POV - Acacia Parks - Guiding Startups Through FDA for Decades, Avoidance Is the Costliest Mistake

You've guided countless digital health startups through FDA conversations. What's the most expensive regulatory mistake mental health founders make by trying to avoid the FDA instead of engaging early?

The most costly mistake people make around FDA interactions is to avoid them altogether. Companies think they will save time and money by not developing a submission package, and they worry that talking to FDA will force them to commit to something. Neither is true, and the consequences of skipping early interactions – particularly for something really innovative, where there isn’t a clear precedent – are potentially disastrous. I’ve seen companies spend years and tons of money on beautifully designed studies that have little or no utility to an FDA panel. They end up having to do more studies, which is very costly and very time consuming. Better to get alignment from FDA early.

Assuming a company does interact with FDA, the next most costly mistake is to skimp on their product description. It’s obvious why this is tempting - it takes a long time to write a good product description, and if your product changes you have to redo a lot. Furthermore, companies worry that any detail included in a presubmission is a promise to FDA about the form the final product will take (it is not). However, interacting with FDA without providing them with a clear understanding of your product can lead to painful results. The review panel may decline to answer your questions due to lack of information. Worse, in my experience, they will do their best to answer your questions with the information they have, but they will misunderstand aspects of your product due to the vague information they were given. This one is insidious, because it will seem like you received meaningful feedback, and you will rely on that feedback to build your regulatory strategy, but that feedback may be based on misunderstandings about your product that will later be difficult to remedy. In this way, submitting a presubmission with a vague product description could be even worse than not submitting a presubmission at all.

You say FDA reviewers aren't the enemy but partners who want safe innovation. What's the secret to getting FDA to reveal what they're really worried about versus what they're asking you to prove?

A good starting point is to be sure you have given FDA the information they need in order to answer each of your questions. They can’t help you unless you help them help you by anticipating their needs and providing a submission that is complete (containing everything they need) while also being streamlined (not full of stuff they don’t need)! 

Next, be sure you ask questions in a way that invites explanation. I love the question stem, “Does FDA agree with…?” X, Y, or Z aspect of your approach. The question puts the reviewers in the position of imagining themselves in the future, reviewing your 510(k) or De Novo, and having to imagine how they would feel about saying “yes” to a particular aspect to it. If the answer is no, it invites them to say so clearly, while, in contrast, if you ask FDA for its opinion, you may never clearly understand whether they agreed or disagreed. Furthermore, if they do disagree, they are invited to explain why – because saying “no” is typically not considered a sufficient response. 

Lastly, well-phrased questions leave you in a good position to have a productive presubmission meeting. You can only ask for clarification about topics that are raised in the FDA written feedback, so there’s no replacement for good questions (see above). But, if the FDA gives you some detail about your thinking in the written feedback, that gives you an opening to dig even deeper in the meeting. Ask for elaboration on the most complex points of their feedback. Put what you understand their feedback to mean into different words and repeat it back to them, then ask if you understand their feedback accurately. Once you feel like you fully understand, you can sometimes ask whether a particular solution (e.g. assessing variable X with measure Y) would be acceptable to FDA to address its concern. Sometimes they will push for you to have another presubmission, but sometimes they will give their reaction.

With the current administration deleting guidances, changing reimbursement pathways, and facing shutdowns, how should digital health companies navigate this regulatory uncertainty without paralyzing their progress?

We never know what will change in the future, but we know how to interact effectively with the Agency now. Interact with the Agency now, while the rules are still relatively well understood.

A memo from HHS says that FDA expects to keep 85% of its staff during the shutdown. It is still operating, for the time being. If you are working on a submission, keep working on it. If you are waiting on a presubmission, it may well still be evaluated. And even if it isn't, you don't want to be last in line when normal operations resume so – keep at it. 

We're used to uncertainty in Medtech. Now is no different from any other time. Act to the best of your ability, with the knowledge you have, and update that knowledge and accompanying strategy as things change.

Mental health apps face unique challenges with FDA clearance now tied to reimbursement codes. What creative regulatory pathways are emerging that founders aren't seeing yet?   

People often make the mistake of assuming that a company is either following a regulated SaMD path, or a wellness software path. Some companies do each of these things exclusively, but the majority I have worked with are starting in wellness and planning to migrate into regulated device territory in a few years. As long as you know your roadmap, there is nothing wrong with this approach. It's smart for some companies, especially if they are looking to collect initial data, validate their product has an impact, and make some revenue in the meantime. That said, it's really, really difficult to become a medical device company after years of operating without compliance infrastructure; so it's wise to plan ahead and lay the groundwork for compliance down the road, even while playing in wellness.