Lessons from the National institutes of health innovation corps program: defining barriers to developing and commercializing novel solutions for persons with opioid use disorder.
Matthew P Heshmatipour, Tyler M Duvernay, Desislava Z Hite, Eboo Versi, Michael P Hite, David F Reeser, Victor Prikhodko, Ariana M Nelson, Bina Julian, Milton L Greenberg
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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.
期刊介绍：
Addiction Science & Clinical Practice provides a forum for clinically relevant research and perspectives that contribute to improving the quality of care for people with unhealthy alcohol, tobacco, or other drug use and addictive behaviours across a spectrum of clinical settings.
Addiction Science & Clinical Practice accepts articles of clinical relevance related to the prevention and treatment of unhealthy alcohol, tobacco, and other drug use across the spectrum of clinical settings. Topics of interest address issues related to the following: the spectrum of unhealthy use of alcohol, tobacco, and other drugs among the range of affected persons (e.g., not limited by age, race/ethnicity, gender, or sexual orientation); the array of clinical prevention and treatment practices (from health messages, to identification and early intervention, to more extensive interventions including counseling and pharmacotherapy and other management strategies); and identification and management of medical, psychiatric, social, and other health consequences of substance use.
Addiction Science & Clinical Practice is particularly interested in articles that address how to improve the quality of care for people with unhealthy substance use and related conditions as described in the (US) Institute of Medicine report, Improving the Quality of Healthcare for Mental Health and Substance Use Conditions (Washington, DC: National Academies Press, 2006). Such articles address the quality of care and of health services. Although the journal also welcomes submissions that address these conditions in addiction speciality-treatment settings, the journal is particularly interested in including articles that address unhealthy use outside these settings, including experience with novel models of care and outcomes, and outcomes of research-practice collaborations.
Although Addiction Science & Clinical Practice is generally not an outlet for basic science research, we will accept basic science research manuscripts that have clearly described potential clinical relevance and are accessible to audiences outside a narrow laboratory research field.
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