# Demystifying the De Novo Process

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2022-05-12
- Length: 37m
- Episode: 260
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-05-12-demystifying-the-de-novo-process
- Listen: https://podcast.greenlight.guru/episode/demystifying-the-de-novo-process

## Summary

Rob MacCuspie, Manager of Regulatory Affairs at Proxima CRO, explains the De Novo pathway for novel medical devices that lack a substantial equivalent predicate. He contrasts this with 510(k) and PMA submissions, highlighting that De Novo allows innovators to set regulatory standards and special controls for future competitors. MacCuspie advises companies to use pre-submission meetings to align with the FDA, avoid analysis paralysis by launching version 1 products, and focus on patient benefit rather than just compliance.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-05-12-demystifying-the-de-novo-process#t=0) Introduction: Rob MacCuspie and Proxima CRO
- [2:48](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-05-12-demystifying-the-de-novo-process#t=168) Defining De Novo: New and Innovative Devices
- [5:04](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-05-12-demystifying-the-de-novo-process#t=304) De Novo vs. 510(k) and Predicate Devices
- [6:17](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-05-12-demystifying-the-de-novo-process#t=377) Strategic Opportunity: Setting Special Controls
- [9:02](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-05-12-demystifying-the-de-novo-process#t=542) The Value of Pre-Submission Meetings
- [13:21](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-05-12-demystifying-the-de-novo-process#t=801) Avoiding Analysis Paralysis and Perfect Product Syndrome
- [19:16](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-05-12-demystifying-the-de-novo-process#t=1156) Communication Pitfalls with the FDA
- [24:01](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-05-12-demystifying-the-de-novo-process#t=1441) Preparing the De Novo Submission Package
- [29:35](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-05-12-demystifying-the-de-novo-process#t=1775) Handling Higher Risk Profiles and PMA Pivot
- [34:03](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-05-12-demystifying-the-de-novo-process#t=2043) Conclusion: Encouraging Innovation

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Starting a product company](https://hardwarepodcasts.com/topic/starting-a-company)

## Most relevant to

early-stage companies

## Mentioned

- Proxima CRO (company)
- FDA (other)
- Green Light Guru (other)
- 510(k) (other)
- PMA (other)
- CE mark (other)

## Related episodes from other shows

- [106 - FOIA, FDA Modernizing 510(k) Program, De Novo Submissions, and more databases with Michelle Lott](https://hardwarepodcasts.com/podcast/lets-combinate/2023-10-24-106-foia-fda-modernizing-510-k-program-de-novo-submissions-and-more-databases-wi) (Let's Combinate)
- [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)
- [S1E13 A Holistic View on Product Development | Devon Campbell](https://hardwarepodcasts.com/podcast/being-an-engineer/2020-06-09-s1e13-a-holistic-view-on-product-development-devon-campbell) (Being an Engineer)
- [Rapid Prototyping for Medical Devices with Ross Dehmoobed](https://hardwarepodcasts.com/podcast/the-pragmatic-embedded-podcast/2024-01-11-rapid-prototyping-for-medical-devices-with-ross-dehmoobed) (The Pragmatic Embedded Podcast)
- [012 - "Asking then Seeing" with Sara Waxberg Mcnew](https://hardwarepodcasts.com/podcast/lets-combinate/2021-12-22-012-asking-then-seeing-with-sara-waxberg-mcnew) (Let's Combinate)

## 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/2022-05-12-demystifying-the-de-novo-process. 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.