• Kate

Production & Manufacturing: “Invisible” Opportunities for Medical Innovation in the Next 10 years.

I was recently asked to give a futurist-type talk, the classic “Five Innovations that will change everything in the next 10 years”. In the medical technology field, these types of presentations are both incredibly popular and (given the way the world has turned upside down in the last two years) rather difficult to do accurately. As I pondered how I could apply my own expertise to future forecasting, I realized that there were urgent issues in my field that, while not regularly featured in news, Hollywood, or political debate, will nevertheless have sweeping impact in the next 10 years. These are exceedingly difficult challenges to solve, but also represent major opportunities for the right entrepreneur. Rather than hitting the current notes on who’s who is tech, or pondering the rapid fluctuations in reimbursement, finance capital or health policy, I turn to what I know: how medical technology is made.

For those unfamiliar with medical device manufacturing, it has two defining traits that make it unique from how we produce anything else. One, it is extremely specialized. Pandemic-Era MacGyvering aside, the materials, processes and equipment used to produce medical devices are not used heavily outside of our industry. Polymer blends, metal alloys and textile materials produced specifically for medical applications are a miniscule percentage of those produced for other industries. This means that medical manufacturers rely on a handful of trusted materials and processes for everything that we produce. Two, medical manufacturing is SLOW to change. Because our products are high risk, we rely on processes and materials with long track records. When we talk about being “innovative” in medical technology, we are referring to product design, new business models or ways of supplying a service. New products are manufactured, inspected, stored, and shipped just like the old ones.

Because of these two factors, when there is pressure to change how we do manufacturing, it has a SUBSTANTIAL impact. Instead of thinking about changes to cardiac catheters or ultrasound scanners, we can talk about changes to anything that comes in a box or is made of a particular type of plastic.

So, if you really want to see some of the broadest changes that will hit our industry in the next 10 years, here are my top 5 areas to watch.

Opportunity 1: Supply Chain Traceability

While this issue hit center stage thanks to runs on toilet paper, masks and gloves, efforts to address the lack of continuous supply chain data have been ongoing in medical device for decades. Our industry’s quality controls have relied heavily on manual methods of certifying and tracking raw materials through production and on to patients. But even this paper trail focused on materials and goods, not on building visibility between the different organizations those goods passed through. Medical device manufacturers are in direct communication with only their most immediate supplier, just like hospitals and clinics may only talk to resellers, not the distributers and manufactures themselves.

There has been growing awareness in recent years of the need to fully trace supply chains for ethical and political reasons. Finding weaknesses that could collapse under (seemingly) minimal risk events like extreme weather or a worldwide pandemic was limited to doomsayers and Hollywood movie producers. This is changing. Between exploding volcanoes in Iceland, tsunamis in Japan, an ongoing worldwide pandemic and an epically failed three-point-turn locking up the Suez Canal for a week, supply chains are reorganizing to optimize robustness over pure cost effectiveness.

Responding to the now recognized impact of these “rare” events, the US FDA’s 2022 budget included funding for a $20 million Resilient Supply Chain and Shortages Prevention Program (RSCSPP) in the Center for Devices and Radiological Health (CDRH). This will be the first permanent program tasked to ensure the resilience of medical device supply chains. With most incumbent supply chain management products still focused on time and financial optimization, this is an opportunity for entrepreneurs looking to address the gaps in traceability and resilience strategy.

Opportunity 2: Environmental Accountability

While environmental sustainability has expanded into the corporate consciousness of most major industries, medical technology has had an extended “pass” due to its essential nature and critical material and manufacturing requirements. As mentioned earlier, medical products use very specialized materials and processes, primarily developed to minimize medical risk. While beverage containers, lightbulbs, cars and power plants have all undergone radical changes to improve sustainability, medical products have not. The first medical device standard to make any mention of sustainability (IEC 60601-1-9) was only produced in the last couple of years. However, with the COP26 Climate Summit calling for Global commitments to sustainability across all industries, and the major medical manufacturers issuing sustainability statements as a critical part of the public relations, medical device’s “pass” is fading. The next 10 years will likely see a complete redesign of medical packaging, an explosion of re-processing and recycling businesses to process what is currently discarded as tons of medical waste, and the incorporation of recycled fiber and polymer materials into non-critical medical applications. All of these are major opportunities to resolve what will likely be an intense and protracted conflict between parties tasked with meeting sustainability goals and those striving for safe and cost-effective healthcare

Opportunity 3: Sterilization

When I said medical device processes are slow to change, I mean VERY slow to change. How we sterilize the mass bulk of our medical products is a prime example. Autoclaves existed in the 1800’s, Ethylene Oxide (EtO) gas started in 1938, and E Beam and Gamma arrived with the expanded research into nuclear power during the 50’s and 60’s. Vaporized Hydrogen, the tech behind some of the new table-top mask sterilizers, has been around since the 1980’s. Most of these processes were developed long before environmental sustainability or occupational health existed. In Feb of 2019, one of the largest EtO facilities in the US was shut down due to occupational health concerns. The highly toxic and explosive gas is currently used to sterilize half of all medical devices, and up to 70% of our disposables. It is the only widespread technology capable of sterilizing most medical plastics without damaging them. The debate about its future was highjacked by the larger supply concerns of the Pandemic, but that has only delayed the inevitable industry conflict. In November of 2019, the FDA announced two Innovation Challenges. One: to identify new technologies that could replace EtO and Two: Methods to reduce the environmental and occupational hazards associated with the process. More research awards and opportunities are in process to develop new polymers compatible with the non-EtO sterilization methods.

Opportunity 4: Batteries

The pressure to consumerise medical devices is often laid at the feet of the major tech giants. Thankfully, the tech giants granted our industry more than heightened product expectation from patients, they gave us better batteries. The global medical device battery market is estimated at about 2 billion USD. While this is not insignificant, new battery technology is being paid for (and driven by) the needs of the much larger consumer electronics market, which sits at around 40-50 billion USD. Functionally, there are many parallels between medical and consumer devices. The general power and performance requirements are similar. Where our needs part ways is in risk. The batteries that go in your calculator, your smartwatch and your pacemaker may be around the same size, but the problems you face if they fail are quite different.

Batteries for critical Class III devices are a particular challenge. These range from crash cart defibrillators to implanted pacemakers. The markets for these products are expanding as demographics age and new electrotherapies are developed as alternatives to medication. Both trends mean a healthy demand for high-density, long-lasting batteries. However, there are already concerns over the stability of Li-ion batteries. Looking forward, it is unclear if tech developed to meet the high weight and performance demands of consumer products will also meet the stability concerns in medical. As broad climate sustainability goals drive fundamental battery research across all industries, new tech that struggles to compete in other markets may leverage high stability to excel in medical.

Opportunity 5: (Soft) Customization at Scale

While 3D printing has been the most popularized, there are a whole spectrum of digitally enabled, low volume production methods that have matured over the last 20 years. These include pharmaceutical compounding and medical textile knitting and sewing. What we have seen the last 10 years is the industrialization of the equipment and facilities, the cheapening of the computer power necessary to auto-generate complex forms, and the adaptation of documentation and inspection techniques for patient specific production. Custom medical device use cases have transitioned from one-of-a-kind, to relatively common case studies, to FDA approved products built around the technology. With the technological and logistical barriers disappearing, what is left is the classic bane of any new medical technology: integrating it into clinical workflows in a way that works for patients, providers, and payers. For custom products, this means finding economical and effective ways to capture the patient data used in design.

Currently, patient data capture is being accomplished via a range of methods, with adoption dependent on in-clinic technical aptitude, tech borrowed from other industries and the exact nature of the tissues involved. The dental and orthopedic industries have been able to drive forward with their own unique systems due to the relative simplicity of modeling stiff structures like teeth and bones. While there are manufacturing solutions for creating custom soft structures via polymers or textiles, 3D models that accurately capture the dynamic deformation of organs and muscles are currently primarily for research. Patient specific soft tissue products require capturing dimensional data over a range of conditions, and then translating that data series into a single part file that will deform and change shape along with the patient's own anatomy. Platforms that simplify data capture, part design and large deformation analysis could support a wide range of soft tissue products, both artificial and (perhaps in another 10 years) organic.

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