Product decisions made during early development determine commercialization outcomes years later. Wrong choices about regulatory pathways, feature sets, and market segments create compounding problems limiting commercial success.
Christian Espinosa and Trevor Slattery explore product management with Brent Lavin, Chief Product Catalyst of Ironwood MedTech Partners, covering why 510(k) pathways average four years while PMA programs require seven to nine years, and how feature set alignment shapes success.
The engineering mindset applies hypothesis testing to product development through iterative refinement.
Practical for MedTech founders and product teams.
Episode Breakdown:
- 00:02 Introduction
- 04:35 Ironwood origin
- 06:02 De-risking decisions
- 10:15 Hypothesis testing
- 14:30 Pathway selection
- 18:45 Timelines
- 22:20 Claims limits
- 26:40 Feature alignment
- 30:15 Segmentation
- 34:55 Clinical trials
- 38:45 Entrepreneurship
- 40:45 Insights
- 43:29 Close
The Med Device Cyber Podcast is brought to you by Blue Goat Cyber, cybersecurity experts providing essential security solutions for the medical device industry. Learn more by visiting https://bluegoatcyber.com.
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Christian Espinosa is the CEO and founder of Blue Goat Cyber. Trevor Slattery is the Chief Operating Officer at Blue Goat Cyber.
Christian Espinosa on LinkedIn: https://www.linkedin.com/in/christianespinosa/
Trevor Slattery on LinkedIn: https://www.linkedin.com/in/trevor-slattery-34852b1a9
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