# #387: The case for Real World Evidence Studies

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2024-10-17
- Length: 29m
- Episode: 387
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-10-17-387-the-case-for-real-world-evidence-studies
- Listen: https://podcast.greenlight.guru/episode/387-the-case-for-real-world-evidence-studies

## Summary

Simon Mason, President of NEST (National Evaluation System for Health Technology), explains how the organization leverages real-world evidence (RWE) to streamline FDA regulatory submissions and accelerate time-to-market for medical device companies. He details NEST's unique governance structure, funded by MDUFA fees, which facilitates collaboration between the FDA, industry stakeholders, and data providers to validate existing data for regulatory use. Mason highlights successful test cases involving Johnson & Johnson and Intuitive Surgical, demonstrating how off-label data from pediatric and robotic surgery applications can support new clearances, significantly reducing clinical trial costs and protecting market share against erosion.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-10-17-387-the-case-for-real-world-evidence-studies#t=0) Introduction: Simon Mason and NEST's Mission
- [2:43](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-10-17-387-the-case-for-real-world-evidence-studies#t=163) NEST's Structure and Evolution Under MDUFA
- [4:51](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-10-17-387-the-case-for-real-world-evidence-studies#t=291) Defining Real-World Evidence and Data Challenges
- [7:14](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-10-17-387-the-case-for-real-world-evidence-studies#t=434) NEST as a Neutral Conduit Between Industry and FDA
- [11:23](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-10-17-387-the-case-for-real-world-evidence-studies#t=683) Case Studies: Johnson & Johnson and Intuitive Surgical
- [13:19](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-10-17-387-the-case-for-real-world-evidence-studies#t=799) Financial Impact: ROI and Market Erosion Prevention
- [14:59](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-10-17-387-the-case-for-real-world-evidence-studies#t=899) Criteria for Engagement: Patient Benefit and Data Availability
- [17:02](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-10-17-387-the-case-for-real-world-evidence-studies#t=1022) Solving for Data: NASMART Process and NEST Window
- [24:56](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-10-17-387-the-case-for-real-world-evidence-studies#t=1496) Key Takeaways and Future Outlook for NEST

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Pricing, margins & unit economics](https://hardwarepodcasts.com/topic/pricing-and-unit-economics)
- [Sourcing & supply chain](https://hardwarepodcasts.com/topic/sourcing-and-supply-chain)

## Most relevant to

early-stage companies, large enterprises

## Mentioned

- NEST (other)
- MDUFA (other)
- FDA (other)
- Johnson & Johnson (company)
- Intuitive Surgical (company)
- MDIC (other)
- Greenlight Guru (other)
- Rook Quality Systems (other)
- Epic (other)
- Health Verity (company)

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## 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/2024-10-17-387-the-case-for-real-world-evidence-studies. 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.