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Ask the Experts is a series of reader questions answered by industry advisors. Send us your questions.
Question: Keeping up with increased regulatory requirements is decreasing our design time. How can we avoid this bottleneck?
Answer from John Kapitan, CEO, Kapstone Medical: It’s important to acknowledge that the regulatory environment is always changing, a statement that is especially true in the U.S. and Europe today. However, new regulations don’t always have to cause massive production delays. After working 25 years in this field, it’s become apparent that there are a few best practices and steps that companies can take to reduce the possibility of design timelines going haywire. The goal is to not actually avoid the bottleneck—it’s to learn to work effectively within the parameters of the regulations and plan projects in a way that makes regulations more manageable.
First, determine the actionable insights. Conduct research to find specific, appropriate information in regards to regulations that will impact your specific design. This information needs to be pragmatic, actionable, and focused on what’s most relevant to the company.
Simple Google searches will produce entirely too much information, much of which will be irrelevant for your purposes. Rather, distill information from the best possible resources. For example, trade journals can be highly useful. Companies can trust the information to be accurate, timely and relevant. It is also beneficial to engage subject matter experts in the field. Regardless of whether these experts are internal or external, it is their job to be up to speed on not just the regulations themselves, but also how the regulations can impact specific companies. Webinars can get the information you need in a fast and focused format. They can be very helpful in jumpstarting your understanding of the regulations and cutting through the noise.
When product development teams engage subject matter experts, it’s best to do so early and often. It’s not unusual for product development experts to operate in silos, but they benefit greatly by engaging with regulatory experts before they actually begin the design process. Moreover, they should touch base with those experts throughout the entire design process.
For example, there have been instances of product development teams getting all the way through the design and development activities before even thinking about regulatory submissions. During preparation for regulatory submissions, “uh oh” moments occur in which teams see the need to compare the new design to predicate devices. Not always being sure what the appropriate predicate devices are, they then scramble to find them. Conversely, if the product development teams engage with regulatory experts sooner, they can save time and reduce stress by having the appropriate information at the ready.
By working with regulatory experts while entering the product development process, there is more time to develop a regulatory plan, pick out predicate devices, choose appropriate testing techniques and even begin writing the submissions that include validations and verifications. Companies won’t have to wait several more months to submit when these processes are done in a parallel manner. The development of a specific regulatory plan early in the process is key.
Another reason to communicate with regulatory experts often is the nature of changing regulations themselves. For example, if a project takes 12 to 24 months to complete, it is quite possible that FDA has made regulatory changes while the project was underway. It would be unfortunate to begin the design process with one set of regulations in mind and at the end of a project learn that regulations are no longer what you thought.
Another tip for product development teams is to delegate responsibilities and admit that no one can do everything alone. Sometimes it is difficult to relinquish some control, but it’s a good thing to ask for help and trust other people to contribute to the process. By delegating regulatory requirements to experts while working on the design process, the overall timeline can be reduced.
At the same time, be realistic about your timeline. Product development engineers can get stuck in developing timelines, determining that it’s going to take exactly six or 18 months to do a project without even considering the regulatory changes. That’s another reason to review regulations several times throughout the process of a project. It’s not just a one and done situation. As regulations change, so will the project timeline.
For example, regulatory bodies these days are focused on things like validations, biocompatibility and supplier control more so than in the past. Typically, the effect of that focus is that more work needs to be done in those areas and that can have a direct impact on both the timeline and the budget.
Lastly, it’s critical to communicate the timeline effectively with upper management and investors. If product developers are overly optimistic about timelines and potential regulation complexities are not communicated to upper management, there’s going to be a lot of disappointment, and no one wants that.
John Kapitan is the CEO of Kapstone Medical, a company he founded in 2007 after 15 years in the medical device industry as a design engineer and regulatory affairs executive. He is an entrepreneur and expert in medical device design and commercialization. Prior to creating Kapstone, Mr. Kapitan was a founding member of Altiva, a spinal implant company that was sold to Exactech in 2008. His experience also includes time with AcroMed, DePuy AcroMed and the Cleveland Clinic Foundation. He has designed and managed development for dozens of commercialized products, is an inventor on over 20 patents and patents pending and has authored multiple industry articles.
