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Business Model

Kapstone Medical provides medical device product development, quality management and project management solutions to clients who value the knowledge, depth of experience and resources that a highly capable outsource partner has to offer.


We can look at every project from multiple angles due to our background in engineering, quality and regulatory affairs. What we provide is not strictly an engineering solution or a quality system, but rather a creatively balanced result that takes into account the various requirements of a medical device organization.

Unlike typical fee-for-service consulting firms, we prefer to work with Inventors on a milestone basis with a focus on deliverables, not on hours. Unlike typical firms, we are positioned to share the risk and the reward of new product development, which better aligns our incentives with those of our client.

We can structure an agreement that best fits your situation.

The most common financial models are:

Fee-for-Service (daily rate)

  • for very early stage development projects with many unknowns
  • for specific tasks within larger projects
  • for quality management system support


Fee-for-Service (fixed price)

  • for proof-of-concept work according to a defined project scope
  • for a milestone-based approach with tangible deliverables
  • for regulatory submissions support


Investment (equity sharing or royalty)

  • for innovative new ideas where preservation of cash is critical
  • for partnership opportunities where Kapstone adds significant intellectual property
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