Yes - and we guide you before, during, and after.

From evaluating whether you need a code, to specialty society engagement, to product positioning and submission strategy, we manage the nuances that matter.

Not quite.

The FDA wants to see that your device works — that it's safe and effective. Payers, on the other hand, want proof that your device actually improves patient outcomes in the real world — and that those improvements last.

Yes — through direct feedback.

We set up interviews with payers, physicians, and hospital leaders to validate assumptions or flag red flags early.

Absolutely.

Clinical trial reimbursement can offset sponsor costs, validate medical necessity and coding early, and set sites up for success upon commercialization. But there are trade-offs you don’t want to ignore.

We design payer education campaigns, coordinate society introductions, and prepare custom coverage advocacy dossiers.