Commercialization

Strategic support for medical technology companies ready to commercialize, expand, and grow globally.

  • Get ready. Get in. Keep growing.
  • One team beside you from first idea to first order.
  • We bring back what the market tells us, so you can adjust early.
  • Ways to hire us: by project, monthly retainer, fractional days, or with an optional success fee.

Marketing and digital leads

Distributors and clinicians need clear material before they will commit to a new device.

  • Write the positioning and key messages for each market
  • Build distributor training kits
  • Prepare clinical and reimbursement guides
  • Write brochures, presentations and website copy
  • Plan B2C campaigns for devices that patients choose for themselves
  • Branding, websites, video and design, done by our own team, so your story looks as strong as your science.

Market entry

International business development comes down to choosing the right markets in the right order and finding partners who will actually sell.

  • Set the market entry sequence, based on clearance, reimbursement and real demand
  • Find and qualify medical device distributors and importers
  • Negotiate distributor and importer agreements
  • Support the first orders and import approvals
  • Train the distributor teams so they can present the device with confidence
  • Plan international marketing for each market, together with the local partner

Regulatory

The regulatory route decides how fast a device reaches its first market.

  • Choose the regulatory pathway for each target market
  • Build the submission team with experienced regulatory consultants
  • Coordinate FDA 510(k) and EU MDR submissions
  • Arrange Free Sale Certificates and country registrations
  • Keep everything in one master regulatory file

Production

A cleared device still has to be built, released and delivered in a way that buyers trust.

  • Select medical device contract manufacturers that fit your device and your volumes
  • Manage the contract manufacturer relationship day to day
  • Set up production planning and product release
  • Prepare the supply documentation that hospital and government buyers ask for
  • Support moving manufacturing to a new contract manufacturer

Grants

Non-dilutive funding can cover a large part of development and market entry if the application is right.

  • Find the right programme for your stage and your plans
  • Write EU grant applications
  • Support applications to Horizon Europe, the EIC Accelerator, EP PerMed and US NIH/SBIR
  • Prepare the budget and the presentation to the examiners
  • Manage the file after approval, including change requests and reporting

Investment

Getting ready to raise? We help medtech companies tell a clear, credible story that investors want to back.

  • Build an investor deck around the clinical value, the market and the path to revenue
  • Shape a realistic business plan and financial model
  • Prepare for due diligence, so the questions don’t catch you off guard
  • Introduce you to the right investors and support you through the conversations
  • Work alongside your board and investors once the round closes

Interim leadership

Some stages need someone who carries the responsibility, not only the advice.

  • Lead the company as interim or part-time CEO
  • Act as fractional head of business development
  • Run international expansion, distributor networks and key negotiations
  • Work with the board, investors and the management team
  • Prepare the handover to a permanent leader

Ready to Talk?

Let’s discuss the next stage of your MedTech growth.