There is significant ambiguity surrounding the digital health regulatory landscape today. It’s a topic of growing concern as more and more biopharma and medtech companies are developing Digital Therapeutics, Software as a Medical Device (SaMD), connected combination products, companion apps and more.
Global medical device software regulations are nuanced and there are a number of complexities in the specific digital health use cases that companies are looking to deploy. Specifically, assessing whether you need a regulated or unregulated infrastructure for hosting your digital health solutions causes a lot of confusion.
We often hear questions like, “why do I need a regulated Internet of Things (IoT) infrastructure?” or, in the United States, “when can or can’t I leverage a Medical Device Data System (MDDS)?”
After numerous discussions in the field, our team decided to launch a research project to address the burning questions that medtech and biopharma execs are struggling to answer.
As part of our research, our team chatted with industry experts – from biopharma execs to partners at law firms who advise biopharma and medtech companies on how to approach their regulatory strategy when it comes to their underlying infrastructure.
Bradley Merrill Thompson, Epstein Becker & Green, P.C. shared his insights: “If your platform solution does anything beyond transferring, storing, converting the format or displaying medical device data – the definition of a Medical Device Data System (MDDS) – the chances are high that some aspect of a biopharma’s software will be regulated. If you want to manage risk, you need to adopt a more conservative point of view to future-proof your business.”
The white paper summarizing our digital health regulatory research goes into detail on each of these 5 takeaways. In it, you’ll learn about the United States and Europe regulatory trends, exactly how an MDDS platform increases your compliance risk, and how to determine if you need a regulated or unregulated infrastructure now and in the future.
Download our new white paper here.