Our Model

Kapstone Medical provides 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 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 on a milestone basis with a focus on deliverables, not on hours. And 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.

Depending upon the preference of the client and the needs of the project, we can structure an agreement that best fits each specific 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

Why Outsource?

Although the benefits of outsourcing all or part of a project will vary according to the type of client, the most common benefits include:

• :: Faster time-to-market for new ideas → we have a singular focus on achieving your milestones
• :: More profitable way to commercialize products → you pay for deliverables with no added overhead
• :: Maintaining focus for other priorities → high priority projects are not affected by adding new projects
• :: Tap into the depth of experience and knowledge of the outsource partner → your R&D staff will benefit from the training that comes along with working with an experienced partner

Why Kapstone?

Clients choose Kapstone for reasons which include our breadth and depth of experience, our creativity in the design process, a risk-sharing approach and for our ability to adapt to the client’s organizational and quality systems.

With a combined 100+ years in medical device product development, the team at Kapstone brings a unique advantage to our client’s existing staff. Our engineers are located in both the U.S. and in Europe, and have experience in all types of medical devices with a strong focus in orthopedics. Our engineers also have diverse backgrounds including mechanical design, electromechanical systems and industrial design.