insights
A Conversation With John Kapitan | Founder & CEO, Kapstone Medical
Medical device development companies large and small face different hurdles when bringing a new device to market. However, no matter their size, all companies cope with the inherent unpredictability of the development process—which, due to shifting regulatory guidance, the complexity of device manufacturing, and other factors, can quickly overwhelm timelines and budgets.
John Kapitan founded Kapstone Medical in 2007 to help companies mitigate these risks. He alone brings more than 25 years of experience in medical device development to the table, which helped him establish a strategic vision and process for how to optimize the product development process. In a recent conversation, he identified five core ways for medical device research and development companies to save money.
1. Run medical device development activities concurrently
John Kapitan and the rest of the team at Kapstone approach the medical device development process with the goal of maximizing efficiency. This translates to running multiple activities in the process simultaneously—or, at a bare minimum, identifying opportunities to productively fill in project gaps.
For example, John notes that teams may be “waiting on some internal decision-making,” perhaps for a team to come to consensus. Or, as is often the case, teams may be waiting for “test results to come back.” Rather than put development on hold in these instances, John suggests designing (or re-designing) the process to allow for more efficient use of time. In practice, this could look like an “iterative design loop” where prototyping and testing are built into the early design stage—meaning that design and testing do not have to stop and start to accommodate one another. Rather, the two disciplines integrate seamlessly to maximize the broader team’s efficiency (and therefore, save money and time).
Pragmatic integration of design and testing also helps medical device development companies identify key learnings at earlier stages in the development lifecycle. “The more you take advantage of these early learning opportunities,” John explains, “the better equipped your team will be to make changes early, often, and when they are much less costly.”
Finally, concurrent activities prevents the brain drain associated with waiting periods. “When projects stretch out and there are long periods of waiting,” John explains. A prototype tester involved in the kickoff who then has to wait months to actually test your device...well, you’re going to lose them to another project. However, a tester whose skills are interwoven into the design process will always keep your project top-of-mind. No need for multiple time- and money-wasting meetings to catch them up—they’ll still be acquainted with the latest developments, and can even lend their expertise to ensure that the designs are carried out with an eye to effective testing.
2. Integrate regulatory affairs early in medical device development
Medical device research and development companies sometimes think of regulatory affairs as a faraway part of the development lifecycle. Why worry about specific FDA guidance when you don’t even have an engineer available to work on your project? Why familiarize yourself with ISO 10993 standards when you haven’t aligned on your device’s intended use? While regulatory submission and approval do occur towards the end of the process, device companies can save time and money by integrating regulatory strategy earlier.
The integrated Kapstone Medical approach includes a regulatory assessment in the early stages of the process, which John argues should “dovetail with the development and intellectual property strategy.” This assessment helps medical device development companies identify the clinical data requirements for their unique device, set a framework for predicate comparison to inform a potential 510(k) submission (more on that here), and altogether plan for regulatory benchmarks instead of adjusting to meet them.
John argues that this approach is “better for the budget and timeline, and allows us to develop the most cost-effective development strategy relative to regulatory requirements.” Here are just a few examples of potential time and cost savings associated with early integration of regulatory affairs:
- Early identification of predicate device → pragmatic design and material selection to ensure adherence to regulatory standards and potentially streamline approval
- Early identification of required tests → structuring those tests into the development plan, and identifying testers with the right expertise, instead of retrofitting the team or doubling back at the submission stage
3. Begin medical device testing early
Henry Ford once said that “failure is simply the opportunity to begin again, this time more intelligently.” We take that advice here at Kapstone Medical, but we’re also cognizant that failure can have different consequences at different times. Failing on Day 1 of medical device development is no problem—in fact, it’s all but expected. However, failures of design, testing, or regulatory adherence are quite consequential (not to mention costly) when they occur in the later stages of the development process.
This is not a new concept, but it’s worth considering in the specific context of medical device development. Based on his years of experience working with medical device development companies, John estimates that the “cost of change actually increases over tenfold from the beginning of a project to the point of launch. If a cost is X today, it could be 10X in the future because of all the things that have to be done and redone.”
Kapstone mitigates the risk of these costs by integrating usability testing into the design phase. There’s no need to wait for a fully manufactured device to run usability testing. “Putting prototypes in the hands of users” as early as possible allows for thoughtful, accurate consideration of whether a device achieves its intended purpose—and, more importantly, allows for revisions to be made when the stakes are lower.
John adds that “here at Kapstone, we also like to develop what’s called a master validation and verification plan.” This plan is particularly beneficial for smaller, less experienced medical device development companies who aren’t necessarily familiar with the testing and regulatory benchmarks that need to be met. “This is where our expertise comes into play. When we create these master plans, we set expectations for essential testing at the outset to avoid unexpected scope creep later in development.” In other words: putting these plans into place at the outset of a project, as well as identifying opportunities to test earlier and often, helps companies fail when it costs and matters less—and learn the right lessons from those failures.
4. Stay flexible—but practical about the costs of change
These measures aside, Kapstone still recognizes that change is an inevitable part of the medical device development process. This is particularly true for companies looking to develop an orphan or otherwise unique product, as the precedent for those development procedures might not be as clear, or even exist. It’s rare for any project, in any industry, to adhere to its budget and timeline dollar-for-dollar, day-for-day.
Here at Kapstone, we’re used to pivoting quickly. Our hope is generally that we can pivot earlier in the development process, and we’ve outlined several measures that help us do so. However, we build financial and scheduling plans that are equipped to withstand even an unexpected pivot. This allows us to remain flexible, responding to changes as they come, while still providing a buffer to safeguard your company.
5. Outsource a full-service medical device development consultancy
As John puts it: “One of the reasons that Kapstone was born in the first place was to provide an efficient single-source solution for medical device research and development companies.” Single-sourcing is perhaps the easiest way for a device company to save money, as it checks multiple competency boxes with a single hire. Rather than hiring several individuals with unique expertise, following time-consuming hiring practices for each, your company can save money (as well as time) by hiring our team. We offer seasoned, multifaceted expertise in regulatory affairs, human factor engineering, manufacturing, validation & verification, and quality assurance, and we’re prepared to work efficiently and seamlessly with your in-house team.
Want to learn more? Explore the Kapstone Medical approach.
