Aug 26, 2026 · 30 min · 13 segments
**Clinical efficacy doesn't matter if the patient won't use the device.** **In this episode of Med Tech Gurus, we sit down with Anat Shani, biomedical engineer and CEO of Synchrony Medical, to…
Anat ShaniGuestTom HickeyHostSo shifting a little bit to the business side, you know, many companies struggle to break into the U.S. market and they find that a real challenge.
What did you learn about the positioning and messaging and gaining early traction in the U.S.?

I mean, product market fit, as I mentioned before, like usability, that's kind of step one.

So understanding... not only the patients, but the entire adoption curve and all the stakeholders involved in the process is something that you should, I would say, clearly identify from the early days.

You know, after regulatory clearance, right, you have the device maybe cleared, but it doesn't mean that it can be sold or can be used.

And targeting the right messages to all the different stakeholders is something that is critical.

And the clinician's overview of the product comes from a different set of considerations.

So getting all of those aligned is really critical to get a product out there properly.
And you touched on this a little bit, but what lessons did you learn about bridging that gap? Did you have to start real early in that whole design process to get that feedback? Yeah.

I would say that we have prepared for the launch way before receiving the update clearance.

And one thing is also to choose the right partners you want to be able to work with.

And whether it's the team members and the employees that are recruited for that, and whether it's the distribution partners or providers that the company works with.
So shifting a little bit to the business side, you know, many companies struggle to break into the U.S. market and they find that a real challenge.
What did you learn about the positioning and messaging and gaining early traction in the U.S.?

I mean, product market fit, as I mentioned before, like usability, that's kind of step one.

So understanding... not only the patients, but the entire adoption curve and all the stakeholders involved in the process is something that you should, I would say, clearly identify from the early days.

You know, after regulatory clearance, right, you have the device maybe cleared, but it doesn't mean that it can be sold or can be used.

And targeting the right messages to all the different stakeholders is something that is critical.

And the clinician's overview of the product comes from a different set of considerations.

So getting all of those aligned is really critical to get a product out there properly.
And you touched on this a little bit, but what lessons did you learn about bridging that gap? Did you have to start real early in that whole design process to get that feedback? Yeah.

I would say that we have prepared for the launch way before receiving the update clearance.

And one thing is also to choose the right partners you want to be able to work with.

And whether it's the team members and the employees that are recruited for that, and whether it's the distribution partners or providers that the company works with.
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