Top 3 Reasons Why Your Medical Device Needs a Clinical Trial

Regulations for research involving devices, in vitro diagnostics (IVDs), and digital therapeutics differ from those governing pharmaceutical development. While drugs require Phase I-III clinical trials—and are also subject to post-approval tracking—digital therapeutics, devices, and IVDs may be able to leverage bench testing, animal studies, pilot studies, and training sets. These are usually followed by validation studies, pivotal trials, literature reviews, and even real-world evidence studies, depending on the individual product’s intended purpose and the risk level.

Medical devices, IVDs, and digital therapeutics have the potential to bring significant health benefits to patients of every age group, including healthy populations and those with varying severity of health ailments and disease burdens. Interpreting evolving regulations for these devices is often a unique challenge for emerging biotech companies. Staying on top of evolving regulatory requireme…

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