In the US medical device companies usually have a board of practitioners to give advice about the state of the art and the challenges with existing practice in the field. You can also start building your own device or system and plan to sell it, but you should find someone to consult on how to lobby the FDA and CMS as early as possible, because some devices get stuck in De Novo or PMA for years, and that’s a big risk to take. You’ll also need to have a long term plan for how the company will grow as you get closer to regulatory approval. A “product role” in these companies is very heavy on managing regulatory approval and making sure the company doesn’t get sued.