Full-Service Medical Device Design
and Engineering

Kapstone Medical brings decades of experience in medical device design to the early stages of development. With extensive knowledge in industries like orthopedics, cardiovascular, and neurology, we help our clients synthesize new device concepts with market research, engineering best practices, intellectual property evaluation, and consultation on the full product lifecycle. We’re here to partner with you on every part of the process from conceptualization through to commercialization.


Our services include:

  • Concept Generation
  • Design and Prototyping
  • Feasibility Assessment
  • IP Strategy

Concept Generation

Generation of Multiple Concepts

If you have not locked in a concept to address a clinical need, Kapstone can step in with a fresh perspective to brainstorm design ideas that meet your or your users’ needs. We recommend having multiple designs available and vetting them early in the process with users. Having options ensures that you don’t have to start over if you encounter obstacles along the way. Moreover, pursuing multiple concepts—or even multiple intended uses—will help your patent attorney (if your idea is patentable) make a broader and therefore more valuable case for your product’s patent.

Not sure if your idea lends itself to multiple concepts? Kapstone’s decades of experience and diverse engineering team will help guide you to new ways of thinking.

Product Positioning

In addition to brainstorming design ideas, it is important to address the following questions early in the NPD process, preferably during the concept phase: 

  • Who are the users and why do they need it? What are the unique or critical aspects to my product?
  • How do I protect it? Are there multiple market opportunities?
  • Is there a clear path forward to achieving regulatory clearance?

Kapstone can help position your product to maximize the chance of success in the marketplace.


We’ve all heard about napkin-sketch concepting. While informal, it does speak to one of the most essential parts of the design process: documentation.

Documentation is an absolute necessity in the medical device design process, especially in the early stages. Not only will it ensure that none of your ideas, concepts, or designs get lost, but it will prepare you for the meticulous record-keeping required for patent protection and regulatory submission. There are many ways to document effectively: storyboards, rudimentary sketches, CAD-enabled mockups, and of course, traditional filing and note-taking. 

You might think that this type of documentation is premature or inefficient. However, many back-of-the-envelope concepts have made it through the rigorous process to become commercially successful products. In our experience, doing it the right way from the beginning avoids headaches, decreases diversions, and is most cost-effective in the long run.

Feasibility Assessment

What is “Feasibility”?

Sometimes an ambiguous term, this principle can mean different things to different people. Individuals also have different requirements for what they need to achieve in order to start, or move forward, a project. Usually, at minimum, there is technical AND market feasibility (see next page for more).

Many times people will view an MVP (minimal viable product) as a deliverable for feasibility – this prototype can be a combination of accomplishing any technical unknowns, being a conduit for early user feedback, or acting as a ‘show-and-tell’ for early investors. For prototyping at this point, the biggest question an inventor should ask his/herself is: “What is the bare minimum I need to have working so that I feel comfortable investing significant time and finances”?


What is the Concept Phase?

The transition between “research” and “development” occurs during this phase. At this time, it is recognized a clear direction for the product exists. The product development process has started, and this phase ends with a ‘concept freeze’. The prototype at this point still may not have all the ‘bells and whistles’ or all sizes/variants.

Thus, even once locking down the concept, the product is not quite ready. There are usually many details and refinements that must be worked out before making ‘production-equivalent’ prototypes to be used for testing in preparation of a regulatory submission. This phase sets up the Development Phase.


Establishing Feasibility

One of the most common questions that is asked early by product developers is whether or not their idea can be designed. Will it work as intended? Will it be too big? Strong enough? A thorough feasibility assessment will also address aspects in addition to design. As a way to mitigate risk and watch cost initially, Kapstone offers a Feasibility Assessment including any or all of the following:

  • Product Engineering – Are the concept’s technical features appropriate for the anatomy/physiology? Are there any risks from a technical standpoint with designing and sourcing the components?
  • Manufacturability – Where can the device be sourced and customized (if desired)? What would a supply chain look like for this device?
  • Regulatory – Are there special regulatory considerations? Quality considerations?
  • Market Research – Is there a market for the device? How large is the market and what are the market drivers? Are there strategic buyers? What does the competitive landscape look like?
  • Financials – What does a financial model look like as the product is scaled? Cost of goods? Potential revenue? Cash required to ramp up?
  • Intellectual Property – Based on the previous search results, what are the areas to stay clear of? Are there areas open for protection?

This question-and-answer process is known as evaluation of an idea’s feasibility, and it involves reviewing and addressing the most pressing risks associated with the product.

When properly planned and executed with an experienced team, a feasibility assessment should motivate you to continue with a higher level of confidence in your idea. 

For more details about a custom Kapstone approach for addressing feasibility, contact the team today.

Design & Prototyping

Technical Engineering

Offering virtually any engineering discipline, in-house or through our partners, we can handle all the technical work needed to design and engineer the device:

  • Mechanical
  • Electrical & Electrical Systems
  • Software & Firmware
  • Optical

Our product engineers are experts at creative designs across the spectrum while understanding the big picture and what is ahead for the later development stages.

Human Factors Engineering

Kapstone specializes in advanced human factors engineering (also known as usability engineering), which is becoming increasingly important to global regulatory bodies for medical device product development. We prioritize testing for human behavior, human error, and biological interactions early in the design process, ensuring your product is set up to succeed and be used as intended.

Click here to learn more about the benefits of human factors engineering. 

Industrial Design

Effective industrial design brings everything together: broad concepting, rapid prototyping, user-centric testing, manufacturability, material selection...the list goes on, but every part is essential. Together with engineering experts, industrial designers ensure that your product will meet its functional and user needs. We pride ourselves on our integration, from start to finish, of efficient industrial design in the engineering process.


We believe in iterating quickly and early stage prototyping to get a design in the hands of users is the most valuable way to do so. Our engineers are creative and focused when considering quick and cost effective methods for creating prototypes to assess the key and critical features of a design. In addition to prototyping the device, we rely on our experience to devise appropriate “gut check” tests to make appropriate assessments.

To learn more about our prototyping capabilities, click here.

Intellectual Property

Ideally, your medical device will solve core problems for clinicians and patients while also creating valuable intellectual property for you or your company. Here at Kapstone, with our in-house patent agent, we know the medical device landscape and understand patent strategy. Ultimately, our goals are the same as yours: make a difference for patients and secure long-term value.

In the early stages, it might seem daunting to establish freedom-to-operate or illustrate patentability. However, even a cursory search of the patent landscape can be incredibly helpful in determining how you should move forward. Kapstone is not a law firm and does not provide legal services, but we have a registered patent agent on staff who can add tremendous value prior to searching with a patent attorney. 

You can learn more about our intellectual property expertise and strategy here.

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