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Medical Device Innovation | Kate Stephenson, PhD

Who better to explain the future of medical device innovation? Xinova’s own medical device Jedi, Dr. Kate Stephenson is a Stanford University Mechanical Engineering PhD with over 20 years of design experience, 15 of those spent exclusively in new medical device products. An additive manufacturing expert, she is the founder of Dyad Engineering, a consulting firm that provides highly personalized, technical consulting services for clients seeking strategic medical device expertise. Built on both deep technical knowledge and broad industry experience acquired from over 60 device projects, Kate focuses on short-term, high-value projects that de-risk new initiatives, and provide clear, actionable pathways for growth. Previous clients include startup founders, investors, industry suppliers, academic groups, and corporate innovation programs.

Medical Device innovation comprises an incredibly small, tight knit community, especially given the wide-spread impact we have on world health, so we can be very near-sighted about challenges we have to work with. The biggest challenges to the industry in 2020 are going to be outside this community. Solutions to those challenges will drive medical device innovation through the next decade.

Medical device innovation 2020

  • New Sterilization Methods
    • How will environmental and OSHA laws force medical devices to drop Ethylene Oxide sterilization, which would trigger redesign of 10-30% of all existing products and possibly lead to wide-spread shortages?
  • Regulatory: Fundamentally Changes to Where and How Clinical Studies are Completed
    • The recent release of the EU medical device regulations has completely turned their industry upside down. Europe was a major location for early stage clinical studies before submitting to US regulatory systems, something that may no longer be possible for the next decade as the new regulations are implemented. This may be particularly devastating to countries like Ireland and the Netherlands, who are working hard to develop Silicon Valley like tech centers for medical entrepreneurship. 
  • Digital Health Regulation & Security

These kind of challenges are going to require highly flexible, creative thinkers who can work with professionals from a wide range of backgrounds and expertise. Med Tech can’t innovate past these problems, regulatory and otherwise, using a siloed approach. The needed response is already manifesting itself in ways that are influencing today’s industry, and will continue to drive Med Tech innovation over the next decade.

The number of different incubator/accelerator models appearing in the med tech space are booming

Med Tech is a VERY hot industry right now. There are a wide range of research institutions, hospitals, and private, state, and federal resources that are building “innovation campuses.” Part of this is driven by the fact that with major corporations being a lot more conservative on when they are looking to acquire new companies, startups are seeing a much longer path to a final payout and are being forced to operate longer with less capital. There is a lot of innovation in business models working to fill the gap. 

Status and future of 3D printing 

3D printing finds its place inside and outside of organizations — and people

Currently, 3D printing of models and guides has become pretty routine in the US. It is in an “expansion” phase where successful integration processes are being implemented at a large number of clinical sites. At the same time, metal 3d printing has advanced to meet the “low hanging fruit” of the orthopedic implant space. These are not completely custom implants, but the tech is being used to create geometry that is difficult to produce any other way. There are now a wide range of potential materials in 3D printing, both in polymers and metals, that are suitable for biocompatible applications. 

Moving medical 3D printing towards 2030, I expect to see the “printing off-site/printing at the hospital” discussion resolved. We’re already seeing partnerships between major medical centers and metal printing service providers for custom implants. The realities of high power, precision manufacturing under the umbrella of a hospital administration make on-site production challenging, but service providers willing to set up “next-door” facilities has a lot of promise.

For bioprinting, I look forward to seeing the first drug trials run on printed artificial micro-organs, and the first printed live-cell grafts on humans. Skin cells, bone defects and vascular grafts are all good candidates for those first trials. From the regulatory stand-point, I see the FDA completing a guidance on the regulation of patient anatomy specific medical devices, and possible patient specific tissue grafts. 

Expanding beyond 3D printing, I expect to see a lot of traditional manufacturing technology be adapted for connected, AI-driven “just-in-time” manufacturing services. 3D printing can cut the expense from injection molding and some CNC machining, but there are still many products that require specific manufacturing methods to be produced. These include plastic extrusion for catheters, wires and cables drawing and spinning, and sheet forming. 3D Printing came first because it started with whole new machines, but the dropping costs in sensors and computational power will allow for retrofitting of traditional capital equipment for these new business models as well. 

Generational divide

In general, a big part of what will be driving health care in 2030 will be end-of-life care for Boomers, and Millennials hitting middle age. We’ll have the tech to support “aging in place” and improve the overall quality of life up until death, but there will still be large societal questions about how we manage the end of such a large generation with dignity.

Jokes aside, Millennials will be the backbone of the workforce in 10 years. Challenges with obtaining regular preventative health care in their young adult years, combined with rising rates of smoking (or vaping), STD rates, poor diet and exercise will result in a generation with significantly MORE health challenges than the previous one. Effective health care will require a deep, system level understanding of behavioral change, mental health and education design, not just the invention of new technology.

In fact, with the shift towards value based healthcare, where providers are paid based on patient health outcomes, we’ll see a simplification of some devices as companies are forced to assess devices based on their actual clinical efficacy, not just their marketing appeal. 



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