Concerns on medical devices

 An astounding paper appeared in Journal of Medical Internet Research (JMIR) on Jun 20, 2022. Sean Day et al in a work titled “Assessing the Clinical Robustness of Digital Health Startups: Cross-sectional Observational Analysis” find out that despite making claims on diagnosis, treatment and prevention (making them medical devices): - 44% of digital health start-ups have zero published research or regulatory approvals.

The digital health sector has experienced rapid growth over the past decade. However, health care technology stakeholders lack a comprehensive understanding of clinical robustness and claims across the industry.

The analysis aimed to examine the clinical robustness and public claims made by digital health companies.

A cross-sectional observational analysis was conducted using company data from the Rock Health Digital Health Venture Funding Database, the US Food and Drug Administration, and the US National Library of Medicine. Companies were included if they sell products targeting the prevention, diagnosis, or treatment phases of the care continuum. Clinical robustness was defined using regulatory filings and clinical trials completed by each company. Public claims data included clinical, economic, and engagement claims regarding product outcomes made by each company on its website.

A total of 224 digital health companies with an average age of 7.7 years were included in our cohort. Average clinical robustness was 2.5 (1.8 clinical trials and 0.8 regulatory filings) with a median score of 1. Ninety-eight (44%) companies had a clinical robustness score of 0, while 45 (20%) companies had a clinical robustness score of 5 or more. The average number of public claims was 1.3 (0.5 clinical, 0.4 economic, and 0.4 engagement); the median number of claims was 1. No correlation was observed between clinical robustness and number of clinical claims (r2=0.02), clinical robustness and total funding (r2=0.08), or clinical robustness and company age (r2=0.18).

Many digital health companies have a low level of clinical robustness and do not make many claims as measured by regulatory filings, clinical trials, and public data shared online. Companies and customers may benefit from investing in greater clinical validation efforts.

As Hugh Harvey commented, “put it another way, imagine if 44% of drugs had no clinical evidence, but were being sold to doctors and patients anyway.”