Medical device market scoring for teams bringing devices to market
MedTechCompass is a decision-support workspace that turns a device description into medical device market scoring and a source-linked market access strategy — regulatory triage, premarket pathway, reimbursement outlook and ranked target markets, produced under a documented AI compliance framework. For broader medical device market intelligence and global FDA pathway coverage, visit medtech.cahir.ai.
Our mission
Remove the guesswork from global market entry
Medical device companies make high-stakes decisions under uncertainty. Which FDA pathway applies? Which markets reimburse the procedure? Where is the competition weakest and the clinical need most acute?
MedTechCompass was built to give regulatory, market-access, and product teams a single place to answer those questions with evidence. We combine public regulatory data, curated market baselines, and AI-assisted synthesis so you can move from device idea to sequenced launch plan faster — without losing the source trail that makes the strategy defensible.
The platform is developed by CAHIR Solutions, a team focused on regulated-industry decision support, AI governance, and total-product-lifecycle data integrity.
Who it's for
Built for the people who decide where a device goes first
Regulatory Affairs
Quickly triage FDA classification, product codes, 510(k) predicates, De Novo feasibility, and EU MDR/UK considerations with citations you can trace.
Market Access & Commercial
Compare global markets across reimbursement, policy, clinical ecosystem, and manufacturing dimensions to prioritize where to launch first.
Product & Portfolio Leadership
Align R&D, clinical, and commercial roadmaps around a shared view of regulatory burden, evidence gaps, and market attractiveness.
Investors & BD Teams
Screen opportunities and diligence portfolio companies with a repeatable, evidence-grounded view of regulatory pathway and market entry risk.
How it helps
From first insight to launch-ready plan
Start with a device description, not a form
Describe intended use, technology, and patient population in plain language. MedTechCompass returns a structured regulatory triage and a first-pass market entry plan.
See every dimension in one score
Regulatory, reimbursement, policy, clinical ecosystem, and manufacturing/infrastructure layers are scored, weighted, and rolled into a composite attractiveness score you can explain.
Trace every claim to a source
Outputs include FDA product codes, classification references, predicate leads, reimbursement signals, and source links so your strategy can survive scrutiny.
Know where you will actually get paid
A reimbursement friendliness score and a payment route for every market: open the "Where will we actually get paid?" view, filter to countries with an existing route for your device archetype, expand any market to see route mechanics and the supporting evidence, then export the result straight into your board deck.
Weight the score to match your goal
Choose a preset emphasis — best launch, best pilot, or best manufacturing — and the composite score reweights regulatory, reimbursement, policy, clinical ecosystem, and infrastructure dimensions to reflect that priority. Compare scenarios side by side before committing the team to a market sequence.
Compare the competitive landscape
Review major competitors across Global and Region settings, then compare markets using different peer cohort groups. Explore the findings in radar and bar charts, tables, and market-by-market lists, with source-backed results and confidence indicators that show the strength of the supporting evidence.
Start building your market entry plan
Use the free checklist to work through FDA classification, pathway, scoring, and evidence gaps — or explore the blog for deep dives on 510(k), product codes, and market selection.