By David J. Giles
Has the medical device industry lost its research mojo?
The industry spends billions on research and product development every year, and these investments are only increasing. The leading medical device companies reinvest 6%-12% of revenues into R&D, with the top 10 companies spending $10.5 billion on R&D in 20131. However, the vast majority of medical device research goes towards incremental improvements in product design or function rather than into truly revolutionary new products.
Revolutionary medical devices – those that upend market expectations or launch a whole new device category – are often built on new scientific discoveries or technological advances made in entirely different fields. To increase innovation in medical devices, we need to do a better job of translating academic research into commercial solutions. As technologies in one area advance, they will combine with other technologies to enable entirely new capabilities. The medical device industry will need to take a broader view of R&D to remain innovative.
The Three Legs of Medical Device R&D
There are a lot of different players in medical device research and development, but most of them will fall into one of three categories. Each of these organization types has its own set of priorities, strengths and weaknesses when it comes to R&D.
Academic institutions: Universities are strongly motivated to attract and retain talent who will enhance their reputation as both a teaching and research facility and help them attract students and research grants. In large research universities such as University of California Los Angeles or Ohio State University, faculty and grad students are given broad leeway in the research they want to pursue. Commercial applications of the resulting discoveries are not usually a high priority. This makes research universities excellent centers for basic and early-stage research. Because researchers are funded by grants and are not held accountable to achieving a return on investment for their efforts, they are free to pursue avenues of inquiry that may seem highly removed from any immediate useful application. In fact, they may not have the capacity to commercialize their findings even when a discovery does have commercial potential.
Commercial companies: Within the medical device market, the commercial sector includes both Fortune 500 behemoths like Abbott and Stryker and tiny biotech startups. However, whether they are publicly traded or privately held, all of these companies share a common goal: to make a profit. While many companies can and do reinvest profits into independent, internally-funded research, they need this research to generate results that can be commercialized within a relatively predictable timeframe. Unlike universities, they cannot afford to pursue interesting research questions that have a low probability of resulting in a financial return. Commercial companies are most likely to engage in late-stage development rather than pure research. Their R&D activities are generally focused on development of a new product or improvement of an existing product to meet a specific market need. Responding to shareholder and Wall Street pressures, public companies need to find ways to “move the needle.” In fact, some R&D executives have said that their organizations would rather acquire a company for $150M than spend $10M on a new product development program. This suggests that they are constantly balancing the risks of research with more quantifiable and certain transactions.
Contract research organizations: CROs fill an important role in the medical device development space. They give commercial companies access to scientific and technical expertise and specialized equipment and facilities that would be cost prohibitive for most commercial companies to host in-house. By engaging with a CRO, commercial companies can vastly expand their R&D capacity and shorten development timelines. Many CROs strictly act as “labs for hire,” performing specific, limited activities needed for product development or registration. Some large independent research institutions, like Battelle, do both contract research for commercial companies and independent or grant-funded basic and early-stage research. This allows them to act as much needed “connectors” between basic scientific discovery and commercial application.
The Disconnect Between Academic and Commercial Research
All three types of research – academic, commercial and contract – are sorely needed in the industry. Too often there is a disconnect between discoveries made on the academic side and application of those discoveries to solve real-world problems.
Basic research forms the foundation of the R&D pyramid; discoveries made here can lead to unexpected applications or even entirely new industries. For example, foundational, publicly funded research in genomics, including the Human Genome Project, led to the emergence of innovative companies like 23&Me as well as numerous commercial applications for diagnostics, personalized medicine and forensics. The global genomics market is anticipated to be worth almost $20 billion by 20202. These markets, which include medical devices such as genomic diagnostic assays, would not exist without the foundational research that preceded them.
There are many areas of basic research that could have implications for medical devices, from materials science to molecular biology. New discoveries in optics could lead to better imaging devices. Research in insect biomechanics may suggest a different design for a prosthetic. Advances in functional materials could lead to implantable devices with lower risk of infection or rejection. But academic researchers may not be close enough to the market to see the potential applications of their research, and commercial companies may not be aware that the research exists. Building better connections between basic and applied research could accelerate the translation of discovery into product development.
Building a Bridge Between Basic and Applied Research
To speed up translation, we need to build stronger connections between basic and applied research and across scientific disciplines. Independent research institutions like Battelle are well positioned to help bridge this gap.
Battelle occupies a unique space within the research ecosystem. As a nonprofit, the organization is mission-focused rather than profit-driven; all profits from contract research are either used philanthropically or reinvested back into research to “translate scientific discovery and technology advances into societal benefits.” This allows Battelle to operate in a middle space between purely academic and purely commercial R&D activities. Without the pressures of immediate commercialization, Battelle researchers can engage in research that builds off of basic research conducted at universities to advance our understanding and explore potential applications. They can also work on translational projects that look for new applications for existing technologies.
For example, Battelle researchers were working on a chemical resistant coating for the U.S. military to protect soldiers and equipment from chemical weapons. Researchers later realized that tweaking the formulation for the coating could result in an antimicrobial coating that could have applications in the medical device field. There are many opportunities like this to translate discoveries in one field or industry into applications in another. However, to make this happen, we need organizations with the capacity and incentives to find them.
There is no shortage of research happening in the medical device field today. Healthy investment continues in both academic institutions and commercial organizations. Where we need more focus is the middle ground that connects the two. It is this middle space where there is the most immediate and fruitful opportunities for groundbreaking medical device development.
About the Author
Dave Giles is Sr. Director of Commercialization for Battelle’s Medical Device and Consumer Products business unit.
1 Saxena, V. & Lawrence, S. (2017) “Top 10 med tech R&D Budgets” Fierce Biotech. Questex, LLC. http://www.fiercebiotech.com/special-report/top-10-med-tech-r-d-budgets
2 Markets and Markets (2016) “Genomics Market by Product (Instruments, Consumables), Technology (Sequencing, PCR, Microarray), Application (Diagnostics, Personalized Medicine), Process (Library Preparation, Sequencing & Imaging), End User - Trends & Global Forecasts to 2020.” Available from http://www.marketsandmarkets.com/Market-Reports/genomics-market-613.html