs to give medical cover to more of their citizens. Further, there are six African countries with projected compounded annual growth rates (CAGR) for 2014 through 2017 of between 7.12% and 9.7%. These are: Rwanda, Tanzania, Mozambique, Cote d’Ivoire, the Democratic Republic of the Congo, and Ethiopia.
 
Notwithstanding, Africa is facing a dual challenge of communicable and parasitic diseases such as malaria, TB and HIV/AIDS and growing rates of chronic conditions such as diabetes, hypertension, obesity, cancer and respiratory diseases. Increased urbanisation in many African countries, along with growing incomes and changing lifestyles, have led to a rise in the rate of chronic conditions, which are projected to overtake communicable diseases as Africa’s principal health challenge by 2030. This suggests that despite the fledging signs of change, over the next decade African healthcare will still be challenged. However, over the past 15 years, NH’s has demonstrated capabilities to meet and overcome similar challenges in India, which positions it well to succeed in Africa where it already has a non-trivial telemedicine presence.
 
Training health professionals
 
The healthcare and wellness sectors are positioned to be significant drivers of the world economy in the 21st century. Healthcare is about a US$6 trillion global market, which is increasing. Advances in medical technology, public health and governance have improved healthcare for about 30% of the world’s population. But billions of people still have no access to healthcare.
 
The WHO estimates that there is a shortage of nearly 13 million healthcare workers globally, but Shetty believes these shortages could be significantly higher. According to the Royal College of General Practitioners the shortage of doctors in the UK is the worst it has been for 40 years. One hundred primary care practices, serving 700,000 patients across Britain, are facing closure and the number of GP-patient consultations is estimated to rise from 338 million in 2013 to 441 million by 2017. UK experts warn that primary care doctors with too many patients will fail to provide adequate healthcare through current delivery methods and they say that this is expected to further drive patients to search online for health-related issues. See: Curing the Problems of General Practice.
 
Such shortages concern Shetty, who believes that the situation will only be improved with a radical change in the way healthcare is delivered. “This”, says Shetty, “will only be achieved with a change in the way health professionals are trained.” Future health professionals need to be trained for a world of e-patients. Digital classrooms will create new connections between students and health professionals and allow for access to the most current information and resources. Shetty advocates the development of a virtual global medical university, with features that include a cross-country curriculum and a reduced training period. “This is the only way we will increase the much-needed pool of healthcare talent,” says Shetty.
 
Takeaways

While change in Western healthcare systems will neither be quick nor easy, NH’s near to medium term growth will most probably come from India, the Caymans, Africa and other developing countries where the need for quality healthcare is high and growing fast, and the barriers to entry relatively low. In time, however, the US and the UK might be able to benefit from some of Narayana’s best practices so that an increasing percentage Americans may have access to high quality affordable healthcare and NHS England maybe reformed to ensure its survival.
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7 years ago

Age of the aged and low back pain

HealthPad
Directory:
Neurosurgery
Tags:
aging population
back pain
commentary
LBP
low back pain
lumbar spinal fusion
minimally invasive spinal fusion
spinal fusion
  • In high-income countries populations are aging
  • By 2050 the world population of people over 60 is projected to reach 2bn
  • Age-related low back pain is the highest contributor to disability in the world
  • Over 80% of people will experience back pain at some point in their life
  • Older people with back pain have a higher chance of dying prematurely
  • The causes of back pain are difficult to determine which presents challenges for the diagnosis and management of the condition
  • The US $100bn-a-year American back pain industry is “ineffective”
  • Each year 10,000 and 300,000 spine fusion surgeries are carried out in the UK and US respectively
  • 20% of spinal fusion surgeries are undertaken without good evidence
  • In 10 to 39% of spine surgery patients pain continues or worsens after surgeries
 
Age of the aged and low back pain
 
A triumph of 20th century medicine is that it has created the “age of the aged”. By 2050 the world population of people aged 60 and older is projected to be 2bn, up from 900m in 2015. Today, there are 125m people aged 80 and older and by 2050 there is expected to be 434m people in this age group worldwide. The average age of the UK population has reached 40. Some 22% will be over 65 by 2031, and this will exceed the percentage of the UK population under 25. 33% of people born today in the UK can expect to live to 100. However, this medical success is the source of rapidly increasing age-related disorders, which present significant challenges for the UK and other high-income nations. Low back pain (LBP) is the most common age-related pain disorder, and ranked as the highest contributor to disability in the world. 
 
At some point back pain affects 84% of all adults in developed economies. Research published in 2017 in the journal Scoliosis Spinal Disorders suggests that LBP is the most common health problem among older adults that results in pain and disability. The over 65s are the second most common age group to seek medical advice for LBP, which represents a significant and increasing workload for health providers. Each year back pain costs the UK and US Exchequers respectively some £5bn and more than US635bn in medical treatment and lost productivity. LBP accounts for 11% of the total disability of the respective populations. This Commentary discusses therapies for LBP, and describes the changing management landscape for this vast and rapidly growing condition.
 
Your spine and LBP

 

Your spine, which supports your back, consists of 24 vertebrae, bones stacked on top of one another.  At the bottom of your spine and below your vertebrae are the bones of your sacrum and coccyx. Threading through the entire length of your vertebrae is your spinal cord, which transmits signals from your brain to the rest of your body. Your spinal cord ends in your lower back, and continues as a series of nerves, which resemble a horse’s tail, hence its medical name, ‘cauda equine’. Between each vertebra are discs. In younger people discs contain a high degree of water. This gives them the ability to act like shock absorbers. During the normal aging process discs lose much of their water content and degenerate. Such degenerative spinal structures may result in a herniated disc when the disc nucleus extrudes through the disc’s outer fibres, or a compression of nerve roots, which may lead to radiculopathy. This is a condition more commonly known as sciatica, which is pain caused by compression of a spinal nerve root in the lower back that is often associated with the degeneration of an intervertebral disc, and can manifest itself as pain, numbness, or weakness of the buttock and outer side of the leg.

 

Challenges in diagnosis
 
Because your back is comprised of so many connected tissues, which include bones, muscles, ligaments, nerves, tendons, and joints, it is often difficult for doctors to say with confidence what causes back pain even with the help of X-rays and MRI scans. Usually, LBP does not have a serious cause. In the majority of cases LBP will reduce and often disappear within 4 to 6 weeks, and therefore can be self-managed by keeping mobile and taking over-the-counter painkillers. However, in a relatively small proportion of people with LBP, the pain and disability can persist for many months or even years. Once LBP has been present for more than a year few people return to normal activities. There is not sufficient evidence to suggest definitive management pathways for this group that accounts for the majority of the health and social costs associated with LBP.
 
Assessing treatment options for back pain

Ranjeev Bhangoo, a consultant neurosurgeon at Kings’ College Hospital Trust, London, and the London Neurosurgery Partnership describes the nature and role of intervertebral discs and how treatment options should be assessed.

“When a person presents with a problem in the lower back, which might manifest as leg or arm pain, you need to ask 3 questions: (i) is the history of the pain compatible with a particular disc causing the problem?  (ii) Does an examination suggest that a particular disc is causing a problem? And (iii) does a scan show that the disc you thought was the problem is the problem? If all 3 answers align, then there maybe some good reason to consider treatment options. If the 3 answers are not aligned, be weary of a surgeon suggesting intervention because 90% of us will experience back pain at some point in our lives, and 90% of the population don’t need back surgery.”
 
 
Back pain requiring immediate medical attention
 
Although the majority of LBP tends to be benign and temporary, people should seek immediate medical advice if their back pain is associated with certain red flags such as loss of bladder control; loss of weight, fever, upper back or chest pain; or if there is no obvious cause for the pain; or if the pain is accompanied by weakness, loss of sensation or persistent pins and needles in the lower limbs. Also, people with chronic lifetime conditions such as cancer should pay particular attention to back pain.
 
Epidemiology of LBP

Back pain affects approximately 700m people worldwide. A 2011 report by the US Institute of Medicine, estimates that 100m Americans are living with chronic back pain, which is more than the total affected by heart disease, cancer, and diabetes combined. This represents a vast market for therapies that include surgery and the prescription of opioids. Estimates of the prevalence of LBP vary significantly between studies. There is no convincing evidence that age affects the prevalence of back pain, and published data do not distinguish between LBP that persists for more than, or less than, a year. Each year LBP affects some 33% of UK adults, and around 20% of these - about 2.8m - will consult their GP. One year after a first episode of back pain, 62% of people still experience pain, and 16% of those initially unable to work are not working after 1 year. Typically in about 60% of cases pain and disability improve rapidly during the first month after onset.

 

Non-invasive therapies for LBP

The most common non-invasive treatment for LBP is non-steroidal anti-inflammatory drugs (NSAIDs), but also other pain medication may include paracetamol, oral steroids, gabapentin/pregabalin, opioids and muscle relaxants, antidepressants, chiropractic manipulation, osteopathy, epidural injections, transcutaneous electrical nerve stimulation (TENS), ultrasound that uses vibration to deliver heat and energy to parts of the lower back, physiotherapy, massage, and acupuncture.
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Prelude to surgery
 
Despite the range of non-invasive therapies for LBP, the incidence of lumbar spinal fusion surgery for ordinary LBP increased significantly over the past 2 decades without definitive evidence of the efficacy of the procedure. Recent guidelines from UK and US regulatory bodies have instructed doctors to consider more conservative therapies for the management of back pain, and this has resulted in the reduction in the incidence of spinal fusion surgeries.
 
Notwithstanding, because there has been clear recognition of the paucity of evidence for reliable rates of improvement following fusion for back pain surgery, it does not necessarily follow that fusions should never be done and indeed there are many instances where fusions are strongly supported by evidence. The gold standard for diagnosing degenerative disc disease is MRI evidence, which has formed the principal basis for surgical decisions in older adults. However, studies suggest that although MRI evidence indicates that degenerative change in the lumbar spine is common among people over 60, the overwhelming majority do not have chronic LBP.
 
Increasing prevalence of spinal fusion surgery
 
Each year, NHS England undertakes some 10,000 spinal surgeries for LBP at a cost of some £200m, which is in addition to the large and growing number of patients receiving epidurals that cost the NHS about £9bn a year, and they too have low evidence as to their efficacy. In the US more than 300,000 back surgeries are performed each year. In 10 to 39% of these cases, pain may continue or even worsen after surgery; a condition known as ‘failed back surgery syndrome’. In the US, about 80,000 new cases of failed back surgery syndrome are accumulated each year. Pain after back surgery is difficult to treat, and many patients are obliged to live with pain for the rest of their lives, which causes significant disability.
  
Back pain and premature death
 
A study by researchers from the University of Sydney published in 2017 in the European Journal of Pain found that older people with persistent chronic back pain have a higher chance of dying prematurely. The study examined the prevalence of back pain in nearly 4,400 Danish twins over 70. They then compared their findings with the death registry and concluded that, "Older people reporting spinal pain have a 13% increased risk of mortality per year lived, but the connection is not causal." According to lead author Matthew Fernandez, “This is a significant finding as many people think that back pain is not life-threatening.” Previous research has suggested that chronic pain can wear down peoples’ immune systems and make them more vulnerable to disease.
 
Spinal fusion
 
While recognizing that a relatively small group of elite spine surgeons, mostly from premier medical institutions, regularly carry out essential complex surgeries required for dire and paralysis-threating conditions such as traumatic injuries, spinal tumors, and congenital spinal abnormalities, the majority of procedures undertaken by a significant number of spine surgeons have been elective fusion procedures for people diagnosed with pain, which is referred to as “axial”, “functional” and “ non-specific”.  People most likely to benefit from spine surgery are the young, fit and healthy. This is according to a study undertaken by the American Spine Research Association. Notwithstanding, the study also suggests that the typical American candidate for spinal fusion surgery is an overweight, over 55 year old smoker on opioids.
 
Steady growth projected for the spinal fusion market

The spine surgery market is relatively mature and dominated by a few global corporations: Medtronic, DePuy, Stryker, and Zimmer-Biomet. According to a 2017 report from the consulting firm GlobalData the market for spinal fusion, which includes spinal plating systems, interbody devices, vertebral body replacement devices, and pedicle screw systems is set to rise from approximately US$7bn in 2016 to US$9bn by 2023, representing a compound annual growth rate of 3.4%. The increasing prevalence of age-related degenerative spinal disorders, and continued technological advances in spinal fusion surgeries, such as expandable interbody cages and navigation systems, and the increased adoption of minimally invasive techniques, have driven this relatively steady market growth.
 
Spinal fusion surgery

Lumbar spinal fusion surgery has been performed for decades. It is a technique, which unites - fuses - 1 or more vertebrae to eliminate the motion between them. The procedure involves placing a bone graft around the spine, which, over time, heals like a fracture and joins the vertebrae together. The surgery takes away some spinal flexibility, but since most spinal fusions involve only small segments of the spine the surgery does not limit motion significantly.
 
Lumbar spinal fusion

Fusion using bone taken from the patient - autograft - has a long history of use, results in predictable healing, and currently is the “gold standard” source of bone for a fusion. One alternative is an allograft, which is cadaver bone that is typically acquired through a bone bank. In addition, several artificial bone graft materials have been developed, and include: (i) demineralized bone matrices (DBMs), which are created by removing calcium from cadaver bone. Without the mineral the bone can be changed into putty or a gel-like consistency and used in combination with other grafts. Also it may contain proteins that help in bone healing; (ii) bone morphogenetic proteins (BMPs), which are powerful synthetic bone-forming proteins that promote fusion, and have FDA approval for certain spine procedures, and (iii) ceramics, which are synthetic calcium/phosphate materials similar in shape and consistency to the patient’s own bone.
 
Different approaches to fusion surgery

Spinal fusion surgery can be either minimally invasive (MIS) or open. The former is easily marketable to patients because smaller incisions are often perceived as superior to traditional open spine surgery. Notwithstanding, open fusion surgery may be performed using surgical techniques that are considered "minimally invasive", because they require relatively small surgical incisions, and do minimal muscle or other soft tissue damage. After the initial incision, the surgeon moves the muscles and structures to the side to see your spine. The joint or joints between the damaged or painful discs are then removed, and then screws, cages, rods, or pieces of bone grafts are used to connect the discs and keep them from moving. Generally, MIS decreases the muscle retraction and disruption necessary to perform the same operation, in comparison to the traditional open spinal fusion surgery, although this depends on the preferences of individual surgeons. The indications for MIS are identical to those for traditional large incision surgery. A smaller incision does not necessarily mean less risk involved in the surgery.

There are three main approaches to fusion surgery, (i) the anterior procedure, which approaches your spine from the front and requires an incision in the lower abdomen, (ii) a posterior approach is done from your back, and (iii) a lateral approach from your side.
 
Difficulty identifying source of back pain
 
A major obstacle to the successful treatment of spine pain by fusion is the difficulty in accurately identifying the source of a patient’s pain. The theory is that pain can originate from spinal motion, and fusing the vertebrae together to eliminate the motion will get rid of the pain. Current techniques to precisely identify which of the many structures in the spine could be the source of a patient’s back pain are not perfect. Because it can be challenging to locate the source of pain, treatment of back pain alone by spinal fusion is somewhat controversial. Fusion under these conditions is usually viewed as a last resort and should be considered only after other nonsurgical measures have failed.
 
Spinal fusion surgery is only appropriate for a very small group of back pain sufferers

Nick Thomas, also a consultant neurosurgeon at King’s College Hospital Trust, London and the London Neurosurgery Partnership suggests there are a scarcity of preoperative tests to indicate whether spinal lumbar fusion surgery is appropriate, and stresses that spinal fusion is appropriate only for a small group of patients who present with back pain.
 
“The overwhelming majority of patients who present with low back pain will be treated non operatively. In a few very select cases, spinal fusion may be appropriate. A challenge in managing low back pain is that there are precious few pre-operative investigations that give a clear indication of whether a spinal fusion may or may not work. Even with MRI evidence it can be very difficult to determine whether changes in a disc are the result of the normal process of degeneration or whether they reflect a problem that might be generating the back pain. If patients fail to respond to non-operative treatments they may well consider spinal fusion. A very small group of patients, who present with a small crack in one of the vertebrae bones - pars defect - or slippage of the vertebrae - spondylolisthesis - may favorably respond to spinal fusion. In patients where the cause of the back pain is less clear the success rate of spinal fusion is far less.” See video:
 
 
Back pain industry

In a new book entitled Crooked published in 2017, investigative journalist Cathryn Jakobson Ramin suggests that the US $100bn a year back pain industry is, “often ineffective, and sometimes harmful”. Ramin challenges the assumptions of a range of therapies for back pain, including surgery, epidurals, chiropractic methods, physiotherapy, and analgesics. She is particularly damning about lumbar spinal fusion surgery.  In the US 300,000 of such procedures are carried out each year at a cost of about $80,000 per surgery. Ramin suggests these have a success rate of 35%.
 
Over a period of 6 years Ramin interviewed spine surgeons, pain specialists, physiotherapists, and chiropractors. She also met with patients whose pain and desperation led them to make life-changing decisions. This prompted her to investigate evidence-based rehabilitation options and suggest how these might help back pain sufferers to avoid the range of current therapies, save time and money, and reduce their anxiety. According to Ramin people in pain are poor decision makers, and the US back pain industry exemplifies the worst aspects of American healthcare. But this is changing.
 
New Guidelines for LBP
 
In February 2017, the American College of Physicians published updated guidelines, which recommended surgery only as a last resort. Also, it said that doctors should avoid prescribing opioid painkillers for relief of back pain, and suggested that before patients try anti-inflammatories or muscle relaxants, they should try alternative therapies such as exercise, acupuncture, massage therapy or yoga. Doctors should reassure their patients that they would get better no matter what treatment they try. The guidelines also said that steroid injections were not helpful, and neither was paracetamol, although other over-the-counter analgesics such as aspirin or ibuprofen could provide some relief. The UK’s National Institute for Health and Care Excellence (NICE) has also updated its guidelines (NG59) for back pain management. These make it clear that in a significant proportion of back pain surgeries is not efficacious. The new guidelines instruct doctors to recommend various aerobic and biomechanical exercise, NHS England and private health insurers are changing their reimbursement policies. As a consequence the incidence of back surgeries have fallen significantly.
 
In perspective

Syed Aftab, a Consultant Spinal Orthopaedic Surgeon at the Royal London, Barts Health NHS Trust, welcomes the new guidelines, but warns that, “We should be careful that an excellent operation preformed by some surgeons on some patients does not get ‘vilified’. If surgeons stop preforming an operation because of the potential of being vilified, patients who could benefit from the procedure lose out”.
 
Surgical cycle

“There seems to be a 20-year cycle for surgical procedures such as lumbar fusion. The procedure starts, some patients benefit and do well. This encourages more surgeons to carry out the procedure. Over time, indications become blurred, and the procedure is more widely used by an increasing number of surgeons. Not all patient do well. This leads to surgeons being scrutinized, some vilified, the procedure gets a bad name, surgeons stop preforming the operation, and patients who could benefit from the procedure lose out,” says Aftab, who is also a member of Complex Spine London, a team of spinal surgeons and pain specialists who focus on an evidence based multidisciplinary approach to spinal pathology.
 
Takeaway
 
LBP is a common disabling and costly health challenge. Although therapies are expensive, not well founded on evidence, and have a relatively poor success rate, their prevalence has increased over the past 2 decades, and an aging population does not explain this entirely. Although the prevalence of lumbar spinal fusion surgery has decreased in resent years, the spine has become a rewarding source of income for global spine companies, and also there have been allegations of conflicts of interest in this area of medicine. With the new UK and US guidelines the tide has changed, but ethical questions albeit historical still should be heeded.
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4 years, 9 months ago

CoVID-19 Reduces The UK’s Primary Care Crisis

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  • The coronavirus CoVID-19 has created the greatest health-cum-economic-cum-societal crisis in history and put unprecedented pressure on overstretched and unprepared healthcare systems
  • Before the coronavirus outbreak, primary care in England already was in crisis, fuelled by an aging population, a large and increasing demand for its services and a shrinking supply of health professionals
  • In 2019, before the outbreak, 75% of primary care doctors (GPs) across 540 clinics in England were over the age of 55 and nearing retirement and a large percentage of newly trained GPs were seeking employment abroad
  • Patients who could not get GP appointments used A&E departments as convenient drop-in clinics for minor ailments, which significantly increased healthcare costs and burden
  • For decades successive UK governments have tried in vain to transform the nation’s primary care services predicated upon face-to-face patient-doctor consultations
  • Several well-funded long-term national plans advocated increased digitization of some routine primary care services
  • But before the coronavirus outbreak only 1% of all primary care consultations were online
  • What these national plans could not achieve in decades appears to have been achieved in days by the UK’s NHS’s response to the coronavirus outbreak
  • Today, millions of patients in England are having face-to-face appointments with their GPs replaced by telephone or video consultations
  • Could CoVID-19 transform the UK’s traditional primary care model?

 

Introduction
 
The UK’s National Health Service’s (NHS) response to the coronavirus CoVID-19 outbreak might improve the nation’s crisis ridden primary care service. This became evident in March 2020, when the UK government ordered all citizens except key workers to stay at home. At the same time, NHS England announced its ‘battle plan’ for CoVID-19, which recommended that England’s 7,000 primary care clinics start conducting as many remote consultations as soon as possible.  In a matter of days, millions of patients had face-to-face appointments with their GP replaced by telephone or video consultations. If this shift to online consultations becomes permanent then the NHS’s response to the coronavirus would have achieved in days what well-funded national healthcare plans, such as the NHS Digital First Primary Care drive, could not achieve in decades.
 
Future healthcare is digital
 
For years, the benefits of online doctor-patient consultations have been advocated by  Devi Shetty, a world-renowned heart surgeon and  founder and chairman of Narayana Health, one India’s largest hospital groups.  According to Shetty, “The next biggest thing in healthcare is not going to be a ‘magic’ pill, a faster scanner or a new operation but information technology (IT). IT will dramatically change the way a health professional will interact with a patient. Every step of patient care will be informed by a protocol embedded in a smartphone. This will make healthcare safer for the patient and remove a lot of traditional dace-to-face healthcare activities and shift healthcare away from the clinic and into the home. Doctors and patients don't need to be together; they could be in their respective homes and effective consultations could take place online.” (see video below)
 
The next ‘big thing’ in healthcare
 
The coronavirus CoVID-19
 
In December 2019, initial reports of a new coronavirus - CoVID-19 - emerged  when patients from Wuhan, the sprawling capital city of China’s Hubei province, which has a population of some 11m, presented with pneumonia of unknown origin. By December 2019 the virus had spread to other countries and on 11th March 2020, the World Health Organization characterised the outbreak as a pandemic. CoVID-19 is an illness caused by a member of the coronavirus family that has never been encountered before but is believed to come from animals.There have been other coronaviruses. For example, severe acute respiratory syndrome (Sars) and Middle Eastern respiratory syndrome (Mers) are both caused by coronaviruses that came from animals. In 2002, Sars spread virtually unchecked to 37 countries, causing global panic, infecting more than 8,000 people and killing about 800, but it soon ran itself out. Mers first emerged in 2012, cases of which have been occurring sporadically since. Mers appears to be less easily passed from human to human, but has greater lethality, killing 35% of about 2,500 people who were infected. CoVID-19 is different to Sars and Mers in that the spectrum of disease is broader, with around 80% of cases leading to a mild infection. There may also be many people carrying the disease and displaying no symptoms, making it even harder to control. CoVID-19 affects your lungs and airways and can cause pneumonia. So, people with an  inflammatory lung disease that causes obstructed airflow from the lungs, such as asthma and chronic obstructive pulmonary disease (COPD), are particularly vulnerable; as are people with weak immune systems, which make them susceptible to infections that might be more severe or harder to treat. In January 2020, China’s national health commission confirmed human-to-human transmission of CoVID-19, and there have been such transmissions in countries throughout the world. Those who have fallen ill are reported to suffer a general feeling of being unwell, fever, dry cough, tiredness, breathing difficulties and a loss of taste and smell. In roughly 14% of cases the virus causes severe disease, including pneumonia and shortness of breath. In about 5% of patients it is critical, leading to respiratory failure, septic shock and multiple organ failure. As this is viral pneumonia, antibiotics are of no use. The antiviral drugs we have against flu will not work. Recovery depends on the strength of your immune system. Many of those who have died were already in poor health. Initially, scientists were challenged to accurately assess how dangerous CoVID-19 was because there were inadequate data. A challenge  to  collecting data was because of a shortage of tests and also because people who had contracted the coronavirus were emitting, or “shedding,” infectious viruses early in the progression of the illness; sometimes before they develop symptoms.

The 1918 Spanish Influenza remains the most devastating virus in modern history. The disease swept around the globe and is estimated to have caused between 50m and 100m deaths. A cousin of the same virus was also behind the 2009 swine flu outbreak, thought to have killed as many as 0.58m. Other major viral outbreaks include the Asian flu in 1957, which led to roughly 2m deaths and the Hong Kong flu, which killed 1m people 11 years later. 
 
In this Commentary
 
This Commentary is produced by HealthPad, which is an online health solutions company. (see below). We begin the Commentary by briefly describing the underlying reasons for the UK’s primary care crisis, which include: (i)  the changing and aging population and the consequent increased demand for healthcare, (ii) the shrinking supply of health professionals, and (iii) failing national initiatives to improve the provision of primary care. We then draw attention to some well funded national plans, whose intentions have been to harness the power of information and digital strategies to reform and improve primary care services in England. We also cite research, which suggests that these plans have failed. The Commentary briefly describes a number of innovative online healthcare solution companies, (HealthPad is one).  The majority of these are private initiatives, which have taken advantage of the UK’s high smartphone penetration rates and advanced wireless networks to enter the UK’s healthcare market with an intention to transform the sector. Notwithstanding, to-date the overall impact of these companies has been marginal, due in part, to the general resistance of private enterprises playing a significant role in England’s public NHS, which offers free healthcare to all citizens at the point of care. However, they represent a nascent UK online healthcare solutions market, which is well positioned to benefit from the nation’s response to the coronavirus outbreak, which has forced more primary care services to be delivered online. To increase their footprint these companies, which are largely driven by technology, will need to become more strategic and consolidate. And this will take time. We conclude the Commentary by looking to China and WeDoctor to understand the potential that online services can make to the delivery of healthcare in England. WeDoctor is a Chinese mobile app launched in 2010 to help patients book doctor appointments. Over the past decade it has added more functions to help unclog China’s fragmented and bureaucratic healthcare system and has become a US$5.5bn healthcare company, which connects some 210m registered users with 360,000 doctors.
 
UK’s primary care crisis
 
There are three drivers to the UK’s primary care crisis: (i) the changing and aging population, which increases the demand for healthcare, (ii)  the shrinking supply of healthcare professionals to a point where GP workloads are becoming unsafe, and (iii) failing national initiatives to improve the provision of primary care. Let us briefly describe these.
 
Changing and aging population
 
The UK’s population is changing and aging, which is fuelled by improvements in life expectancy and a decrease in fertility. According to the UK’s Office of National Statistics, in 2016, there were 12m UK residents aged 65 years and over, representing 18% of the total population. 25 years before, in 1991, there were 9m, accounting for 16% of the population. By 2040, it is projected that there will be an additional 8m people aged 65 years and over in the UK: a population roughly the size of present-day London, which will account for 25% of the total population.
 
A report by Deloitte,  a consultancy, suggests that as people age so their propensity for illness increases and more than a quarter of the UK’s population of some 66m have long-term chronic illnesses. This places a significant extra burden on the nation’s overstretched primary care services by utilizing about half of all GP appointments. Deloitte’s analysis is supported by a British Medical Association’s 2019 GP Patient Survey, which found that GP clinics are now caring for 0.72m more patients than they were in 2018. Findings of a 2016 report by the UK’s Royal College of General Practitioners (RGCP), suggest that GPs see 1.3m patients a day and do more than 370m consultations annually: 60m more than in 2010. A research study on GP productivity carried out by the King’s Fund and also published in 2016, suggested that between 2010 and 2015 the total number of telephone consultations increased by 15%, but still only accounted for 1% of all patient-doctor consultations.
 
Shrinking supply of GPs
 
As the UK’s population has grown and aged and the consequent demand for healthcare has increased, so there has been a sustained fall in the number of GPs. This  dynamic is described in a Nuffield Trust report published in May 2019, which confirms the findings of a joint report from the Institute of Fiscal Studies and the Health Foundation for the NHS Confederation, which concluded that, “The fall in GPs per person reflects insufficient numbers previously being trained and going on to join NHS England, failure to recruit enough from abroad and more GPs leaving for early retirement”. As to the future, a  2019 report by three leading think tanks - the Nuffield Trust, the Health Foundation and the King's Fund - predicts that GP shortages in England will almost triple to 7,000 by 2024. According to NHS Statistics, Facts and Figures, currently there are just over 42,000 GPs working in England, down by nearly 1,500 since 2016.
 
Failure to stop or slow these trends means today, primary care services in England struggle with staff shortages and a rising demand for care. A 2019 Pulse Magazine survey found that  GPs in England are seeing more patients than is safe. A probe undertaken by The Times in 2019 suggested that the  national shortage of GPs has left some surgeries with one permanent doctor caring for as many as 11,000 patients and one in 10 GPs are seeing up to 60 patients a day, double the number considered safe.
 
GPs across the UK work an average 11-hour day. In that time, they typically see patients for 8 hours and spend the other 3 on administrative tasks such as checking test results and reading letters sent by hospitals.  A 2019 British Medical Association survey found that more than 80% of GPs said the pressure to attend to multiple tasks at once meant they were unable to guarantee safe care, while 91% said excessive workload was the main reason the NHS was struggling to recruit enough staff. The situation has resulted in patients having to wait longer - up to three weeks - for a GP consultation. It seems reasonable to suggest that GPs with too many patients and using traditional face-to-face delivery methods will fail in their duty of care, which obliges them to inform patients about their health and reach shared clinical decisions about treatments. This requires that patients understand their condition/s and are well informed. In many cases, a 10-minute  face-to-face GP consultation might not be the best way to achieve this.
 
Failing national initiatives to improve primary care
 
Subsequent UK governments have struggled to reduce the primary care crisis with well funded national plans. In 2019, the British Medical Journal published findings of a survey to report UK GPs’ views and experience of national healthcare initiatives introduced in England to address the workforce crisis in general practice. The survey was conducted in the same region as a similar survey undertaken in 2014. This allows for a comparative analysis to see how GPs’ views have changed over time. Findings confirm that primary care in England remains in crisis and suggest that numerous national initiatives to improve general practice are perceived by GPs as, “reactive in approach”. To reduce the primary care crisis, respondents suggested, “more GPs and better education of the public". 
 
The UK’s NHS
 
Healthcare in the UK is mainly provided by the National Health Service (NHS), which is a vast public institution funded largely from general taxation to the tune of some £134bn (US$161bn) a year. Created in 1948, the NHS  provides free health services at the point of care for everyone living in the UK and has become the largest single payer health system in the world, and the biggest employer in the UK with 1.2m full time equivalent (FTE) workers, which is the fifth-largest workforce in the world. NHS England is a vast bureaucratic and fragmented organisation, which has proven difficult to change. Private provision of NHS services has always been controversial, even though some services, such as dentistry, optical care and pharmacy, have been provided by the private sector to the NHS for decades and most GP practices are private partnerships. It is challenging to determine how much the NHS spends each year on the private sector because central bodies do not hold detailed information on individual contracts with service providers, especially where these contracts may cover relatively small amounts of activity and spending. Notwithstanding, estimates suggest the share of the NHS’s total revenue budget that is spent on private providers is about 7.3%. 

National plans to improve the NHS
 
The planning and authorising of NHS services is the responsibility of regional Clinical Commissioning Groups (CCGs). Although CCGs are constantly changing because of mergers, as of 2019, there were 191 CCGs in England supporting about 7,000 primary care clinics, some 42,000 GPs and about 15,800 FTE nurses who work in GP clinics, and 1,257 hospitals, which include NHS Trust-managed hospitals and private hospitals that provide services to the NHS. In total, the NHS employs around 150,000 doctors  and over 320,000 nurses and midwives.
 
Successive UK governments have been aware of the impact of technological advances, changing healthcare needs and societal developments on healthcare and have introduced a succession of well-funded national plans to change and improve the NHS. For example, in June 2018, the UK’s Prime Minister announced a new five-year funding settlement for the NHS that amounted to an extra £20.5bn (US$25.2bn) between 2019 and 2024, which represents a 3.4% real average annual increase.
 
NHS long term plan to transform primary care
 
To unlock the funding, national bodies were asked to develop a long-term plan to help the NHS cut costs and improve services. The suggested plan articulated the need to integrate care in order to meet the needs of a changing population and was in line with the Forward View, a planning document published in 2014 and the General practice forward view,which was first published in 2016 and updated in subsequent years. The long-term plan committed the government to an extra £2.4bn (US$3bn) a year to speed up the transformation of primary care and suggested GP clinics join together to form networks typically covering 30,000 to 50,000 patients and provide them with multidisciplinary integrated care. The plan also suggested ‘significant changes’ in the existing performance management and payment of NHS GPs [the Quality and Outcomes Framework (QOF)] in order to encourage more personalised care.
 
NHS long term plans and private online healthcare solution companies have delivered little change
 
Three of five principal objectives of the latest NHS long term plan are to: (i) “give people more control over their own health and the care they receive”;  (ii) “increase the contribution to tackling some of the most significant causes of ill health, including new action to help people stop smoking, overcome drinking problems and avoid Type 2 diabetes”, and (iii) “provide more convenient access to services and health information for patients”.

The plan emphasises the importance of developing digital services, and recommends that within five years, all patients should be able to access GP consultations via a telephone or online. This goal is supported by NHS Digital, which is the national information and technology partner to the UK’s health and social care system. Its mission is to harness the power of information and technology to improve healthcare. Over the past decade there has been an increasing number of innovative online private  healthcare solutions companies entering the market. (see below). Notwithstanding, these and the NHS’s well-funded national plans, have failed to dent the primary care crisis by slowing the vast and escalating demand for healthcare and reversing the shrinking supply of healthcare professionals. So, for the past two decades at least, the NHS has tended to operate on the cusp of a crisis.
 
The death of distance
 
According to Deloitte, the UK has more than 90% smartphone penetration. The main driver of high smartphone adoption rates is the take-up among older age groups. By 2023 smartphone ownership among 55-to-75-year-olds will reach 85% in the UK, and the difference in smartphone penetration by age will disappear. Further, the UK’s smartphone market has seen a greater variety of choice of models and the introduction of faster and more reliable wireless networks. This has benefited the online private healthcare solution companies, which have entered the UK market to provide varying degrees of qualified online healthcare information, consultations, networking opportunities, triage and Q&A. According to Shetty, “A doctor only needs to touch a patient if s/he is going to operate on that patient. If a doctor doesn’t need to operate, a doctor-patient consultation can take place remotely. For a patient-doctor communication distance doesn’t matter.” (see video below)
 

 A doctor only needs to touch a patient if s/he is going to operate on that patient
 
Innovative online healthcare solution enterprises
 
The new online healthcare solution enterprises are a combination of private, public and charitable initiatives, which are well positioned to contribute to the transformation of the UK’s traditional primary care model and include: Babylon Health, which provides remote consultations with doctors and healthcare professionals via text and video; BioBeats, a workplace wellbeing platform designed to empower and improve mental health; Docly, a digital messaging healthcare service, which is a spin-off of Min Doktor; Doctorlink, which partners with payers, healthcare professionals and pharmacists to provide a 24-7 platform for NHS patients to assess symptoms; DrDoctor, a patient engagement platform, which enables patients to book, change and cancel their appointments; EggPlant, a software testing and monitoring company, which helps to streamline patient activities; Dr Fox, an online primary care clinic and pharmacy service; Gogodoc, an online GP video consultation service with possible follow-up home visits; Healthcare Communications UK, which provides appointment management software and patient experience surveys; HealthPad, an online platform that manages and distributes healthcare video information between health providers and patients in order to improve outcomes and cut costs, and has accrued a proprietary content library of over 6,000 short videos contributed by leading clinicians that address peoples FAQs across some 30 therapeutic pathways, (HealthPad is the publisher of this Commentary).  HealthTalksOnline, an events and community portal for health; HealthUnlocked, a social networking service that offers peer support to help people manage their health; Healum provides healthcare professionals with a software, which enables them to support and motivate their patients to better manage their conditions; LIVI, provides GP video consultations; Medshr, a platform for medical professionals to discover, discuss and share clinical cases and medical images; Microtest Health, a health informatics company that provides practice management systems for NHS GP surgeries. MSKnote Limited creates clinical applications for healthcare professionals and patients with a focus on musculoskeletal conditions; MyWay Digital Health provides advice and solutions to help patients better manage diabetes; NHS.uk/conditions provides online text-based information and advice about medical conditions; NHS 111, a free-to-call medical helpline; the Now Healthcare Group, a GP video consultation platform and tele-pharmacy; Patient Access, which started by enabling patients to book GP appointments online and order repeat prescriptions and has evolved to allow patients to connect with their GPs remotely and access their medical records online; Patientinfo provides patients and health professionals with online health information. PatientAccess and Patientinfo are subsidiaries of EMIS Health, a leading supplier of  software used by NHS England; Patients Know Best, a social enterprise, which provides patients with access to their medical records and information about treatments; PatientsLikeMe, an online service that helps patients find people with similar health conditions in order to take actions that are expected to improve outcomes; Push Doctor, an online video consultation service; SaySo Medical is a digital communications agency, which connects people in order to improve their health; SystmOne, a centrally hosted computer system that provides primary care professionals with electronic patient health records in real time at the point of care; uMotif, a platform that captures electronic patient-reported outcomes data across a range of conditions and works with pharmaceutical companies to measure patient’s health, outcomes and experience; Unmind, a workplace mental health platform designed to  empower organisations and employees to improve their mental wellbeing; Visiba Care, a digital solutions company, which provides communication and administration software for healthcare practices; VisionHealth provides NHS primary care professionals with software solutions; VisualDX provides clinical decision support systems to enhance diagnoses and therapeutic decisions in order to improve patient safety; WebMD, an online publisher of healthcare news and information, and Zava, an online GP and pharmacy service.
 
 Technologically heavy and strategically light
 
Despite a significant number of online healthcare solution enterprises entering the market and the fact that some provide services to millions of people in the UK, this market segment is in its infancy and fragmented. All the initiatives mentioned above have been advantaged by the NHS’s response to the coronavirus outbreak. Notwithstanding, to permanently increase their footprint and significantly influence primary care in England, barriers to private enterprises and to online services will need to be reduced; and private companies in this segment will need to act more strategically and consolidate.
 
Most of these online healthcare service providers are technologically heavy and strategically light. For private companies in this market to grow and increase their influence on the NHS they will need to increase their focus on profitability and scale, which will require them to become more strategic and develop merger-integration skills. To become a dominant player, a company will have to successfully consolidate. Speed and merger competence are paramount. Companies that capture critical ground early and move up the consolidation curve the fastest will be successful. Enterprises that are slow to consolidate will become acquisition targets and disappear. Companies that stay out of the consolidation contest altogether will not survive.

A Chinese example
 
History has shown that many short-term emergency measures have a tendency to  become permanent fixtures. Thus, the UK’s response to the coronavirus CoVID-19 outbreak might permanently reduce the barriers to moving routine primary care tasks to innovative private online enterprises.
 
In an attempt to fully appreciate the potential of increasing online primary healthcare services in England, consider WeDoctor, a Chinese mobile app launched in 2010 by artificial intelligence expert Jerry Liao. Originally called Guahao (Mandarin for “booking”), WeDoctor started as a simple booking platform that made it easier for patients to make appointments with doctors. From these humble beginnings WeDoctor grew by adding extra functions such as reminders for regular medical checks, screening, prescriptions and online diagnoses and consultations. This helped to unclog China’s fragmented and bureaucratic healthcare system and made quality healthcare more accessible to the average person.
 
WeDoctor secured backing from Tencent Holdings, a Chinese multinational conglomerate, Sequoia Capital, the Goldman Sachs Group and the insurer AIA Group. In 2018, the company raised US$0.5bn in a private financing round at a valuation of US$5.5bn. Today, WeDoctor has more than 210m registered users mainly in China for its online appointment booking, prescription and diagnosis services and is linked to about 3,200 hospitals and 360,000 doctors. In March 2020, at the height of the CoVID-19 pandemic, it was reported that, in the latter half of 2020, WeDoctor intends to raise HK$1bn in an IPO on the Hong Kong Stock Exchange at a valuation of HK$10bn.
 
Although NHS England is much smaller than China’s healthcare provision, it is similarly fragmented and bureaucratic. The UK online solutions enterprises described in this Commentary have significant potential simply by helping to reduce GPs large and increasing burden of administration while increasing the connectivity between patients and GPs. This will help GPs to concentrate on what they have been trained to do and improve healthcare for people in most need.
 
Takeaways
 
Over the past two decades, legacy primary care systems and attitudes in the UK have slowed the uptake of online healthcare solutions. Notwithstanding, the NHS’s response to the coronavirus CoVID-19 outbreak might prove to have helped to transform the UK’s traditional face-to-face primary care model by making GPs deliver some of their services online. In a recent interview with the New York Times, Dr Bruce Aylward, Assistant Director-General of the World Health Organization, stressed how the Chinese had responded to the coronavirus outbreak by significantly increasing the amount of medical care the nation provides online.  In light of the discussion in this Commentary, be minded that in Mandarin the word “crisis” is denoted by two characters: 危机, one means ‘disaster’ and the other means ‘opportunity’.
 
 
#coronavirus #coVID-19 #NHSEngland #NHS #pandemic #primarycarecrisis #ChinaWeDoctor #WeDoctor #DigitalHealthcare 
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2 years, 2 months ago

Brain disorders and the changing nature of neurosurgery

HealthPad
Directory:
Neurosurgery
Tags:
aneurysm
brain disorders
brain tumour
commentary
Gamma Knife radiosurgery
neurosurgery
stereotactic neurosurgery
traumatic brain injury
  • Neurosurgery is a discipline that diagnoses and treats a range of injuries and disorders of the brain and the central nervous system
  • For millennia the speciality was dominated by forms of craniotomies, which are procedures to remove portions of the skull to gain access to brain disorders
  • In the early and mid-20th century visual, guidance and radiation technologies disrupted the treatment of some brain disorders by introducing less- and non-invasive procedures to the discipline
  • At the beginning of the 21st century, a flurry of rapidly developing innovative technologies including, augmented reality, artificial intelligence (AI), robotics and genomic and cellular therapies, are accelerating the trajectory of neurosurgery towards a less- and non-invasive speciality
 
Brain disorders and the changing nature of neurosurgery
 
Populations throughout the world are growing and aging, the prevalence of age-related disabling neurological disorders is increasing, and healthcare systems are facing large and escalating demands for treatment, rehabilitation, and support services for such disorders. According to the most recent Global Burden of Disease (GBD) Study, neurological disorders are the leading cause of disability and the second leading cause of death in the world.
 
The total annual global burden of traumatic brain injury alone is ~US$400bn and in the US, ~16% of households are affected by brain impairment, with many individuals requiring 24-hour care. This suggests that often several family members are involved in the caregiving process, and some are juggling the responsibilities of caregiving, child rearing and employment simultaneously.
 
The scarcity of established modifiable risks for most of this vast and rapidly growing neurological burden suggests that innovations are required to develop efficacious prevention and treatment strategies. This Commentary describes some of these, especially those that have changed or have the potential to change neurosurgery, by making therapies less- and non-invasive, and hold out the prospect of improving patient outcomes and lowering healthcare costs.
 
Neurosurgery is a medical speciality concerned with diagnosing and treating a range of disorders and injuries of the brain and central nervous system (CNS) in patients of all ages. These include tumours of the brain and CNS, infections of the CNS, pituitary tumours and neuroendocrine disorders, traumatic brain injury, cerebral aneurysms and stroke, hydrocephalus and other conditions that affect the flow of cerebrospinal fluid, degenerative spine disorders, Parkinson’s disease, Alzheimer’s, epilepsy, spina bifida, and psychiatric disorders.

Treating brain conditions is complex and challenging. This is partly because the brain is one of the best protected organs of the human body. It is encased in the bones of the skull, covered by the meninges, which consist of three membranes and cushioned by cerebrospinal fluid (CSF). It is also protected by the blood-brain barrier (BBB), which is a network of blood vessels and tissue comprised of closely spaced cells, which shield the brain from toxic substances in the blood, supply brain tissue with nutrients, and filter harmful compounds from the brain back into the bloodstream. The BBB limits the ability of therapeutics to be effectively delivered to the brain and thereby complicates the treatment of CNS disorders. Further, the brain does not feel pain because there are no nociceptors (a sensory receptor for painful stimuli) located in its tissue, which often makes diagnosis of neuro disorders late when treatment becomes more challenging and costly, and survival less likely.

Such factors partly explain why neurology and neurosurgery have been slower than some other specialities to take advantage of new and evolving technologies. However, this is changing. Over the past five decades, progress in three-dimensional (3D) visualization, miniaturisation, digital technology, robotics, computer assisted manipulation, radiation therapy, early diagnosis of cancer, and precision medicine, have contributed to improvements in the diagnosis, prognosis, and prevention of some neurological conditions and started to transform neurosurgery towards less- and non-invasive procedures that efficaciously execute complex challenges, eliminate mechanistic errors, reduce operating times, and improve patient outcomes.
 
Further, the growing significance of applying artificial intelligence (AI) and machine learning techniques to pre-, intra- and post-operative clinical data introduces the possibility of a new suite of medical services that have the potential to enhance patient outcomes and reduce costs by improving diagnosis, planning and the rehabilitation of patients. And more recently, there are growing synergies between neurosurgery and gene and cellular therapies, which promise to accelerate personalized, non-invasive treatments for a range of neuro disorders.
 
In this Commentary
 
This Commentary is divided into 9 sections. Section 1 provides a brief history of neurosurgery, which has its genesis in ancient times when a form of craniotomy (surgical removal of a portion of the skull) was practiced and note the difference between craniotomy and craniectomy. Section 2 describes how, in the mid-20th century, neurosurgery took ~4 decades to pivot when Lars Leksell, a Swedish surgeon, introduced a stereotactic guided device that permitted the accurate positioning of probes to treat small targets in the brain, which were not amenable to conventional surgery. Shortly afterwards Leksell developed ‘stereotactic radiotherapy’, which formed the basis the Gamma Knife®, a device that provides non-invasive surgeries for a range of brain disorders. Section 3 details how advances in magnification, illumination, and the development of fibreoptics contributed to less-invasive endoscopic neurosurgeries, which facilitated a range of brain disorders to be treated through a small burr hole in the skull. Previously such procedures would have required a craniotomy. This section also notes the rapid development of endovascular neurosurgery, which uses tools that pass-through blood vessels to diagnose and treat diseases and conditions of the brain rather than using open surgery. Today, neuro-endovascular surgery is the most practiced therapeutic approach for a range of vascular conditions affecting the brain and spinal cord and is positioned to grow further over the next decade. Section 4 suggests howneurosurgery has benefitted from a range of rapidly developing 21st century technologies including: augmented reality, artificial intelligence (AI), robotics and genomic and cellular therapies. All help to increase less- and non-invasive neurosurgical procedures and contribute to advancing personalized therapies that improve patient outcomes and lower costs. Section 5 provides some insights into the life of a neurosurgeon through the lens of Henry Marsh, an English neurosurgeon who, between 2014 and 2022, published three candid memoirs, which chronicle his career, describe daily challenges and frustrations of the speciality and explain how neurosurgical units have changed the way they are organized and run. Sections 6 briefly mentions the increasing prevalence of dementias. Although outside the direct realm of neurosurgery, the scale and speed of their growth are likely to have an indirect impact on it. Section 7 introduces traumatic brain injury (TBI), a condition caused by a blow to the head and suffered by millions. The section describes the gold standard management of severe TBI and flags a pressing need to develop a non-invasive modality for managing the condition. Section 8 notes the frustration of neurosurgeons with the late diagnosis of brain tumours and describes well-resourced global endeavours to detect a wide range of cancers from a single blood test in asymptomatic people. Takeaways follow in Section 9 and suggest that a significant proportion of neurological disorders, which previously were treated with craniotomies, are now treated with either less- or non-invasive procedures. With the speed at which technology and biomedical science are developing, the only direction of travel for neurosurgery is towards non-invasive procedures.
 
Section 1
History
 
Neurosurgery has a long history with its genesis in Mayan civilizations ~1500 BCE, who practiced cranial deformations that included flattening frontal skull bones. During the Egyptian era, when mummification started to be practiced ~2,500 BCE, embalmers did not use a form of craniotomy to gain access to the brain. Instead, they used hooked instruments to remove the brain through the nose: a prototype of modern transsphenoidal surgery, which is a common procedure today for removing tumours of the pituitary gland. Rather than opening the skull with a traditional craniotomy, the physician reaches the tumour through the nasal passages and the sphenoid sinus.
 
In ancient Peru Inca surgeons practiced an early form of craniotomy referred to as trepanation, which used a scraping technique to penetrate the skull. Such procedures were performed on adult men to treat injuries suffered during combat. A version of this procedure called a trephination was also practiced in Egyptian and Roman times and performed on individuals who had experienced head traumas. The approach entails making a hole in the skull to relieve the build-up of intracranial pressure (ICP) caused by brain oedema (swelling) and is described by Hippocrates in the Greek era. The first known neurosurgery in Greece took place ~1900 BCE in Delphi when skull trephinations were probably performed for religious reasons. Later, the technique was recommended by Galen during the Roman period for people who had suffered a traumatic brain injury (TBI) in battle. From ~500 to ~1500 AD, the rise of religion and war resulted in many craniocerebral traumas, which contributed to the early development of neurosurgery as a distinct specialty.
 
Similar trephination procedures were performed during the American Revolutionary War, which secured American independence from Great Britain, and culminated in the Declaration of Independence on July 4, 1776. During the war soldiers suffered TBIs after being hit on the head with the butt of a rifle. Although the treatment for severe TBI is similar today, (see Section 7) the main difference is that the surgical instruments used in the 18th century were not powered. About 132 years later, in 1909, Theodore Kocher, a Swiss physician and Nobel Laureate in Medicine was the first person to systematically describe a decompressive craniectomy procedure for severe TBI patients. A craniectomy is different to a craniotomy. The latter is a surgical procedure in which a section of the skull is removed to expose the brain and is performed to treat various neurological conditions, or when an injury or infection has occurred in the brain. A craniectomy involves a different surgical technique and is used on people suffering severe TBI to relieve brain oedema. In such a procedure the bone fragment removed may not be replaced immediately and is either replaced during a subsequent surgery or discarded in favour of a future reconstruction using an artificial bone.
 
Section 2
Stereotactic surgery
 
For millennia, a form of craniotomy dominated what we now know as neurosurgery. During the 20th century advances in medical science paved the way for the introduction of less- and non-invasive modalities to treat brain disorders (see below). A landmark event occurred at the beginning of the 20th century with the introduction of stereotactic surgery, which makes use of three-dimensional (3D) coordinates to locate and treat lesions in the brain. The method was first reported in the May 1908 edition of Brain, by two British surgeons Victor Horsley, and Robert Clarke. The device they described became known as the Horsley-Clarke apparatus, and was used to study the cerebellum in animals by enabling accurate electrolytic lesioning to be made in the brain of a monkey. It took ~40 years before the technique was introduced to humans following the publication of a seminal paper by Ernest Spiegel and Henry Wycis,  in the October 1947 edition of Science. Spiegel was a Vienna trained neurologist who moved to Temple Medical School in Philadelphia, which in 2015 was renamed the Lewis Katz School of Medicine. Wycis was one of Spiegel’s students who became a neurosurgeon. By the time they published their 1947 paper, they had performed several neurosurgeries and there had been sufficient advances in neurophysiology, pneumoencephalography, radiology, and electrophysiology for them to design a device like the Horsley-Clarke apparatus, which was fixed to a patient’s head by means of a plaster cast and was accurate enough to be used in human stereotactic surgery. Spiegel’s and Wycis’s surgical innovations attracted attention from physicians internationally, but there were no commercial stereotactic frames and neurosurgeons were obliged to design and manufacture their own. A pivotal moment occurred in 1947, when Lars Leksell, a Swedish physician and Professor of Neurosurgery at the Karolinska Institute, in Stockholm, visited Wycis in Philadelphia and afterwards designed a lightweight titanium head frame to provide the basis for stereotactic surgery, which he described in a 1949 paper entitled, ‘A stereotaxic apparatus for intracerebral surgery’.
 
The Gamma Knife®   
In the early 1950s, Leksell and Börje Larsson, a biophysicist from the University of Uppsala, Sweden, were convinced that agents other than cannulas and electrodes could be used to eradicate pathologies in the brain, and combined a source of radiation with a stereotactic guiding device. This led to the development of a non-invasive device, which Leksell used to perform the first radio-neurosurgical procedure and discovered that a single dose of radiation could successfully destroy deep brain lesions. He called this technique “stereotactic radiosurgery”, which, in 1968, led to the first stereotactic Gamma Knife® that used a focused array of intersecting beams of gamma radiation to treat lesions within the brain. Its success encouraged Leksell to use the device over the ensuing decade in functional brain surgeries to treat intractable pain and movement disorders. Leksell’s radio surgical device used Cobalt-60 (a synthetic radioactive isotope) as a radiation source. The basic physics that drives stereotactic radiosurgery today is substantially the same. It focuses ~200 tiny beams of radiation on a target in the brain with submillimetre accuracy. Although each beam has little effect on the brain tissue it passes through, a strong dose of radiation is delivered to the place where the beams meet.
 
Over time, the Gamma Knife® has been refined and enhanced and its efficacy and safety have been well established. Today, the Gamma Knife® provides a non-invasive operative system for a range of brain disorders, including small to medium size tumours, vascular malformations, epilepsy, and nerve conditions that cause chronic pain. Before its introduction such disorders were treated by surgeries, which involved craniotomies. In 1987, the Gamma Knife® was introduced into the US and installed at the Universities of Pittsburgh and Virginia. Although it took decades to achieve regulatory approval and be widely used throughout the world, the Gamma Knife® represents a significant technological advance in neurosurgery. Unlike craniotomies the device provides painless procedures that do not require anaesthesia, treatments take just one session, and patients can return to normal activities almost immediately. The Gamma Knife® is ~90% successful in killing or shrinking brain tumours, and today, there are ~300 Gamma Knife® sites worldwide, which each year treat >60,000 patients.
 
Neurosurgeon Ranjeev Bhangoo, Clinical Director for neurosurgery at King’s College Hospital, London, UK likens the Gamma Knife® to, “an umbrella, that sits above the patient’s head, rather like the old-fashioned hair dryers in women’s hair salons, but much bigger and more complex”, and stresses that the procedure, “is not painful. Forget any notion of surgery: there’s no knife, there’s no operating theatre. It’s done with the patient awake: you walk in, have your treatment, and walk out.” See videos.
 

What is Gamma Knife Radiosurgery?
 

Is Gamma Knife Radiosurgery painful?

 
Section 3
Endoscopic and endovascular neurosurgery
 
Neuroendoscopy
Neurosurgery pivoted again in the 1990s when disorders that would normally require opening the skull began to be treated less invasively through a small burr hole. Improved magnification, miniaturization, and illumination of lenses and the development of fibre optics facilitated an endoscopic surgical procedure to treat hydrocephalus, a condition in which cerebrospinal fluid (CSF) abnormally accumulates in the brain. There is currently no prevention or cure for the condition, but it can be managed with surgery. The procedure includes creating an opening in the floor of the third ventricle using an endoscope (a thin, flexible, tube-like imaging instrument with a small video camera on the end) placed within the ventricular system through a burr hole in the skull. In the late 1990s, neuro-endoscopy expanded to treat lesions outside the ventricular system and the endoscopic endonasal approach was established as a technique that allowed surgeons to go through the nose to operate on areas at the front of the brain and top of the spine.

Since the early use of the endoscopic procedures for treating intrasellar pituitary adenomas, the approach has been expanded to treat a range of skull base lesions. Today, skull base surgery is undertaken to remove both noncancerous and cancerous growths, and abnormalities on the underside of the brain or the top few vertebrae of the spinal column. Because this is such a difficult area to see and reach, skull base surgery has been advantaged by endoscopic procedures where surgeons insert instruments through natural openings in the skull - the nose or mouth - or by making a small hole just above the eyebrow. This type of surgery requires a team of specialists that may include ear, nose, and throat (ENT) surgeons, maxillofacial surgeons, neurosurgeons, and radiologists. Before endoscopic skull base surgery was developed, the only way to remove growths in this area of the body was by making an opening in the skull. In some cases, today, this type of surgery may be still needed.

Recent advances in endoscope design have produced equipment that is smaller and more efficient, with improved resolution and brighter illumination, than earlier models. Such developments, combined with surgeon enthusiasm, have contributed to the expansion of neuro-endoscopy to treat a range of neuro disorders including intracranial cysts, intraventricular tumours, skull base tumours, craniosynostosis (a birth defect in which the bones in a baby's skull join too early), degenerative spine disease, hydrocephalus and a rare benign tumour called hypothalamic hamartoma.
 
Neuro-endoscopic surgery causes minimal damage to normal structures, carries a lower rate of complications, shortens hospital stays, minimizes cosmetic concerns associated with many neurosurgical conditions and improves patient outcomes. It is positioned to take advantage of further miniaturization of cameras and optical technology, innovations in surgical instrumentation design, and further innovation in navigation and robotics systems.
 
Endovascular neurosurgery
Another innovation that has developed over the past five decades is endovascular surgery. The term ‘endovascular’ means ‘inside a blood vessel’. Endovascular neurosurgery uses tools that pass-through blood vessels to diagnose and treat diseases and conditions of the brain rather than using open surgery. The genesis of endovascular neurosurgery is credited to Professor Alfred Luessenhop, an American physician at Georgetown University Hospital in Washington DC, who, in 1964, carried out the first embolization of a cranial arteriovenous malformation and the first intracranial arterial catheterization to occlude an aneurysm. Over the past 60 years, endovascular neurosurgery has developed and has become a subspeciality. Today, >50% of cerebral aneurysms are treated through this minimally invasive approach.
 
Neuro-endovascular surgery has become the most practiced therapeutic approach for the majority of vascular conditions affecting the brain and spinal cord. It is used more frequently than open surgery for the management of complex vascular conditions, with high rates of safety and efficacy. The expansion of endovascular techniques into the treatment of stroke, the third highest cause of death in the US, has provided meaningful benefits to large numbers of patients worldwide. Further, with populations throughout the world aging neuro-endovascular techniques are poised to become one of the most necessary and important treatment modalities within neurosurgery.
 
With age our brains shrink, which causes a space to develop between the surface of our brain and its outermost covering. This increases the possibility that a knock to the head of a person >60 will result in a brain blood vessel rupturing and bleeding: a subdural hematoma. Research suggests that, “significant numbers occur after no significant antecedent trauma”, and could be the result of “an inflammatory process occurring at the level of the dural border cell”. A chronic version of this disorder can manifest itself within weeks of the first bleeding in which blood accumulates. With aging populations, chronic subdural hematoma (cSDH), is a condition predicted to become one of the most common neurosurgical conditions in the near-term future and expected to be treated with neuro-endovascular techniques.
 
Further, minimally invasive neuro-endovascular procedures are now commonly used to repair cerebral aneurysms, which are weak or thin spots on arteries in the brain that balloon and fill with blood. A bulging aneurysm can put pressure on brain tissue, and may also burst or rupture, spilling blood into the surrounding tissue (brain haemorrhage). Today most brain aneurysms are treated minimally invasively with neuro-endovascular techniques, which means an incision in the skull is not required. Instead, the surgeon guides a catheter or thin metal wires through a large blood vessel in the patient’s groin to reach the brain, using contrast dye to identify the problematic blood vessel. The aneurysm is then sealed off from the main artery, which prevents it growing and rupturing. In the US ~6.5m people are living with an unruptured brain aneurysm. The annual rate of rupture is ~10 per 100,000: ~30,000 Americans suffer a brain aneurysm rupture each year. Ruptured cerebral aneurysms are fatal in ~50% of cases and those who survive, ~66% suffer some permanent neurological deficit. Each year, there are ~0.5m deaths worldwide caused by brain aneurysms and ~50% are <50years.
 
Section 4
Evolving technologies affecting neurosurgery

At the beginning of the 21st century scientific and technological advances are again changing the face of neurosurgery. This section briefly describes four such changes.
 
Neurosurgery and augmented reality
Neurosurgery relies on visualization and navigational technologies and makes liberal use of computed tomography (CT) and magnetic resonance imaging (MRI) scans during preoperative planning and intraoperative surgical navigation. More recently, augmented reality (AR) applications have been used to complement more conventional visualization and navigational technologies to enhance neurosurgery. AR can bring digital information into the real environment and is beginning to play an increasing role to help neurosurgeons train, as well as plan and perform complex surgical procedures. In June 2020, surgeons atJohns Hopkins University successfully carried out a spinal fusion surgery for the first time in the US using xvision™, an FDA approved AR device for spine surgery developed by Augmedics Inc., a Chicago based company, which went public in 2020 through a reverse merger with Malo Holdings. Xvision™ allows surgeons to “see” the patient's anatomy through skin and tissue as if they have X-ray vision, to accurately navigate instruments and implants during surgical spine procedures. Each year, there are ~1.62m instrumented spinal procedures performed in the US, the majority of which are undertaken using a freehand technique, which can lead to suboptimal results.  
 
Neurosurgery and artificial intelligence
Such heavy use of advanced imaging and guidance technologies creates a vast amount of clinical data during a patient’s neurosurgical journey. It is not altogether clear how effectively pre-, intra-, and post-operative clinical patient data are collected and analyzed to enhance surgical procedures and patient outcomes. An article in the August 2021 edition of the journal Neuroscienceentitled, ‘Neurosurgery and Artificial Intelligence’, suggests that the collection and analysis of such data are beginning to happen. Over the past decade, AI techniques applied to data collected during patients’ neurosurgical journeys have enhanced diagnoses and prognostic outcomes and contributed to post operative care and the rehabilitation of patients. Being able to predict prognosis, identify potential postoperative complications, and track rehabilitation are enhanced with AI applications. The future suggests that the symbiotic relationship between AI and neurosurgery, which today is in its infancy, is positioned to grow. This will not only help AI to develop better and more robust algorithms but will provide opportunities for MedTechs to gain access to new revenue streams by providing enhanced patient services.
 
Robotics
Linked to medical imaging and navigation technologies is the increasing use of surgical robotics. However, neurosurgery has been slower than other specialties to incorporate robotics into routine practice owing to the anatomical complexity of the brain and the spatial limitations inherent in neurosurgical procedures. Notwithstanding, the first documented use of a robot-assisted surgical procedure was in neurosurgery. In 1985 Yik San Kwoh and colleagues, at the Memorial Medical Center in Long Beach, California, used an Unimation Programmable Universal Machine for Assembly (PUMA) 200 (which was originally designed for General Motors’ factories) to perform a CT-guided stereotactic biopsy of a brain lesion. Although discontinued, the PUMA 200 is considered the predecessor of current surgical robots.  There are now several robotic systems that have gained regulatory approval for cranial surgery. These include Zimmer Biomet’s ROSA ONE Brain, which obtained FDA approval in 2012 for intracranial applications, and Renishaw’s Neuromate robotic system, which was granted approval by the FDA in 2014. The former has been used extensively in the treatment for epilepsy, and the latter provides surgeons with five degrees of freedom for use in stereotactic applications. Robotics is a fast-moving discipline, which together with AI and machine learning, is positioned to impact neurosurgery in the near to medium term.
  
Neuro-pharmaceuticals and Trojan horses
There are growing synergies between neurosurgery, gene, and cellular therapies. However, the BBB, which plays a significant role in controlling the influx and efflux of biological substances essential for the brain to operated effectively, makes it extremely difficult to effectively deliver drugs to the brain. Over the past three decades, many biologics (medications developed from blood, proteins, viruses, or living organisms) have entered brain and CNS clinical studies. However, they have not gained FDA approval mainly because they did not have effective mechanisms to deliver neuro-pharmaceuticals across the BBB. Instead, the clinical trials were predicated upon a variety of BBB avoidance strategies. Cerebrospinal fluid (CSF) injections are the most widely practiced approach that delivers drugs to the brain by attempting to bypass the BBB. However, this results in limited drug penetration to the brain because of the rapid export of CSF from the brain back into the bloodstream. Future drug or gene-based neuro-pharmaceuticals will need to be accompanied by advances in BBB delivery vehicles.
 
Currently, there are numerous scientific endeavours to devise innovative and effective ways to deliver gene therapies across the BBB to the brain. Success in this regard will mean that genomic and cellular therapies will increasingly have the potential to work synergistically with neurology and neurosurgery to provide non-invasive, personalized care for a range of brain disorders including Alzheimer’s, Parkinson’s, spinal muscular atrophy, spinocerebellar ataxia, epilepsy, Huntington’s disease, stroke, and spinal cord injury. Endeavours are underway to re-engineer biologic drugs as brain-penetrating neuro-pharmaceuticals using BBB molecular Trojan horse technologies. This approach employs genetically engineered molecular Trojan horses (proteins), which carry genes across the BBB to have a therapeutic impact on brain disorders. The future development of neuro-pharmaceuticals linked to effective means to deliver these across the BBB are together positioned to reduce the need for interventional neuro therapies, but this may take some time.
 
Section 5
A perspective: life as a neurosurgeon
 
Three memoirs by Henry Marsh, an English neurosurgeon who treated a range of brain disorders over a 40-year career at a leading neurosurgical unit in London, provide insights into the human dramas that occur in a busy modern hospital. Marsh studied Politics, Philosophy and Economics (PPE) at Oxford University before starting medical school at the Royal Free Hospital in London. In 1984, he became a Fellow of the UK’s Royal College of Surgeons and in 1987, was appointed a consultant neurosurgeon at the Atkinson Morley Regional Neurosciences Centre at St George’s Hospital in London, where he spent his entire career.
 
Marsh’s first book is an unflinching memoir entitled, Do No Harm: Stories of Life, Death and Neurosurgery, which was published in 2014, and describes, with compassion and candour, challenging professional experiences filled with risk and imminent death. The book opens with the sentence, “I often have to cut into the brain and it's something I hate doing.” His first operation as a neurosurgeon was to treat a cerebral aneurysm. Forty years ago, this would have required opening the skull to access the brain. The procedure had a profound impact on Marsh, who commented, “What could be finer than to be a neurosurgeon. The operation involved the brain, the mysterious substrate of all thought and feeling, of all that was important in human life: a mystery, it seemed to me, as great as the stars at night and the universe around us.”
 
Marsh describes the difficult decisions, which neurosurgeons and patients regularly must make that change lives forever. He recalls moments of celebration and gratification when complex operations go well, and candidly recounts some of the more undesirable outcomes and slips of the hand that result in devastating outcomes. Marsh liked working with American neurosurgeons and came to “love their optimism, their faith that any problem can be solved if enough hard work and money is thrown at it, and the way in which success is admired and respected and not a cause for jealously”. He found the attitudes of American surgeons, “a refreshing contrast to the weary and knowing scepticism of the English”. However, after visiting hospitals in the US he expressed some scepticism about “the extremes to which treatments can sometimes be pushed” and wondered whether American physicians and patients “have yet to understand the famous American dictum that ‘death is optional’, was meant as a joke”. Tellingly, Marsh notes that “sometimes doctors admit their mistakes and ‘complications’ to each other, but are reluctant to do so in public, especially in countries that have commercial, competitive healthcare systems.” 
 
Marsh’s second memoir, Admissions: A Life in Brain Surgery, was published in 2017 two years after he retiredfrom his full-time job in England to work pro bono in Ukraine and Nepal. A documentary of his work in Ukraine, The English Surgeon, won an Emmy award. Marsh uses ‘Admissions’ to take an inventory of his life, which makes the book an even more introspective memoir than his first. He compares the challenges of working in troubled, impoverished countries like Nepal with his experience as a neurosurgeon in wealthy nations like the UK and US. The excesses of American medicine intrigued Marsh and he comments, “only in America have I seen so much treatment devoted to so many people with such little chance of making a useful recovery.” But he also expresses disillusionment with the administrative red tape in the English National Health System (NHS), which he maintains has eroded the authority and status of surgeons. In his final years working as a surgeon in St George’s Hospital in London he bemoans, “The feeling that there was something special about being a doctor had disappeared.” Marsh’s true love was patients and neurosurgery and at the end of his career, he was spending less time with patients and more time in meetings justifying his judgements and familiarizing himself with the latest UK government’s targets and edicts, which led him to say, “doctors need regulating, but they need to be trusted as well. It is a delicate balance, and it is clear to me that in England the government has got it terribly wrong”. 
 
Marsh suggests that patients’ fear encourages surgeons to exaggerate their competence and knowledge to “shield our patients from the frightening reality they often face”.  Over time, Marsh suggests, surgeons tend to believe the exaggerated versions of themselves. But the best un-learn their self-deception and come to accept their shortcomings and learn from their mistakes. “We always learn more from failure . . . . . . Success teaches us nothing,” Marsh writes.
 
Marsh’s third memoir,And Finally: Matters of Life and Death, was published in August 2022 and is very British, full of self-deprecation and dominated by the news that he is diagnosed with incurable prostate cancer. Marsh describes the sudden reversal of roles, from omniscient and omnipotent neurosurgeon to humble patient and provides descriptions of the ebbs and flows of his therapeutic journey, which gives valuable insights into how medicine in England works.
 
All three books bear witness to the fact that neurosurgery is a stressful and demanding profession, which requires extensive training, stamina, a high degree of manual dexterity, excellent hand-eye coordination, exquisite precision, extraordinary attention to detail, an ability to rapidly gather and process complex information to resolve challenging problems, compassion and empathy for patients, communication skills and teamwork. Unlike other surgical disciplines, a relatively small mistake can lead to “appalling disability”, coma, and death. According to research published in the October 2014 edition of Surgical Neurology International, ~25% of neurosurgical errors can be prevented or reduced with the increased use of evolving technologies, some of which are described in this Commentary.
 
Changes in the organization of neurosurgical units 
During Marsh’s 40-year career there were changes in the way neurosurgical units were organized and run; particularly the development of subspecialities among physicians and the use of multidisciplinary team approaches to clinical challenges. Much of Marsh’s career reflected a time when neurosurgeons worked in relative isolation and treated a wide range of neurosurgical conditions that presented in their clinics. Today, most neurosurgeons have a primary interest in a subspeciality such as epilepsy, neurovascular surgery, spinal surgery, the excision of tumours etc., and a secondary interest, which they share with colleagues. This tends to facilitate cross referral of patients among a team of physicians and improves patient care and the training of health professionals. In the operating room (OR) neurosurgeons work with other physicians, anaesthetists, trainee doctors, theatre nurses, and medical students. Outside the OR they collaborate with radiologists who use a range of diagnostic tools, including CT, MRI scans, and cerebral angiographies, which are used to detect abnormalities in blood vessels such as aneurysms, blockages, and bleeding. These neuroimaging technologies and neurosurgery have become inseparable. Neurosurgeons also work with neurologists, oncologists, ophthalmologists, and paediatricians. In 2017, Bob Carter, head of neurosurgery at the Massachusetts General Hospital, in the US, appreciated the interconnections between several clinical disciplines that care for people with neurological disorders and merged his neurosurgery department with the departments of neurology, psychiatry, and neuroradiology. While sub specialisms and teamwork have made an impact on the organization of neurosurgical units, new and emerging technologies have expanded the repertoire of neurosurgeons.
 
Awake brain procedures
Marsh specialised in operating on the brain while the patient is awake. This aspect of his work was the subject of a BBC documentary, Your Life in Their Hands. Awake brain procedures are usually performed when a lesion is located near the frontal lobes responsible for motor skills and speech. In the video below, Ranjeev Bhangoo describes the procedure, “It’s a technique where the patient is awake during the brain surgery. The patient is neither in pain nor suffering. When we make a cut in the skin and raise a trapdoor in the skull the patient is completely asleep. We wake them up after that point and the good news is the brain itself doesn’t feel pain. So, you can do this operation without the patient being in any distress or pain. It’s an unusual situation and the patient is prepared for it beforehand. The reason why you might want to do an awake craniotomy is because in some situations, tumours are close to critical structures of the brain that control speech or movement. While we have good maps of the brain and we have image guidance, they’re not precise enough. You want the patient to be talking to you and you want to be stimulating bits of the brain to see precisely where speech is so that you can avoid those areas and do the same with movement, you want to see the patient moving his or her arm or leg while you’re stimulating bits of their brain. So, we use an awake craniotomy when we’re operating near to what we call ‘eloquent’ areas of the brain that, if damaged, would produce a devastating deficit such as problems with speech or movement”. See video.
 

When and why is an awake craniotomy performed?

 
Section 6
The increasing burden of dementias on healthcare systems and economies
 
As populations age and live longer so dementia conditions increase. Alzheimer's, which effects parts of the brain that control thought, memory, and language, is the most common dementia in Western societies. It is a progressive disorder that begins with mild memory loss and leads to a loss of the ability to carry on a conversation and respond to your environment. In the three decades between 1990 and 2019, the global incidence of Alzheimer’s and other dementias increased by ~148%. In 2022, there were >6.5m Americans living with the condition: ~73% >65 and ~66% of these women, but this simply may be due to women living longer. By 2050, it is projected that ~13m Americans will suffer from dementia, which is expected to kill 1 in 3 seniors; that is more than breast and prostate cancers combined.
 
According to the World Health Organization (WHO), there are ~55m people with dementia globally, and >60% are living in low- and middle-income countries (LMIC). Age is the most significant risk factor: the likelihood of Alzheimer’s doubles every 5 years after you reach 65. But also, dementias appear to be increased by conditions that damage the heart and blood vessels, which include heart disease, diabetes, stroke, high blood pressure and high levels of cholesterol. As the proportion of older people in populations increase in nearly every country, people living with dementias are expected to rise to ~78m by 2030 and 139m in 2050. There is no cure for Alzheimer's, and treatments tend to fall to neurologists.  Drug therapies include galantamine, rivastigmine, and donepezil, which are cholinesterase inhibitors (also known as anti-cholinesterase, are chemicals that prevent the breakdown of the neurotransmitter acetylcholine) that are prescribed for mild to moderate Alzheimer's symptoms and may help reduce or control some cognitive and behavioural symptoms. Also, there are non-drug options.  Although outside the direct realm of neurosurgery, the scale and speed of the growth of Alzheimer’s and other dementias are likely to indirectly impact neurosurgery by increasing the burden on over-stretched healthcare systems. Under such circumstances, it seems reasonable to assume that there will be increased pressure on neurosurgery to become less resource intense, which means less invasive and less costly while improving patient outcomes.
 
Section 7
Traumatic brain injury

On Thursday 29th September 2022, Tua Tagovailoa, the Miami Dolphins’ quarterback received a head injury during a match against the Cincinnati Bengals and was stretchered off. Four days earlier he left the field after receiving another head injury while playing against the Buffalo Bills. He was then checked for a concussion and cleared and came back onto the field in the third quarter. Subsequently, the NFL Players Association exercised its right to remove the independent neurological expert who was involved in the decision to clear Tagovailoa to return to the Buffalo Bills game after being evaluated for a traumatic brain injury (TBI). This raises the significance of injuries to the brain and the challenges of accurately assessing their severity and adequately treating them.
 
TBI is as an alteration in brain function pathology by a sudden trauma, causing damage to the brain. Each year, the condition affects ~69m individuals worldwide. Symptoms can be mild, moderate, or severe, depending on the extent of the damage: annually ~5.5m severe cases are recorded globally. The epidemiology of the disorder is challenging because, in low-resourced regions of the world, where the prevalence of TBI is believed to be high, data are poor. According to the World Health Organization (WHO), ~90% of deaths due to head injuries occur in low- and middle-income countries (LMICs), where ~85% of the global population live and where the standards of care are patchy. TBI not only causes health loss and disability for individuals and their families, but also represents a costly burden to healthcare systems and economies through lost productivity and high healthcare costs. The total annual global burden of TBI is ~US$400bn.
 
Since the beginning of the 20th century, our knowledge and understanding of the pathophysiology of brain oedema (swelling) in head trauma patients has increased and today decompressive craniectomy is a recognised procedure for severe TBI to mitigate intracranial hypertension and its impact on clinical outcomes. One of the largest clinical studies, which sought to determine the efficacy of decompressive craniectomies for TBI patients, was the RESCUEicp trial: findings of which were published in the September 2016 edition of the New England Journal of Medicine. The study was carried out over a 10-year period, between 2004 and 2014, on 408 randomly assigned patients, 10 to 65 years of age, and concluded that, “At 6 months, decompressive craniectomy in patients with traumatic brain injury and refractory intracranial hypertension resulted in lower mortality and higher rates of vegetative state, lower severe disability, and upper severe disability than medical care”. 
 
In the US, TBI is a leading cause of death and disability. Each year, ~1.5m Americans sustain a TBI, ~50,000 die from the insult, ~230,000 are hospitalized and survive, and ~90,000 experience the onset of long-term disability. According to the US Centers for Disease Control and Prevention, ~5.3m Americans (~2% of the population) are living with disability as a result of a TBI. In 2010, the economic impact of TBI in the US was estimated to be ~US$77bn in direct and indirect costs. Each year in the UK ∼1.4m patients attend hospital following head injury and TBI is the most common cause of death for people in the UK <40 years.
  
Gold standard monitoring of intracranial pressure
There is no cure for severe TBI, and the gold standard management is to monitor intracranial pressure (ICP), caused by brain oedema (swelling). Current clinical guidelines for raised ICP levels suggest thresholds, usually between 20 and 25 millimetres of mercury (mmHg), at which treatment is recommended to either prevent or reduce further damage to the brain. The device used to monitor ICP is an intraventricular catheter system that requires drilling a burr hole in the skull to insert a catheter and placing it in a cavity (ventricle) in the brain, which is filled with cerebrospinal fluid (CSF). This is then connected to an extra-ventricular drain (EVD) that measures ICP. Such systems are accurate and reliable, but also, they are health-resource-intensive modalities, which run a risk of haemorrhage and infection.

Challenges with gold standard monitoring
According to research findings published in the January 2017 edition of the Journal of Neurosurgery, haemorrhage is a common complication of an EVD placement. Among the cases in which patients underwent imaging after a placement procedure, haemorrhage was found in 94 (21.6%). Another study, of 246 EVDs placed in 218 patients over a 30-month period and published in the November 2014 edition of Interdisciplinary Perspectives on Infectious Diseases, reported the cumulative incidence of EVD-related infections to be 8.3%. Further, because of the dearth of qualified neurosurgeons in under-resourced regions of the world, EVD systems are not widely available in LMIC, where the incidence rates of TBI are understood to be high and increasing.

Non-invasive ICP monitoring
Numerous alternatives to invasive gold standard ICP monitoring are in development, but none have established a valid place within a daily clinical setting. A review paper published in the December 2020 edition of the journal Neurotrauma, entitled “Non-Invasive Techniques for Multimodal Monitoring in Traumatic Brain Injury: Systematic Review and Meta-Analysis”, stresses the significance of monitoring ICP and brain oxygenation continuously in severe TBI patients, and suggests that the “two most prominent and widely used technologies for non-invasive monitoring in TBI are near-infrared spectroscopy [a form of photoplethysmography (PPG)] and transcranial Doppler”. Researchers conclude that, “both techniques could be considered for the future development of a single non-invasive and continuous multimodal monitoring device for TBI”.

Transcranial Doppler (TCD) ultrasonography is a non-invasive, painless ultrasound technique that uses high-frequency sound waves to measure cerebral blood flow velocity that may correlate with ICP. Research suggests that in ~15% of cases the ultrasound waves are unable to penetrate the patients’ skulls, and measurement is prone to intra- and inter- observer variability and accuracy. As the TCD system for measuring ICP non-invasively is encountering challenges, so near infra-red spectroscopy is gaining significance. This is a form of PPG technology, which is an uncomplicated, inexpensive, non-invasive, and convenient optical measurement that has the potential of being used at the site of injuries to quickly assess the severity of the head trauma. In the recent case of Tagovailoa, such a non-invasive ICP measurement device could have been applied on the playing field. Over the next decade, expect PPG technology to impact neurosurgery by potentially providing more accurate triaging and further disrupting the gold standard of care for severe TBI patients.
 
Section 8
Brain cancer and early diagnostics

We mentioned the Gamma Knife’s® ability to treat some brain tumours and suggested that patients have benefitted significantly from its use. The first successful modern brain tumour excision was performed in 1878 by William Macewen, a pioneering Scottish surgeon, at the Glasgow Royal Infirmary. At the beginning of the 20th century, contributions by Americans started with Harvey Cushing, who is generally recognised as the father of modern neurosurgery. Working at the John’s Hopkins Hospital in Baltimore, Cushing introduced meticulous documentation of the clinical and pathological details of cerebral tumours and devised several surgical techniques for operating on the brain that became the foundation of neurosurgery as an autonomous surgical discipline. In 1912, he discovered an endocrinological syndrome caused by a malfunction of the pituitary gland, which is named after him: Cushing’s disease.
 
The prognosis for a brain tumour is dependent upon its type, location, size and time of diagnosis, growth and how much can be surgically removed or treated. Factors including age and general wellbeing as well as some recognised genetic factors also influence prognosis. Poor prognosis for brain cancers is perpetuated by the lack of cost-effective, accurate tests that can be used in a primary care setting to diagnose the conditions. This means that a large proportion of brain cancers are diagnosed too late for current treatments to be effective. However, in recent years there have been advances made in detecting brain cancers early and this is expected to significantly improve prognosis.
 
Although there are >120 different types of brain tumours, lesions and cysts, your chances of developing brain cancer is <1%. Brain tumours account for ~90% of all primary central nervous system (CNS) tumours. In 2020, >0.3m people worldwide were diagnosed with a primary brain or spinal cord tumour. According to the Annual Report of the US Central Brain Tumor Registry, >84,000 Americans were diagnosed with a primary brain tumour in 2021. The US National Cancer Institute, suggests ~0.6% of Americans will develop brain cancer in their lifetime and the 5-year survival rate for those that do is only ~33%. This year, >4,000 Americans <15, are expected to be diagnosed with a brain or CNS tumour. In the UK, each year ~16,000 people are diagnosed with a brain tumour and ~ 60,000 people are living with a brain tumour.
 
The causes of brain tumours are not fully understood and occur because of an abnormal growth of brain cells or cells in the brain’s supporting tissues, which can damage the brain, threaten its function and result in death. Some tumours may occur around the edge of the brain and press on certain parts of it, while others can be more diffuse and grow among healthy tissue. In the video below, neurosurgeon Christopher Chandler, who leads the Paediatric and Adolescent Neurosurgical Service at King’s College Hospital, London explains that, “A brain tumour is an uncontrolled growth of a bunch of cells where the ‘off’ switch is missing. This means that there’s nothing telling these cells to stop growing, so they grow and divide. As this uncontrolled mass, or tumour, grows it displaces brain tissue and causes pressure on the surrounding brain. If you don’t remove the tumour or stop it from growing, it will grow so large that it causes critical pressure on the surrounding structures of the brain, which eventually, if untreated, can kill the patient.” See video.  
 
What is a brain tumour?
 
The Holy Grail
Neurosurgeons are frustrated by the fact that brain cancers are often diagnosed late. This is because brain tumours often present with non-specific symptoms and are therefore challenging to diagnose. In the video below, neurosurgeon Ranjeev Bhangoo explains the reasons for a brain tumour to be diagnosed late. “Firstly, the symptoms are non-specific: tiredness, headache, poor concentration - maybe not finding your keys as well as you use to – the sort of thing that can happen to any of us when we’re tired. The classic thing of having a fit or collapsing occur, but they’re unusual. Your GP is only likely to see just one or two brain tumour cases in his or her whole career. . . . Now, if you do get a scan, the chances of you having a brain tumour are incredibly rare. So, just because a neurologist has organized a scan, you mustn’t get worried because it’s very unlikely that you’ll have a brain tumour. But ultimately, through some path or other, you have a scan, usually a CT scan, which is a form of X-ray, which is quick and safe and if there is a tumour it will show. At that point, what will normally happen is that your doctor will refer you to a neurosurgeon”.    
 
How are brain tumors diagnosed?
 
Technologies positioned to reduce neurosurgeons’ frustration with late diagnosis of brain cancers are quick, easy-to-use, and inexpensive blood tests that can diagnose cancer early. Such tests fall into four general categories: (i) complete blood count used to evaluate your overall health and detect a wide range of disorders, (ii) biomarkers, which are molecules found in your blood and other body fluids that can indicate specific cancers, (iii) blood protein testing that measures the amount of protein in your blood to diagnose cancer, and (iv) circulating tumour cell tests, which look for tumour cells that are shed from a tumour and are now circulating through your bloodstream.
 
Detecting brain cancers early
Two recent examples of simple diagnostic blood tests are reported in the August 2022 edition of Clinical Cancer Research and the October 2019 edition of Nature Communications. In the former paper, scientists at Massachusetts General Hospital (MGH) report findings of a study, which detected the presence of brain cancers early by identifying pieces of tumour cells’ genetic material - mRNA - that circulate in your blood. The test, which has a sensitivity of 72.8% and a specificity of 97.7% can characterize brain tumours and monitor their status after treatment. According to Leonora Balaj, a co-senior author, and assistant professor of Neurosurgery at Harvard Medical School, “There is a real need to make brain tumor diagnosis less invasive than the current technique of tissue biopsy. This research demonstrates that it is now feasible to diagnose a brain tumor via a blood test for one of the most common mutations detected in brain tumors”. Findings of the latter paper suggest that certain brain cancers may be detected early from a simple blood test using PPG technology, which has been used in hospital settings since the 1980s to monitor heart rate and relative blood volume. Today, the technology is used in a wide range of commercially available medical devices, as well as smartwatches (the Apple version is an FDA approved medical device) and fitness trackers, for measuring oxygen saturation, blood pressure and cardiac output, assessing autonomic function and detecting peripheral vascular disease. Previously we described how PPG technology is positioned to provide a non-invasive means to monitor ICP in TBI patients.

The 2019 Nature paper describes how PPG easily, cheaply, and accurately identified asymptomatic people with suspected brain cancer. In the first instance, the technology was used on a retrospective cohort of 724 people, which included those with primary and secondary cancers as well as control participants without cancer. PPG was employed to identify biomarkers from patients’ blood samples and a machine learning algorithm was trained to identify specific biomarkers with cancer present. The algorithm was then used on a sample of 104 random participants and brain cancer was detected in 12. The PPG test revealed a sensitivity of 83.3% and a specificity of 87%. According to Matthew Baker, from the University of Strathclyde, Scotland, the paper’s lead author, “This is the first publication of data from our clinical feasibility study, and it’s the first demonstration that our blood test works in the clinic.”
 
A global endeavour
These two studies are part of a well-resourced global endeavour to develop an affordable, simple, point-of-care, blood test, which detects cancer before any symptoms occur. Today, biomedical advances move at a much faster pace than medical technology did in the 1950s and 60s when Lars Leksell was developing minimally invasive stereotactic radiosurgery procedures to accurately locate and remove brain tumours. For example, in ~7 years since its foundation in 2015, GRAIL, a US biomedical start-up backed by Jeff Bezos and Bill Gates, has become a global leader in a ground-breaking multi-cancer, early detection, blood test, Galleri®, which has the potential to detect >50 types of cancers before they are symptomatic. This is achieved by looking for abnormal DNA shed from cancer cells in the blood, called cell-free DNA (cfDNA). The Galleri® test uses genetic sequencing technology and artificial intelligence (AI) to scan for patterns of chemical changes in the cfDNA that come from cancer cells but are not found in healthy cells. If validated, the GRAIL test will provide a simple, cheap, non-invasive means to identify a range of cancers in asymptomatic people when they are more likely to respond positively to therapy.
 
Large UK clinical study
In May 2019, the GRAIL Galleri ® blood test was granted US FDA Breakthrough Device designation. The test is only available commercially in the US but is rapidly gaining provenance in other regions of the world. For example, in September 2021, NHS England launched a massive clinical study for Galleri® and set up ~150 mobile clinics in convenient locations across the country to recruit ~140,000 participants. In July 2022, participants were invited to attend two further appointments spaced ~12 months apart. Findings from the study are expected to confirm the accuracy of the test in asymptomatic participants and lead to its regulatory approval. Although Galleri® is the first of its kind to be trialled on such a scale in the UK, it is not the only player and cfDNA is not the only technology.
 
Guardant Health
Another US biotech developing capabilities to detect a range of cancers early from a simple blood test is Guardant Health. Founded in 2011, the company is now ~US$6bn Nasdaq traded global enterprise with annual revenues ~US$110m. In April 2022, Guardant presented new data at the American Association for Cancer Research Annual Meeting. Findings suggested that the company’s investigational next-generation Guardant SHIELD™ assay has the capacity to analyse ~20,000 epigenomic biomarkers that help to detect a broad range of solid tumours using a single blood test. Guardant’s co-CEO, Amir Ali Talasaz said: “These positive results show that the next-generation Guardant SHIELD multi-cancer assay provides sensitive detection of early-stage cancers with the ability to identify the tumor tissue of origin with high accuracy”.
 
Section 9
Takeaways

For millennia neurosurgery, which has its roots in ancient civilizations, was dominated with forms of craniotomies, which opened the skull to access cerebral disorders. In the 20th century the speciality pivoted and introduced less- and non-invasive procedures to deal with a range of brain and CNS conditions. However, the introduction of these were slowed by the fact that the brain is such a well-protected organ and they took nearly half a century to gain regulatory approval and enter the clinic. At the beginning of the 21st century biomedical research is advancing at such a pace and it positioned to significantly transform neurosurgery towards a less- and non-invasive modality. Further, in the next two decades expect gene and cell therapies to substantially increase their influence as treatments for neurodisoders. Over the past three decades novel neuro-pharmaceuticals have been constantly in clinical trials but failed to receive regulatory approval because they did not have an efficatious mechanism to deliver the therapeutics across the BBB. Today, there are a myriad of novel vehicles under development, which are expected to effectively smuggle 21st century pharmaceuticals across the BBB. These are being advanced in parallel to the drugs, and together are positioned to significantly disrupt traditional neurosurgical procedures over the next two decades.  
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The impact of big data, artificial intelligence, and machine learning on the medical technology industry

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  • The core business of medical technology companies (MedTechs) has been manufacturing and marketing physical devices
  • Physical devices will continue to be a substantial part of their business, but on their own, are unlikely to deliver high growth rates, which are more likely to come from artificial intelligence (AI) data driven strategies that improve patient outcomes
 
The impact of big data, artificial intelligence, and machine learning on the medical technology industry
 
James Carville, an American strategist, who played a leading role in Bill Clinton winning the 1992 presidential race, insisted that the campaign focus on the economy and coined the phrase “It’s the economy, stupid”. If Carville was asked today for a winning long-term growth strategy for medical technology companies, might he say, “It’s big data, stupid”?
 
This Commentary suggests that while physical products have been the backbone of MedTech companies in the past, they are unlikely to contribute significantly to future growth rates, which are more likely to come from artificial intelligence (AI) driven big data innovations, which create new solutions that improve patient journeys and outcomes.
 
In this Commentary
 
This Commentary describes the meaning of ‘big data’ in a healthcare context, explains ‘the data universe’ and stresses not only its immense volume, but also its variety, and the phenomenal speed at which the data universe is growing. Today, most industries leverage big data and AI techniques to create innovative offerings that drive growth and enhance competitive advantage. However, with few exceptions, traditional MedTechs have been relatively slow to collect and analyse a wide range of health, medical and lifestyle data which have the potential to provide innovative software offerings that improve patients’ therapeutic journeys and complement physical products. This is partly because the industry must adhere to strict regulations and partly because many medical technology companies lack the necessary capabilities and mindsets to collect and leverage big data. Most have business models that tweak legacy physical products and accept growth rates of ~5% as the ‘new normal’. We provide a brief history of big data and AI business strategies mainly to underline that these are relatively new. It was only in the early 2000s that electronic health records (EHR) began to replace paper-based patient records, which were stored in numerous filing cabinets in healthcare silos. It was not until ~2015 that EHRs became standard practice and researchers started to apply algorithms to EHRs and other data to detect patterns and make predictions that could improve diagnoses and treatments, enhance patient outcomes, and reduce healthcare costs. The increased use of big data and AI techniques in healthcare raises important cybersecurity concerns and trust issues because health professionals and patients do not understand how algorithms arrive at their conclusions and actions. Cybersecurity concerns are addresses by a range of encryption techniques and security protocols. Trust in algorithms has been helped by the development of  ‘explainable AI’, which is software that describes the essence of algorithms in easily understood terms. However, more work is still needed in these two areas. We introduce cloud and cloud services together with an explanation why these have experienced such rapid growth across all industries in recent years. The cloud makes it easier to store and access big data via the internet from anywhere in the world. Cloud services provide security for big data as well as a range of management and analytical tools that help to transform data into revenue generating software offerings. For MedTech companies, the cloud and cloud services provide the basis for more efficacious R&D. The medical technology industry has become bifurcated between companies that leverage AI driven big data strategies to enhance growth rates and those that predominantly focus on legacy physical product offerings and settle for lower growth rates. Over the past decade the nature of the medical technology industry has changed; partly because of AI big data strategies supported by the cloud computing and a large and rapidly growing range of open-source, easy-to-use AI tools. This has given small companies a competitive advantage. The Commentary concludes by describing a few of these small MedTechs with disruptive digital products that target large, rapidly growing, underserved market segments.       
 
Big data and healthcare

Big data are comprised of a wide range of information collected from multiple sources that surpasses the traditionally used amount of storage, processing, and analytical power and is unmanageable using conventional software tools. In healthcare settings, big data include hospital records, medical records of patients, results of medical examinations, and data generated by traditional medical devices as well as various biomedical and healthcare tools such as genomics, wearable biometric sensors, and smartphone apps. Biomedical research also generates data relevant for the medical technology industry.
 
The data universe

The massive amount of data, which is generated from the entirety of the internet is referred to as the ‘data universe’. It is not only its volume that makes this special, but it is also the variety of the data and the phenomenal speed at which the universe is growing. The International Data Corporation (IDC) estimated that the data universe grew from ~130 exabytes in 2005 to >40,000 exabytes in 2020.  To put this in perspective: 1 gigabyte of data is 1bn bytes (18 zeros after the 1 or 230 bytes), and 1 exabyte is equal to 1bn gigabytes.
Data generated healthcare innovations

In the past, collecting and interpreting vast quantities of data was not feasible, partly because computer systems were relatively small and did not generate much data, and partly because technologies to manage big data were underdeveloped. Fast forward to the present, and businesses across most industries now generate enormous amounts of data. Organizations apply AI and machine learning (ML) techniques to these data to create innovative product offerings to access new revenue streams with significant growth potential. Such technologies, combined with health-related big data, can positively impact the medical technology industry by generating novel diagnostics and treatments for patients, streamlining the process of medical record keeping and developing more personalized and responsive care plans that improve patient journeys and outcomes.

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The new rapidly evolving AI data driven healthcare ecosystem

Despite the potential commercial advantages of AI data driven diagnostic and therapeutic solutions, many traditional MedTechs have been slow to collect health and lifestyle data from multiple sources to develop software offerings, which complement their legacy physical products. One notable exception is Philips Healthcare. In the early 2000s, the company was challenged by new entrants to the market who were successfully leveraging information from health wearables and other sources to create and market AI data driven offerings. At the 2016 annual conference of the American Healthcare Information and Management Systems Society (HIMSS) in Chicago, Jeroen Tas, a Philips executive, said, “We are in the midst of one of the most challenging times in healthcare history, facing growing and aging populations, the rise of chronic diseases, global resource constraints, and the transition to value-based care. These challenges demand connected health IT solutions that integrate, collect, combine, and deliver quality data for actionable insights to help improve patient outcomes, reduce costs, and improve access to quality care”.
 
Philips had the mindset and resources to respond positively to this rapidly changing ecosystem. In 2017 the company appointed Tas as its Chief Innovation & Strategy Officer, tasked with launching a suite of big data AI driven solutions, the IntelliVue® patient monitors, which support the growing demands of health professionals to provide quality care and improved outcomes for an expanding population of older, sicker patients with fewer resources. These monitoring solutions seamlessly connect big data, AI technology and patients to support health professionals to manage patients as they transition through their care journeys. In 2016, Philips and Masimo, a medical technology company specializing in non-invasive AI data driven patient monitoring devices, entered a multi-year business partnership involving both companies’ innovations in patient monitoring. Philips agreed to integrate Masimo's measurement technologies into its IntelliVue® monitors, to help clinicians assess patients’ cerebral oximetry and ventilation status. The outcome of the collaboration was the launch of a new suite of patient solutions, called Connected Care, which give healthcare providers the ability to monitor patients more effectively and reduce costs.
 
The bifurcation of the MedTech market

In addition to large MedTechs such as Philips and Masimo, there are hundreds of small companies developing AI driven big data offerings aimed at improving patient outcomes. The reasons for many traditional companies’ slowness to fully leverage big data and AI applications are partly because medical devices are required to comply with stringent regulatory guidelines and partly because of the lack of capabilities. The different responses have bifurcated the industry. On the one hand there are traditional MedTechs, which predominantly focus on existing customers and market legacy physical offerings in slow growing markets. On the other hand, there are many small companies and a few very large medical technology corporations, which have embraced AI driven big data patient-centric solutions.
 
A brief history

Big data has its genesis in the 1950s and 1960s when scientists and mathematicians began exploring the possibility of using computers to process large amounts of data to make intelligent decisions. This led to the development of technologies such as the first neural networks, which laid the foundation for modern Deep Learning. In the 1980s, researchers at IBM popularized the concept of big data to describe the process of collecting and analyzing large amounts of data, which empowered organizations to gain insights from information that previously was too complex to process. The 1990s saw the development of AI and ML, which enabled computers to learn from data and make decisions without the need for explicit programming. By the early 2000s, AI-based algorithms empowered machines to learn from data and make predictions. Many organizations, across a range of industries, saw the commercial opportunities of this and acquired capabilities to collect, store and analyse large amounts of information to identify patterns and trends that were previously impossible to detect.  Without large amounts of data, AI and ML techniques are less effective, which is significant for healthcare and the medical technology industry.
 
Big data in healthcare

AI driven big data strategies are becoming increasingly important in healthcare. This is because AI techniques applied to masses of health-related information can improve patient care, enable more effective decision-making, reduce costs, identify new treatments, explore new markets, and create more efficient healthcare systems. Further, such applications can provide more accurate and timely diagnoses, as well as insights into how various treatments affect different people. As increasing amounts of health information become available, and data handling techniques improve, so traditional MedTech companies will have opportunities to boost their growth by complementing their physical devices and volume-based care with digital assets and personalised care.
 
Paper-based mindset

Until recently health professionals were responsible for most of the different types of data associated with a patient’s treatment journey, which included medical histories, known allergies, medical and clinical narratives, images, laboratory examinations, and other private and personal information. Until the early 2000s these data were recorded on paper and stored in filing cabinets across numerous healthcare departments. It was not until 2003 that the US Institute of Medicine used the term ‘electronic health records’ (EHR). By 2008, only ~10% of US hospitals were using EHRs, which increased to ~80% by 2015. As EHRs became standard practice across multiple providers and data interoperability issues were resolved, the provision of healthcare improved, and medical errors and healthcare costs were reduced. Currently, the American National Institutes of Health (NIH) is inviting 1m people from diverse backgrounds across the US to help build a comprehensive big data set, which can be used to learn more about how biology, environment and lifestyles affect health in the expectation of discovering new ways to treat and prevent disease.
 
Trust and medical algorithms
 
As AI driven big data applications have increased, so trust in algorithms has been raised as an issue. This has been a major concern in healthcare. To address this challenge, explainable AI, has been developed. This is an AI technology that explains decisions and actions made by algorithms in a way that is easily understood by health professionals and patients. Explainable AI has helped to create trust in algorithms by providing a level of transparency, understanding and accountability. Further, incorporating feedback from medical professionals, patients, and other stakeholders into the development of medical algorithms has also helped to build trust. However, this entails collecting a wider variety of data than many healthcare companies are used to.
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Big data healthcare strategies and security
 
With the increasing number of big data and AI healthcare solutions, cybersecurity has become a concern. Reducing this involves using technologies such as data encryption, secure cloud computing (see below), and authorization protocols to protect data stored in large databases. Additionally, organizations may use AI-driven applications to monitor their systems to find anomalies, detect malicious activity and unauthorized access to sensitive, personal information. To ensure the security of healthcare data, organizations also employ measures such as risk assessments, incident response plans, and regular security training of their staff.
Cloud storage and services

Since the early 1990s, big data have benefitted from cloud storage, which makes it easier to store and access data over the internet and helps businesses to become more efficient and productive. It also offers organizations scalability, more control over their data and reduced costs. Organizations can: (i) easily increase their storage capacity as their data needs grow, (ii) access their data from anywhere in the world, and (iii) stop investing in expensive local storage devices. Further, cloud storage is becoming more secure, with encryption and other security measures making it safer to store data.
 
Companies moving their data from local storage devices to the cloud is more than just a simple transfer process and can be a complex, multi-year journey. Any organization that has accumulated several legacy databases and infrastructures will have to develop and manage a hybrid architecture to transfer the data. However, once in place and shared among stakeholders, cloud-based platforms can assist in unlocking clinical and operational insights at scale while speeding up innovation cycles for continuous value delivery. In combination with a secure and interoperable network of connections to hospital systems, cloud-based solutions represent an opportunity for healthcare leaders to unlock the value of data generated along the entire patient journey, from the hospital to the home. By turning data into insights at scale, it is possible to empower healthcare professionals by helping them to deliver personalized care, improved patient outcomes and lower costs.
 
The cloud also offers an increasing number of computing services. These are provided by companies such as Amazon Web Services, Google Cloud Platform, Microsoft Azure, IBM Cloud, Oracle Cloud, and Rackspace Cloud. The services include: (i) Infrastructure-as-a-Service (IaaS), which provides users with access to networks, storage, and computing resources, (ii) Platform-as-a-Service (PaaS) helps users to develop, run, and control applications without the need to manage infrastructure, (iii) Software-as-a-Service (SaaS), provides access to a variety of applications, (iv) Data-as-a-Service (DBaaS), gives users access to several types of databases, and (v) Serverless Computing enables users to run code without needing to provision or manage servers. Such services are expected to continue growing and help to transform healthcare. The provision of cloud computing services in healthcare makes medical record-sharing easier and safer, automates backend operations and facilitates the creation and maintenance of telehealth apps. The increasing use of data and cloud services by MedTech companies helps to break down data silos and develop evidence-based personalized solutions for a connected patient journey. In 2020, the healthcare cloud computing market was valued at ~US$24bn, and it is expected to reach ~US$52bn by 2026, registering a CAGR of >14% during the forecast period. Major drivers of cloud services include the increasing significance of AI driven big data applications.
 
Changes the nature of R&D

Further, the cloud can change and speed up R&D. The starting point for MedTech R&D should be evolving patient needs and affordability. Healthcare-compliant cloud platforms offer a flexible foundation for the rapid development and testing of AI driven big data solutions created by cross functional teams working across an entire life cycle of an application: from development and testing to deployment. This changes medical technology companies’ traditional approach to R&D by transforming it into short cycles undertaken by multiple stakeholders. This modus operandi is replacing traditional lengthy and expensive R&D often carried out in an organisational silo and constrained by annual budgeting cycles. This often means that a significant length of time passes before an innovation gets into the hands of health professionals and patients for testing. Digital health solutions, on the other hand, can be tested by physicians and patients early in their development and improved features quickly added.   
 
Free and easy to use AI and ML software libraries

In the early 2000s, when AI and ML were in their infancy, companies needed data engineers with advanced mathematical capabilities to build complex AI systems. Today, this is unnecessary because of the development of simplified AI and ML libraries such as PyTorch and Tensorflow. These are free, easy to use, open-source, scalable AI, and ML packages, which reduce the need for data engineers to have advanced mathematical skills to build effective software health solutions. PyTorch, released in 2016,  was developed by Facebook and then Meta AI, and is now part of the Linux Foundation. The technology is known for its ease of use and flexibility, making it favoured by developers who want to rapidly prototype and experiment with new ideas. Its tools support graphics processing, which is popular with deep learning medical imaging strategies that involve training large, complex models on big data. TensorFlow was developed by the Google Brain team and originally released in 2015 for internal use.  It is a highly scalable library for numerical computations and allows its users to build, train and deploy large-scale ML models. Both platforms have become significant open-source tools for AI and ML due to their ability to support the development and training of complex models on large datasets. They have been widely adopted by researchers and developers throughout the world and are regularly used in a variety of applications relevant to the medical technology industry. Significantly, they give smaller MedTechs a competitive advantage. 
 
Disruptive effects of AI driven big data strategies

The development and availability of big data and predictive AI help small medical technology companies enter markets, grow, and strengthen their competitive positions, which has the potential to change market dynamics. Over the past decade, several large medical technology companies have experienced their markets dented by small companies, which have successfully used open-source AI applications to leverage big data. For example, Philips Healthcare’s market was affected by the emergence of innovative offerings developed by new entrants using cloud computing services and big data from medical wearables. Above we described how Philips robustly responded to this and became a market leader in AI data-driven patient monitoring technology. Siemens Healthineers’ market share suffered from small MedTechs with innovative AI driven offerings. Further, the rise of digital imaging technology caused GE Healthcare’s market share to shrink. These vast companies have since developed AI driven big data strategies and bounced back. However, traditional MedTechs that fail to leverage big data and AI capabilities risk being left behind in an increasingly competitive digitalized industry.
 
Small MedTechs using big data and AI

Examples of small MedTechs that leverage big data, AI, and ML techniques to capture share of large underserved fast-growing market segments include Brainomix, which was spun out of Oxford University, UK, in 2010 and serves the stroke market. Iradys, a French start-up specialising in interventional neuroradiology. Elucid, a Boston, US-based MedTech founded in 2013, which has developed innovative technology that supports the clinical adoption of coronary computed tomography angiography, and Orpyx Medical Technologies, a Canadian company that provides sensory insoles for people living with diabetes. These are just a few examples of small agile companies that collectively have helped to bifurcate and disrupt segments of the medical technology industry by developing offerings predicated upon big data, AI and ML that deliver faster, more accurate diagnoses to ensure that patients get the treatment they need, when they need it.

Brainomex’s lead product offering is a CE-marked e-Stroke platform, which has been developed using data from images sourced across 27 countries including the UK, Germany, Spain, Italy, and the US and provides fast, effective and accurate analysis of brain scans that expedite treatment decisions for stroke patients. The platform has been adopted across multiple healthcare systems throughout the world, and for the past two years, England’s National Health Service (NHS) has been using the technology on suspected stroke patients. Early-stage analysis of the technology predicated on >110,000 patients suggests that eStroke can reduce the time between presenting with a stroke and treatment by ~1 hour and is associated with a tripling in the number of stroke patients recovering with no or only slight disability - defined as achieving functional independence - from 16% to 49%. With this disease, time is of the essence because after a stroke, each minute that passes without treatment leads to the death of ~2m neurons (nerve cells in the brain), which cause permanent damage. It can be challenging for health professionals to determine whether stroke patients need an operation or drugs, because the interpretation of brain scans is complicated and specialist doctors are required. Sajid Alam, stroke consultant at a large regional hospital in the UK, (Ipswich Hospital), reflected: “As a district general hospital, we don’t have ready access to dedicated neuroradiologists to interpret every stroke scan. Having Brainomix’s AI software gives us more confidence when interpreting each scan.”

Intradys is a French start-up, which develops algorithms that combine ML and mixed reality to empower interventional neuroradiologists and help them enhance the care of stroke patients. Orpyx Medical Technologies provides sensory insoles for people living with diabetes who have developed peripheral neuropathy to help prevent foot ulcers. The insoles collect data on pressure, temperature, and steps and give feedback to the wearer and healthcare professionals. Elucid is a Boston-based MedTech founded in 2013. The company’s offerings are predicated on big data, AI, and ML to provide fast and precise treatments that improve the outcomes of patients with cardiovascular disease and reduce healthcare costs. Heart attack and stroke are primarily caused by unstable, non-obstructive plaque (the buildup of fats, cholesterol, and other substances in and on the artery walls) that often goes undiagnosed and untreated. Current non-invasive testing cannot visualize the biology deep inside artery walls where heart disease develops. Elucid’s lead offering is an FDA-Cleared and CE-marked non-invasive software to quantify atherosclerotic plaque.
 
Takeaways
 
The potential benefits for medical technology companies that leverage AI driven big data strategies include: (i) improved diagnoses and treatments, (ii) enhanced patient journeys and outcomes, (iii) cost savings, (iv) a better understanding of stakeholders’ needs, (v) superior decision-making, (vi) more effective products and services, and (vii) increased competitive advantage. Big data strategies may also be used to uncover insights from large datasets to develop predictive models that can automate repetitive tasks, optimize care processes, free up resources for healthcare professionals to focus on providing care, and staying ahead of the competition by providing greater insights into customer trends and needs. Medical technology companies that do not leverage AI driven big data strategies to develop innovative products for growth and competitive advantage potentially risk: (i) falling behind the competition in terms of product innovation, (ii) missing out on key market opportunities, as data-driven insights can help identify new trends and customer needs, (iii) struggling to keep up with the changing pace of technological change, as staying ahead of the competition requires a deep understanding of the latest developments in data-driven product development and (iv) losing the trust of customers, as they may be wary of MedTechs that do not use advanced technologies to develop their product offerings. Future significant growth for medical technology companies is more likely than not to come from AI driven big data strategies. Start collecting data.
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