PMID- 37145687
OWN - NLM
STAT- MEDLINE
DCOM- 20230508
LR  - 20231102
IS  - 2689-0186 (Electronic)
IS  - 2689-0186 (Linking)
VI  - 4
IP  - 5
DP  - 2023 May 5
TI  - A Quantitative Framework to Identify and Prioritize Opportunities in Biomedical 
      Product Innovation: A Proof-of-Concept Study.
PG  - e230894
LID - 10.1001/jamahealthforum.2023.0894 [doi]
LID - e230894
AB  - IMPORTANCE: Prioritization and funding for health initiatives, including 
      biomedical innovation, may not consistently target unmet public health needs. 
      OBJECTIVE: To (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 PARTICIPANTS: The 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 MEASURES: The 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. RESULTS: Among 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. CONCLUSIONS: In 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.
FAU - Gressler, Laura Elisabeth
AU  - Gressler LE
AD  - Center for Devices and Radiological Health, US Food and Drug Administration, 
      Silver Spring, Maryland.
AD  - University of Arkansas for Medical Sciences, Little Rock.
FAU - Crowley, Kenyon
AU  - Crowley K
AD  - Robert H. Smith School of Business, University of Maryland, College Park.
AD  - Accenture Federal Services, Arlington, Virginia.
FAU - Berliner, Elise
AU  - Berliner E
AD  - Cerner Enviza, Kansas City, Missouri.
FAU - Leroy, Hartley
AU  - Leroy H
AD  - Center for Devices and Radiological Health, US Food and Drug Administration, 
      Silver Spring, Maryland.
FAU - Krofah, Esther
AU  - Krofah E
AD  - Faster Cures and Center for Public Health, Milken Institute, Washington, DC.
FAU - Eloff, Benjamin
AU  - Eloff B
AD  - Office of the Assistant Secretary for Health, US Department of Health and Human 
      Services, Washington, DC.
FAU - Marinac-Dabic, Danica
AU  - Marinac-Dabic D
AD  - Center for Devices and Radiological Health, US Food and Drug Administration, 
      Silver Spring, Maryland.
FAU - Vythilingam, Meena
AU  - Vythilingam M
AD  - Office of the Assistant Secretary for Health, US Department of Health and Human 
      Services, Washington, DC.
LA  - eng
PT  - Journal Article
DEP - 20230505
PL  - United States
TA  - JAMA Health Forum
JT  - JAMA health forum
JID - 101769500
SB  - IM
MH  - Humans
MH  - Cross-Sectional Studies
MH  - Pilot Projects
MH  - *Health Care Costs
MH  - *Health Expenditures
MH  - Prevalence
PMC - PMC10163391
COIS- Conflict of Interest Disclosures: Dr Gressler reported grants from the US Food 
      and Drug Administration (FDA) ORISE Fellowship during the conduct of the study. 
      Dr Crowley reported funding from the US Department of Health & Human Services as 
      salary support via the Intergovernmental Personnel Act to conduct the research 
      during the conduct of the study; employment from Accenture Federal Services, a 
      subsidiary of Accenture, which provides consulting services for biomedical 
      manufacturers and health agencies outside the submitted work. No other 
      disclosures were reported.
EDAT- 2023/05/05 12:42
MHDA- 2023/05/08 06:42
PMCR- 2023/05/05
CRDT- 2023/05/05 11:34
PHST- 2023/05/08 06:42 [medline]
PHST- 2023/05/05 12:42 [pubmed]
PHST- 2023/05/05 11:34 [entrez]
PHST- 2023/05/05 00:00 [pmc-release]
AID - 2804458 [pii]
AID - aoi230019 [pii]
AID - 10.1001/jamahealthforum.2023.0894 [doi]
PST - epublish
SO  - JAMA Health Forum. 2023 May 5;4(5):e230894. doi: 
      10.1001/jamahealthforum.2023.0894.