Hardware Podcasts

#447: Solving the Pediatric MedTech Gap with Edwin Lindsay

Global Medical Device Podcast · 16 Feb 2026 · 43m · Episode 447

What this episode covers

Edwin Lindsay, a MedTech operator and QARA leader who co-founded SureMakers and runs Compliant Solutions, discusses the systemic barriers to pediatric medical device development, noting that these devices face adult-level regulatory risks with significantly lower financial returns. He describes a personal experience in a neonatal ward that highlighted the dangers of using adult devices off-label, such as skin damage from adhesives and alarm fatigue from overly sensitive sensors. Lindsay explains his initiative to build a collaborative network of regulatory consultants, testing houses, and grant writers willing to provide pro-bono or at-cost support to help startups navigate the complex regulatory landscape. The conversation emphasizes the need for a streamlined pediatric regulatory roadmap and a mindset shift among manufacturers to prioritize patient safety over cost concerns.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
SureMakers, Compliant Solutions, Greenlight Guru
Also
FDA, Midwest Pediatric Consortium

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