Podcast: “Clinical Evidence, The Key to Market Adoptions”

Market access strategies for medical devices

In the latest Global Medical Device podcast 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 also explore the nuances of clinical evidence, the significance of strategic planning, and the role of advisory panels in navigating the MedTech landscape. Listen to the full episode to gain valuable insights from one of the leading experts in the field. Don’t miss out on this opportunity to learn from Shaherah’s wealth of knowledge. Tune in: Clinical Evidence: The Key to Market Adoption (greenlight.guru)

Why is clinical evidence important?

  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.

Memorable quotes from this episode

  • “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 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

 

Regulatory approval is just the beginning of your medical device journey

Attention MedTech Innovators and Entrepreneurs

 

Regulatory approval is just the beginning of your journey to market success!

One of the greatest misconceptions in the world of MedTech is the singular focus on regulatory approval. While crucial, it’s merely the starting line, not the finish. Let’s debunk some common myths together:

💡 **510(k) Shortcut? Not Always!**
While the 510(k) route may seem like the easiest and cheapest path, especially for “me too” devices, remember, convincing end-users to switch requires evidence. Medical providers are understandably hesitant to change when they already have functioning solutions.

💡 **Breakthrough Designation: Not a Magic Bullet!**
Attaining Breakthrough Designation isn’t a guaranteed shortcut either. Truly novel devices may lack existing reimbursement codes, necessitating clinical data for gaining reimbursement status. Quick doesn’t always mean easy.

💡 **Exit Strategy Fallacy!**
Thinking only about positioning for an exit overlooks the crucial aspect of long-term viability. Investors and Strategics seek devices with the highest potential for commercial success. Market access alone isn’t enough.

This tunnel vision has led many promising companies to fall short of their goals.

✨THE BIG IDEA ✨
Identify and follow the regulatory path that aligns best with your company’s goals (not your predicate). Embrace clinical studies; they’re not as daunting as they seem! Craft a commercial plan that’s proactive, far-sighted, and tailored specifically to your product.

🚀Let’s reshape the narrative and shift to comprehensive success. 🚀