Acacia Parks, PhD, MBA, Advisor to Lindus Health, discusses the journey to commercialisation for digital therapeutics and how best to engage the FDA in this process. 

While there is no “one size fits all” approach to the development of any class of treatments, this is especially true for digital therapeutics (DTx). Being so new to the scene, their journey to commercialisation is not so clear-cut. Clinical trials for pharmaceuticals follow the traditional phased approach to achieve commercialisation. Like DTx interventions, medical devices may follow various regulatory pathways depending on their risk and complexity; however, unlike DTx, medical devices have been part of healthcare for long enough where these frameworks are relatively well-defined. 

The FDA is paving the way for the successful development of digital therapeutics as the industry continues to evolve. Many DTx companies mistakenly believe they must wait until they’ve finalised their plans to engage with the FDA, when in reality, meeting with them early and often is key. Their requirements can vary depending on the risk and complexity of an intervention, along with the clearance of new DTx products or the drafting of guidance documents. It’s crucial to gauge their insights sooner rather than later throughout the development of your DTx product to utilise your resources most effectively. 

Pre-submission meetings: the key to avoiding regulatory pitfalls

Pre-submission (also known as pre-sub or Q-sub) meetings are a critical component of effective FDA engagement on the medical device side. These meetings allow DTx companies to receive formal feedback on specific elements of their clinical development plan, such as study design, data collection, statistical approaches, and much more. The agency can also weigh in on what endpoints are most appropriate in measuring therapeutic responses. 

There are several time points throughout the development of a digital therapeutic where pre-sub meetings are highly valuable. An initial meeting can address your overall strategy and other high-level elements before initiating a trial, while subsequent interactions could cover more in-depth clinical operational tactics at critical stages. Meeting with the FDA after key milestones—such as the completion of Phase I or Phase II studies, and in preparation to file for a 510(k) or DeNovo classification—ensures that any new expectations or changes in thinking are accounted for. 

Waiting too long to engage with the FDA can backfire, as their guidance may necessitate a pivot in strategy. It would be a major setback to have all your ducks in a row to launch your first trial – or worse, for the trial to already be underway – only to learn later that your initial trajectory would not lead to regulatory clearance. Engaging with the FDA early allows sponsors to sidestep major timeline delays and avoid wasting valuable resources, ensuring smoother development progress. 

Setting expectations for pre-submission meetings

A large part of my job is helping DTx companies craft their regulatory strategies and plan for these pre-sub meetings. Before the FDA agrees to meet with you, you must prepare a submission to request a meeting with their regulators and wait for it to be reviewed. In my experience, the internal process of assembling the pre-sub documentation takes about two to three months. There is a further 70-day review period after submission before meeting with the FDA to discuss their feedback – so all in all, it’s a roughly six-month process to get input from CDRH. Six months is a long time to wait, so it is critical to ensure everything is in order to navigate these interactions effectively.  

The FDA wants to see a well-defined strategy of how you expect to develop and assess the performance of your digital therapeutic. They can provide insights into the potential outcomes of different approaches or offer feedback on your proposed strategies, but these conversations are most fruitful if you bring them a proposal that is already relatively close to what they are expecting. DTx manufacturers who go into these meetings without a clear roadmap often leave flustered because they originally hoped the agency would just tell them what to do – something that is not within their scope. 

The agency’s job is to uphold legal standards and ensure that therapeutics entering the marketplace are safe and effective. Therefore, it is important to view the FDA as a valuable partner working alongside you to bring your digital health intervention to life, rather than a barrier to overcome. They don’t just want to tell sponsors “No,” but sometimes they must. 

Handling regulatory feedback and adjusting timelines

Reaching a fully developed clinical development plan is no easy task. Should the FDA suggest changes to your plan, it’s important not to get too discouraged—you must remain open to constructive feedback and the possibility of having to switch gears. As a result, you may need to invest more time and energy to refine your strategy for development. It’s advisable to build in ample time buffers into your projected study timelines to accommodate any changes or recommendations from the FDA. 

I’ve also seen setbacks as a result of DTx companies not providing the agency with enough information to offer meaningful feedback. It’s crucial to ensure submission materials are comprehensive and well thought out to facilitate productive conversations, as well as phrase questions to regulators carefully to ensure you receive the responses you desire. 

Building a path to success through FDA collaboration 

Successfully bringing digital therapeutics to market requires more than innovation; it demands a strategic approach for regulatory compliance. By engaging with the FDA early and maintaining a proactive dialogue, DTx companies can bypass avoidable hurdles to development, fine-tune their clinical development plans, and ultimately accelerate their path to obtaining clearance for their groundbreaking digital health interventions.

About the author  

Acacia Parks, PhD, MBA, who serves as an Advisor to Lindus Health, is a digital health executive whose experience revolves around scientific, product, and regulatory strategy for digital therapeutics/software as medical devices (SaMDs).