The evolution of digital health has been massive since the concept was first introduced.
FREMONT, CA: Digital health is a vast scope, including mobile health, health information technology, wearable devices, telehealth and telemedicine, and personalized medicine.
The traditional methods to develop robust evidence are incongruent with the agile approach taken in software development. So much so that the conventional approaches present fundamental limitations for researchers to create evidence for digital health solutions. Evaluation of digital health solutions has been identified as needing improvement and has been cited as a significant obstacle for broader adoption. Digital solution evaluation requires collective efforts from multiple parties, such as health authorities, healthcare providers, and manufacturers such as small and medium-sized enterprises (SMEs), multinational corporations (MNCs).
Limited resources to undertake clinical studies
SMEs traditionally prioritize and allocate their research and development budget to product development. Anecdotal evidence suggests that close relationships between innovator and adopter are a critical driver of initial adoption decisions. More comprehensive implementation needs robust evidence of benefit, yet this isn't easy to prioritize, given the many challenges for establishing new ventures. Besides, a well-designed and executed studies require skilled researchers, often via collaboration with academia, adding further complexity. Moreover, it has been estimated that the timescale for submitting a research proposal and receiving ethical approval for a pilot or trial study can take as long as three years.
Out of date evidence, not an investment priority
Larger corporations have more resources to develop evidence but are equally limited by time. Internal budget allocation can be challenging to provide a rationale for investments into expensive and time-consuming clinical studies for early-stage solutions when such products are continually evolving. Given it typically takes 2–3 years to conduct a study, evidence published today may reflect a product that has been updated and refined multiple times. Furthermore, many companies' investments in sales and manufacturing, for example, are more tangible with a more predictable return on investment than those in clinical studies.
Focus on research output, not widespread adoption
A growing number of academic centers have created digital health research programs to develop and evaluate digital health solutions. However, such research units generally favor traditional research methodologies because of the increased likelihood of high-impact publication. The timeliness of studies is mainly immaterial; therefore, potentially valuable solutions may be delayed and are never implemented at scale. Obtaining sufficient research funding can also be a challenge.