Gigi Hirsch, Sharon E Phares, Jane Barlow, Murray Aitken, Mark Cziraky, Gregory Daniel, Chester Good, Annie Kennedy
{"title":"Optimizing Biomedical Health Efficiency: Unlocking the Full Potential of Life Science Innovation Through System Design.","authors":"Gigi Hirsch, Sharon E Phares, Jane Barlow, Murray Aitken, Mark Cziraky, Gregory Daniel, Chester Good, Annie Kennedy","doi":"10.1007/s43441-025-00847-2","DOIUrl":null,"url":null,"abstract":"<p><p>Major advances in biomedical science have transformed healthcare. However, system barriers to the appropriate, timely, and equitable use of biomedical innovations have led to slow and inconsistent adoption, limiting and delaying our ability to leverage their full potential to improve health. System barriers include inconsistent coverage, imperfect information systems for decision making and real word evidence, policy constraints, system capacity, social influences on health, and infrastructure gaps.We propose the development of an open access dynamic design \"engine\" to align biomedical and health system innovation. This engine will include coordinated collaborative design processes, frameworks, and tools, developed with input from all stakeholders, and centered around two critical, interdependent capabilities: (1) system design and (2) impact measurement. These capabilities will build capacity for efficient, model-driven design and implementation planning of sustainable, patient centered system innovations.The stakes are high for both the clinical promise of transformational products and their budget impact. Our current healthcare system is not ready to maximize benefit from transformational science and emerging biomedical innovations. We need to help the healthcare system catch up with the science.</p>","PeriodicalId":23084,"journal":{"name":"Therapeutic innovation & regulatory science","volume":" ","pages":""},"PeriodicalIF":1.9000,"publicationDate":"2025-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Therapeutic innovation & regulatory science","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s43441-025-00847-2","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"MEDICAL INFORMATICS","Score":null,"Total":0}
引用次数: 0
Abstract
Major advances in biomedical science have transformed healthcare. However, system barriers to the appropriate, timely, and equitable use of biomedical innovations have led to slow and inconsistent adoption, limiting and delaying our ability to leverage their full potential to improve health. System barriers include inconsistent coverage, imperfect information systems for decision making and real word evidence, policy constraints, system capacity, social influences on health, and infrastructure gaps.We propose the development of an open access dynamic design "engine" to align biomedical and health system innovation. This engine will include coordinated collaborative design processes, frameworks, and tools, developed with input from all stakeholders, and centered around two critical, interdependent capabilities: (1) system design and (2) impact measurement. These capabilities will build capacity for efficient, model-driven design and implementation planning of sustainable, patient centered system innovations.The stakes are high for both the clinical promise of transformational products and their budget impact. Our current healthcare system is not ready to maximize benefit from transformational science and emerging biomedical innovations. We need to help the healthcare system catch up with the science.
期刊介绍:
Therapeutic Innovation & Regulatory Science (TIRS) is the official scientific journal of DIA that strives to advance medical product discovery, development, regulation, and use through the publication of peer-reviewed original and review articles, commentaries, and letters to the editor across the spectrum of converting biomedical science into practical solutions to advance human health.
The focus areas of the journal are as follows:
Biostatistics
Clinical Trials
Product Development and Innovation
Global Perspectives
Policy
Regulatory Science
Product Safety
Special Populations