Medtech companies need to expand their philosophy: Here’s why


innovation materials biomaterials FDA medtech

[Image from Unsplash]

Medtech companies should expand their notion of who their customers are and dig deeper to discern what those customers want, according to health provider- and insurer-connected experts at the recent DeviceTalks Minnesota in St. Paul.

Artificial intelligence and the proliferation of healthcare data have made it possible for medtech to consider not just individual patients as their ultimate customers, but entire populations, the DeviceTalks panelists said. The industry would also do well to seek collaborations with not only the established experts in particular areas of medicine, but younger, hungrier physicians and researchers who want to make a name for themselves, they advised.

“The last decade or so has seen a steady proliferation of ethnographic, human-centered design methodologies. This has led to a number of critical breakthroughs in several therapeutic areas,” said Shayan Bhattacharyya, director of strategic partnerships for Blue Health Intelligence, an arm of the Blue Cross Blue Shield system. “I think the next horizon will be to expand that philosophy to include the perspective of other stakeholders, such as payers. Insights derived from big data analytics, such as what we have Blue Health Intelligence, will be critical in enabling that process.”

Institutions such as the Mayo Clinic and the University of Minnesota want to build these relationships, panelists said. Mayo has a lively startup setting and capital coming into its Rochester, MN, location, according to James Rogers, chair of business development at Mayo Clinic Ventures. Mayo is spearheading the 20-year development of the Destination Medical Center project, in which $585 million in state and local government infrastructure funds are expected to leverage about $5 billion of private investment in Rochester.

“We have seed funds, we have a venture fund, we have very engaged clinicians and researchers and we’re really focused on how do we effectively collaborate with industry,” Rogers said in discussing a collaboration with Boston Scientific that took two years to establish. “There’s an openness to entrepreneurism, there’s an openness to innovation and there’s an openness and a willingness to try new things, and so I think all of that was fertile ground for us to be able to try a collaboration like this, and so far, so good.”

Device makers should also look to the pediatric market for product development opportunities, even though it’s a smaller market, added Gwenyth Fischer, M.D., director of the Pediatric Device Innovation Consortium (PDIC) and an assistant professor of pediatrics at the University of Minnesota.

The development of pediatric medical devices is 10 years behind that of medtech for the larger adult market, Fischer said. The consortium was developed to find alternative funding sources and to accelerate development of devices that will benefit children. The FDA is helping the group find ways around running expensive, multicenter clinical trials such as using simulated patients and creating fast-track approval pathways. Companies should also consider that some devices developed for children could yield an opportunity for adult devices.

“We are working with a group at the university who has the technology to make a growing valve. This would be something that would be transformative for pediatrics, would allow a large number of our patients to avoid multiple heart surgeries and would prevent a lot of the complications they’re in,” Fischer said. “But this device also has a lot of adults potentials. So if you think about the vascular space, coronary space, that is the way that we’re currently approaching it and we have found that companies are very open to approaching the pediatric market if there is another upside for them in that market.”

Minnesota-based companies have been very supportive of these efforts, despite their reputation as “very traditional,” Fischer added. “What we will continue to need is companies of all sizes who are willing to think outside the box, see the larger profit for everybody, and be willing to work with a group like the PDIC that has the support and the funding and other development resources to help push something through.”

Medtech companies can take better advantage of all the data being generated in healthcare, according to Bhattacharyya. Payers and medtech companies’ data can affect real-world clinical and coverage decisions, Bhattacharyya added.

Daniel McLaughlin, director of the Center for Health and Medical Affairs at the University of St. Thomas in Minneapolis, gave some advice from his years in medtech, IT and heading Hennepin County Medical Center, a Level 1 Trauma Center in Minneapolis. When electronic health record data started flowing into the Centers of Medicare and Medicaid Services, Medicare payments had an unanticipated jump in payments and a sudden deficit, he said.

“I wonder about these things we’re doing right now where people don’t think through the total consequences,” McLaughlin said. “If I give one piece of advice to people in developing in the device industry it’s to think through — beyond next year — think about how all the other stakeholders, the system, are they going to react to that. What’s going happen next? Just think through all those consequences. I think that would be helpful.”

Inside Hologic's evolving definition of women's healthcare

textadimage Steve MacMillan took over as CEO of Hologic in 2013, drawing on his experience at medtech titans like Stryker and Johnson & Johnson. Since then, Hologic has grown into a $3 billion business.

At DeviceTalks Boston, MacMillan will provide exclusive insights into the Massachusetts-based company and its evolving definition of women's healthcare. You don't want to miss it!


Use code WOMENSHEALTH to save an additional 10%.

Speak Your Mind