Medtech R&D is in dire need of a reboot.
 
Value-driven healthcare, evolving regulatory requirements, and the emergence of new, nontraditional players are rewriting longstanding rules for medical device development and production. Companies accustomed to traditional R&D strategies are finding those methods ineffective at gaining (or maintaining) market share. Consequently, medtech firms are revamping their research and development models by collaborating with organizations outside the industry; incorporating sensors and software into devices and diagnostics for data generation and transmission; and rebalancing their portfolios.
 
Device manufacturers also are shifting their focus from core products and line extensions to more transformational innovation—i.e., technologies that create and deliver customer value through novel products, solutions and business models that address unmet market needs.
 
Such solutions, however, are not easily attainable without outside help. Thus, device companies increasingly are outsourcing R&D work to firms that specialize in value-driven product development. MPO’s January/February feature story “Valued R&D” examines the trends and challenges confronting medtech R&D teams as they strive to adapt to the changing healthcare ecosystem. Steve Maylish, chief commercial officer at Fusion Biotec, was among the experts interviewed for the feature; his full input is provided in the following Q&A.

Michael Barbella: An EY report last fall concluded that R&D spending is declining. How could that potentially impact future medical device/technology innovation?
Steve Maylish: 2018 was a banner year for institutional investment in medical devices (VCs, angels, family offices, etc.). Startups in our space are being funded and IPOs [initial public offerings] are doing well. Decreased R&D spending could be an indication of less OEM innovation or a strategy to innovate through acquisition.

Barbella: Where are companies spending their research dollars now—is it more on incremental improvements, or game-changing innovation? Why is that?
Maylish: I believe if there is a shift in spending, it's toward game-changing innovation due to the fact that incremental improvements are not enough to move the corporate needle and value-based reimbursement doesn't reward incremental improvement, especially if it comes with additional cost.

Barbella: How has value-based healthcare impacted the kinds of medical devices/technology being developed through R&D? Are costs prompting more companies to develop combo devices that perform several functions in one embodiment as compared to developing bigger, more revolutionary technology?
Maylish: This is an interesting question. I think there are two answers here. For large OEMs, the transition from incremental improvement to value-based products started a number of years ago and is in full swing. For startups, the need for value-based products hasn't fully sunk in. Im not convinced that the cost issue can be solved by developing combo devices. The key is innovation and large OEMs are not known for that. This is why I believe that there could be a shift from internal innovation to acquiring innovation. Another reason that I believe this may be happening is because the healthcare industry is in the middle of a major shift. It's easier to know a solution when you see it (acquisition), rather than be able to predict it (internal development).

Barbella: Many companies are targeting emerging markets to qualify new devices first before introducing them to the U.S. market. How do these companies find the right partner for this strategy? What should companies be looking for in these partners?
Maylish: This is another interesting question and I am not familiar with the various CROs. I do know, however, that certain segments of our industry find great collaborators in emerging markets along with reduced cost. For example, the ophthalmology industry for years now has relied on a number of Mexican clinics for clinical trials. The aesthetics market has relied on a number of Brazilian clinics, and so on. Typically, CROs have specific partner clinics/organizations with whom they work. These groups may or may not be the right fit, depending on your segment of the industry.

Barbella: How is digital healthcare, big data, and trends like miniaturization affecting the way companies conduct R&D and their R&D business models?
Maylish: I believe that these are some of the reasons why OEMs are outsourcing engineering and acquiring companies. With everything that is going on in healthcare, it's impossible to be an expert in all of them (interoperability, connectivity, machine learning, artificial intelligence, software-as-a-service model, value-based outcomes, remote patient monitoring, MEMs, etc.).

Barbella: Why should a company outsource R&D? What is driving the need to outsource R&D?
Maylish: In the past, you could point to a lack of resources or bandwidth of the engineering department. But now, you can't expect the internal team to be up on all of the new technology—it's just changing too quickly. Traditional OEMs have designed at a much slower pace and there wasn't a need to incorporate new technology. In fact, there was a disincentive. Now, much of this technology is a necessity.

Barbella: How does your company source talent for internal product development?
Maylish: Luckly, through our networks and people that we have worked with in the past, we have been able to hire employees. We also rely on long-term relationships with a number of consultants to staff our busy periods.

Barbella: How important is outside collaboration in medtech R&D?
Maylish: We collaborate all of the time. We have some very close vendor relationships. We also have partners who will collaborate with us on a development project, where they might design a disposable cartridge and we the instrument. These partnerships are a result of long-term relationships that developed over many years. Typically, they start out with a small effort/project and then as things go well, they develop into more of a strategic partnership.