# How to Construct an Effective Regulatory Strategy

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2020-05-27
- Length: 41m
- Episode: 148
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-05-27-how-to-construct-an-effective-regulatory-strategy
- Listen: https://podcast.greenlight.guru/episode/how-to-construct-an-effective-regulatory-strategy

## Summary

Mike Drues of Vascular Sciences, joined by host Jon Speer of Greenlight Guru, explains that a regulatory strategy is a dynamic communication tool, not merely a pathway like 510(k) or De Novo. Drues details the components of a Regulatory Strategy Executive Summary, including device description, labeling matrix, classification, risk assessment, and potential pathways, emphasizing its use in investor pitch decks and internal stakeholder buy-in. The discussion highlights the importance of bringing regulatory experts in early to avoid costly design changes and demonstrates how to balance short-term speed with long-term strategic goals using a 'future features list.'

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-05-27-how-to-construct-an-effective-regulatory-strategy#t=0) Introduction: Defining Regulatory Strategy vs. Pathway
- [7:32](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-05-27-how-to-construct-an-effective-regulatory-strategy#t=452) The Regulatory Strategy Executive Summary Components
- [12:06](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-05-27-how-to-construct-an-effective-regulatory-strategy#t=726) Startup Pitfalls: Speed vs. Strategic Fit
- [16:24](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-05-27-how-to-construct-an-effective-regulatory-strategy#t=984) Future Features List and Long-Term Planning
- [21:38](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-05-27-how-to-construct-an-effective-regulatory-strategy#t=1298) Timing: Bringing Regulatory In Early
- [25:11](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-05-27-how-to-construct-an-effective-regulatory-strategy#t=1511) Detailed Summary Elements: Labeling, Risk, and Reimbursement
- [37:28](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-05-27-how-to-construct-an-effective-regulatory-strategy#t=2248) Using the Summary with the FDA and Investors

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Crowdfunding & preorders](https://hardwarepodcasts.com/topic/crowdfunding)
- [Design for manufacturing & NPI](https://hardwarepodcasts.com/topic/design-for-manufacturing)

## Most relevant to

early-stage companies

## Mentioned

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

## Related episodes from other shows

- [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)
- [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)
- [165 - Anatomy of a Target Product Profile(TPP): All 10 Sections EXPLAINED with Marta New](https://hardwarepodcasts.com/podcast/lets-combinate/2024-12-04-165-anatomy-of-a-target-product-profile-tpp-all-10-sections-explained-with-marta) (Let's Combinate)
- [022 - "What Chapter are you in?" with Susan Neadle](https://hardwarepodcasts.com/podcast/lets-combinate/2022-03-02-022-what-chapter-are-you-in-with-susan-neadle) (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/2020-05-27-how-to-construct-an-effective-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.