How to Better Prepare for Clinicals in MedTech featuring CTO Kevin Stewart

Clinical success is often decided long before a device ever reaches a patient.
In this episode of Medtech Snapshot, Kevin Stewart, CTO of Revalve Solutions, shares how R&D teams can better prepare for clinical development and avoid the common pitfalls that show up later.

There’s this idea in Medtech that clinical is where everything gets proven out.
But if you talk to Kevin, he’d tell you that’s not really true. By the time you’re in the clinic, a lot of the important decisions have already been made. You’re not starting from scratch. You’re seeing the result of how well you prepared.
And most of that preparation comes down to something pretty simple. Reps.
Early in his career, and something he still expects from his team, is spending as much time as possible in the wet lab. Running procedures over and over. Seeing what happens. Breaking things. Fixing them. Then doing it again.
Because when you’re finally in a clinical setting, things will go sideways. Not always in big, obvious ways. Sometimes it’s small, unexpected stuff. A step that doesn’t go as planned. A behavior you didn’t quite anticipate. And in those moments, you don’t rise to the occasion. You fall back on what you’ve seen before.
That’s where those reps matter.
The other thing he pointed out, and this one hits a little harder, is how easy it is to ignore what the lab is trying to tell you.
You see something off in an animal study or on the bench and the instinct is to explain it away. It’s just the model. It’s not perfect. It won’t happen in real life.
Maybe. But maybe not.
Those early signals are usually trying to tell you something. And if you brush them off too quickly, they have a way of showing back up later when the stakes are a lot higher.
There’s also a bit of human nature baked into that. Engineers want things to work. You’ve put time into the design, the procedure, the system. Of course you want it to be right. So if you’re not careful, you start filtering what you see. You look for confirmation instead of problems.
And that’s where things can drift.
Another place teams get tripped up is waiting too long to bring physicians into the process.
There’s this tendency to want to polish everything first. Get the device right. Get the procedure dialed. Then show it to the people who are actually going to use it.
Kevin’s take is pretty blunt. That’s a mistake.
The earlier you involve physicians, the better. They’re the ones who understand how things actually work in practice. Not how they should work. How they do work. That kind of feedback, early on, can save a lot of time and a lot of rework.
When you step back, none of this is overly complicated. But it does require a shift in mindset.
Spend more time in the lab than you think you need. Take early findings more seriously than you want to. And bring in real-world input earlier than feels comfortable.
Because by the time you get to clinical, you’re not hoping things work.
You’re finding out if they already do.

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