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apstone partners with inventors to rapidly develop and commercialize new medical devices on time and on budget. We provide services for all aspects of product development & distribution, including quality assurance, regulatory affairs, supply chain management and IP monetization.

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.

Realize your idea with Kapstone Medical


All you need is an idea. Whether you have a napkin sketch or a working prototype, Kapstone can help.

Your privacy is important to us, so we start by signing a Mutual Non-Disclosure Agreement. After that, our goal is idea generation. If your idea is in its infancy, we may start by presenting you with a few concept sketches. These 2D illustrations will convey potential embodiments of your device. From there, you will select a leading design for further development into 3D CAD models.

If your concept is more refined, we may begin by evaluating the feasibility of your idea.

Feasibility Study


Your design engineering team is assembled to meet your specific needs. The team will stay with you during the whole project, acting as your R&D department. During the Feasibility Study phase, your team will do a comprehensive assessment of your device to ensure that the concept works from both a biomechanical and clinical use perspective.

The team will also consult with various suppliers to make sure that the design is “manufactureable” and as cost-effective as possible. The market potential of the technology is also evaluated. Creative options are proposed to ensure marketability and profitability.



The Design and Development stage of your project is a very exciting phase. Your design team, composed of CAD (Computer Aided Design) experts, will turn your invention into engineering prints and a functional prototype.

3D Rapid Prototyping


Kapstone in-house rapid prototyping equipment allows you to witness the birth of you idea in a matter of days after your initial brief.

Our team utilizes the latest 3D software to transform your ideas from sketches into virtual models. We then bring your device to life on a 3D printer. With finite element analysis (FEA) we determine the weaknesses of the design and strengthen them to ensure a high quality product.

Typically, our Rapid Prototyping system can produce 3D models within a few hours.

Patent Protection


Good IP strategy is critical to making sure that our clients fully realize the value of their inventions.

Discover “IP Fit,” a new Intellectual Property initiative developed to help Kapstone’s clients orchestrate their IP strategy more efficiently and cost-effectively. Read more…

Click here for more information on Kapstone IP Services



Generally speaking, a new medical device invention should be validated through mechanical testing of production level prototypes.

Kapstone has a breadth of experience with Class I and Class II medical devices. We specialize in developing appropriate testing protocols and work with certified testing laboratories to evaluate your design. Ultimately, a successful test will prove that your invention will meet the criteria needed to proceed to regulatory approval and the desired use.

Regulatory Submission


Expertise & experience drive successful FDA submission processes. Kapstone possesses both.

Our team will prepare and submit your 510(k) documentation on your behalf to address FDA requirements and anticipate potential questions, leading to on-time and on-budget regulatory approvals timelines. Our record speaks for itself. Call us now for more details.

Regulatory Strategy
An important element of Kapstone’s development process is to identify predicate devices and develop a regulatory strategy early in the project to minimize future costs and maximize potential for success.

Regulatory Submissions

Kapstone is experienced in drafting and submitting 510(k)’s as well as managing communication with the FDA. We also have established partners who are able to self-certify for CE Marking.

Post-Market Regulatory Guidance

Kapstone can help with regulatory questions that arise on products currently on the market. This includes questions related to design changes, labeling changes, recall requirements, etc.

Regulatory Compliance and Training

Kapstone can provide on-site audits to help identify gaps with FDA and CE requirements and implement a strategy to get you into compliance. We can also provide and prepare you for internal audits.

Manufacturer & Distribute Your Ideas

Kapstone Medical Device IP Fit StrategyProtect Your Idea With IP Fit

An effective IP strategy is a direct extension of your overall strategy. Intellectual Property protection has an enormous impact on the value of your invention.

To address this key point, we have created “IP Fit”. “IP Fit” is a new more efficient and cost-effective way for you to orchestrate your IP strategy.

Diane Dobrea, our in-house Intellectual Property Specialist, will lead you step-by-step through the IP value creation process, on time and on budget. Call us now to discover how our “IP Fit” can help you.

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