Value-Based Environment is Crucial to Developing Innovative R&D

It will be different next time. Much different, hopefully.
 
Future pandemics are unlikely to resemble the disjointed patchwork of COVID-19 mitigation efforts implemented worldwide by lawmakers and health officials. Instead, they possibly will involve more coordinated responses and widespread testing, as well as technological innovations inspired by design thinking.
 
Such thinking could result in redesigned public spaces that double as treatment areas during an outbreak and airports with more security screening lanes. Hospitals are likely to rethink conventional schematics too, potentially employing such pandemic-busting features as negative pressure zones, special patient evaluation areas, telehealth centers, and flexible-use rooms (i.e., those easily modified between acute care and ICU).
 
With the COVID-19 threat unlikely to abate in the fore- seeable future, design thinking could potentially become a powerful tool in helping to better manage and control forthcoming pandemics. The approach is already being used to improve healthcare equity and spawn creative solutions to medicine’s most pressing dilemmas.
 
MPO’s January/February feature, “Inventive Interaction,” explores the various forces at play in medtech R&D. Steve Maylish, chief commercial officer at Fusion Biotec, was among the various experts interviewed for the story. His full input is provided in the following Q&A.
 
Michael Barbella: Where are companies spending their research dollars now—on incremental improvements to existing devices, or game-changing innovation?
Steve Maylish:When I think of medtech companies, I put them in two categories (startups and established companies). For established companies, they saw the fee-based system evolving to a value-based system years ago and have mostly adjusted. This includes moving away from incremental changes as a chance to re-engage customers and to product changes that reduce cost and improve function. Startup companies have always been great at trying new technology and thinking out of the box. Unfortunately, a number of startups don’t consider the new value-based environment early enough. When an idea is still being incubated, there should be consideration for the value of the product. Too many products are still being conceived as an additional test or as an adjunct or pre-screening. This may help to detect a problem sooner, but often adds cost to the system. Some products are difficult to define in a value-based environment. Such as, how will you prove better patient outcomes? Who will benefit from the cost savings? Will the beneficiaries care or are the savings too convoluted across the healthcare system? See the MPO column, Designing from Finish to Start.
 
Barbella: How is value-based healthcare shaping the kinds of medical devices/technology being developed?
Maylish: Now especially in established firms, marketing is reviewing product ideas with an eye on the value-based environment and value-analysis committees that decide whether or not to purchase the product. In established firms, this process is well understood. For startups unfamiliar with this process, it can be devastating. Imagine reaching the end of all of your efforts (research, development, clinical trials and FDA submission) only to find out that your product doesn’t get over the value-based bar.
 
Barbella: Please discuss the importance of university/academic partnerships in developing cutting-edge medical devices.
Maylish: More than ever, technology is playing a key role in healthcare products and this will continue for the foreseeable future. University and academia are providing much of the research and foundation for this technology. Importantly, academia needs to filter these technologies through the lense of serial entrepreneurs and commercialization experts in order to properly access their commercial viability. Translation always presents unique challenges, especially if a technology is being force-fit into a clinical environment.
 
Barbella: Are startups better suited than their mid-size or large OEM cohorts to develop medical technology that addresses value-based healthcare solutions? If so, how? (Or, if not, why not?)
Maylish: I believe startups could be better suited, if they were more familiar with the value-analysis process.
 
Barbella: Can a company effective tackle a healthcare need/problem and devise a solution based on its own internal R&D? Please explain.
Maylish: Yes, and this process happens thousands of times a year, especially in the core competency areas of established companies. It is much more difficult to accomplish in areas where there are no internal expertise – but not impossible.
 
Barbella: How can companies “innovate the process of innovation” to achieve more transformational products through R&D?
Maylish: This involves different processes and a different mindset. Years ago, it was called a skunk works or an offsite development lab. Today, innovation teams need to be separated from the typical corporate constraints (planning product breakthroughs, discouraging failure, “not invented here” mentality, avoiding risks, etc.).
 
Barbella: How will AI, big data, and digital health affect the R&D process going forward?
Maylish: For medtech products, these technologies and technologies like them (interoperability, SaaS, personalized medicine) will completely change the face of healthcare. We all acknowledge the high cost of healthcare without the resulting benefits. Numerous investors are betting that this can be turned on its head through investment and adoption of this and other technologies.
 
Barbella: What is driving the need to outsource medtech R&D? Does the R&D process even need to be outsourced?
Maylish: Some of the biggest drivers of outsourcing medtech R&D can be access to qualified people, knowledge experts and new technology. As the pace of technology increases, it becomes more difficult to keep R&D teams apprised of cutting-edge technology.