The FDA Are People, Too.

Government agencies seem like monolithic entities governed by complex rules that are hard to relate to. Still, under that seemingly impenetrable exterior, it helps to remember that, just like your startup, the agency is made up of people, too.

We just reached a massive milestone in our FDA-regulated software-as-a-medical device startup. The U.S. FDA issued a new regulatory classification for our novel technology and granted us De Novo pre-market approval to begin to commercialize it. We are so excited! (If you are interested in the details, check out our press release at www.fiftheye.com).

This momentous occasion has me reflecting on our 2 ½ year journey with the FDA and one of the essential lessons I learned along the way. Lessons that apply to my experiences with the FDA, the Department of Energy, and the National Institutes of Health over my career as a startup CEO.

When we started down the path with the FDA, we did not know what we did not know. We did not know the communication rhythms, protocols, and patterns. We did not know how the decision-making process worked. We did not know how to present our arguments, evidence, and statistics.  Guided by some outstanding FDA consultants with deep insider experience, one of my colleagues and I worked closely together to make mistakes and learn as quickly as possible.  Now we are across that giant learning chasm, and now our consultant tells us we are one of her best clients in producing FDA documents that require minimal editing to be ready to go. What a learning curve!

Probably the most essential lesson we learned along the way was realizing that even as we write documents ranging in length from 35-pages to nearly 1,000 pages that say things like “As FDA requested…”, “We would like to remind the Agency…,” and “developed with input from FDA,” underneath all of that formality, we are engaging with real people, not some impersonal monolith. That realization now shapes how I think about FDA and how I engage with them. Remembering that I am dealing with people, not an impersonal government agency, brings into focus and play many of the skills I have cultivated leading teams, recruiting investors, and engaging customers:

• The Foundations of Relationships — Authenticity, Integrity, and Commitment:  Our lead reviewer and his team at FDA were the same over our multi-year journey. That means that even though we had to abide by some strange communication protocols, we were developing a relationship through those interactions.  It proved essential to develop empathy, communicate respect, and build trust.  As part of our process, we ended up having three pre-submission meetings with FDA before our full submission as we negotiated the basis on which we could prove to FDA that our product did what we claimed and that it was safe and effective for use.  Our consultant recommended we do the first meeting in-person. For the second, we opted for a conference call. When we were struggling to sort out confusion, we went back in-person again in the third pre-submission meeting. Even though COVID-19 makes this hard for a season, knowing what I know now, even though the meetings only last an hour, I will invest my time and money to meet in-person with the FDA team every chance I get. Something is humanizing about getting in a room together. All of a sudden, body language and the little niceties of looking someone in the eye and communicating respect, care, and intent smooth every part of the interactions. After both of our in-person FDA meetings, two separate consultants who had spent decades at FDA shared with me that I was building trust by helping the FDA team see that we cared about doing the right thing, that we cared about giving them what they needed, and that we cared about what they thought.  Authenticity, integrity, and commitment are things that connect person-to-person and build trust that lubricates interactions and earns the benefit of the doubt. It was a bit of social lubrication and trust-building that helped us establish a relationship between Fifth Eye and the FDA. 
  
  
• Sales: Asking the FDA to approve our application is ultimately a sales process to an organization that really is a group of smart people trying to do a good job. Like any complex sales process, it is vital to understand your customer and their needs., both as people and as an organization. The FDA is first and foremost focused on the safety of the medical devices they review. This shapes the information that is important to them as you work to overcome their questions and objections to the proposition that your novel device should be cleared for market. Because their point of view is distinct and multi-faceted, with different FDA specialists focused on various aspects of your submission, it can be confusing to figure out what information will help address their questions. We often felt that the FDA’s questions were curve balls coming from directions we did not anticipate, reflecting their different point of view. As our champion within the FDA, our lead reviewer wanted our help addressing the questions of his colleagues.
  
  As one of our potential investors pointed out, the way you compare your product to other marketed medical devices for the FDA is focused on showing the similarities. In contrast, when you compare your product to other devices commercially, you must focus on the differences. This means that you cannot merely repurpose your material developed for different audiences such as potential investors or future potential customers when you prepare documents and presentations for the FDA. This does not mean you are not consistent in your product positioning (you must be); however, it does mean that the areas of emphasis shift. Notice and respond to the fact that the people you are addressing are distinct.
  
  
• Ownership and Context: While meeting regulatory requirements demands significant investments of time and energy, it is a mistake, in my opinion, as a leader of an FDA-regulated company to delegate understanding your regulators to only your internal and consulting regulatory resources. I have now heard many stories of startup CEOs who did just that and ended up suffering delays and suboptimal outcomes because the context and commitment required for excellent execution were not there. Those who ask their regulatory team to “just take care of it” often find that the assumptions those teams are forced to make can come back to become difficult issues late in the regulatory process. Also, some CEOs try to give their standard investor pitch to the FDA and do not adapt their story to address the regulatory issues and concerns, resulting in being politely excluded from the process going forward. Therefore, it is crucial to commit to learning about what the FDA values and to be able to speak to that and to contribute to strategic problem-solving.  You need to own it and provide the strategic context to the process to ensure that, as a regulated company, you navigate the complexities of these waters effectively and ensure that your company arrives in the right place.

In my experience, these concepts extend to interactions with the Department of Energy and the Department of Health and Human Services as well. They likely extend to all government agencies. For example, reviews for funding opportunities are conducted by people. People often feel more comfortable when they know the people making the proposal.  Proposals are often most effective when they address the needs and perspectives of the people and the agency they are made to. When you engage with government agencies and other organizations, remember that there are always people involved who respond to people as people. That point of view can help you successfully navigate the process.