A Landscape Study to Determine the Innovation Mortality Rate in Health Technology Innovations Across the Globe Global Health Innovation Mortality in Health Technology Innovation
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Keywords
Health technology innovation, Regulatory approval, Medical devices, WHO Compendium, BIRAC, Global innovation agencies
Abstract
Introduction : Health technology innovation encompasses many areas, such as medical devices, diagnostics, pharmaceuticals, digital health solutions, telemedicine, health informatics, and more. These innovations aim to enhance healthcare delivery, improve patient outcomes, increase access to services, reduce costs, and advance medical research.
Methodology : We have analyzed health technology innovations reported between January 2011 and December 2022. Regulatory approval for the innovative products was determined based solely on official open-access websites of health agencies, disregarding information from company websites or third-party sources. The search process utilized identified innovation agencies and sources like Primary Health Care (Innovations were thoroughly examined from these sources, focusing on health technologies, and success was gauged through regulatory approval.
Results : The WHO Compendium includes 200 health innovations primarily intended for low-resource settings, with the USA accounting for the highest number, followed by India, the only low- and middle-income country (LMIC) with significant innovations. However, 58% of the listed innovations did not obtain regulatory clearance. Medical devices dominated the listed innovations, while scalable assistive technologies were limited. Global innovation agencies, particularly Grand Challenges, supported many innovations, but the regulatory approval rate remained low. In India, BIRAC supported 92% of the mapped innovations, with a similar trend of low regulatory approval rates.
Conclusion: The study observed the highest number of innovations during 2015-2017, with medical devices being the most prominent category. However, most innovations from both global and domestic agencies were unapproved, raising concerns about regulatory clearance for these health technologies.
Manuscript Highlights: The manuscript presents several important highlights concerning health technology innovation and regulatory approval. It highlights the evaluation of health innovations from 2015 to 2022, focusing on their success rate based on health agency approval. It reveals an uneven distribution of innovations from different countries and emphasizes the need for critical interventions to improve the process. This study emphasizes the significance of innovations in achieving healthcare equity and sustainable development goals.
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