# #374: Clinical Evidence - The Key to Market Adoption

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2024-06-25
- Length: 47m
- Episode: 374
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-06-25-374-clinical-evidence-the-key-to-market-adoption
- Listen: https://podcast.greenlight.guru/episode/374-clinical-evidence-the-key-to-market-adoption

## Summary

Shaherah Yancy, CEO of Research Lifecycle Solutions and former executive at Medtronic, Stryker, and Smith & Nephew, explains why robust clinical and regulatory strategies are critical for MedTech companies to secure funding and achieve market adoption. She argues that while market access via 510(k) is a milestone, true success requires generating clinical evidence that demonstrates superiority over the standard of care to drive surgeon adoption and payer reimbursement. Yancy advises early-stage founders to design comprehensive studies with 'smart endpoints' that capture economic and workflow benefits, and to use limited market releases to gather real-world evidence for novel technologies.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-06-25-374-clinical-evidence-the-key-to-market-adoption#t=0) Introduction and Background
- [6:41](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-06-25-374-clinical-evidence-the-key-to-market-adoption#t=401) The 75% Failure Rate and Funding Strategy
- [15:47](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-06-25-374-clinical-evidence-the-key-to-market-adoption#t=947) Market Access vs. Market Adoption
- [27:17](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-06-25-374-clinical-evidence-the-key-to-market-adoption#t=1637) Designing Comprehensive Clinical Studies
- [34:24](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-06-25-374-clinical-evidence-the-key-to-market-adoption#t=2064) Smart Endpoints for Surgeon Adoption
- [40:08](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-06-25-374-clinical-evidence-the-key-to-market-adoption#t=2408) Strategies for Novel Technologies and Limited Releases

## Topics

- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Fundraising & investors](https://hardwarepodcasts.com/topic/fundraising)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Pricing, margins & unit economics](https://hardwarepodcasts.com/topic/pricing-and-unit-economics)

## Most relevant to

early-stage companies, companies scaling up

## Mentioned

- Greenlight Guru Clinical (company)
- Research Lifecycle Solutions (company)
- Medtronic (company)
- Stryker (company)
- Smith & Nephew (company)
- 510(k) (other)
- PMA (other)
- FDA (other)

## Related episodes from other shows

- [S5E8 Aaron Call | How to Find Money for MedTech Startups](https://hardwarepodcasts.com/podcast/being-an-engineer/2024-02-23-s5e8-aaron-call-how-to-find-money-for-medtech-startups) (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)
- [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)
- [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)
- [S4E47 Mark Byrne | Startup Engineering, Funding, & Assumptions](https://hardwarepodcasts.com/podcast/being-an-engineer/2023-12-08-s4e47-mark-byrne-startup-engineering-funding-assumptions) (Being an Engineer)

## 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/2024-06-25-374-clinical-evidence-the-key-to-market-adoption. 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.