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Medical Product Development

Reports

Displaying 1 - 10 of 22. 10 per page. Page 1.

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Research Summary

Premarket Notifications and Patents for Breast Pumps Before and After the ACA

This study investigated whether ACA policies to increase access to breast pumps and lactation care were associated with innovation in the market for breast pumps.
Report

Competition in Prescription Drug Markets, 2017-2022

The cornerstone of a well-functioning market is competition. President Biden’s Executive Order 14036, “Promoting Competition in the American Economy” identified a lack of competition as a key driver for problems across economic sectors.
ASPE Issue Brief

Understanding Markets for Antimicrobial Drugs

Development of novel antimicrobials has slowed, and the preclinical and clinical pipeline is likely to be insufficient to support current and future patient needs.
Report

Analysis of Market Challenges for Antimicrobial Drug Development in the United States

The market for antimicrobial (AM) drugs is unique in that it is associated with a positive externality (public health) as well as a negative externality (antimicrobial resistance, or AMR) (Mossialos, et al., 2010). AMR occurs when microbes change over time and no longer respond to available medicine.
Report

Bridging the Patient-Center Outcome Research Infrastructure and Technology

The goal of this project was to strengthen the coordinated registry network as a real-world data source for high quality, relevant, reliable, timely and actionable evidence to improve patient outcomes of medical devices, specifically for technologies affecting women’s health.
ASPE Issue Brief

FDA User Fees: Examining Changes in Medical Product Development and Economic Benefits

This issue brief provides a primer on FDA user fees, presents findings of how user fees affect the cost of medical product development, and summarizes the research literature on user fees, most notably in expediting medical product development and approval.
Research Summary

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

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

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

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

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: