JMIR Publications

ABSTRACT

Background:

Digital Therapeutics (DTx) represent a transformative shift in healthcare delivery, offering software-driven, evidence-based therapeutic interventions. Despite their potential, adoption remains low across healthcare systems, partly due to insufficient economic evidence. Significant knowledge gaps persist regarding stakeholders' approaches to economic decisions in DTx development, with prior studies also indicating limited consideration of economic factors in early DTx development stages, particularly from researchers.

Objective:

This study investigates how researchers approach decision-making regarding factors that influence the economic impact of DTx during technological development and clinical validation phases, examining the underlying mechanisms and contextual conditions that shape these processes.

Methods:

Using a critical realism philosophical approach, 17 semi-structured interviews were conducted with researchers involved in DTx development, including research engineers (n=5), health systems and social science researchers (n=6), clinician-researchers (n=4), and practitioner-researchers (n=2). The approach combined deductive and inductive coding, followed by abductive and retroductive processes to identify generative mechanisms underlying observed decision-making patterns. System dynamics modeling was applied to visualize causal relationships through triangulated data sources.

Results:

Three interrelated generative mechanisms were identified that shape researchers' decision-making regarding economic considerations: 1) the Professional Norms, operating through reinforcing loops that systematically prioritize clinical validation while marginalizing economic considerations; 2) the Researcher Experience, revealing how professional training and limited economic literacy create cognitive biases that systematically obscure economic factors; and 3) the DTx Adoption Uncertainties, demonstrating how implementation concerns influence development decisions through both reinforcing and balancing dynamics. These mechanisms explain why, despite growing recognition of the importance of economic evidence, economic considerations remain peripheral in researchers' decision frameworks.

Conclusions:

This study reveals complex interactions between institutional structures, intrapersonal factors, and implementation uncertainties that systematically deprioritize economic considerations in DTx development. The identified mechanisms provide valuable intervention points for strengthening the development process, towards more comprehensive assessment of clinical, technical, and economic value throughout DTx development, ultimately enhancing their adoption in healthcare systems. Clinical Trial: Not applicable.