# Developing a Regulatory Strategy

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2022-11-23
- Length: 43m
- Episode: 291
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-11-23-developing-a-regulatory-strategy
- Listen: https://podcast.greenlight.guru/episode/developing-a-regulatory-strategy

## Summary

Mike Drues, President of Vascular Sciences, explains to host John Speer that a regulatory strategy is a dynamic plan of action, not merely a submission pathway like 510(k) or PMA. Drues emphasizes the importance of integrating international regulatory requirements early to avoid costly re-testing and highlights the critical need to align regulatory strategy with reimbursement strategy, using CMS as a key example. He argues that the EU MDR primarily impacts administrative processes rather than engineering testing, while stressing that post-market surveillance remains an industry-wide failure that requires proactive management.

## Chapters

- [1:11](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-11-23-developing-a-regulatory-strategy#t=71) Introduction: Mike Drues and Vascular Sciences
- [2:21](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-11-23-developing-a-regulatory-strategy#t=141) Defining Regulatory Strategy vs. Pathway to Market
- [5:30](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-11-23-developing-a-regulatory-strategy#t=330) The Importance of Competitive Regulatory Strategy
- [10:23](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-11-23-developing-a-regulatory-strategy#t=623) Timing and Dynamic Nature of Regulatory Plans
- [13:33](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-11-23-developing-a-regulatory-strategy#t=813) International Regulatory Strategy and Common Pitfalls
- [21:22](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-11-23-developing-a-regulatory-strategy#t=1282) Impact of EU MDR on Regulatory Strategy
- [29:26](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-11-23-developing-a-regulatory-strategy#t=1766) Post-Market Surveillance Failures and Requirements
- [32:30](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-11-23-developing-a-regulatory-strategy#t=1950) Integrating Reimbursement Strategy with Regulatory Strategy

## 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)

## Most relevant to

early-stage companies

## Mentioned

- Greenlight Guru (company)
- Vascular Sciences (company)
- FDA (other)
- EU MDR (other)
- CMS (other)
- 510 K (other)
- PMA (other)
- De Novo (other)

## Related episodes from other shows

- [031 - "The Five Stages Of Regulatory Grief" with Michelle Lott](https://hardwarepodcasts.com/podcast/lets-combinate/2022-05-04-031-the-five-stages-of-regulatory-grief-with-michelle-lott) (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)
- [058 - PMSR Globally, Different Clinical Roles and Risk Management with Khaudeja Bano](https://hardwarepodcasts.com/podcast/lets-combinate/2022-11-09-058-pmsr-globally-different-clinical-roles-and-risk-management-with-khaudeja-ban) (Let's Combinate)
- [145 - Regulatory Policy, Advocacy, Legislation, Combination Product Regulatory Harmonization, IMDRF and Ikigai with Ryan Hoshi](https://hardwarepodcasts.com/podcast/lets-combinate/2024-07-17-145-regulatory-policy-advocacy-legislation-combination-product-regulatory-harmon) (Let's Combinate)
- [079 - How FDA Reviews Combination Products, Policy, EPR's, and Harmonization with Rumi Young](https://hardwarepodcasts.com/podcast/lets-combinate/2023-04-05-079-how-fda-reviews-combination-products-policy-eprs-and-harmonization-with-rumi) (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/2022-11-23-developing-a-regulatory-strategy. 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.