Digital Health Innovation: A Toolkit to Navigate From Concept to Clinical Testing

Digital health technologies such as smartphone apps, Web-based platforms, and wearable devices are rapidly emerging as promising interventions for acute and chronic disease management, particularly in the field of cardiovascular medicine. However, there is limited guidance on how to effectively develop and rigorously test digital health interventions (DHIs). Through our experience with innovating Corrie, a smartphone-based app paired with a smartwatch and blood pressure monitor for myocardial infarction recovery in the acute setting, we aim to provide a toolkit for navigating the digital health technology development and clinical testing processes. The toolkit consists of 6 steps: step one emphasizes concept generation by defining a specific clinical problem and the existing solutions aimed to address it; step two aims to recruit a multidisciplinary team within an academic institution; step three leverages technology accelerators and industry partnerships; step four develops the digital health technology with continuous feedback from patient and family end-users; step five solicits feedback from a diverse array of stakeholders; and step six performs a clinical study at a single site that, if successful, rapidly scales to multiple sites. DHI development is often a complex and vastly uncharted territory. By exploring the steps we took from concept to clinical testing with the first cardiology CareKit app, we hope to provide useful insights to teams that are starting out on their path to digital health innovation. We emphasize the central importance of embracing transdisciplinary work to move from silos to synergy.