Reimbursement can kill a good device. It doesn't have to kill yours.
A medical device can be FDA-approved, clinically effective, and still fail — because no code describes it, no policy covers it, or the payment doesn't cover the cost of using it.
Ascalon Market Access exists to make sure you see those problems while they can still be solved.
Three ways to work together, depending on where you are:
A fixed-scope look at all three legs of the stool:
Coding — Does a defensible code exist, or is there a gap that changes your timeline?
Coverage — What do Medicare and major payers say today, and what evidence would change it?
Payment — Does the payment cover your device, or does the hospital lose money using it?
You get a written assessment — opportunities, barriers, plain-language recommendations you can put in front of investors. Fixed fee, scoped in a 30-minute conversation.
Your assessment stays alive. Rules change every year. Every assessment includes monitoring of CMS rulemaking and AMA coding agendas through the following calendar year — if something changes that affects your findings, you hear it from us first.
Reimbursement Landscape Assessment
For companies that need to know where they stand — usually because an investor just asked.
Reimbursement Strategy
For companies designing their pivotal study or preparing to launch.
The last safe moment to get serious about reimbursement is pivotal study design — if your endpoints don't support a reimbursement strategy, you're behind before you enroll a patient. Strategy engagements build the pathway to full reimbursement:
Endpoints that serve payers, not just FDA
Pathway decisions — NTAP, pass-through, breakthrough, RAPID — with honest odds
Pricing grounded in payment reality
Application development when the answer is "go"
Market Access Partnership
For companies that want a reimbursement leader at the table — without hiring one.
At Abbott, Boston Scientific, and Zimmer, Steve was in the room when launch, pricing, and payer decisions were made — because reimbursement touches all of them, and retrofitting it is expensive. A Market Access Partnership is that role, fractional: defined monthly scope, one standard — Ascalon is at the table before decisions are made, not after.
Past the assessment stage and heading toward launch?
Not sure which fits?
Start with the assessment — it's designed to be the first step, and everything else builds on it. Or just describe where you are, and you'll get a straight answer about what you need (including "not us, not yet" if that's the truth).