Effectively Engaging the FDA

Some vital resources and lessons learned along our software-as-a-medical device FDA journey may help others who are finding their own pathways to market with a regulated product.  While these ideas are focused on the FDA, they have broader applicability to working with other regulatory bodies as well.

The process of working with regulators and other government agencies is distinctly different from many other types of work that startups engage in.  The protocols for communicating are often formal and confusing. The engagement patterns are unusual. Yet, for regulated medical device manufacturing startups, successfully navigating the pathway to premarket authorization to market your regulated medical product requires that you get up to speed on the nuances and own the process in a positive and proactive way.

As a startup, we often engage in collaborative relationships with partners, consultants, and other collaborators. Working with a regulator is distinctly different. While the FDA may facilitate new products coming to market, fundamentally, they are responsible for ensuring that new products are safe and effective.  This dynamic between companies and regulators reminds me of a court of law, where the roles of the parties in the room are inherently adversarial. As a medical device manufacturer, you have your job of producing safe, effective, and marketable products. As regulators, the FDA team is responsible for ensuring that marketed medical devices meet high standards to protect public health. Recognizing these distinct and conflicting points of view upfront helps frame the process of engaging with your regulator as a sort of formal negotiation with incredibly long communication cycles built in.

First, we had to come to grips with the FDA’s communication timelines and procedures. While there are various communication pathways with the FDA, likely all of them will feel long and formal to an agile startup.  For example, to have a pre-submission meeting with the FDA, we had to work for weeks on a content package that we submit to the FDA with an agenda of questions we would like to discuss. Following a couple of months for the FDA to review the package, we get written feedback and questions from the FDA.  Suppose we still want to have a meeting. In that case, we have three (!) days (including the weekend since almost always we got their feedback on a Friday evening) to develop a presentation and response before we have a one hour meeting with them, following which we submit formal written minutes within three weeks to which they respond with edits a month or so later.  The whole process takes months to execute – and there was really only one hour of “discussion.” We did this three times.  Now, let me be clear.  These meetings were invaluable. My point is that this kind of communication style and cadence is unlike anything I have experienced in any other context, except perhaps government funding proposal writing to agencies like the NIH, DOE, and NASA.

Another lesson we learned in the process of having multiple pre-submission meetings and ultimately engaging in a De Novo premarket approval process with the FDA was that I could not follow my impulse to provide the FDA with options and ask which one they preferred.  This is a technique I use all the time with various collaborators. However, the FDA does not engage that way.  Instead, you provide the FDA with a complete and specific proposal, and they respond to it with their feedback.  Our team calls this process the “show me a rock game” because sometimes it feels like you are going and finding a specific rock with particular characteristics and “showing” it to the FDA, only to have them come back and say, “nope, show me another rock.”  This process took some getting used to because our collaborative and agile culture always pointed us towards offering options and making decisions together with others. We were forever asking our FDA consultant, “Can’t we just ask FDA if they would prefer option A or option B?” The answer was always a definitive no. With the FDA, you make your very best singular proposal of what you want them to agree with. No choices. No options. Just a well-developed and well-justified proposed path.

Resources and Tips

Some of the resources you should engage to help you get up the learning curve include FDA guidance, regulatory consultants, and just plain attention and hard work. Here are some tips for successfully engaging with the FDA and other regulators:  

• Start from a position of respect. In our experience, our contacts at FDA work hard, are incredibly thoughtful and thorough, and take their mission seriously. Assume that they have good intentions that are aligned with their mission. You can build trust with your regulator by understanding and respecting their role, constraints, and process; providing high-quality, well-documented work; and responding clearly and quickly to their requests.
  
  
• Be sure to read the regulatory guidance published by the FDA that applies to your product.  The FDA produces a prodigious amount of documentation to guide industry on working with them and what they are looking for.  Of necessity, the guidance tends to be fairly abstract because it is designed to cover a wide variety of cases. However, it is vital to digest what the FDA is sharing so you get up the learning curve as fast as possible. Invest the time to understand the FDA’s requirements and constraints. This saves you time and money as it helps you identify what is important to the FDA and eliminate confusion.
  
  
• Hire a regulatory consultant who can bring direct experience with products and clients similar to you. An excellent regulatory consultant interacts with the FDA frequently, has extensive expertise regarding the FDA’s processes, and knows how to navigate an often complicated and confusing process. They are an indispensable guide to engaging the FDA successfully.  You will save their fees many times over by avoiding wasted cycles and minimizing time to market.
  
  
• Remember that documentation defines reality. From a regulator’s point of view, if it is not documented, it did not happen. This is a foundational principle for establishing and executing required quality management systems and developing effective submissions. It takes creativity to create systems that can both meet the regulator’s requirements and be as value-adding as possible to your product development, manufacturing, and customer engagement processes.
  
  
• Own your regulatory strategy and execution.  For medical device manufacturers, effectively engaging your regulator(s) needs to be a core competency.  While you will need to invest in both employees and consultants to focus on this area, it is a mistake to delegate critical decisions to the specialists. You need to learn the ropes.  Read the guidance. Engage and listen to great consultants. Understand the dynamic. Invest both personally and organizationally to execute well.  If you do not, you risk over or underweighting the regulatory elements of your business.  Remember that, by law, you are responsible – and you do not want to be taking risks with people’s lives and health!