Medical Device Market Entry. Regulated. Distributed. Executed.

Enter new markets with a clear path — not a distribution agreement and hope. We run the full entry program: regulatory, clinical positioning, distribution, and on-ground execution.

The Problem We Solve

Entering a new geography with a medical device is not a distribution problem — it is a regulatory, clinical, and commercial problem that requires simultaneous execution. Signing a distribution agreement without regulatory clearance, clinical positioning, or on-ground execution capability wastes time and market opportunity. We run the full entry program.

What We Do

Four coordinated disciplines — from commercial strategy through to on-ground territory execution.

📈 Product-Market Fit & Commercial Strategy

Target segment identification and buyer journey mapping
Clinical positioning and KOL engagement strategy
Pricing strategy by channel and geography
Competitive displacement approach and messaging
Market sizing and revenue potential validation

📜 Regulatory Pathway Guidance

Regulatory classification and pathway identification by target market
Submission strategy and timeline planning
Local Authorised Representative (LAR) identification
Pre-submission engagement with regulatory bodies
Liaison with CDSCO, US FDA, and EU Notified Bodies

🤝 Distribution & Channel Partnerships

Distributor identification and capability assessment
Distribution agreement structuring and negotiation support
Distributor training and commercial onboarding
Channel performance monitoring and governance
Direct vs. indirect channel strategy advisory

🌍 On-Ground Execution

Territory launch planning and pilot deployment
Clinical demonstration and evaluation program management
Sales enablement: clinical evidence, pricing decks, competitive comparators
Customer feedback loop and product-market refinement
Tender and institutional sales support

Who This Is For

We work with device companies entering new geographies or relaunching stalled commercial programs.

International device companies entering India for the first time

Indian device companies expanding into US, EU, or Middle East markets

Startups with cleared devices seeking distribution without an internal commercial team

Companies whose existing distribution partnerships are underperforming

Why 369 Innovations

We have built commercial programs for medical devices across India and international markets. We know the regulatory sequencing, the distributor qualification criteria, and the clinical engagement model that determines whether a device achieves commercial traction — or stays on a shelf.

Key Differentiator: Market entry as a coordinated regulatory, distribution, and commercial execution program.