Medical Device Development from Pre-Commercialization to Post-Market

Kapstone Medical takes a fully integrated approach to new product development (NPD), weaving our expertise in design, IP strategy, engineering, regulatory affairs, quality assurance, and manufacturing into a comprehensive and effective development process based on decades of experience and dozens of projects. Our medical device experts partner with your team to advance your product at any stage of the process and help you to navigate a cost-effective and expedited route to market.

Prototyping and Refinement

Once the team has aligned on a concept, you can move into iterative prototyping and refinement. This is an essential stage of the development process that will help you finalize the best possible version of the product. Our technical capabilities span virtually any engineering discipline.


In-house or through our partners, we can handle all the technical work needed to engineer the device:

  • Mechanical, including for various materials
  • Electrical & Electrical Systems
  • Software & Firmware
  • Optical

Kapstone’s focus is to integrate all the appropriate disciplines to get the product to a design freeze in a comprehensive approach while staying on-time and on-budget. After the design freeze, the product is ready for manufacturing and testing.

Integrated Approach

Development of a medical device requires more than product engineers. Kapstone’s approach to new product development projects involves integrating various disciplines including regulatory affairs, quality assurance, human factors, industrial design, manufacturing, intellectual property, and others. Our process and offering includes almost every resource skillset needed to effectively and efficiently develop a product.


Our typical NPD project offering includes:

  • Project Manager
  • Product Engineer(s)
  • Regulatory Affairs
  • Quality Assurance
  • Manufacturing Engineer

Additionally, if appropriate we can provide:

  • Registered Patent Agent
  • Industrial Designer

Our team does not typically provide a product manager or marketing role, but we can support user need studies and market analyses to help drive inputs for the design and project team.

Design Inputs and Risk Analysis

The Kapstone approach for development is built on a foundation of understanding true user needs and product risks. While User Needs should be established before a development stage begins, oftentimes the project team is still finalizing the Design Inputs. These can be based on technical learnings, additional user interviews or assessments, and a risk analysis. Kapstone’s integration of risk management starts early in the process and lasts throughout the entire new product development project. This decreases the chance of project direction changes during the development process or product issues after launch.

Testing Strategy & Predicate Devices

Kapstone can assist with medical device testing in many ways. As part of our new product development process or as a consultant to your team, we identify the right tests to conduct, compose test protocols, coordinate the test, and write test reports. We can also help you select a comparative predicate device as early as possible so that specific substantial equivalence measures can inform product design and testing.

Learn more about our testing support here.

Patentability Assessment

Kapstone can help you determine whether your design can be patented through an initial Patentability Assessment at the fraction of a cost of a patent attorney. Let us combine our design and engineering expertise in the medical device industry with our understanding of patent law.

Our on-staff patent agent can help to devise the strategy for applying for patents and help prepare a patent application. It’s best to engage a patent attorney to execute the provisional and final application, and we can provide a recommendation or work with your selection.

Learn more about our intellectual property support here.

Identification of Manufacturing Partners

Selecting the right manufacturing partner or partners is a crucial part of medical device development. Your ability to commercialize will ultimately depend on the efficiency, effectiveness, compliance, and quality of your supply chain.

Kapstone has decades of experience in medical device manufacturing. We can help you select the right partners for every stage of your supply chain and set up protocols to maintain manufacturing quality and efficiency.

Learn more about our supply chain management support here.

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