A Single-Source Solution to Medical Device Development

Kapstone Medical was founded to make medical device development easier, more efficient, and even more enjoyable. We do that by providing a single-source solution for medical device devices, big to small, allowing them to check multiple competency boxes under the same roof. No need for multiple hires: your company can save money and time by bringing our team on board, whenever and wherever you need us.

We offer seasoned, multifaceted expertise in:

  • Product engineering
  • Regulatory affairs
  • Quality assurance
  • Industrial design, including human factors
  • Manufacturing
  • Validation and verification testing
  • and more

New Product Development

We take 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.

Our NPD teams are fully customizable and flexible to meet your needs for developing product. Whether looking to employ one resource or multiple, we can step in and step out at any stage of the NPD process. Whether you want to be completely hands off or involved in the project, our NPD teams are accustomed to working in our quality system or a customer’s. You have the flexibility to dial in our team as best suited.

Typically, we follow a phase based approach for NPD. Our development teams are flexible to work in your system or within your process.

Design & Engineering

We’ll help you bring your idea to fruition the right way with thoughtful concept generation, engineering for human factors, IP considerations, and more.


Once a concept freeze is achieved, integrating DFx principles, finalizing the specifications, and planning for testing is crucial for a smooth NPD process.

Human Factors Engineering

Also called Usability Engineering, our methodical and early integration of Human Factors in our NPD process is not only better for product design and user success but is increasingly required by regulatory bodies.


Our comprehensive, platform-agnostic approach to medical device prototyping is efficient, cost-effective, and optimized for success, no matter the design.


From rudimentary testing to formal verification and validation, we’ll design test protocols, execute test plans, and write test reports that appropriately address standards and mitigate risk.

Intellectual Property

We understand the importance of being protected and minimizing risk. With combined creativity for product design and IP strategy, we work early to examine prior art and establish paths forward for the new design to maximize the monetization potential.

What Our Clients Are Saying

I started a very complex project with Kapstone. What I found was a group that was incredibly responsive to my needs and receptive to my ideas.

Dr. Garcia Bengochea, Neurosurgeon
What Our Clients Are Saying

Kapstone has done a marvelous job. Everything from prototyping, intellectual property development as well as helping me get to market.

Wyatt Geist CEO, Safewire Inc.

See Our Process in Action

Download our New Product Development (NPD) Roadmap to take a deeper dive into our seamlessly integrated process.