Our Services

End-to-end medical device commercialization

We guide inventors, startups, and clinicians from working prototype through commercial launch. No single path fits every device — we help you pick the right one.

Regulatory Strategy & QMS

FDA pathway planning (510(k), De Novo), ISO 13485 quality management system setup, design history file (DHF) preparation, and risk management per ISO 14971.

  • ✓FDA pathway analysis & submission support
  • ✓ISO 13485:2016 QMS implementation
  • ✓Design controls & DHF
  • ✓Risk management (ISO 14971)

Clinical Validation

Study design, site coordination, data collection, and clinical evidence generation to support regulatory submissions and market adoption.

  • ✓Clinical study design & protocol
  • ✓Site identification & coordination
  • ✓Data collection & analysis
  • ✓Publication & dissemination

Reimbursement Strategy

The difference between a device that sells and one that sits on the shelf. HCPCS coding, CMS coverage determination, payer strategy, and economic modeling.

  • ✓HCPCS code application support
  • ✓CMS coverage strategy
  • ✓Payer engagement & negotiations
  • ✓Health economics & outcomes research

Manufacturing Partner Introductions

Access to vetted manufacturing partners — domestic and offshore — matched to your device, volume, regulatory class, and cost targets. We don't manufacture ourselves, so our recommendations are honest.

  • ✓Manufacturer matching & vetting
  • ✓Cost & quality analysis
  • ✓Domestic and offshore options
  • ✓Sourcing via trusted partners

Prototype to Production

Design for manufacturability review, tooling strategy, first-article qualification, and production ramp planning. We help you cross the gap between one-off prototype and scalable product.

  • ✓Design for manufacturability (DFM)
  • ✓Tooling & fixture strategy
  • ✓First-article inspection
  • ✓Production ramp planning

Go-to-Market & Distribution

Commercial launch planning, distribution channel strategy, sales enablement, and market positioning. Get your product into the hands of clinicians.

  • ✓Launch planning & positioning
  • ✓Distribution channel strategy
  • ✓Sales enablement materials
  • ✓KOL engagement

Not sure where you are in the journey?

Schedule a free consultation and we'll map out your path from where you are to commercial product.

Schedule a Call