Abstract
BACKGROUND: Translating innovative research advancements into commercially viable medical interventions presents well-known challenges. However, there is limited understanding of how specific patient, clinical, social, and legal complexities have further complicated and delayed the development of new and effective interventions for Opioid Use Disorder (OUD). We present the following case studies to provide introductory clinical, social, and business insights for researchers, medical professionals, and entrepreneurs who are considering or are currently developing medical. METHODS: Four small business recipients of National Institute on Drug Abuse (NIDA) small business grant funding collected a total of 416 customer discovery interviews during the 2021 National Institutes of Health (NIH) Innovation-Corps (I-Corps) program. Each business received funding to advance an OUD-specific innovation: therapeutics (2 companies), medical device (1 company), and Software as a Medical Device (SaMD) (1 company). Interview participants included stakeholders from a variety of disciplines of Substance Use Disorders (SUD) healthcare including clinicians, first responders, policymakers, relevant manufacturers, business partners, advocacy groups, regulatory agencies, and insurance companies. RESULTS: Agnostic to the type of product (therapeutic, device, or SaMD), several shared barriers were identified: (1) There is a lack of standardization across medical providers for managing patients with OUD, resulting in diverse implementation practices due to a fragmented healthcare policy; (2) Underlying Social Determinants of Health (SDOH) present unique challenges to medical care and contribute to poor outcomes in OUD; (3) Stigma thwarts adoption, implementation, and the development of innovative solutions; (4) Constantly evolving public health trends and legal policies impact development and access to OUD interventions. CONCLUSION: It is critical for innovators to have early interactions with the full range of OUD stakeholders to identify and quantify true unmet needs and to properly position development programs for commercial success. The NIH I-Corps program provides a framework to educate researchers to support their product design and development plans to increase the probability of a commercially successful outcome to address the ongoing opioid epidemic.