# How to Establish a Solid Foundation for Fundraising and Product Success by Focusing on Regulatory

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2020-02-19
- Length: 36m
- Episode: 134
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-02-19-how-to-establish-a-solid-foundation-for-fundraising-and-product-success-by-focus
- Listen: https://podcast.greenlight.guru/episode/how-to-establish-a-solid-foundation-for-fundraising-and-product-success-by-focusing-on-regulatory

## Summary

Isabella Schmitt, a regulatory affairs consultant at Proxima Clinical Research, joins host John Spear to discuss how a strong regulatory strategy underpins fundraising and product success for medical device companies. Schmitt advises startups to avoid starting with technology without a clear problem, emphasizing the importance of Minimum Viable Products (MVPs) and design controls to prevent perpetual iteration. She highlights the '1/10/100 rule' to illustrate how early validation reduces costs and increases company value by hitting major milestones like animal studies or clinical trials. The conversation also covers selecting regulatory pathways (PMA vs. 510(k)) based on market size and reimbursement, and navigating current global regulatory landscapes like the EU MDR and FDA requirements.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-02-19-how-to-establish-a-solid-foundation-for-fundraising-and-product-success-by-focus#t=0) Introduction: Isabella Schmitt and Proxima Clinical Research
- [3:31](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-02-19-how-to-establish-a-solid-foundation-for-fundraising-and-product-success-by-focus#t=211) Starting with Technology vs. Problem and Lack of Focus
- [5:21](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-02-19-how-to-establish-a-solid-foundation-for-fundraising-and-product-success-by-focus#t=321) Minimum Viable Product (MVP) and Locking Algorithms
- [9:25](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-02-19-how-to-establish-a-solid-foundation-for-fundraising-and-product-success-by-focus#t=565) Design Controls, User Requirements, and Justifying Changes
- [14:43](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-02-19-how-to-establish-a-solid-foundation-for-fundraising-and-product-success-by-focus#t=883) The 1/10/100 Rule and Design Verification/Validation
- [19:20](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-02-19-how-to-establish-a-solid-foundation-for-fundraising-and-product-success-by-focus#t=1160) Human Factors, Usability Testing, and Biocompatibility Risks
- [22:30](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-02-19-how-to-establish-a-solid-foundation-for-fundraising-and-product-success-by-focus#t=1350) Platform Technologies, Regulatory Pathways, and Marketability
- [30:07](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-02-19-how-to-establish-a-solid-foundation-for-fundraising-and-product-success-by-focus#t=1807) Global Regulatory Landscapes: US, EU MDR, and Canada

## Topics

- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Fundraising & investors](https://hardwarepodcasts.com/topic/fundraising)
- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)

## Most relevant to

early-stage companies

## Mentioned

- Proxima Clinical Research (company)
- Green Light Guru (company)
- FDA (other)
- EU MDR (other)
- 510(k) (other)
- PMA (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)
- [S5E8 Aaron Call | How to Find Money for MedTech Startups](https://hardwarepodcasts.com/podcast/being-an-engineer/2024-02-23-s5e8-aaron-call-how-to-find-money-for-medtech-startups) (Being an Engineer)
- [S2E37 Defied the odds:  A Physical Product Development Firm That Focuses on Startups & Small Businesses, Mako Design + Invent –Kevin Mako](https://hardwarepodcasts.com/podcast/being-an-engineer/2021-08-23-s2e37-defied-the-odds-a-physical-product-development-firm-that-focuses-on-startu) (Being an Engineer)
- [S4E47 Mark Byrne | Startup Engineering, Funding, & Assumptions](https://hardwarepodcasts.com/podcast/being-an-engineer/2023-12-08-s4e47-mark-byrne-startup-engineering-funding-assumptions) (Being an Engineer)
- [Episode 1 - The Hardware Story of Inito w/ Aayush Rai | Building a B2C medical hardware company](https://hardwarepodcasts.com/podcast/the-hardware-story/2024-06-26-episode-1-the-hardware-story-of-inito-w-aayush-rai-building-a-b2c-medical-hardwa) (The Hardware Story)

## 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/2020-02-19-how-to-establish-a-solid-foundation-for-fundraising-and-product-success-by-focus. 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.