A Quantitative Framework to Identify and Prioritize Opportunities in Biomedical Product Innovation

Author:

Gressler Laura Elisabeth12,Crowley Kenyon34,Berliner Elise5,Leroy Hartley1,Krofah Esther6,Eloff Benjamin7,Marinac-Dabic Danica1,Vythilingam Meena7

Affiliation:

1. Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland

2. University of Arkansas for Medical Sciences, Little Rock

3. Robert H. Smith School of Business, University of Maryland, College Park

4. Accenture Federal Services, Arlington, Virginia

5. Cerner Enviza, Kansas City, Missouri

6. Faster Cures and Center for Public Health, Milken Institute, Washington, DC

7. Office of the Assistant Secretary for Health, US Department of Health and Human Services, Washington, DC

Abstract

ImportancePrioritization and funding for health initiatives, including biomedical innovation, may not consistently target unmet public health needs.ObjectiveTo (1) develop a quantitative, databased framework to identify and prioritize opportunities for biomedical product innovation investments based on a multicriteria decision-making model (MCDM) that includes comprehensive measures of public health burden and health care costs, and (2) pilot test the model.Design, Setting, and ParticipantsThe Department of Health and Human Services (HHS) convened public and private experts to develop a model, select measures, and complete a longitudinal pilot study to identify and prioritize opportunities for investment in biomedical product innovations that have the greatest public health benefit. Cross-sectional and longitudinal data (2012-2019) for 13 pilot medical disorders were obtained from the Institute for Health Metrics Global Burden of Disease database (IHME GBD) and the National Center for Health Statistics (NCHS).Main Outcome MeasuresThe main outcome measure was an overall gap score reflecting high public health burden (composite measure of mortality, prevalence, years lived with disability, and health disparities), or high health care costs (composite measure of total, public, and out-of-pocket health spending) relative to low biomedical innovation. Sixteen innovation metrics were selected to reflect the pipeline of biomedical products from research and development to market approval. A higher score indicates a greater gap. Normalized composite scores were calculated for public health burden, cost, and innovation investment using the MCDM Technique for Order of Preference by Similarity to Ideal Solution method.ResultsAmong the 13 conditions tested in the pilot study, diabetes (0.61), osteoarthritis (0.46), and drug-use disorders (0.39) had the highest overall gap score reflecting high public health burden, or high health care costs relative to low biomedical innovation in these medical disorders. Chronic kidney disease (0.05), chronic obstructive pulmonary disease (0.09), and cirrhosis and other liver diseases (0.10) had the least amount of biomedical product innovation despite similar public health burden and health care cost scores.ConclusionsIn this cross-sectional pilot study, we developed and implemented a data-driven, proof-of-concept model that can help identify, quantify, and prioritize opportunities for biomedical product innovation. Quantifying the relative alignment between biomedical product innovation, public health burden, and health care cost may help identify and prioritize investments that can have the greatest public health benefit.

Publisher

American Medical Association (AMA)

Subject

General Earth and Planetary Sciences,General Environmental Science

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