Diabetech - Diabetes Tech, Research, News Why Diabetes Tech Innovation Is So Slow & The Work To Speed It Up
Sep 1, 2025
Shannon Lantzy, a regulatory innovation expert with a NASA background and experience at the FDA, discusses the slow pace of diabetes tech innovation. She highlights safety, reimbursement, and legacy regulations as major hurdles. Shannon explains the importance of balancing risk and efficacy in medical devices and advocates for new automated testing methods to accelerate innovation. She also emphasizes the role of community-driven, open-source initiatives in driving standards and improving patient outcomes.
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Advisory Committee Clash Over DKA Risk
- Shannon described working on the sotagliflozin advisory committee exercise illustrating benefit-risk weighting disagreements.
- Reviewers disagreed on trading DKA risk against modest benefits, highlighting subjective trade-offs.
Healthcare Needs Different Cybersecurity Assumptions
- Security models that 'fail closed' (national security) don't fit healthcare where devices must still function.
- Medtech requires different cybersecurity assumptions and lifelong security assurances.
Build Security In From Day One
- Follow FDA's evolving cybersecurity guidance and prepare to prove devices stay secure across their lifecycle.
- Treat security as part of design, not an add-on, to meet new statutory requirements.