Playbook
Designing Medtech Clinical Trials For Approval & Beyond
A solid clinical study does more than get you regulatory approval — it sets your device up for market adoption. This playbook pulls together hard-earned insights from medtech leaders who’ve designed trials with payers, acquirers, and real-world success in mind.
Key Lessons from this Playbook
Your endpoints define your success: Once you get an approval, you can’t go back. When picking your primary endpoint, focus on the claims you’ll make, the patients you’ll serve, and how your device will stand out in the market.
Prove for the real world: Clinical trials take place in controlled environments, but payers and providers need to know your therapy works in everyday practice. Avoid being biased when picking your patient population in order to show your treatment can deliver reliable results in the real world, too.
Be open and transparent: Honesty and clarity will get you much further than trying to outsmart the regulatory system. Regulators can spot shortcuts and sidesteps a mile away. Address challenges head-on to build trust and maintain your momentum.
Cascade secondary endpoints strategically: Start with the most direct measure of success—what your device is designed to do—but don’t put all your weight on a single endpoint. Build a sequence of secondary endpoints that progressively strengthen your hand.
If you’re not the pioneer, be a game-changer: Learn from those who came before you to avoid mistakes and reduce risk, but don’t settle for small improvements. Being late to the game isn’t a problem if you bring something that’s truly transformational.
