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

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.

In pursuit of functional electrospun materials for clinical applications in humans.

Electrospinning is a simple, low-cost and versatile approach to fabricate multifunctional materials useful in drug delivery and tissue engineering applications. Despite its emergence into other manufacturing sectors, electrospinning has not yet made a transformative impact in the clinic with a pharmaceutical product for use in humans. Why is this the current state of electrospun materials in biomedicine? Is it because electrospun materials are not yet capable of overcoming the biological safety and efficacy challenges needed in pharmaceutical products? Or, is it that technological advances in the electrospinning process are needed? This review investigates the current state of electrospun materials in medicine to identify both scientific and technological gaps that may limit clinical translation.