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  • Low back pain (LBP) and degenerative spinal disc disorders are leading age-related causes of disability throughout the world
  • Global populations continue to age, and incidence rates of LBP and degenerative disc disorders continue to increase
  • Surgery has become a common therapy for the conditions and their incidence rates have risen sharply over the past two decades
  • This has fuelled a global US$10bn spinal implant and devices market
  • Spine surgeries tend to be paid for by working age populations
  • In wealthy spine markets working age cohorts are shrinking
  • This suggests spending levels on spine surgery will be squeezed
  • The knock-on effects of this are likely to put pressure on spine companies to adapt their strategies and business models
 
Low back pain and the global spine industry

Low back pain, spine surgery and market shifts
 
Low back pain (LBP) is a common age-related health condition associated with degenerative spinal disorders, and recognised by the World Health Organisation (WHO) as one of the top ten global disease burdens. In most wealthy nations, low birth rates and relatively high life expectancy have resulted in the number of working age people shrinking and the number of retirees with sedentary lifestyles increasing. This has led to a high prevalence of LBP and age-related spinal disorders.
 
First-line clinical guidelines for LBP recommend non-surgical treatments and encourage physicians to be cautious about surgical solutions. Diagnosing LBP is challenging, and doctors constantly contend with treatment dilemmas. However, over the past three decades spine surgery has become a significant therapy for LBP.
 
A common procedure used to treat a range of degenerative disc disorders, which present as LBP, is spinal fusion. This is a neurosurgical or orthopaedic surgical technique to permanently connect two or more vertebrae in your spine so that they heal into a single, solid bone. The procedure can be performed at any level in the spine and prevents any movement between the fused vertebrae. The technique is designed to mimic the normal healing process of broken bones.

 
In this Commentary
 
This Commentary suggests that as global populations have aged, so the incidence rates of LBP and degenerative disc disorders have increased and become a leading cause of age-related disability throughout the world. Spine surgery has become a common therapy for the conditions. This has fuelled a global spinal implant and devices market. Spine surgeries tend to be paid for by working age populations, which are shrinking in the wealthy spine markets of the world. This suggests that spending levels on spine surgeries will be squeezed and this will put pressure on spine companies to transform their strategies and business models.
 
The global burden of LBP

A series of three research papers on LBP and its associated disabilities published in the March 2018 edition of The Lancet estimate that ~0.54bn people worldwide are living with LBP, which has risen by more than 50% since 1990, and is projected to increase even more as the world's population ages and as populations in lower- and middle-income countries move to urban centres and adopt more sedentary lifestyles.
 
The importance given to treating LBP is because of the significant burden it inflicts on individuals, healthcare systems and productivity. The Global Burden of Disease Study 2017 suggests that LBP accounts for some of the highest numbers of disability-adjusted life years (DALYs) worldwide [DALY is a measure of overall disease burden, expressed as the number of years lost due to ill-health, disability or early death].
 
According to the UK’s 2014 NHS National Pathfinder StudyLBP is responsible for the loss of 2,313 DALYs per 100,000. This is a substantially higher ratio than the remainder of musculoskeletal conditions (911), depression (704) and diabetes (337) combined, and accounts for 11% of the overall disability burden from all diseases in the UK, where the burden of LBP is on the increase both in absolute (~3.7%) and proportionate (~7 to 8.5%) terms. The increased prevalence of LBP creates added demand and escalating costs for NHS England, estimated to be >£12.3bn (US$17bn) per year.
A 2012 study published in The Spine Journal suggests that LBP accounts for >3% of all visits to A&E in the US and estimates that each year, “>2m episodes of LBP occur among an at risk population of over 1.48bn person-years for an incidence rate of 1.39 per 1,000 person-years”. Findings of a 2016 study suggest that, “US adults with LBP are socioeconomically disadvantaged, make frequent healthcare visits and are often covered by government-sponsored health insurance”. The US Bureau of the Census estimates that, each year, LBP costs Americans ~US$50bn in healthcare costs. If you add in lost wages and decreased productivity, this figure easily rises to >US$100bn.

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Age of the aged and low back pain

LBP and degenerative spinal disorders

In the video below Ranj Bhangooa consultant neurosurgeon at King’s College Hospital, London explains how LBP and degenerative disc disorders are overwhelmingly the result of normal wear and tear, which occur over time as you grow older. Years of constant use and absorbing daily shocks take their toll, which suggests that, sometime during your lifetime, you will suffer from LBP. In most cases, it is not your spinal vertebrae that experience the effects of the wear and tear, but the 23 cartilage-based structures (discs), which sit between your vertebrae. These are filled with a jelly-like substance and act as shock absorbers, help to hold your vertebrae together and facilitate slight mobility in your spine. As you age, your discs lose their jelly-like substance, start to crack, and begin to naturally degenerate. This is believed to manifest itself as LBP, which can radiate down your leg and cause a condition called sciatica.
 
 
Spine surgery
 
If you are over 50, suffer from LBP, live in the US, Europe, or Japan, and have medical insurance, it is likely that during your lifetime you will have surgery to reduce your pain following a period of a non-surgical therapy. Scientific evidence supports surgery in a select group of patients who have failed to respond to non-operative treatments over a minimum of six months. However, a significant percentage of spine operations fail to relieve back pain and between 10% and 46% of primary spine procedures require revision surgeries.
 
In the video below, Ranj Bhangoo describes the care taken by clinicians not to rush into surgery for LBP.  When a patient presents with back pain, it is important to ask three questions: “Is the history of the pain compatible with a particular disc causing that pain? Does an examination suggest that a particular disc is causing the problem? Does a scan show that the disc you thought was the problem is the problem? If the answers ‘fit”, then there might be benefit in considering some treatment options, but not necessarily surgery. . . . . . Because 90% of us will get back pain at some point in our lives, 90% of us don’t need an operation”, says Bhangoo, whose opinion resonates with that of the Mayo Clinic: “Back surgery can help relieve some causes of back pain, but it’s rarely necessary,” and although “back pain is extremely common, surgery often fails to relieve it”.


 
 
 
Clinical dilemmas

Although first line clinical guidelines recommend non-surgical treatments for LBP and degenerative disc disorders and clinicians are cautious about possible treatment options, over the past three decades surgery has become a relatively common therapy for LBP and has fuelled a global spinal implant and devices market. The Lancet’s 2018 studies on LBP suggest that, “gaps between evidence and practice exist, with limited use of recommended first-line (non-surgical) treatments and inappropriately high use of surgery”.
 
However, the nature of evidence underpinning the use of non-surgical treatments for LBP does not help clinicians in their choice of therapies. A research paper, published in the March 2020 edition of the BMC Medical Journal, critically appraises the current evidence for non-surgical therapies for LBP and concludes that while, “pain management services may be cost effective for the management of low back pain the quality of evidence is variable”.
  
Spinal fusion

Spinal fusion is a common surgical therapy for a number of spinal disorders, some of which may present as LBP and include: (i) degenerative disc disease, which occurs when one or more of your discs between your vertebrae deteriorate and cause pain, (ii) spondylolisthesis, which occurs when one of your lower vertebrae slips forward onto the bone directly beneath it, (iii) spinal stenosis, a narrowing of the spaces within your spine, most often in your lower back and neck, which can put pressure on the nerves that travel through your spine, (iv) kyphosis, a spinal disorder in which an excessive outward curve of your spine results in an abnormal rounding of your upper back, and (v) scoliosis, which is a sideways curvature of your spine.
 
Despite being a common procedure, spinal fusion is a major surgery, which can be associated with significant morbidity and occasionally with mortality. In the video below Nick Thomas, a consultant neurosurgeon at King’s College Hospital, London, describes spinal fusion, which in certain circumstances, may be beneficial in improving pain.

 
 
Incidence rates of spinal fusion increasing

According to findings published in the March 2019 edition of the journal Spine, >2m spinal fusions were performed in the US in 2015. This represented an increase of 32% since 2004, with the largest increase (73%) among patients ≥65. Outcomes of spinal fusion procedures vary depending on the condition for which the surgery is performed. When performed for spinal deformities and spondylolisthesis, reported outcomes are generally favourable. However, the success rate of spinal fusion as a therapy for LBP and degenerative disc disorders is patchy.
 
Evolving techniques

Given these uncertainties, emphasis has been given to several evolving techniques such as interbody fusion and lumbar disc arthroplasty, which are more complex, technically demanding, and higher risk types of fusion. The former procedure involves removing your intervertebral disc and joining two or more vertebrae together using screws and interbody spine cages. These are hollow threaded cylindrical implants commonly constructed of polyetheretherketone (PEEK) and titanium, which have desirable biocompatibility and mechanical properties. Cages are filled with bone graft, and eventually become part of your spine.


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The latter procedure replaces a damaged spinal disc with an artificial one designed to support your vertebrae while preserving motion. These, and other hybrid techniques, are still relatively novel procedures despite promising near-term outcomes. Long-term studies demonstrating their superiority over traditional spinal fusion are required before they may be recommended to replace traditional fusion as the gold standard.

Further, recent scientific advances have allowed clinicians to explore innovative stem cell therapies in spinal fusion procedures in attempts to reduce morbidity and compensate for the limitations of autografts. However, results of research have not yet been translated into common practices to treat patients.
The incidence rates of spine surgery in the US

The US has the highest rate of spine surgeries in the world. In the 1980s rates increased by 55%. In the 1990s studies of spine surgery rates became more challenging because >20% of common spine procedures shifted to out-patient settings. Extrapolations from ambulatory surgical data suggest that throughout the 1990s, spine surgery rates continued to rise. The most rapid increase was for spinal fusion, which tripled during the decade and accounted for an increasing proportion of all spine procedures.
 
Since the 1990s, numerous studies have described the continued growth of spine surgery in the US, where today ~1.6m spine procedures are performed annually. Between 2004 and 2015, the volume of spinal fusions increased by 62%. During this 12-year period, aggregate hospital costs increased 177%, exceeding US$10bn in 2015 and averaging >US$50,000 per admission. A 1994 international comparative study found that, “the rate of back surgery in the US was at least 40% higher than in any other country and was more than five times that in England. Back surgery rates increased almost linearly with the per capita supply of orthopaedic and neurosurgeons in the country”.
 
The spinal implant and devices market

Over the past four decades, the high and increasing prevalence of spine surgeries has contributed to a high margin, profitable, global spinal implant and devices industry, comprised of ~400 companies but dominated by just four large American corporations: Medtronic, DePuy Synthes (Johnson & Johnson), NuVasive  and Stryker. These four control ~70% of the market, which in 2019 was valued at ~US$10.3bn, projected to grow at a compound annual growth rate (CAGR) of ~5%, and reach ~US$14bn by 2025. The US market segment alone was valued in 2020 at ~US$7.5bn, growing at a CAGR of 5.3% and expected to reach ~US10bn by 2025.
 
These spine market numbers include revenue from implants, instruments, and surgical assistance systems (robotics and navigation) to treat a variety of conditions. The industry has benefitted from advances in spine surgery technologies, the launch of novel bone grafting products and the increasing adoption of minimally invasive spine surgery (MISS). However, spinal fusion devices are the second largest segment of spine products behind plates and screws.
 
As a possible consequence of the industry’s rapid growth and relatively high margins, many spine companies have come to rely on linear supply chains and developed “cosy labour-intensive relationships” between producers, clinicians, hospitals, and payors. However, the high cost of spine surgery, tightening regulations and more stringent reimbursement policies threaten this business model.
 
Good news for spine companies

We know that age-related LBP and degenerative spinal disorders are significantly correlated to the incidence rates of spine surgery. The good news for the spine market is that, “virtually every country in the world is experiencing growth in the number and proportion of older persons in their populations”, and global life expectancy is rising and is expected to reach 77 years by 2050, up from 70 in 2015. The number of people ≥65, who account for most incidence of spine surgeries, is expected to increase by >60% in the next decade, from just >0.6bn in 2015 to ~1bn by 2030. A study published in the March 2020 edition of the Journal of the American Medical Association (JAMA) suggests that between 1996 and 2016, Americans spent ~US$134bn on therapies for back pain, which is more than that spent on the combined treatments for diabetes and heart disease.
 
Bad news for spine companies
 
Working age populations in the US and other spine markets ‘pay’ for the surgeries of the large and growing cohorts of retirees with sedentary lifestyles and LBP. However, working aged populations in these regions are declining because of falling fertility rates and professional women delaying motherhood. This suggests, ceteris paribus, that for the foreseeable future, a shrinking pool of working-age people will be forced to support expensive spine surgeries for a vast and rapidly expanding cohort of aging retirees.  Thus, it seems reasonable to suggest that the current trajectory of spending on spine surgeries in the major spine markets of the world is unsustainable, and increasingly, likely to exert downward fiscal pressure on spine companies.
 
Changing ecosystem

Such demographic trends are already exerting pressure on the spine market to deliver enhanced clinical outcomes at lower costs. For example, US reimbursement policies have moved away from a fee-for-service model towards a value-based model, which aims to utilize resources more efficiently by shifting the costs of over-treatment, revision surgeries and adverse clinical outcomes from payors to providers. Similar shifts are taking place in Europe and Japan. For example, in Europe fiscal pressure on healthcare systems has meant rationing and/or delaying elective spine surgeries. In Japan, more spine surgery costs are being shifted to employers and patients.
 
Population effectiveness

In wealthy spine markets decisions that used to be the sole preserve of doctors are increasingly being made by regulators, hospital administrators and other non-clinicians. This broader set of influencers have different objectives to doctors and prioritize cost effectiveness or even just costs. This is fuelling a shift away from individual patient outcomes towards a focus on the cost effectiveness of specific spine procedures on a given population. For example, the overall improvement within a cohort of patients ≥65 with LBP and degenerative disc disorders and a given level of spending by a hospital group on spinal fusions.
 
Innovations increasing in significance
 
Such shifts have encouraged innovations, which enhance outcomes and are positioned to change the standard of spine care. These include, minimally invasive spine surgery (MISS), robotics, computer assisted navigation, motion preserving technologies, and ortho-biologics, which will be discussed in future Commentaries. For now, let us finish by suggesting that such innovations could erode the competitiveness of traditional spine companies that are slow to change, and enhance the competitiveness of companies with the mindset, resources, and capabilities to invest in these evolving technologies.
 
Takeaways

Fiscal, technological, and demographic trends are driving the demand for competitively priced spinal implants and devices. Cost conscious US hospitals have consolidated to increase their buying power. Purchasing has become more centralized as hospital groups have leveraged their scale by standardizing processes and procedures across facilities. Providers have sharpened their focus on the cost effectiveness of spinal implants and devices and engaged in M&A activities to enhance their scale, R&D, and marketing. This has expanded the range of product offerings a single company supplies, but also it has increased market concentration, which advantages a few large dominant companies. The effect of these trends has yet to transform the strategies and business models of the overwhelming majority of traditional medium to small size spine companies, which will be needed for them to remain relevant in the future.
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Live streaming cataract surgery could assist medical students In their learning, this technique would be of interest to ophthalmologists who wish to deliver safe enhanced experiential learning to undergraduate ophthalmology teaching during the COVID-19 pandemic.

http://ow.ly/QPgv50EDJyF

#Ophthalmology #MedicalStudents #Covid19

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May the Rahmat of Almighty Allah shine upon you and your family always!

Welcome to the month of Ramadan with a heart filled with peace, harmony and joy.

May the divine blessings of Allah protect and guide you.

Sending best wishes to you from the HealthPad Team on this Holy occasion.

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PEACE, HEALTH AND BEST WISHES FOR 2021
from the HealthPad Team

 

2020 has undeniably been a challenging year. A pandemic has led the world to a global crisis, claiming the lives of many and disrupting so many others with the consequences it brought.

But the impact of CoVid-19 managed to inspire a renewed sense of community and showed the potential of what can be achieved when we work together and support each other.

The HealthPad Team wishes for this spirit to endure in 2021. May you and your loved ones stay safe and well, have a Happy Holiday season and a peaceful and prosperous New Year.

Thank you for your continued support throughout 2020, we look forward to another year together!
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  • The ‘needle’ has moved significantly since the FDA approved the first artificial human skin in 1996
  • Researchers in Australia have developed an electronic artificial skin (e-skin) that reacts to pain just like real skin 
  • Researchers in the US have developed an e-skin that mimics the functions and properties of human skin
  • These are just 2 examples of 100s of e-skin developments currently taking place around the world
  • Research findings on the functions and properties of e-skin pave the way for enhancing non-invasive alternatives to skin grafts, improving consumer healthcare, developing smarter prosthetics and advancing intelligent robotics
  • Such improvements are likely to take place over the next decade
  • One possible near-term application for e-skin is to enhance the Apple Watch
  • The commercial beneficiaries of e-skin are more likely to be giant tech companies rather than traditional manufacturers of medical devices
  
E-skin set to disrupt healthcare
 
 
In September 2020 researchers from Australia’s Royal Melbourne Institute of Technology (RMIT) published findings of a study entitled, “Artificial Somatosensors: Feedback Receptors for Electronic Skins” in Advanced Intelligent Systems. The study’s focus was an electronic artificial skin (e-skin) made of silicone rubber with integrated electronics with the capacity to mimic the functionality of real skin and almost instantaneously distinguish between less and more severe forms of pain. Just as nerve signals instantaneously travel to your brain to inform you that you have encountered something sharp or hot, the e-skin reported in this study triggers similar mechanisms to achieve comparable results. This represents a significant advance towards the next generation of biomedical technologies, non-invasive skin grafts, smart prosthetics and intelligent robotics: all large, underserved fast growing global markets.
 
A significant advance in bioengineering

According to Madhu Bhaskaran, the study’s lead author, a professor at RMIT and the co-leader of the University’s Functional Materials and Microsystems Research Group, the research is the first time that electronic technologies have been shown to mimic the human feeling of pain. “No electronic technologies have been able to realistically mimic that very human feeling of pain - until now. It’s a critical step forward in the future development of the sophisticated feedback systems that we need to deliver truly smart prosthetics and intelligent robotics,” said Bhakaran.
 
Her remarks were emphasised by Md Ataur Rahman, a researcher at RMIT who said, “We’ve essentially created the first electronic somatosensors - replicating the key features of the body’s complex system of neurons, neural pathways and receptors that drive our perception of sensory stimuli . . . . While some existing technologies have used electrical signals to mimic different levels of pain, our new devices can react to real mechanical pressure, temperature and pain and deliver the right electronic response . . . .  It means our artificial skin knows the difference between gently touching a pin with your finger or accidentally stabbing yourself with it - a critical distinction that has never been achieved before electronically.”
 
Combination of three smart technologies

The RMIT device combines three ”game-changing” technologies to deliver its superior sensing capabilities, all previously designed and patented by Bhakaran’s team. The first is a stretchable, transparent and unbreakable electronic device made of oxide materials and biocompatible silicone, which allows it to be as thin as a piece of paper. The second is a temperature-reactive coating that is, “1,000 times thinner than a human hair”, which can transform when it comes into contact with heat. The third is a “brain-mimicking memory”, which facilitates electronic cells to simulate your brain’s ability to remember temperature and pain thresholds and store these in its own long-term memory bank. Further development is required to integrate these technologies into biomedical applications and demonstrate their stability over time, but crucially says Bhaskaran, “the fundamentals - biocompatibility, skin-like stretchability - are already there."
 
E-skin research has been progressing for decades

E-skin research is not new and has been developing for at least the past three decades. Here we cannot do justice to the breadth and depth of such research, but we can give a flavour of its history and briefly describe another e-skin that mimics human skin, which was reported in the February 2018 edition of Science Advances.
 
As early as the 1970s, researchers were exploring the potential application of tactile‐sensing simulation and had demonstrated certain touch sensors, but with low resolution and rigid materials. Notwithstanding, over the ensuing two decades significant breakthroughs were achieved in malleable and stretchable electronic devices for various applications. More recently, tactile sensors with enhanced performance have been developed based on different physical transduction mechanisms, including those affecting: (i) the change in the electrical resistivity of a semiconductor or metal when mechanical strain is applied (piezoresistivity), (ii) the ratio of the change in electric charge of a system to the corresponding change in its electric potential (capacitance), and (iii) the electric charge that accumulates in certain solid materials in response to applied mechanical stress (piezoelectricity). Parallel to these advances, significant progress also has been made in design, manufacturing, electronics, materials, computing, communication and systems integration. Together, these developments and technologies open new areas for applications of bioengineered systems.
 
Breakthrough e-skin by a US group

The 2018 e-skin research study reported in Science Advances was led by Jianliang Xiao, a Professor of Mechanics of Materials and Wei Zhang, a Professor of Chemistry, both from the University of Colorado Boulder. They describe the characteristics of their e-skin, as “thin, translucent, malleable and self-healing and mimics the functions and properties of human skin.” Reportedly the e-skin has several distinctive properties, including a novel type of molecular bond, known as polyamine, that involves the sharing of electron pairs between atoms, which the researchers have embedded with silver nanoparticles to provide enhanced mechanical strength, chemical stability and electrical conductivity. “What is unique here is that the chemical bonding of polyamine we use allows the e-skin to be both self-healing and fully recyclable at room temperature,” said Xiao. Further, the e-skin’s malleability enables it to permanently conform to complex, curved surfaces without introducing excessive interfacial stresses, which could be significant for its development. The Boulder group has created a number of different types and sizes of their wearable e-skin, which are now being tested in laboratories around the world.
 
In the Commentary

In this Commentary we not only report the research findings of the two e-skin studies mentioned above, but we also describe, in simple terms, how you experience pain to illustrate the achievement of the Australian researchers from RMIT. We then describe human skin, its capacity to be wounded and traditional skin graft therapies to deal with such wounds. We briefly reference the invention of the first artificial human skin to receive FDA approval and highlight some of the massive and significant technological and market changes that have taken place since then. We conclude by suggesting that, over the next decade as e-skin technologies are enhanced, their potential healthcare applications are more likely to be owned and controlled by giant tech companies than traditional manufacturers of medical devices. More about this later. In the meantime, let us return to Bhakaran’s new pain-sensing e-skin and briefly describe the devilishly complex functionality of how you experience pain.
The function of pain and how you experience it
 
Your skin constantly senses things and your sensitivity to pain helps in both your survival and your protection. Pain prompts reflex reactions that prevent damage to tissue, such as quickly pulling your hand away from something when you feel pain. Notwithstanding, your pain response only begins when a certain threshold is breached. For example, you do not notice pain when you pick up something at a comfortable temperature, but you do when you prick your finger or touch something too hot. Consider this brief, over-simplified, description of how you experience pain.


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When you prick your finger on something sharp it causes tissue damage, which is registered by microscopic pain receptors in your skin. These send electrical signals through your nerve fibres that are bundled together with others to form a peripheral nerve. These electrical signals pass up your peripheral nerve and spinal cord to your neck area. Here they are transferred from one nerve cell to another by means of chemical messengers. The signals are then passed to three areas of your brain: one, the somatosensory cortex, that deals with physical sensation, another, the frontal cortex, which is linked with your thinking and a third area, your limbic system, which is associated with your emotions. All this occurs in nano seconds and results in you instantaneously feeling pain, wincing and becoming irritated when a pin pricks your finger.
 
Human skin and traditional skin grafts

Skin is your body’s largest and most versatile organ, which is unlike any other, not least because you wear it on the outside of your body. Not only is your skin a huge sensor packed with nerves for keeping your brain in touch with the outside world, it provides you with free movement. Adults carry  between 1.5 and 2.0 square metres of skin on their bodies, which weighs about 3.5kgs (≈16% of your body weight). Your skin is a “smart”, multifunctional organ that not only serves as a protective shield against heat, light, injury and infection, but also it is a sensory organ that regulates body temperature, stores water and fat, prevents water loss and helps to produce vitamin D when exposed to the sun. Skin wounds are relatively common and can be caused by trauma, skin diseases, burns or removal of skin during surgery. In the US alone, each year some 35m cases require clinical intervention for major skin loss.Your skin has three layers. The thin, outer layer that is visible to the eye is called the epidermis and the deeper two layers are called the dermis and hypodermis. Due to the presence of stem cells, a wound to your epidermis is able to stimulate self-regeneration. However, in cases of deeper injuries and burns, the process of healing is less efficacious and leads to chronic wounds. Any loss of full-thickness skin more than 4cm diameter needs to be treated immediately. Traditional ways of dealing with significant losses of skin have been skin grafts. The most common is to use either your own shin (autograft) or the skin from another person (allograft). Skin  grafts can also be obtained from a non-human source, usually a pig (xenograft). Autographs suffer from the fact that you may not have enough undamaged skin to treat the severity of your injury. Allografts and xenografts suffer from the possibility of rejection or infection. These challenges drove a need to develop an artificial skin.
 
The first FDA approved artificial human skin

The first artificial human skin to receive FDA approval was invented in the late-1970s by John Burke, a Professor of Surgery at the Harvard University Medical School and Chief of Trauma Services at Massachusetts General Hospital and Ioannis Yannas, a Professor of Polymer Science and Engineering at the Massachusetts Institute of Technology (MIT) in Cambridge, Massachusetts. Burke had treated many burn victims and realized the need for a human skin replacement. Yannas had been studying collagen, a protein found in human skin. In the mid-1970s the two professors teamed-up to develop a material - an amalgam of plastics, cow tissue and shark cartilage - that became the first commercially reproducible, artificial human skin with properties to resist infection and rejection, protect against dehydration and significantly reduce scarring. In 1979 Burke and Yannas used their artificial skin on a woman patient, whose burns covered over half her body. In the early 1990s the Burke-Yannas skin was acquired by Integra LifeSciences Corporation. In March 1996 the company received FDA approval for it to be used on seriously burned patients, and Integra Artificial Skin became the first tissue regeneration product to reach the market. Since then, it has been used in therapies throughout the world and has saved and enhanced the lives of innumerable severely burned people. More recently, the Integra Artificial Skin has also been used in a number of other indications.
 
Technological advances and market changes since the first artificial skin

Since Integra’s launch of the first FDA approved artificial human skin, healthcare markets and technolgies have changed radically. In the mid-1970s when Professors Burke and Yannas came together to develop their artificial skin, Apple and Microsoft, two giant tech companies with interests in healthcare, were relatively small start-ups, respectively founded in 1976 and 1975.  it would be more than another  decade before Tim Berners-Lee invented the World Wide Web (1989), and then another decade before the internet became mainstream. The tech giants, Amazon and Google, also with interests in healthcare, were not founded until some years after that: 1994 and 1998 respectively. Over the past four decades substantial progress has been made in tissue engineered skin substitutes made from both artificial and natural materials by employing advances in various fields such as polymer engineering, bioengineering, stem cell research, nanomedicine and 3D bioprinting. Notwithstanding, a full thickness bioengineered skin substitute with hair follicles and sweat glands, which can vascularize rapidly is still not available. 
 
Market changes, e-skin, the Apple Watch and giant tech companies

In closing, we briefly focus on one potential near-term application for e-skin - to enhance the capabilities of the Apple Watch.  We do this to emphasise the significant market shifts, which are occurring in healthcare and the large and growing impact that giant tech companies are having on the sector.

The Apple Watch was first released in April 2015 by Tim Cook, Apple’s CEO, as a fashion accessory. Notwithstanding, its focus quickly shifted and within three years it had become a FDA approved medical device. The watch, not only can detect falls, but it also has 3 heart monitoring capabilities: one recognises and sounds an alarm when your heart rate is low, a second detects irregular heart rhythms and a third is a personal electrocardiogram (ECG), which is a medical test that detects heart problems by measuring the electrical activity generated by your heart as it contracts. According to Strategy Analytics, a consumer research firm, in 2019, an estimated 30.7m Apple Watches were sold worldwide; 36% higher than the 22.5m watches Apple sold in 2018.

In 2020, during the coronavirus public health emergency, the FDA expanded its guidance for non-invasive patient-monitoring technologies, including the Apple Watch’s ECG function. This expanded use is intended to help facilitate patient monitoring while reducing patient and healthcare provider contact and exposure to CoVID-19.

 
Currently, the Apple Watch is worn like any other watch and if it is loose, its data harvesting capacity could be compromised. In the form of a watch, e-skin would conformally adhere to irregularly shaped surfaces like your wrist. The two e-skins described in this Commentary; both with intrinsic stretchability could potentially facilitate the Apple Watch to be more integrated with the wearers own skin.

The unstoppable march of giant tech companies into healthcare
 
Today, not only do giant tech companies such as Apple, Amazon, Google and Microsoft have their global market presence as a significant comparative advantage to enter and expand into healthcare, but they also have unparalleled data management capabilities. Since the invention of artificial skin by Burke and Yannas healthcare has become digital and global. Because giant tech companies’ have superior access to individuals’ data and state-of-the-art data handling capabilities; they know customers/patients significantly better than any healthcare provider. This, together with their global reach, positions giant tech companies to provide discerning patients with the healthcare solutions they need and increasingly demand.
 
IBM Watson Health estimates that by the end of 2020, the amount of medical data we generate will double every 73 days. According to Statisticaan analytical software platform, new healthcare data generated in 2020 are projected to be 2,314 exabytes. Traditional healthcare providers cannot keep up with this vast and rapidly growing amount of health information, despite the fact that such information is increasingly significant as healthcare shifts away from its traditional focus on activity and becomes more outcomes/solutions orientated. Giant tech companies are on the cusp of meeting a large and growing need to understand, structure and manage health data to build a new infrastructure for the future of healthcare.
 
Takeaways

The potential impact of e-skin is significantly broader than enhancing the Apple Watch. The research findings reported in this Commentary suggest that e-skin is well positioned to disrupt substantial segments of healthcare over the next decade. Findings published in Advanced Intelligent Systems and Science Advances suggest that one potential application is for e-skin to be seamlessly integrated with human skin. This not only positions it to become the next generation for a number of traditional MedTech applications, such as non-invasive skin grafts, but also to deliver a step change in the consumer health market by producing breakthroughs in human-machine interfaces, health monitoring, transdermal drug delivery, soft robotics, prosthetics and health monitoring. If traditional manufacturers are to benefit from e-skin they will need to adapt and transform their processes because the natural fit for e-skin technologies is industry 4.0, [also referred to as smart manufacturing and the Internet of Things (IoT)], which is expected to become more pervasive over the next decade as developments of e-skin unfold. Industry 4.0 combines physical production and operations with smart digital technology, machine learning and big data to create more solution orientated healthcare ecosystems and thereby tends to favour the giant tech companies and their growing healthcare interests.
 
#e-skin #artificialskin #AppleWatch 
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Changing the code of life



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On 7 October,  the Royal Swedish Academy of Sciences announced that it had awarded the 2020 Nobel Prize for Chemistry to two women scientists: Emmanuelle Charpentier (L), a French microbiologist, geneticist and biochemist,  who is now the director of the Max Planck Unit for the Science of Pathogens in Berlin, Germany, and Jennifer Doudna (R), an American biochemist  who is a professor of chemistry, biochemistry and molecular biology at UC Berkeley.

The scientists developed a simple, cheap, yet powerful, and precise technique for editing DNA, which is called CRISPR-Cas9 (an acronym for Clustered Regularly Interspaced Short Palindromic Repeats) and popularly referred to as a pair of ‘genetic-scissors’. The technology endows science and scientists with extraordinary powers to manipulate genes to cure genetic diseases, improve crops to withstand drought, mould and pests, and affect climate change, and is considered to be the most important discovery in the history of biology. The Nobel citation refers to Charpentier’s and Doudna’s scientific contribution as a, “tool for rewriting the code of life”, which has “a revolutionary impact on the life sciences, by contributing to new cancer therapies and may make the dream of curing inherited diseases come true”.


For more than four years HealthPad has been following and publishing Commentaries on the scientists’ work. Our Commentaries have a large and growing global following of leading physicians, scientists, policy makers, journalists and students. The Commentaries listed below about CRISPR techniques, which we re-publish to celebrate Charpentier’s and Doudna’s Nobel Prize, have had more than 120,000 views.
 
Gene editing positioned to revolutionise medicine
1 Feb 2017

 
Gene editing battles
15 Mar 2017

 
Who should lead MedTech?
18 Jul 18
Base-editing next-generation genome editor with delivery challenges
17 oct 2018
CRISPR-Cas9 genome editing a 2-edged sword
31 Oct 2018
Will China become a world leader in health life sciences and usurp the US?
27 Feb 2019
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“I’m sweating a lot these days. I’m losing my temper in no time. Perhaps my BP needs to be checked”!
These are common notions and you must have experienced such thoughts at some point of time or the other. BP (blood pressure) checking is one of the first steps taken by your doctor while he or she examines you for some health complaints that you have made! Before discussing the common and the lesser-known causes of abnormally high blood pressure, let’s start with what blood pressure (BP) is?


Blood pressure is the pressure exerted by the flowing blood on the walls of the arteries. The numbers look like a fraction where the ‘numerator’ figure is known as systolic pressure and the ‘denominator’ figure called the diastolic pressure. What do these numbers denote?


The systolic pressure is a higher figure and is a measure of the pressure in the arteries when the heartbeats, the diastolic one is when the heart rests in between two beats. Normal blood pressure reads – 120/80mmHg. A figure that is abnormally and consistently higher than this denotes hypertension (or high blood pressure).


Normally, a patient with high blood pressure is advised to consume fewer amounts of sugar, kept on medication, and sometimes prescribed to take low cholesterol foods (if cholesterol on the artery walls increases the pressure). However, some lesser-known factors might lead to Hypertension. They have been elucidated here in this article.


Some lesser-known causes of Hypertension


Obstructive Sleep Apnea
Years of repeated interrupted breathing causes the nervous system to release certain chemicals that consequently raises the blood pressure. Interrupted breathing also results in lesser oxygen in the body that adversely affects the blood vessel walls!


Low potassium profile
Our kidneys are responsible for maintaining a balance of sodium and potassium in our bodies. Suppose, you are on a low-salt diet and you rest assured that the blood pressure level in your body will remain unaffected. That's not the case! You could still have high blood pressure if there is an insufficient intake of fruits, veggies, fish, and dairy. Bananas, broccoli, spinach, etc. are good sources of potassium.


The use of NSAID
NSAIDs are Non-Steroidal Anti-Inflammatory Drugs such as Ibuprofen and other pain killers used in large quantities and over longer periods often damages kidney functioning. Like I already said, your kidneys are responsible for maintaining the sodium balance. This balance keeps the functioning of the blood vessels intact. When the balance is disrupted some amount of vasoconstriction could possibly raise the BP of your body.


Anxiety or the “doctor’s chamber” effect
A rise of up to 10 points for systolic and 5 points for diastolic pressure is a common phenomenon when the patient is inside the doctor’s chamber and is being examined. This is simply due to the anxiety that makes the blood run faster through the vessels. This raises both the pulse and the BP!


The use of decongestants
Decongestants squeeze the blood vessels. When the same amount of blood has to pass through a narrower passage, blood pressure is raised. Pseudoephedrine and phenylephrine are drugs that are responsible for such a condition. Sinus and congestion problems due to cold have other over-the-counter solutions for high BP individuals.


Dehydration
Lack of water supply to the cells of your body results in tightening up the blood vessels. That raises your BP. Why does this happen? Actually, the brain sends some signals to the pituitary gland to release certain hormones. This chemical results in the shrinking of the vessels. The kidneys release a lesser amount of pee to retain the remaining water that the body possesses. This again triggers the vessels of the heart to squeeze more!

The list is quite a long one - Overuse of antidepressants, consumption of too much sugar, and several other factors may be responsible for a raised blood pressure level!
However here is a quick read on common FAQs about Sphygmomanometers

 

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