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Can 3D printing and the use of new alloys reduce the high costs of producing and marketing spinal implants?

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People are living longer, the prevalence of age-related degenerative disc disease is increasing and sufferers are more and more turning to spinal implant surgery as a solution
As this significantly raises the burden on over-stretched healthcare systems, so is spine surgery increasingly becoming a key target for cost reduction within healthcare systems
This intensifies the pressure on manufacturers to innovate and make spinal implants more cost effective

Can 3D printing and the use of new alloys reduce the high costs of producing and marketing spinal implants?

On January 8^th 2019 surgeons at Joseph Spine, a specialist surgery centre based in Tampa Bay Florida, were the first in the US to implant a 3D printed interbody fusion device, which was produced by Osseus Fusion Systems. The company uses its proprietary 3D printing technology, also known as additive manufacturing, to build spinal implants from titanium material that is optimized for bone fusion and biological fixation. In August 2018, a suite of Osseus’s devices received clearance from the US Food and Drug Administration (FDA) for a range of heights and lordotic (inward spinal curvature) angles, which make them adaptable for a variety of patient anatomies. The interbody fusion devices work by being packed with biomaterials and bone grafts and inserted in between two vertebrae, where they fuse with the spine and work to prevent back pain.

In this Commentary

This Commentary explores whether 3D printing and the use of new alloys could be an appropriate strategy to help spine companies reduce their production and sales costs and enhance their market positions. Our suggestions here complement a strategy, described in a previous Commentary, for MedTech companies to develop and implement digital strategies to enhance their go-to-market activities, strengthen the value propositions of products and services and streamline internal processes. The reasons spine companies might consider both strategies are because spinal implant markets, which are segmented by type of surgery, product and geography, are experiencing significant competitive, regulatory, pricing and technological challenges as well as mounting consumer pressure for improved outcomes; and the business model, which served as an accelerator of their financial success over the past decade is unlikely to be effective over the next decade.

3D printing

3D printing is a process, which creates a three-dimensional (3D) object by building successive layers of raw material. Each new layer is attached to the previous one until the object is complete. In the healthcare industry, 3D printing is used in a wide range of applications, such as producing dental crowns and bridges; developing prototypes; and manufacturing surgical guides and hearing aid devices. Increasingly, 3D printing is being used for the production of spinal implants.

Spine surgery increasing significantly

An estimated US$90bn is spent each year in the US on the diagnosis and management of low back pain (LBP). LBP, caused by age related degenerative disc disease, is one of the most common and widespread public health challenges facing the industrialized world. It is estimated that the condition affects over 80% of the global population and inflicts a heavy and escalating burden on healthcare systems. Also, LBP affects economies more generally in terms of lost production due to absenteeism, early retirement and the psychosocial impact caused by the withdrawal of otherwise active people from their daily activities. According to the American Association of Neurological Surgeons, more than 65m Americans suffer from LBP annually and the Chicago Institute of Neurosurgery and Neuroresearch suggests that by the age of fifty, 85% of the US population is likely to show evidence of disc degeneration. It is estimated that 10% of all cases of LBP will develop chronic back pain, which is one of the main reasons for people to seek surgical solutions and this significantly raises the burden on over-stretched healthcare systems.

Findings of a study published in the March 2019 edition of Spine, entitled, “Trends in Lumbar Fusion Procedure Rates and Associated Hospital Costs for Degenerative Spinal Diseases in the United States 2004 to 2015”, report that the rate of elective lumbar fusion surgeries in the US has increased substantially over the past decade. Such trends are indicative of most advanced industrial societies, which are changing and ageing, primarily driven by improvements in life expectancy and by a decrease in fertility. This results in people living longer, reaching older ages and having fewer children later in life. Over the next decade, these market drivers are expected to make spine surgery a key target for cost reduction within healthcare systems and this, in turn, is likely to increase pressure on manufacturers of spinal implants to make spine surgery more cost effective.

The first surgery using a 3D printed spinal implant

The first surgery to implant a 3D printed interbody fusion device was carried out in China in August 2014, when surgeon Liu Zhongjun from Peking University Hospital successfully implanted an artificial 3D printed vertebra into a 12-year-old bone cancer patient to help him walk again. Liu first removed a tumour located in the second vertebra of the boy's neck before replacing it with the 3D printed implant between the first and third vertebrae to allow him to lift his head. “The customized 3D printed technology made the disc replacement stronger and more convenient than normal procedures”, said Liu.

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Age of the aged and low back pain

In July 2017, a team of doctors, led by Xiao Jianru, Professor of Orthopaedic Surgery at Shanghai Changzheng Hospital, China, treated a 28-year-old woman with a massive, rare neck tumour, by giving her a 3D printed spine. The patient had to have six consecutive cervical vertebrae replaced because they had been affected by the cancer, which was challenging to treat with chemotherapy. Cervical vertebrae, seven in total, which form your spine column in the neck are the most delicate bones in your body. The patient was discharged from the hospital after the operation. Reports suggest that she was able to walk, but had some difficulties turning her head.

First US company to receive FDA approval for 3D printed spinal implants

The first US company to receive a 510(k) FDA approval for a 3D printed spinal implant was 4WEB Medical, in 2012. The company was founded in 2008 and since then has become a leader in 3D printed implant technology. Following FDA clearance, the company launched its proprietary and patented Truss Implant platform, which features a unique open architecture that allows for up to 75% of the implant to be filled with graft material and includes an anterior spine Truss System, a cervical spine Truss System, an osteotomy Truss System and a posterior spine Truss System. In April 2018, at the annual meeting of the International Society for the Advancement of Spine Surgery (ISASS) 4Web announced that it has surpassed 30,000 implants worldwide of its proprietary Truss Implant Technology.

There is a plethora of established MedTech companies entering the 3D printing spinal implant market, which include Stryker, K2M, DePuy Synthes, Camber Spine, CoreLink, Medicrea, Renovis, NuVasive and Zimmer Biomet. With Stryker’s acquisition of K2M and DePuy Synthes’ acquisition of Emerging Implant Technologies GmbH (EIT), both in September 2018, the market for 3D printed spinal implants is positioned to grow rapidly over the next few years.

Increasing FDA approvals for 3D printed spinal implants

Significantly, spinal implants have become one of the most common cases of the FDA-cleared 3D printed medical devices. For instance, in 2018 Zimmer Biomet received FDA clearance for the company’s first 3D printed titanium spinal implant. EIT received FDA approval in 2018 for its 3D printed multilevel cervical cage, which can treat multiple injuries in both the middle and top parts of the spine. Centinel Spine Inc, a US company based in Pennsylvania, which develops, manufactures and markets spinal devices used to treat degenerative disc disease, also received FDA clearance in 2018 for its 3D printed spinal implants called FLX devices, which are titanium fusion implants that work to stabilize vertebrae from the front of the spine in order to increase the healing process for patients.

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MedTech must digitize to remain relevant

3D printing medical devices market

The 3D printing medical devices market is projected to grow at a CAGR of 17.5% and reach US$2bn by 2022. Currently, the market is dominated by North America, followed by Europe, Asia Pacific and the rest of the world. Over the next decade, the Asia Pacific 3D printing medical devices market is expected to grow at the highest CAGR. Emerging markets are attractive for spine companies as they have large patient populations, which are growing fast, rising government healthcare expenditure, vast and rapidly increasing middle classes, rising income levels and rising obesity cases.

One example is India, with a middle class about twice the size of the US population, an economy growing at a rate of 7% year-on-year and a pro-business Prime Minister who has established himself as the country’s most formidable politician in decades and is committed to increasing healthcare spending. According to the World Bank’s March 2018 India Development Update the GDP of India had surpassed that of France and was on track to overtake the UK economy to make India the 5^th largest economy in the world. Significantly, India’s GDP per capita has reached US$2,000, which is generally recognised by economists as a “tipping point”: when a country’s economic prospects improve, peoples’ confidence increases, and investment momentum remains at a desirable level for a long period. For instance, when the GDP per capita of China and South Korea reached US$2,000 their respective economies witnessed more than a decade of high growth with an average growth rate of about 10%. India appears to be on the cusp of something similar.

3D printing's competitive advantages

3D printing, although in its infancy, has the capacity to manufacture products of any complexity anywhere, at any time, which gives it a significant competitive-advantage over traditional manufacturing. Further, 3D printing is cheaper and quicker than traditional production methods because there is less machine, material, labour and inventory costs and less materials' waste. Complex designs can be created as a computer added design (CAD) model and then transformed into a reality in just a few hours. By contrast, traditional manufacturing methods can take weeks or even months to go from the design stage to a prototype and then onto the production process. Also, 3D printing is cost-effective in low production quantities and more environmentally friendly as the place of manufacture can be the same as the place of the product’s application.

The benefits of 3D printing specifically for spinal surgery include; (i) implants can be shaped to custom-fit patients, (ii) porosity and pore size can be personalized to a specific patient’s bone quality, which may improve integration. But perhaps the most significant potential advantage is bioprinting, where cells, growth factors and biomaterials are used to create living tissue.

Thinking beyond traditional metals used for spinal implants

Some spine companies are complementing their 3D printing endeavours by experimenting with new and stronger alloys. For the past two decades metals used for spinal implants have been mostly composed of cobalt chrome, titanium and stainless steel. The physical properties of these have prevented producers to reduce the size of spinal implants. But this is changing with the introduction of new alloys such as molybdenum-rhenium (MoRe), which is stronger than the traditional metals used for spine implants and has the potential to use less metal to achieve stronger, more durable constructs, while allowing for smaller sized products.

Already, MoRe is used for stents in cardiology and findings of a small animal study presented at the 2018 North American Spine Society meeting in Los Angeles suggested that MoRe is significantly more hydrophilic (having strong affinity to water) and therefore friendlier to bone when compared with cobalt chrome, titanium and stainless steel. This suggests MoRe might provide smaller rods with smaller pedicle screw heads, which decrease the prevalence of protruding, painful hardware in patients with wasting of the body due to severe chronic illness. Further, smaller spinal implants would be beneficial in minimally invasive spine surgery.

Another added benefit of MoRe is that it potentially decreases biofilm formations, which are typically caused by chronic medical device-related infections and allergenicity when compared to the traditional metals used in spine surgery. Bacteria are tougher to kill when they attach to the surface of a spinal implant, even before they form a biofilm. Research findings published in the December 2018 edition of Heliyon draws attention to the prevalence of the antibiotic-resistant nature of bacterial biofilm infections on implantable medical devices and describes current state-of-the-art therapeutic approaches for preventing and treating biofilms. As the range of materials for spinal implants with improved biocompatibility, biodegradability and load bearing properties increase, so are biofilm infections expected to decrease.

Takeaways

Spine surgery is positioned to become a key target for cost reduction within healthcare systems over the next decade. This is because low back pain, caused by age related degenerative disc disease, is a common condition affecting most individuals at some point in their lives and increasingly people are turning to surgical solutions. As a consequence, we can expect increased pressure on stakeholders, including spinal implant manufacturers, to innovate to make spine surgery more cost effective. 3D printing and the use of new alloys, while in their infancy, are possible strategies to reduce the costs of producing spinal implants while improving patient outcomes.

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The Future of Healthcare

Fahad Aziz

Co-founder of Caremerge, which provides comprehensive web and mobile communications and care-coordination solutions for senior living communities. Fahad is the author of several technical papers, and the recipient of Pakistan’s prestigious Performance Excellence Award.

How will machine learning, virtual reality, the Human Genome Project, and the Internet of things change healthcare?

Will technology result in a healthier future full of empowered patients?
Will big data strategies help physicians perform their jobs better?
Will 3D printing be used to replace tissue and organs?
Will VR allow scientists to experience physical and psychological challenges rather than observe them?

Living in Silicon Valley I have a front row seat to the in technology poised to reshape the future of humanity. Machine learning, Virtual Reality, the Human Genome Project and the Internet of things will undoubtedly impact our lives in general, but they can also have a major impact on the Healthcare industry in particular.

To visualize the future of healthcare, I took a look at what’s trending in Silicon Valley and applied them to the healthcare industry. If the possibilities seem farfetched today, remember the iPhone is less than a decade old and has spawned countless industries that have shaped our daily existence, and will continue to do so. Technology moves fast and these four trends can potentially disrupt all aspects healthcare.

Machine learning
Artificial Intelligence (AI) is not new to the technology world, but with machine learning, AI has taken on an open-ended form rife with endless opportunities for technology in general and healthcare in particular.

Machine learning enables computers to identify patterns and observe behaviors based on empirical data, and use all that to ‘learn’. In other words, machine learning is a set of self-learning algorithms that can eventually become smarter than any human being on this planet.

In 2012, Vinod Khosla, an American businessman and a co-founder of Sun Microsytems, predicted that in time, “Technology will replace 80% of what doctors do”; sparking outrage and umbrage within the healthcare industry. Physicians overlooked what Khosla was really saying: that big data, properly harnessed and utilized, had the potential to help physicians perform their jobs better. Farfetched at the time, big data and machine learning have come far enough in just four years to provide levity to Khasla’s argument.

When given access to a trillion gigabytes of patient data collected from devices, electronic health records (EHRs), laboratories, and DNA sequencing - alongside surrounding factors such as weather, geo-location, and viral outbursts - computers learn quickly, and they learn everything. The depth of information provided at such a scale suggests patients will not need to consult with various specialities to figure out what’s ailing them in the future. Instead, consolidated data will create and provide a fully coordinated treatment plan.

If you are thinking this sounds crazy, consider the fact that IBM acquired Truven Health for $2.6 Billion in early 2016. Truven delivers information, analytic tools, research, and services to the healthcare industry, and gives IBM access to data of some 200 million patients to feed Watson, which is IBM’s machine learning product that is a powerful question answering computer system capable of answering questions posed by natural language.

I can only imagine what Watson will offer after digesting this massive data, but one thing is for sure: the result is nothing but good news for patients and their care plans.

The Internet of things
Gartner, a US IT research and advisory firm, estimates six billion devices will be “connected” by 2020; collecting data for consumption, analytics and a whole lot more.

Healthcare has historically been a sucker for devices, embracing hardware that captures data, provides diagnostics and even treats patients. Previously, these devices have been in use only at hospitals and other healthcare locations, but in the future this technology has the potential to become a part of every single home; marking a new era in care.

How can the NHS innovate? - Mike Farrar, former NHS Confederation CEO

In the future, doctor’s visits will begin before we even head out the door. Our vitals will be captured at home and sent to our doctor. In some cases, we may even receive treatment in the comfort of our home. Further, once treatment begins, a real-time feed of our vitals and conditions will be shared and analyzed automatically via set protocols, which will trigger alerts if our health declines and requires a change in treatment.

The Internet of things has implications elsewhere for the healthcare industry. Pharmaceutical research could bid farewell to clinical trials once they can access millions of patients’ data to accurately analyze behaviors and outcomes.

Challenges facing immunizations could also be solved using simple, digitized solutions. Currently, vaccinations are rendered ineffective by temperature changes during their transport; a simple tracking device with a thermometer could solve that problem. Similar challenges with manufacturing, delivery and tracking of vaccination can also be digitized to make the immunization programs successful globally.

Last but not least, I foresee nano devices embedded within the human body to monitor glucose, blood pressure, temperature, and more; to allow for swifter, more effective decisions to be made so treatments can begin as soon as needed, significantly increasing positive outcomes.

The Human Genome Project
One of the greatest breakthroughs in healthcare this last decade was decoding the human genome to understand the DNA sequencing. It took over 10 years and a staggering US$2.7bn to crack the code of one human being. Just a decade later, it takes US$1,500 and a couple of hours to run the genome for any person.

The more we learn about DNA and its sequencing, the more accurately we can treat patients for their illnesses. There will be no guesswork involved, instead, a complete technical report will show exactly what went wrong since last time, and what can be done to fix it.

The future is closer than we think. I suspect human genome machines will be deployed at healthcare locations in the near term. The appetite for this type of information will grow, and eventually, we may live in an age where small genome devices are installed under your sink or inside your toilet seat to analyze changes in your DNA sequencing several times a day.

Today, researchers in Europe are using 3D printers and DNA sequencing to create human body parts that can potentially replace limbs or ailing organs. Prototypes already exist. DNA sequencing will help people take more control over their bodies, allowing them to make better informed decisions about their lifestyle, illnesses and treatments. This means that doctors’ roles will change, potentially allowing for a complete shift in the healthcare paradigm.

Virtual reality in healthcare
Mark Zuckerberg, chairman, CEO and co-founder of Facebook, takes every opportunity he can to promote his latest US$2bn acquisition, Oculus VR, an American virtual reality company, whose product, Oculus Rift, is a virtual reality (VR) headset. I had the opportunity to try Oculus Rift, and was blown away. Market analysts say Zuckerberg was crazy to bet on this, but I know he has discovered a platform with the potential to be larger than Facebook.

Virtual reality transports you into another world by creating an artificial environment, deceiving your sense of sight and touch, so your mind believes you are part of that environment. At a recent Aging2.0 conference, I watched a man in his 30s struggle to walk while wearing an Oculus Rift headset. A moment after putting it on he experienced the physical shortcomings of someone in there 80s. These types of experiences open up a new world for researchers by providing them with the ability to directly experience physical and psychological challenges rather than rely on observations.

Doctors' resistance to change - Devi Shetty, founder of Narayana Hrudayala, Bangalore, India

The environment created by VR is artificial and programmed, at least for now. But fast forward three to four years, and you will likely be in a real environment. Consider this: a doctor could be transported to a hospital in Kenya while sitting in the relative comfort of his clinic in San Francisco. VR would allow the user to move around and interact with people enabling participation in treatments, research or even surgery.

I suspect Zuckerberg will combine social networking and virtual reality, allowing people from any part of the world to meet up with one another, to visit places they have previously only dreamed of, and go on adventures their body would never allow in the real world.

In healthcare, innovators are already leveraging VR for treating post-traumatic stress disorder (PTSD), autism, social cognition, meditation, and help with exposure therapy and surgical training. And this is just the beginning.

Takeaways
The day is fast approaching when I will be able to virtually go to hospital to meet with doctors and specialists, share my vitals through various devices and a video camera to gain assessment and treatment plans from the comfort of my own home.

Healthcare information and management systems (HIMSS) have never disappointed me in terms of their participation and size, and I am hopeful that innovations will continue to shock, whispering promises of a healthier future full of empowered patients.

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