STRATEGIZE · REGULATORY STRATEGY
Construct the whole strategy before you write a word.
Regulatory strategy is a market question before it's a paperwork question. We hold enough of the record—pathways, competitor clearances, evidence bars, and reimbursement—to build an end-to-end strategy, from the first market read to the actual submission.
THE METHOD
Everything to build a strategy end to end.
From the market to the submission on one connected record: how devices get classified, how competitors got cleared, what evidence each path demands, and what it pays once you're on the market.
Dynamic Decision Trees
Match your device description to the classification rules and walk a live decision tree to the pathway—unregulated, exempt, 510(k), De Novo, or PMA—and everything each implies downstream.
Competitor Pathways
Examine exactly how comparable and competitor devices were cleared: the pathway they took, the predicates they cited, the lineage they built on, and how long it took.
Evidence Requirements
See the exact evidence a given clearance type demands in a given pathway—bench, biocompatibility, software, cybersecurity, clinical—before you commit a dollar to proving it.
Billing & Reimbursement
Tie a strategy to what it pays. We connect the CPT/HCPCS codes and Medicare reimbursement to the clearance you land, so market viability is part of the plan, not an afterthought.
DYNAMIC DECISION TREES
From device description to the right pathway.
Start where strategy starts: which pathway does your device even fall under? From its description, we work out how the regulations govern it—and walk the live decision tree to the pathway and the requirements that follow.
The pathway sets everything downstream—the evidence you owe, the timeline, and whether you need a predicate at all. We ground it in how comparable devices were actually classified.
COMPETITOR PATHWAYS
See exactly how comparable devices were cleared.
Every competitor's clearance is a map. We trace the pathway and predicate lineage of comparable devices back to their foundational clearances—so you can follow a proven route or deliberately avoid a crowded one.
The highlighted path is a well-trodden lineage—densely cited, clean post-market, traceable to a foundational clearance. The side branches are routes competitors took that you can learn from or leave behind.
EVIDENCE & REIMBURSEMENT
Know the evidence—and the market—before you commit.
A strategy isn't real until you know what it costs to prove and how big the reimbursement pool is once you're cleared. We map the evidence a clearance type demands to the billing that flows through these codes every year.
Evidence required
- Bench performance testing
- Biocompatibility (ISO 10993)
- Electrical safety & EMC
- Software V&V (IEC 62304)
- Cybersecurity documentation
- Substantial-equivalence comparison
Reimbursement pool
| CPT 76705 | Ultrasound, abdominal, limited | $312M/yr |
| CPT 76942 | Ultrasound guidance, needle | $224M/yr |
| CPT 93971 | Duplex scan, extremity veins | $186M/yr |
Switch the clearance type and the evidence bar changes—and so does the economic case. Strategy is the loop between what you can prove and what the market will pay.
HOW IT WORKS
From a market read to a submission-ready strategy.
The market informs every decision, end to end.
Read the market
Competitor pathways, the predicates they cited, and the reimbursement in your space—assembled from the full record, not guesswork.
Resolve the pathway
The decision tree matches your device to a pathway and surfaces the exact evidence bar and economics that come with it.
Assemble the strategy
Pathway, predicate lineage, evidence plan, and reimbursement—one connected strategy, ready to flow straight into the submission.
Ready to map your strategy?
Bring your device—we'll show you the pathway, the competitors, the evidence, and the reimbursement.