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Medical Product Development

Reports

Displaying 1 - 10 of 16. 10 per page. Page 1.

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Research Summary

Characteristics of Medical Device Shortages in the US, 2006-20

December 5, 2022
Shortages of critical medical devices during the COVID-19 pandemic exposed vulnerabilities in device markets. From 2010 to 2019 there were approximately five shortages annually, but that number increased fourfold in the first half of 2020.

Therapeutic Complex Medical Device Development

November 4, 2022
This report quantified the potential impacts of select clinical strategies on the cost, duration, and phase transition probability associated with therapeutic complex medical device development stages. The model used data from a variety of sources (public and non-public) and widely accepted economic methods.
Report

Evaluating the Potential Impacts of Different Clinical Trial Strategies on Drug, Preventive Vaccine, and Therapeutic Complex Medical Device Development

November 4, 2022
This environmental scan, conducted from September 2016 – September 2021, examines the potential impacts of select strategies on the cost, duration, and phase transition probability associated with drug, preventive vaccine, and therapeutic complex medical device development stages.
ASPE Issue Brief

Estimated Cost of Developing a Therapeutic Complex Medical Device in the US

October 3, 2022
This document presents the abstract of this paper, as published in JAMA Network Open. The full text of the article is available at: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2796179 Related Products:

National Action Plan for Combating Antibiotic-Resistant Bacteria Progress Report: Year 4

February 13, 2020
Antibiotic Resistance continues to pose a significant threat to our Nation’s public health. To coordinate and enhance the public health response to this threat, the U.S. Government developed the National Action Plan for Combating Antibiotic-Resistant Bacteria (CARB). The CARB Task Force is co-chaired by HHS, USDA, and DOD.
ASPE Data Point

Current Estimates of Supply and Utilization of Immune Globulin Products

May 12, 2019
In February 2007, the Eastern Research Group (ERG) submitted to the Office of the Assistant Secretary for Planning and Evaluation (ASPE) Analysis of Supply, Distribution, Demand, and Access Issues Associated with Immune Globulin Intravenous (IG

Economic Incentives for the Development of Rapid Point-of-Care (POC) Diagnostic Devices for C.Difficile, Carbapenem-Resistant Enterobacteriaceae (CRE), and Neisseria Gonorrhoeae

January 1, 2019
Antibacterial resistance is responsible for excess morbidity, mortality, and medical costs around the globe. Estimates vary widely, but the economic cost of antibacterial resistance in the United States could be as high as $20 billion and $35 billion a year in excess direct healthcare costs and lost productivity costs, respectively. CDC’s most recent report on U.S.

National Action Plan for Combating Antibiotic-Resistant Bacteria Progress Report: Year 3

November 12, 2018
Antibiotic Resistance continues to pose a significant threat to our Nation’s public health. To coordinate and enhance the public health response to this threat, the U.S. Government developed the National Action Plan for Combating Antibiotic-Resistant Bacteria (CARB). The CARB Task Force is co-chaired by HHS, USDA, and DOD.

National Action Plan for Combating Antibiotic-Resistant Bacteria Progress Report for Years 1 and 2

November 12, 2017
Antibiotic resistance (AR) poses a significant threat to our Nation’s public health. To coordinate and enhance the public health response to the AR threat, the U.S. Government developed the National Action Plan for Combating Antibiotic-Resistant Bacteria (CARB). The CARB Task Force is co-chaired by HHS, the U.S. Department of Agriculture, and the U.S. Department of Defense.

Analysis Report: Understanding the Role of Partnerships in Medical Product Development

July 26, 2017
Partnerships involving public sector organizations, academia, non-profits, and pharmaceutical companies have demonstrated their potential for addressing unmet needs in medical product research and development (R&D). Effective partnerships can enhance access to innovation, reduce risk, manage costs, and may provide a means for steering R&D investment to address societal objectives.