From device description to ranked target markets: FDA triage, reimbursement outlook, and auditable scoring in a single workflow your team can adopt today.
What the model does
MedTechCompass turns a single device description into a structured, source-linked view of where and how to bring it to market — covering medical device market access, reimbursement strategy, and market entry sequencing in one pass.
Product overview
Navigating the complexities of medical device regulations and global markets access just got easier.
Meet our MedTech Compass— the all-in-one power workspace where custom multi-dimensional scoring, forecasting, and a retrieval-grounded intelligence model converge into one command center for FDA triage, global market attractiveness, and boardroom-ready decisions.
Whether you're sizing up 24 global markets at once or drilling into a single geography's attractiveness, MedTech Compass hands you the clarity to lead — not chase — your next MedTech breakthrough.
Why multi-modal
Most market-intelligence tools show you one lens at a time. MedTech Compass ingests and fuses distinct multi-modal data layers into one composite attractiveness score for every geography-device pair on the planet. It's not another dashboard bolted onto one-dimensional healthcare data. It's a map-first, evidence-based decision cockpit that turns independent data modalities into one number you can defend.
Market access in medical devices is the whole route between a cleared device and paid, repeatable use: the regulatory pathway, the reimbursement and coding route that lets a provider get paid, health technology assessment or tender requirements, and local distribution rules. MedTech Compass models each of those layers per country, so a commercialization strategy rests on the same evidence as the regulatory one.
Stop researching. Start deciding. MedTech Compass doesn't just score today's market — it models and explains where opportunity is heading.
Guide
Six steps that turn a device concept into a medical device market access strategy and a sequenced market entry plan — from intended use and FDA classification through reimbursement and ranked target markets. Each step links to a free tool or guide you can use right now, no account required.
Start with the intended use statement. It decides whether the product is regulated as a medical device, software as a medical device, or a general wellness product — and everything downstream depends on it.
Take the classification quizThe product code ties your device to a regulation number, a device class, and the review path FDA expects. Search by device name or keyword to find the closest match and its classification panel.
Search FDA product codesLook at devices already cleared under your product code. Predicates show what testing, indications and labeling FDA accepted, and reveal who your direct competitors already are.
Search the FDA 510(k) databaseExempt, 510(k), De Novo, or PMA. The class and predicate landscape usually point to one route; the cost and timeline difference between them is the single largest variable in a launch plan.
Compare regulatory pathwaysClearance is not revenue. Check the coding, coverage and payment route in each target country, plus health technology assessment or tender requirements, before committing a commercial budget.
Read the market entry strategy guideScore candidate countries on regulatory burden, reimbursement, clinical ecosystem, and manufacturing factors, then sequence a first market, a fast-follow market, and a pilot site.
How to pick the best marketMedTech Compass is built with layered controls across infrastructure, access, and payments — so your regulatory strategy and market intelligence stay yours.
Hosted on cloud infrastructure that maintains SOC 2 Type II and ISO 27001:2022 certifications.
Row Level Security scopes every record to your organization. No cross-tenant access, by policy and by design.
Payments processed by Stripe (PCI-DSS Level 1). Card and bank details never touch CAHIR servers.
Transparency & governance
Toggle below to see how MedCompass aligns with global medical device and AI compliance frameworks.
Keeps data Attributable, Legible, Contemporaneous, Original, and Accurate across all regulatory decision logs.
MedCompass is a decision-support tool for medical device market scoring; its internal data practices are designed to align with this AI compliance framework. For broader medical device market intelligence and global FDA pathway coverage, visit medtech.cahir.ai.
Access is granted per organization. Request access and an administrator will activate your workspace.
See every market. Score every opportunity. Move before your peers finish their spreadsheet.
Common questions
More detail in choosing the best market for a medical device, the FDA 510(k) database guide, and the full question list.