First Global Map of Early Device Trials Shows Rapid Growth

Researchers have built the first worldwide database of early feasibility studies for new medical devices. They found 621 such studies launched between 2013 and May 2025. The number has risen steadily each year, with a peak in 2024. Before this, no single list existed, making it hard to track trends or shape policy.

The team searched major public trial registries like ClinicalTrials.gov and the WHO platform. They also checked scientific papers, regulatory files, and medical news sites. Since there is no official label for these studies, they created their own definition. They looked for interventional trials with 30 or fewer participants, no control group, and no randomization. Keywords in titles or summaries helped confirm the match. Two reviewers checked every record by hand.

Geography tells an interesting story. About 40 percent of the studies took place fully or partly in the United States. Europe hosted 30 percent. The remaining 36 percent involved sites in other parts of the world. This spread shows that early device testing is truly global, not limited to a few rich countries.

The new database aims to support a dedicated European framework for early feasibility work. Policymakers can now see real patterns in design, endpoints, clinical areas, and study duration. Better transparency may help regulators, developers, and patients understand risks and benefits sooner. The work also highlights the need for a permanent, standardized registry.