insights
A Conversation with John Kapitan | Founder & CEO, Kapstone Medical
Bringing a medical device to market is a challenging process, to say the least. From ideation to product classification to obtaining final approval in a target market, so many of these necessary steps can become pain points for established and fledgling companies alike.
To make things more difficult, regulations governing medical device approval and use continue to evolve along different paths in different markets. In the US, device approvals are overseen by the Food and Drug Administration (FDA), an organization with a unique set of regulations. In the EU, companies now have to contend with the recently implemented Medical Device Regulation (MDR), a departure from the body’s long standing Medical Devices Directive (MDD). Ever-changing governance is inevitable in an ever-changing industry, but compliance is certainly harder to enact under these volatile circumstances. Companies of all sizes, in all sectors of the medical device industry, continue to face roadblocks to approval in their target markets.
In this context, medical device companies stand to benefit from outside expertise. Outsourcing has long been a cost-and-time-saving solution in many industries. It allows companies (particularly smaller ones) to focus on their core business, while delegating essential-but-time-consuming work to the experts.
We recently sat down with our founder and fearless leader, John Kapitan, to discuss the benefits of outsourcing to a regulatory affairs consultant. He discusses the broad role a consultant can play throughout the approval process, the financial benefits of hiring one, and the unique expertise a Kapstone consultant brings to the table for your business.
What is the role of regulatory affairs in developing new medical devices?
Currently, many medical device companies take a last-minute approach to regulatory affairs. They bring in their internal teams (or a consultant) at a late stage in product development, after many key decisions have already been made. It’s like “checking a box,” as Kapitan puts it. “They’re ready to jump into the regulatory submission process, and then they call in the regulatory expert. But that’s not the way it should go.”
Regulatory affairs experts should play a significant role throughout the product ideation, design, development, and submission timeline. “There needs to be a strategy that starts at the beginning of the project and progresses through as the project develops,” Kapitan argues. “The regulatory consultant should get involved early and often, working to understand unmet needs, design requirements, initial outputs, indications, and intended use.”
Jobs for a regulatory consultant involved early in the process could include:
- Research: Who are the competitors? How do their products function? What are their indications and intended uses?
- Positioning & Strategy: How will this new product be differentiated from a regulatory point of view?
- Conceptualization & Design: What guardrails should be observed to ensure regulatory compliance, cost savings during the process, and optimal outcomes? What does the regulatory plan look like?
- Development Process: What verification and/or validation testing will need to be completed to ensure a smooth regulatory submission process?
- Submission & Compliance Assurance: What documentation needs to be prepared for the final regulatory submission? How should companies manage communications with regulatory bodies? Are there recent changes in governance that need to be taken into account?
It’s important to acknowledge that a regulatory affairs consultant is not intended to replace the function of an internal regulatory team. Instead, “they will come in and supplement, and actually help the internal team succeed.” Whether a company needs assistance with one, two, or all of the steps described above, outsourcing responsibility to a trained consultant—and bringing the consultant on early in the process—is an effective strategy.
How can a regulatory affairs consultant help a medical device company reduce risk and conserve costs?
The steps listed above represent only a broad overview of the regulatory affairs and compliance process, and they do not account for the variance that individual companies and teams will experience. As Kapitan summarizes: “There’s a lot to know about regulatory affairs, and regulations are changing.” And that means “there are a lot of mistakes that can be made.”
Under these circumstances, mistakes can be quite costly. “Often a mistake made, especially late in the process, is expensive because the impact is great,” Kapitan says. “If a company makes the wrong decision about what regulatory path to take, or makes a false judgment about strategy, that is often a major stumbling block to the development effort. It’s going to be costly in terms of time, effort, and dollars to reroute and take a different direction towards approval.”
The stakes are high, but medical device companies themselves shouldn’t have to worry about them. Not too much, at least. Involving a regulatory affairs consultant early in the process allows that consultant to leverage their expertise at all key decision points, steering the overall effort towards compliance and approval. It’s very difficult to adjust a project strategy days prior to regulatory submission, or to double black and pursue a different indication in the eleventh hour. With an experienced consultant on board, these roadblocks—and the associated costs—can be anticipated and strategically avoided.
“It’s all about the most streamlined path to approval—in time and dollars—and avoiding the pitfalls,” as Kapitan puts it. “It’s typically (though not always) the case that the consultant has more breadth and depth of experience, and can help the internal team stay aware and proactive in terms of regulations and best practices.”
What differentiates Kapstone’s approach from that of other regulatory consultants?
Kapstone consultants are equipped to assist in every facet of the regulatory affairs process. They have expertise in both pre- and post-commercialization procedures, and maintain an expert understanding of the current regulatory landscape. As previously mentioned, consultants do not replace the functions of companies’ internal regulatory departments. Instead, they work to supplement those teams, slotting into the product development cycle wherever it’s currently stalled.
A consultant’s involvement in a project naturally “depends on the market and the scope of the project or device.” Some engagements are short (a few months), and some last years, particularly if companies require assistance with multiple full submissions. The allocation of Kapstone team members is also flexible, and will be determined based on a project’s scope and needs. Some projects only need one consultant, but some benefit from the support of a broader team.
Altogether, the Kapstone approach is unique in its amplification of the regulatory consultant’s role as well as the integrated, team-based approach relative to other disciplines. “Our approach is to ensure that regulatory affairs has a seat at the table, early and often, and to be very hands-on in guiding the development of the new medical device. In doing so, we can ensure that we’re taking the most efficient path to market—and the most effective for the company.”
Kapstone solutions are customizable to different business needs, and a cost-effective way to mitigate the challenges and risks of medical device regulatory affairs. We are equipped to help in the current regulatory environment, but our expert consultants will also evolve as the industry and governing bodies do—all to ensure that your company can, too. Get in touch with an expert consultant today.
