Designing Successful Clinical Trials for Medtech Startups
Transparent, well-designed clinical trials are crucial for medtech companies. The FDA approves many new medical devices annually, but unfortunately, faulty devices have led to numerous injuries and deaths. This highlights the importance of rigorous processes to prove safety and efficacy, especially in the current environment. This article gathers advice from experienced leaders in the medtech space on best practices for clinical trials, including choosing endpoints, managing risks, and demonstrating real-world value.
Think Like a Medtech Acquirer from Day One
Dr. Eric Fain, President and CEO of Procyrion, approaches clinical development with an acquirer’s mindset. He emphasizes that the study design is the foundation. Consider the claims you’ll want to make after FDA approval; your data must support these claims. For example, your device should clearly outperform standard care within the target patient population. Signaling future potential is critical to attract acquirers. Consider showcasing scalability and vision through secondary claims. Align with the FDA, define your claims, and design the best studies possible early on.
Involve Payers from the Beginning
Jason Hannon, a medtech executive, stresses that reimbursement is the ultimate deciding factor in healthcare. Anticipate what payers will require, as it’s difficult to change the study later. Consult medical directors from various payers early to understand their priorities. Hannon’s first senior hire was a head of reimbursement, demonstrating its importance. He also highlights the value of selecting unbiased control groups to ensure that the study reflects real-world patient outcomes. Independent economic analysis conducted by third parties builds trust and credibility.
Learn from Others and Lead with Transparency
Timothy Boire and Geoffrey Lucks, co-founders of VenoStent, advise learning from others’ experiences. Studying existing research, clinical trial endpoints, and relevant technologies is critical for understanding what works. VenoStent focused on proving feasibility through preclinical studies and computational modeling before human trials. Embrace the feedback from the FDA, even if it’s challenging, and address concerns point by point. VenoStent secured Breakthrough Designation after demonstrating promising early data.
Keep Endpoints Aligned with Your Device’s Core Function
Amar Sawhney, a serial entrepreneur, emphasizes that endpoints should reflect the core function of your device. Avoid overcomplicating trials by including secondary endpoints that introduce external variables. For embolics, the primary endpoint could be cessation of blood flow, which is a simple metric tied directly to the device’s purpose. When a trial’s goal, like preventing uterine adhesions, is at odds with the FDA’s goals, have them as separate studies if possible. Make pre-market endpoints you can control.
Balance Regulatory Risk by Learning from Established Companies
Brian Fahey, co-founder and CEO of Adona Medical, recommends learning from companies that have already paved the way to minimize clinical and regulatory risks. If you are late to the market, your product must offer undeniable value to overcome the momentum of established players. He indicates that a clear clinical path isn’t enough if the product doesn’t deliver exceptional results and that it’s important to have a product that is a next-generation version of the therapy.
Final Thoughts
Strategic clinical trial design can lay the groundwork for market adoption and getting regulatory approvals. Setting the right endpoints, demonstrating your device’s effectiveness in real-world scenarios, and maintaining transparency with regulators are essential. This approach, which balances strategic endpoint selection with real-world applicability, builds credibility and increases your chances of market impact.
