Breaking into healthcare is hard. Breaking into MedTech is harder — thanks to complex regulations, long sales cycles, and conservative procurement paths. For early-stage medtech startups, choosing the right go-to-market (GTM) strategy can be the difference between scaling and stalling.
This guide breaks down the GTM playbook for MedTech in 2025, with a focus on startups launching in Europe and beyond. Based on real-world cases and regulatory insights, it’s built for those bringing medical devices, diagnostics, SaMD, or digital therapeutics (DTx) to market.
1. Choosing Your Commercial Model
Startups typically consider three primary go-to-market approaches:
1. Direct Sales (Field Reps, Clinical Liaisons)
- Best for: High-margin products requiring clinician education (e.g. surgical robotics, diagnostics)
- Challenges: Expensive ramp-up, long hiring timelines, regulatory training
2. Distributor & Channel Partnerships
- Best for: Physical devices, CE-marked products in new geographies
- Challenges: Less control over brand, data access, or customer experience
Example: Aidar Health used local channel partners to launch its multi-parameter diagnostic device in the EU before expanding direct.
3. Hybrid Model (Digital + Field, Centers of Excellence)
- Best for: DTx, connected devices, AI-enabled diagnostics
- Combine inbound marketing, centralized KOL outreach, virtual demos, and sales hubs
Example: Kaia Health built its GTM around remote clinical onboarding + digital HCP engagement, reducing cost-per-acquisition in Germany.
2. B2B vs B2C vs B2B2C in MedTech
MedTech isn’t one market — it’s multiple buyer archetypes:
| Model | Buyer | Example | Risk |
| B2B | Hospitals, GPOs | Surgical robots, AI diagnostics | Long cycles, tender processes |
| B2C | Patients | Wearables, chronic disease apps | Acquisition cost, compliance |
| B2B2C | Employers, insurers | DTx, remote monitoring | Value-based outcomes required |
Key takeaway: Align GTM strategy to your reimbursement model and data capture capabilities.
3. Launch Sequence: What Comes First
Here’s a 4-step playbook most successful medtech startups follow:
Step 1: Identify Use Case + Early Adopter Segment
- Focus on a narrow clinical pathway (e.g. remote respiratory monitoring in COPD)
- Validate with 3–5 pilot sites
Step 2: Secure Certification or Reimbursement Milestone
- EU: CE Mark under MDR, DiGA listing in Germany
- UK: NICE DHT Evidence Standards
- US: FDA 510(k) or De Novo
Step 3: Establish Clinical + Economic Credibility
- Publish real-world evidence or observational data
- Prepare short HTA dossiers (see EUnetHTA)
Step 4: Build Repeatable GTM Engine
- Onboard 2–3 KOLs as advisors
- Launch pilot-to-procurement playbook
- Invest in sales enablement tools (e.g. Showpad, Veeva)
4. The Rise of Digital-First MedTech GTM
- Virtual engagement is now table stakes. Over 70% of HCPs prefer virtual or hybrid touchpoints post-COVID (Accenture Life Sciences Report).
- AI-powered reps, modular education, and asynchronous demos are outperforming live-only tactics.
- Tools like ExplORer Surgical are now used in complex OR sales motions.
5. Budget Benchmarks for GTM Readiness
For pre-Series A startups, GTM budgets vary by model:
| GTM Model | Typical Budget (Year 1) | Headcount |
| Direct sales | €300K–€1M | 3–5 reps |
| Distributor | €100K–€250K | 1–2 BD FTEs |
| Hybrid/Digital | €150K–€500K | Growth + Med affairs + digital comms |
Up Next in the Series
📌 Post 2: Market Access in Europe — What Founders Need to Know
We’ll explore DiGA (Germany), PECAN (France), NICE (UK), and how early-stage companies can position for public system adoption.
Explore related reading: – Bigfoot Biomedical’s GTM model – Pear Therapeutics: Why commercialization failed
This content has been enhanced with GenAI tools.
