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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Why Diabetes Tech Feels Glacial
- Diabetes tech moves slowly because safety, liability, FDA clearance, and reimbursement impose hard constraints.
- Those constraints force conservative timelines that prioritize tolerable failure over rapid iteration.
From NASA Intern To Decision Scientist
- Shannon started at NASA, studied decision science, then aimed to improve FDA decision making.
- That background shaped her focus on automating and improving regulatory decisions for medtech.
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.