Fall is coming - and so is regulation for digital health products. This spring, the CDC officially ended the United States’ pandemic “public health emergency,” which means that companies who received emergency exceptions for their products will have to remove them from the market if they don’t get them FDA-cleared by early November.
This is no abstract threat: earlier this summer the FDA sent a stern warning letter to iRhythm for overstating the scope of use for one of their wearable heart monitors. That action sent iRhythm’s stock price tumbling, showing that even a market leader like them will have trouble if they’re not diligent about staying in compliance.
In general, the recent digital-health explosion - from smart-trackers to decision support systems - has largely outpaced the regulatory frameworks needed to ensure that these tools are safe, effective, and used appropriately. For companies in the space, a strong regulatory strategy is essential to ensure that digital health products meet necessary regulatory requirements, are cleared for market access as quickly as possible, and are optimally positioned for reimbursement. The challenge is that the current regulatory landscape is difficult to navigate in light of how fast-evolving regulatory science and requirements can be. It’s hard for innovators to know how to interact with regulators, which ones, and when.
This is where a new education course from Digital Medicine Society (DiMe) comes in. “Unlocking Regulatory Success for Digital Health Product Developers” aims to help product developers build fit-for-purpose regulatory strategies, strengthen their organization’s business strategy, and both differentiate and build trust in their products.
The six-lesson course from DiMe helps learners identify the regulatory requirements applicable to their particular work, as well as build regulatory strategies for their product portfolios. After completion of the course, learners will be able to identify whether their digital health products are likely to be regulated and through which mechanisms. They will be equipped with the skills to build and implement a regulatory strategy, and positioned to advance the success of their digital health product portfolios. And they will be empowered to build high-quality evidence-based products without having to pay for expensive consulting services.
“For anyone developing new digital-health products, optimizing your regulatory strategy will save you valuable time, energy, resources, money, and frustration,” said DiMe CEO Jennifer Goldsack. “It is due time that all of us in the field have clear knowledge of the regulatory requirements and pathways that apply to us and the safety of our products and services.”
The strategy course includes modules on the “why”, “what” and “how” of digital health regulation, outlining the components of a fit-for-purpose regulatory strategy and ways to optimize it for success over time. This includes:
- Identifying target markets
- Defining product claims
- Conducting risk-benefit profiles
- Determining product class
- Communicating with regulators
- Designing clinical and non-clinical testing plan
The course builds off of the February launch of DiMe’s Regulatory Pathways project, which includes multiple interactive tool kits and a glossary focused on helping organizations better understand federal regulatory pathways so that they can make better decisions about their products.
Health-tech executives who have taken the course have already seen it pay major dividends in terms of feeling prepared to bring their products to market, and speak of how they are requiring their developers to take the course, expecting it to save them valuable time, energy, resources, and money.
