User input in iterative design for prevention product development: leveraging interdisciplinary methods to optimize effectiveness

Abstract

The development of HIV-preventive topical vaginal microbicides has been challenged by a lack of sufficient adherence in later stage clinical trials to confidently evaluate effectiveness. This dilemma has highlighted the need to integrate translational research earlier in the drug development process, essentially applying behavioral science to facilitate the advances of basic science with respect to the uptake and use of biomedical prevention technologies. In the last several years, there has been an increasing recognition that the user experience, specifically the sensory experience, as well as the role of meaning-making elicited by those sensations, may play a more substantive role than previously thought. Importantly, the role of the user-their sensory perceptions, their judgements of those experiences, and their willingness to use a product-is critical in product uptake and consistent use post-marketing, ultimately realizing gains in global public health. Specifically, a successful prevention product requires an efficacious drug, an efficient drug delivery system, and an effective user. We present an integrated iterative drug development and user experience evaluation method to illustrate how user-centered formulation design can be iterated from the early stages of preclinical development to leverage the user experience. Integrating the user and their product experiences into the formulation design process may help optimize both the efficiency of drug delivery and the effectiveness of the user.

Keywords: Adherence; Iterative design; Prevention product development; Sexual health; Translational science; User experience; User input.

Fig 1

Integrated Iterative Design, combining drug development, bioengineering, and user experience evaluations. Iterations proceed as needed until target product profile and target user profile are aligned for co-optimization of drug delivery and user adherence. Dotted lines indicate potential paths for iterations

Fig 2

User Experience Data Collection Process Flow and Primary Results. Procedural process, rationale for changes in properties/concepts discussed, and results of iterative qualitative methods used to evaluate fiber based formulation prototypes.