Unmet Needs in Fetal Interventions for Congenital Heart Disease: A Systematic Review and Biodesign-Based Assessment

There is a significant lack of medical devices designed for fetal cardiac interventions, forcing clinicians to use existing devices off-label, which carries considerable risk. To foster innovation, we aimed to identify needs that could drive potential new device solutions to address surgical challenges in fetal interventions for severe congenital heart disease (CHD). We conducted a systematic review with an electronic search of PubMed, Scopus, and the Cochrane database, analyzing data on pain points associated with these interventions. These pain points were translated into six need statements using the Stanford Biodesign methodology to inspire future innovations. The search yielded 985 results, with 24 studies reviewed. Identified pain points included challenges with fetal positioning (17 studies), catheter visualization issues (8 studies), and suboptimal tool designs such as mismatched balloon and cannula sizes (14 studies), and limited catheter control (9 studies). Significant technical complications and adverse events followed current off-label device use, proving that there is an urgent need for minimally invasive cardiac devices specifically designed for percutaneous fetal interventions.