No One Sees the Whole Picture
On September 30, Michigan’s medical device community gathered at Washtenaw Community College for the 2026 MichBio Medical Device Summit. The agenda covered many of the issues shaping our industry right now: artificial intelligence, regulatory change, reimbursement, manufacturing, commercialization, cybersecurity, and the challenge of building and maintaining strong teams.
But the idea I left with was much simpler: Input from an experienced, multidisciplinary community is critical.
Medical device development has become too complex for any one person, company, discipline, or agency to see, let alone address, the whole problem.
That theme surfaced throughout the day.
I had the privilege of kicking off the Summit by moderating the opening C-suite panel with Mike Blue, CEO of HistoSonics, and Ted Bloomfield, COO of Everis Medical. We talked about the major forces confronting medtech companies today, including AI, reimbursement, regulatory uncertainty, supply chains, and the pressure to demonstrate value.
But one of the most refreshing parts of the conversation was where we ended up when we talked about risk.
For all the attention being paid to artificial intelligence, all three of us identified investment in our people as one of the important risks our organizations are intentionally taking.
Hiring talented people before every uncertainty has been resolved is a risk. Developing a team is an investment. Keeping that team together when market conditions are less than perfectly predictable requires commitment.
And yet, for companies trying to solve difficult healthcare problems, hiring, developing, and caring for strong people remains one of the most important investments we can make.
At a conference filled with discussion about artificial intelligence, it was encouraging to hear executives spending time talking about the importance of humans.
Keeping the patient in the conversation
The keynote speaker was Dr. Michelle Tarver, Director of FDA’s Center for Devices and Radiological Health.
Dr. Tarver brings an unusual combination of perspectives to that role. She is a board-certified ophthalmologist and epidemiologist, has spent more than 15 years as a medical-device regulator, has led significant patient-engagement work within FDA, and continues to care for patients clinically a half day a week.
That combination of clinical and regulatory experience brings an important perspective to FDA leadership.
Regulatory discussions can quickly become conversations about pathways, submissions, evidence requirements, timelines, and guidance documents. Those things are important, but ultimately they exist because there is a patient on the other side of the process.
Among the issues facing CDRH are the MDUFA VI cycle, staffing, and the rapidly growing role of AI throughout healthcare and medical technology. Dr. Tarver’s comments reflected neither alarm nor complacency, but a practical recognition that FDA and industry will need to navigate these issues together.
Following Dr. Jeff Shuren’s tenure as CDRH Director, I was particularly interested to see what the Center’s relationship with industry would look like under new leadership. I left very encouraged. Dr. Tarver’s emphasis on patients, evidence, and engagement suggests that constructive collaboration between FDA and the medical-device community remains very much alive.
Clearance is not access
An interesting conversation between Dr. Tarver and in2being Director of Product Development, Aaron Kehrer, highlighted another challenge facing medical device companies: the gap between regulatory authorization and patient access. The two had participated in the same regulatory-science conference the previous week and briefly discussed the relationship between FDA and the Centers for Medicare & Medicaid Services.
The challenge is easy to describe, even if it is much harder to solve: FDA authorization does not necessarily mean patient access.
FDA determines whether a medical device may be marketed for a particular use. Coverage and payment are separate questions involving CMS, commercial payers, health systems, physicians, and others.
For device companies, those distinctions can be consequential.
FDA and CMS continue to explore ways to coordinate earlier, including pathways for certain FDA-designated Breakthrough Devices. But even with improving coordination, regulatory authorization does not automatically answer the questions of coverage, coding, payment, adoption, or commercial viability.
A company can successfully invent a device, demonstrate that it works, navigate the FDA process, and receive market authorization, and still have substantial work ahead before that technology routinely reaches patients.
That is why reimbursement and payment were recurring themes throughout the Summit.
Clearance is an important milestone. It is not the finish line.
AI changes the tools, but not the fundamentals
Artificial intelligence was, unsurprisingly, another thread running throughout the conference.
The conversation has matured considerably from where it was even a few years ago.
AI is no longer simply a discussion about medical devices that incorporate machine learning. It is increasingly being used throughout the product lifecycle: research, engineering, documentation, regulatory work, manufacturing, quality, business analysis, and countless other activities.
That creates enormous opportunities.
It also makes human judgment and ownership more important, not less.
AI can accelerate research. It can summarize enormous quantities of information. It can automate work that previously consumed hours.
It can also produce confident, yet false, outputs.
That means responsible use still requires patients, clinicians, engineers, regulatory experts, reimbursement experts, manufacturers, investors, and experienced business leaders who understand both the question being asked and the consequences of the answer.
We’ve explored this topic in more detail, including real-world examples of where AI can help and where it can create problems. Watch our video on the good and bad uses of AI in medical device development.
Community as risk reduction
That may have been the most valuable reminder from this year’s Summit.
Medical devices are multidisciplinary almost by definition.
Engineers need clinicians who can tell them whether the product actually fits into care.
Clinicians need engineers who understand what can realistically be built.
Product development and regulatory need to be embedded together throughout the process, so that the evidence being generated supports the path the company ultimately intends to pursue.
Regulatory strategy needs to be informed by reimbursement strategy.
Manufacturing partners need to be involved early enough that a clever prototype can eventually become a repeatable product.
Investors need visibility into all of those risks, not just the technical milestone immediately in front of the company.
And leaders need talented people around them who are willing to challenge assumptions, see things they cannot, and speak up when the plan needs to change.
Then leaders need to listen.
No one can see the entire problem. That is precisely why communities like the one MichBio continues to build are so valuable.
The real benefit of a conference like the Michigan Medical Device Summit isn’t simply having FDA, manufacturers, clinicians, investors, developers, reimbursement experts, and policymakers give presentations in the same building.
It’s putting those perspectives into conversation with one another.
At in2being, we have spent more than 16 years helping companies translate medical technologies from early concepts into real products by integrating product development and regulatory strategy rather than treating them as separate exercises.
One lesson continues to become clearer: The best answers rarely come from simply working harder inside your own silo.
Sometimes the most important thing you can do is to widen the circle of people helping you think.
Bringing a medical device to market takes more than technical expertise. At in2being, we combine product development and regulatory strategy to help companies navigate challenges, reduce risk, and move promising technologies forward. If you’re working on a medical device, we’d love to hear what you’re working on and explore how we can help.
Gene Parunak
Managing Director, in2being