Product guide
How MedTech Compass works
Regulatory and market intelligence, navigated. MedTech Compass is one workspace for FDA triage, global market attractiveness, and executive-ready decisions — turning a single device description into a structured, source-linked view of where and how to bring it to market.
What the model does
Most teams answer regulatory questions in one tool and commercial questions in another, then try to reconcile them in a spreadsheet. Compass runs both analyses from the same device description, so the route to clearance and the case for a market are assessed together.
- FDA regulatory triage: likely device class, candidate product codes, and the probable premarket route
- EU MDR and UK considerations, including Annex VIII classification rules and UKCA/MHRA requirements
- Global market attractiveness scoring across 25+ markets
- Policy and reimbursement forecasting: coding, coverage, and who ultimately pays
- Clinical and manufacturing layers that shape evidence and supply expectations
- Evidence-grounded answers, with every claim linked back to its source
How MedTech Compass works, step by step
The workflow is deliberately short: the point is to reach a defensible shortlist quickly, then go deep only where it pays.
- 1Describe the device in plain language — intended use, technology, and target patient population.
- 2Review the regulatory triage: device class, candidate product codes, and the likely premarket pathway.
- 3Score markets with weights that reflect your strategy rather than a generic index.
- 4Drill into a single geography for reimbursement, procurement, competition, and adoption detail.
- 5Export an executive-ready summary with sources attached, ready for a board or investor conversation.
Medical device market scoring, multi-modal by design
Most market-intelligence tools show one lens at a time. Compass ingests distinct data layers and fuses them into a single composite medical device market score for every geography-device pair, so two countries can be compared honestly instead of described separately.
Inputs include openFDA product codes and 510(k) records, the Federal Register, CMS payment schedules, and EU MDR Annex VIII rules. It is not a dashboard bolted onto one-dimensional healthcare data — it is a map-first decision cockpit that turns independent modalities into one number you can defend, and it models where opportunity is heading rather than only where it stands today.
For the discipline behind the score, see the medical device market intelligence guide, the global FDA pathways guide, and the EU MDR and UKCA guide.
Enterprise-grade security and AI compliance framework
Compass is built with layered controls across infrastructure, access, and payments, and follows an AI compliance framework aligned to ALCOA+ data integrity, 21 CFR Part 11 controls, FDA AI guidance and GMLP, and ISO 13485 / IEC 42001 — so your regulatory strategy and market intelligence stay yours.
Full details are on the MedTech Compass security page.
- Certified infrastructure: hosted on cloud infrastructure maintaining SOC 2 Type II and ISO 27001:2022 certifications
- Organization-scoped isolation: Row Level Security scopes every record to your organization, with no cross-tenant access by policy and by design
- PCI-DSS payments: processed by Stripe (PCI-DSS Level 1) — card and bank details never touch CAHIR servers
Access and tiers
Access is granted per organization. Teams usually start on the free Market Signal tier to validate one market question, then move to a single launch-ready report or an ongoing Pro, Executive, or Portfolio workspace.
Tier details sit on the product suite page. You can request access directly, or book a live demo for a walkthrough against your own device.
Frequently asked questions
- What does MedTech Compass do?
- MedTech Compass turns a single device description into a structured, source-linked view of where and how to bring the device to market. It covers FDA regulatory triage, EU MDR and UK considerations, global market attractiveness scoring, policy and reimbursement forecasting, and clinical and manufacturing layers — all in one workspace with evidence-grounded answers.
- How does market attractiveness scoring work?
- Compass fuses distinct data layers — regulatory route, payment and reimbursement, competition, procurement and adoption readiness — into one composite attractiveness score for every geography-device pair. Weights are configurable, so the score reflects your strategy rather than a generic index, and every input links back to its source.
- Which data sources does it use?
- Answers are grounded in primary sources such as openFDA product codes and 510(k) records, the Federal Register, CMS physician fee schedule data, and EU MDR Annex VIII classification rules, alongside market and competitive data. Each output is source-linked so it can be checked and defended.
- Who is MedTech Compass for?
- Regulatory, market access, and commercial leaders at medical device start-ups, digital health and SaMD teams, and small-to-mid-size manufacturers who need a defensible answer to where and how to launch next — and an executive-ready summary to take to the board.
- How do we get access?
- Access is granted per organization. You can start on the free Market Signal tier to validate a single market question, or request access and an administrator will activate your workspace. Book a live demo if you would like a walkthrough against your own device first.