Top Three Reasons Why Your Medical Device Needs A Clinical Trial

By Alethea Wieland, Managing Expert

Medical devices, in vitro diagnostics (IVDs), and digital therapeutics have the potential to provide substantial health advantages to patients across all age groups, populations, and those with diverse levels of health conditions and disease burdens. However, getting them to market involves meeting different regulations. For example, where drugs require Phase I-III clinical trials, digital therapeutics, devices, and IVDs may be able to leverage bench testing, animal studies, pilot studies, and training sets. Depending on the product’s intended use, regulations will also require a validation study, pivotal trial, literature review, or a real-world evidence study as well.

These measures not only help to ensure the safety and effectiveness of the product, but they also provide valuable data to support regulatory submissions and market adoption. Gain insight from three key reasons why a clinical trial is necessary for medical devices, including meeting regulatory requirements, demonstrating device safety and effectiveness, and generating data to support reimbursement and market adoption.