# #364: Building a Partnership with your Regulatory Consultant

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2024-04-30
- Length: 40m
- Episode: 364
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-04-30-364-building-a-partnership-with-your-regulatory-consultant
- Listen: https://podcast.greenlight.guru/episode/364-building-a-partnership-with-your-regulatory-consultant

## Summary

Christine Luk, Associate Regulatory Affairs Manager at Proxima, shares her journey from a failed women's health startup to navigating FDA regulatory pathways. She details the critical importance of aligning with regulatory consultants early, managing time-and-materials budgets, and structuring effective FDA interactions like pre-submissions. Luk emphasizes that founders must provide clear design inputs and roadmap context to avoid costly pivots and ensure efficient market entry.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-04-30-364-building-a-partnership-with-your-regulatory-consultant#t=0) Introduction: Christine Luk and Proxima
- [1:11](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-04-30-364-building-a-partnership-with-your-regulatory-consultant#t=71) Background and Early Startup Failure
- [8:52](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-04-30-364-building-a-partnership-with-your-regulatory-consultant#t=532) Vetting and Selecting Regulatory Consultants
- [11:01](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-04-30-364-building-a-partnership-with-your-regulatory-consultant#t=661) Managing Consultant Relationships and Budgets
- [12:20](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-04-30-364-building-a-partnership-with-your-regulatory-consultant#t=740) FDA Interactions and Submission Strategy
- [14:42](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-04-30-364-building-a-partnership-with-your-regulatory-consultant#t=882) Design Controls and Quality Systems Timing
- [19:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-04-30-364-building-a-partnership-with-your-regulatory-consultant#t=1140) Communication, Documentation, and Failure Analysis

## Topics

- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Hiring & workforce](https://hardwarepodcasts.com/topic/hiring-and-workforce)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)
- [Pricing, margins & unit economics](https://hardwarepodcasts.com/topic/pricing-and-unit-economics)

## Most relevant to

early-stage companies, companies scaling up

## Mentioned

- Proxima (company)
- FDA (other)
- Texas Medical Center Innovation Institute (company)
- J-Labs (company)
- Rice University (company)
- Lily's Spec (company)
- Coda Health (company)
- General Magic (company)
- Texas A&M (company)

## Related episodes from other shows

- [We're launching Founders & Formulators - Here's Why](https://hardwarepodcasts.com/podcast/the-startup-cpg-podcast/2026-06-18-were-launching-founders-formulators-heres-why) (The Startup CPG Podcast)
- [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)
- [133 - A Year of Saying No, Advice & Good MedTech Consulting, Humility in Leadership, andToxicity in Teams with Devon C. Campbell](https://hardwarepodcasts.com/podcast/lets-combinate/2024-04-24-133-a-year-of-saying-no-advice-good-medtech-consulting-humility-in-leadership-an) (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)
- [S2E40 Voice of the Customer, Using Questions, and the Technology Adoption Life Cycle Curve | Ted Newill](https://hardwarepodcasts.com/podcast/being-an-engineer/2021-09-17-s2e40-voice-of-the-customer-using-questions-and-the-technology-adoption-life-cyc) (Being an Engineer)

## 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/2024-04-30-364-building-a-partnership-with-your-regulatory-consultant. 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.