Oftentimes the big issues with the development of new Medical Devices are pre/post market studies and data collection for those studies. The regulatory path for this ends up quite complicated & contradictory when juggled with HIPPA, GDPR and the various rules around how these studies are executed. This means there is a lot of tricky nuance to what markets a Medical Device company might try to target.

While I certainly wouldn't call myself an expert on this, having worked within the industry I've been able to make the following observations:

- Novel medical devices are often created by very small startups, who in essence exist solely to create a PoC. A larger Medical Device company then buys them to actually start walking through the regulatory hurdles which will bring them to market.

- The market it gets initially released in is rarely connected to the location it was invented (ex: Invented by European startup but released in the US is weirdly common). But if a product is successful enough then an even larger Medical device company with access to more international markets might swoop in and purchase the mid sized company.

- European regulatory agencies will oftentimes be lenient on products that have received FDA approval, but the reverse is less clear cut. So going through the FDA first can be more efficient, especially when considering the market size of the US along with the fact that you only need to support one language. In practice this pushes out the timeline for the first European release of a device.

- GDPR is actually not very different from HIPPA, perhaps not even as strict, but it is more ambiguous and that's a problem. The key difference is that, right now, everyone knows exactly how to follow HIPPA but the reverse is not true for GDPR. Some things that might be allowed by one might subtly contradict the other and there is no third party Medical Device companies can throw money at that will absorb the liability of this by saying whether or not they are GDPR compliant.

- Since Medical Device companies live & die on their study data, this data collection paradox has further pushed out timelines for when medical devices are first released in Europe.

- A European might see a cool new Medical device from a startup in their local newspaper but then never actually gain access to it for another 20 years.

So personally I'd say it largely reduces down to the regulatory environment + market size. The US can be among the strictest, but not only is getting past that worth it for market access, but by passing those strict hurdles, releasing to other international markets becomes much easier since you got the hard part over with.

Not to mention the fact that, in a similar way a popular programming language might have more "community resources" and a larger hiring pool, the same could also be said for navigating regulatory environments. So popularity has a self-amplifying effect.