In this episode, Etienne Nichols is joined by Shaherah Yancy, CEO of Research Lifecycle Solutions. They dive deep into the critical importance of developing robust clinical and regulatory strategies for MedTech companies. Shaherah shares her extensive experience in the field, providing practical advice on securing funding, ensuring market access, and achieving market adoption. They explore the nuances of clinical evidence, the significance of strategic planning, and the role of advisory panels in navigating the MedTech landscape.

Key Timestamps:

• 00:00 - 03:00 Introduction and Sponsor Message
• 03:01 - 05:20 Introduction to Shaherah Yancy and her background
• 05:21 - 10:30 Importance of Clinical and Regulatory Strategies
• 10:31 - 17:15 Challenges of Securing Funding and Developing Strategy
• 17:16 - 25:45 Differences Between Market Access and Market Adoption
• 25:46 - 33:50 Developing Effective Clinical Plans for Market Adoption
• 33:51 - 39:40 Importance of Evidence and Study Design
• 39:41 - 48:00 Examples and Case Studies from Early Stage Companies
• 48:01 - 55:15 Endpoints for Market Adoption
• 55:16 - 01:02:30 Strategies for Novel Technologies
• 01:02:31 - 01:07:45 Final Advice and Contact Information

Notable Quotes:

• "Market access is a milestone. Market adoption is the goal." - Shaherah Yancy
• "Understanding the problem you’re solving is crucial for your strategy." - Shaherah Yancy
• "Don’t be afraid of clinical evidence; it’s your key to success." - Shaherah Yancy

Key Takeaways:

MedTech Trends:

1. Strategic Planning is Essential: Early and comprehensive planning for clinical and regulatory strategies can significantly enhance a company's chances of success.
2. Clinical Evidence is Critical: Collecting robust clinical data is vital for both market access and long-term market adoption.
3. Market Adoption Over Market Access: The ultimate goal should be market adoption, not just getting to market.

Practical Tips:

1. Form Advisory Panels: Engage with surgeons and clinical experts early to guide product development and market entry strategies.
2. Comprehensive Studies: Design studies that include both primary endpoints for regulatory approval and secondary endpoints for market adoption.
3. Prepare for Limited Market Releases: Use limited market releases to gather real-world evidence and refine products before a full launch.

References:

• Research Lifecycle Solutions: Shaherah Yancy's company, specializing in clinical and regulatory strategies for MedTech. RLC Solutions
• Greenlight Guru Clinical: The sponsor of this episode, offering a platform for streamlining clinical trials. Greenlight Guru Clinical
• Etienne Nichols LinkedIn: Connect with Etienne on LinkedIn for more insights. Etienne Nichols LinkedIn

MedTech 101:

Clinical Evidence: Data collected from clinical trials and studies to demonstrate the safety and efficacy of a medical device.

510(k) Clearance: A premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally...