# #447: Solving the Pediatric MedTech Gap with Edwin Lindsay

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2026-02-16
- Length: 43m
- Episode: 447
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-02-16-447-solving-the-pediatric-medtech-gap-with-edwin-lindsay
- Listen: https://podcast.greenlight.guru/episode/solving-the-pediatric-medtech-gap-with-edwin-lindsay

## Summary

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.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-02-16-447-solving-the-pediatric-medtech-gap-with-edwin-lindsay#t=0) Introduction: The Pediatric Gap and Edwin Lindsay's Background
- [2:56](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-02-16-447-solving-the-pediatric-medtech-gap-with-edwin-lindsay#t=176) Personal Hospital Experience and the 'Guinness Philosophy' of Giving Back
- [5:24](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-02-16-447-solving-the-pediatric-medtech-gap-with-edwin-lindsay#t=324) Safety Risks: Adhesives, Skin Damage, and Off-Label Adult Device Adaptation
- [8:36](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-02-16-447-solving-the-pediatric-medtech-gap-with-edwin-lindsay#t=516) Building a Collaborative Network of Testing Houses and Consultants
- [12:42](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-02-16-447-solving-the-pediatric-medtech-gap-with-edwin-lindsay#t=762) Regulatory Roadmaps: Age Variability, Clinical Trials, and FDA Programs
- [18:19](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-02-16-447-solving-the-pediatric-medtech-gap-with-edwin-lindsay#t=1099) Clinical Friction: Alarm Fatigue, Sensor Sensitivity, and Workflow Disruption
- [20:57](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-02-16-447-solving-the-pediatric-medtech-gap-with-edwin-lindsay#t=1257) Hidden Costs: Manufacturing Complexity, Multiple SKUs, and Low-Volume Production
- [33:45](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-02-16-447-solving-the-pediatric-medtech-gap-with-edwin-lindsay#t=2025) Industry Ecosystem: University IP, Conferences, and Consultancy Models

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Manufacturing partners & offshoring](https://hardwarepodcasts.com/topic/manufacturing-partners)

## Most relevant to

early-stage companies

## Mentioned

- SureMakers (company)
- Compliant Solutions (company)
- Greenlight Guru (company)
- FDA (other)
- Midwest Pediatric Consortium (other)

## Related episodes from other shows

- [T-24-002 : Kevin Lavelle - Performance Fabric to Pediatric Telemedicine](https://hardwarepodcasts.com/podcast/tradeoffs/2024-10-02-t-24-002-kevin-lavelle-performance-fabric-to-pediatric-telemedicine) (TRADEOFFS)
- [S2E40 Voice of the Customer, Using Questions, and the Technology Adoption Life Cycle Curve | Ted Newill](https://hardwarepodcasts.com/podcast/being-an-engineer/2021-09-17-s2e40-voice-of-the-customer-using-questions-and-the-technology-adoption-life-cyc) (Being an Engineer)
- [S6E19 Stuart Grant | MedTech Innovation](https://hardwarepodcasts.com/podcast/being-an-engineer/2025-05-09-s6e19-stuart-grant-medtech-innovation) (Being an Engineer)
- [027 - "Become a Historian of the Problem" with Duane Mancini](https://hardwarepodcasts.com/podcast/lets-combinate/2022-04-06-027-become-a-historian-of-the-problem-with-duane-mancini) (Let's Combinate)
- [Closing the gap between Regulatory and Development with Milton Yarberry](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2024-03-05-closing-the-gap-between-regulatory-and-development-with-milton-yarberry) (The Pragmatic Embedded Podcast)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-02-16-447-solving-the-pediatric-medtech-gap-with-edwin-lindsay. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Global Medical Device Podcast.