This episode features a conversation between host, Sera Evcimen, and Alan Cohen, author of 'Prototype to Product: A Practical Guide for Getting to Market'. They delve into the complexities, misconceptions and opportunities in medical device development. The discussion includes the importance of generating good requirements, handling regulatory requirements, and conducting risk analysis. They also highlight the value of hiring experts conversant in both engineering and regulatory matters to guide a startup through navigating the FDA and EU approval processes.

You can find his consultancy at www.alancohen.com.

Rundown of Episode for easy navigation to topics of interest:

• 00:00 Introduction and Host Background
• 00:58 Guest Introduction: Alan Cohen
• 01:32 Alan Cohen's Background and Experience
• 02:37 Challenges in Medical Device Development
• 05:40 Identifying a Hardware Medical Application Need
• 07:48 Understanding Reimbursement and Business Models
• 09:32 Regulatory Bodies and Compliance
• 12:50 Risk Assessment in Medical Device Development
• 21:22 Fault Tree Analysis vs Failure Modes and Effects Analysis
• 27:48 Balancing Documentation and Process in Medical Device Development
• 33:01 Understanding Development Process Standards
• 33:19 Importance of Following Your Process
• 33:42 Inspection and Audit Procedures
• 34:16 Balancing FDA Requirements and Lean Operations
• 35:13 Testing and Validation in Medical Device Development
• 36:43 Navigating FDA and Institutional Review Boards
• 40:02 Challenges in Medical Device Innovation and Funding
• 47:16 Podcast Break
• 47:29 Podcast break
• 56:02 Navigating Supply Chain and Manufacturing Challenges
• 01:04:09 Understanding FDA and EU Regulatory Differences
• 01:07:00 Final Thoughts and Advice for Medical Device Startups
• Ending with TLDL!

Music by: Tom Stoke (in addition to royalty-free music provided by Descript)

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