This Is Not Your Grandmother’s Medical Device: What Happens When Medical Device Software, Data and Connectivity Spurs New Medtech Business and Regulatory Strategies?

Wednesday, October 26, 2022 10:45 AM to 12:00 PM · 1 hr. 15 min. (America/New_York)
Room 259 AB
Panel Session
Regulatory, Quality and Good Manufacturing PracticesDigital Technologies


Cloud computing, AI/ML, smartphones and wearables, FHIR and web services integration and more. Medtech is eagerly incorporating modern computing technologies to connect and enhance the core functions of regulated medical devices. The tangible fruits of these efforts include the rapidly growing product domains of Software as a Medical Device (SaMD), Digital Therapeutics (DTx) and connected medical device systems. By leveraging the power of modern distributed computing, all of these software-based devices and tools have the potential to move the needle on patient outcomes and close inequities in our health care system. But to get there, individual companies and our entire ecosystem will need to embrace new opportunities (e.g, new business, operating and development models) and overcome new challenges. For example, the tech vendors creating cloud and other modern computing technologies continually impress us with the speed of their endless upgrades. However, combining the iterative software launch with MedTech’s traditional waterfall approach to regulated change management can be challenging.

To adapt to this cloud challenge, and many others like it, we need to adapt to a new set of architectural approaches, best practices and systems thinking, and embrace an even more customer centric (or dare we say Agile) approach to design, development, operation to achieve much greater effectiveness at the level of safety and efficacy we expect from a regulated medical device. By shifting to a new paradigm, manufacturers of connected medical devices, the regulators that oversee them and the providers and patients that use them can all be more confident that the medical devices they are using are state-of-the-art, reliable, safe and effective.

In the first part of this session, we’ll provide a framework for thinking about the larger business and clinical context of SaMD. In the second part of this session, you’ll learn about an emerging success story in adapting medical devices to a mainstay of the modern computing world, public cloud computing. And in the third and final part of this session, a seasoned group of MedTech executives, a leading health care expert from Big Tech and an expert in developing medical device software will put this all together. They’ll talk about what we can learn from the cloud computing example, and paint an exciting (also also intimidating) picture of what’s next for our individual companies and our industry as a whole.