Development and application of the Rapha® device for the treatment of diabetic foot ulcers.

ABSTRACT

INTRODUCTION: Transforming medical research into real-world healthcare solutions is a complex endeavor that may benefit from the synergy between academic research, governmental support, and industry innovation. OBJECTIVES: In this article we delve into the framework of Translational Medical Research (TMR) in Brazil, elucidating the possible interplay between public universities and other pivotal stakeholders in the translational journey. METHODS: Our focal point is the Rapha® device, an innovative medical technology, as we explore its ethical and regulatory journey. We seek to understand the environment that shapes healthcare technology development through a mixed-methods research design, combining policy analysis with stakeholder interviews. RESULTS: The research begins by examining public policies, aiming to carve out a socially inclusive and advantageous ecosystem. We then highlight the pivotal components-steps, milestones, stakeholders, and policies that underpin the TMR process. Our findings reveal that while TMR frequently culminates in patents and technology transfer agreements, specific regulatory and production challenges exist, particularly during transitioning from the T3 (clinical trials) to T4 (public health practice) phase. We provide insights into its translational progression by tracing the developmental stages from foundational research (T0) to clinical trials (T3) for the Rapha® device. CONCLUSION: Ultimately, this study underscores TMR's vital role in advancing healthcare access and posits that academic institutions can significantly influence the creation of ethically robust, regulated, and impactful medical innovations, contributing meaningfully to global healthcare.