# How Proper Design Controls & a Quality System Could Save You $20M With Ronny Bracken

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2019-11-07
- Length: 22m
- Episode: 6
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-07-how-proper-design-controls-a-quality-system-could-save-you-20m-with-ronny-bracke
- Listen: https://podcast.greenlight.guru/episode/how-proper-design-controls-a-quality-system-could-save-you-20m-with-ronny-bracken

## Summary

Ronny Bracken, Principal at Paladin Biomedical Consultants and COO for Nano Fiber Solutions and Innate Medical, explains how medical device startups often suffer a $20 million valuation haircut during mergers and acquisitions because their design controls and quality systems are inadequate. He argues that startups must embrace risk management as a tool for product improvement rather than a regulatory checkbox, and that large acquirers like Bard or Johnson & Johnson will significantly reduce offers if they have to rebuild Design History Files to mitigate compliance risks. Bracken emphasizes that startups need to generate revenue and clinical data, not just technology, to be attractive acquisition targets, and advises founders to 'lose early' if customer feedback indicates a lack of product-market fit.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-07-how-proper-design-controls-a-quality-system-could-save-you-20m-with-ronny-bracke#t=0) Introduction: Ronny Bracken and Greenlight Guru
- [1:50](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-07-how-proper-design-controls-a-quality-system-could-save-you-20m-with-ronny-bracke#t=110) Ronny Bracken's Background at Bard and Current Startups
- [3:39](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-07-how-proper-design-controls-a-quality-system-could-save-you-20m-with-ronny-bracke#t=219) Biggest Startup Mistakes: Falling in Love with Technology
- [7:53](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-07-how-proper-design-controls-a-quality-system-could-save-you-20m-with-ronny-bracke#t=473) Risk Management: Checkbox vs. Product Improvement
- [10:27](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-07-how-proper-design-controls-a-quality-system-could-save-you-20m-with-ronny-bracke#t=627) M&A Due Diligence and the $20M Valuation Haircut
- [14:04](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-07-how-proper-design-controls-a-quality-system-could-save-you-20m-with-ronny-bracke#t=844) Market Consolidation and Startup Negotiating Power
- [17:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-07-how-proper-design-controls-a-quality-system-could-save-you-20m-with-ronny-bracke#t=1020) Revenue vs. Technology in Medical Device Acquisitions
- [20:35](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-07-how-proper-design-controls-a-quality-system-could-save-you-20m-with-ronny-bracke#t=1235) Advice: Lose Early and Understand the Customer

## Topics

- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Growth, exits & acquisitions](https://hardwarepodcasts.com/topic/growth-exits-and-acquisitions)
- [Design for manufacturing & NPI](https://hardwarepodcasts.com/topic/design-for-manufacturing)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Fundraising & investors](https://hardwarepodcasts.com/topic/fundraising)

## Most relevant to

early-stage companies, large enterprises

## Mentioned

- Greenlight Guru (company)
- Ronny Bracken (other)
- Paladin Biomedical Consultants (company)
- Nano Fiber Solutions (company)
- Innate Medical (company)
- Bard (company)
- Johnson & Johnson (company)
- FDA (other)
- ISO (other)
- 510 K (other)
- IDE (other)
- EU Mark (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)
- [071 - Steel Industry to MedTech & Important Quality Systems with Etienne Nichols](https://hardwarepodcasts.com/podcast/lets-combinate/2023-02-08-071-steel-industry-to-medtech-important-quality-systems-with-etienne-nichols) (Let's Combinate)
- [217 - 5 Fixable Problems Holding Back Drug–Device Programs](https://hardwarepodcasts.com/podcast/lets-combinate/2025-12-10-217-5-fixable-problems-holding-back-drug-device-programs) (Let's Combinate)
- [176 - The Fastest Way to Ruin Drug/Device Development (And How to Avoid It!) with Eric Sugalski](https://hardwarepodcasts.com/podcast/lets-combinate/2025-02-19-176-the-fastest-way-to-ruin-drug-device-development-and-how-to-avoid-it-with-eri) (Let's Combinate)
- [S1E12 Simplifying Quality Management | Jon Speer](https://hardwarepodcasts.com/podcast/being-an-engineer/2020-06-05-s1e12-simplifying-quality-management-jon-speer) (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/2019-11-07-how-proper-design-controls-a-quality-system-could-save-you-20m-with-ronny-bracke. 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.