# #396: Mastering Device Descriptions: The Cornerstone of Medical Device Submissions

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2024-12-19
- Length: 50m
- Episode: 396
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-12-19-396-mastering-device-descriptions-the-cornerstone-of-medical-device-submissions
- Listen: https://podcast.greenlight.guru/episode/mastering-device-descriptions-the-cornerstone-of-medical-device-submissions

## Summary

Regulatory consultant Mike Drues, president of Vascular Sciences, explains why device descriptions are the most poorly written part of FDA submissions and how they determine classification, testing, and approval pathways. He advises manufacturers to write layered descriptions—simple overviews for general audiences and detailed appendices for specialists—and to test efficacy by having unfamiliar readers explain the device back to them. Drues recommends using videos to demonstrate device function during pre-submission meetings to avoid real-time failures and suggests starting with simple objects like a garden hose to refine the writing process.

## Outline

1. Introduction: The critical importance of device descriptions
2. Why device descriptions are poorly written and misunderstood
3. Impact on classification, pathway, and testing requirements
4. Testing description efficacy with unfamiliar readers
5. Layered writing and pre-submission meeting strategies
6. Using videos and simple metaphors to clarify complex devices

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Industrial & consumer product design](https://hardwarepodcasts.com/topic/industrial-design)
- [Mechanical engineering](https://hardwarepodcasts.com/topic/mechanical-engineering)

## Most relevant to

early-stage companies

## Mentioned

- Greenlight Guru (company)
- Vascular Sciences (company)
- FDA (other)
- 510k (other)
- PMA (other)
- De Novo (other)

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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/2024-12-19-396-mastering-device-descriptions-the-cornerstone-of-medical-device-submissions. 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.