A Crisis-Responsive Framework for Medical Device Development Applied to the COVID-19 Pandemic
The disruption of conventional manufacturing, supply, and distribution channels during the COVID-19 pandemic caused widespread shortages in personal protective equipment (PPE) and other medical supplies. These shortages catalyzed local efforts to use nontraditional, rapid manufacturing to meet urgen...
Saved in:
Published in | Frontiers in digital health Vol. 3 |
---|---|
Main Authors | , , , , , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
Switzerland
Frontiers Media S.A
22.03.2021
|
Subjects | |
Online Access | Get full text |
Cover
Loading…
Summary: | The disruption of conventional manufacturing, supply, and distribution channels during the COVID-19 pandemic caused widespread shortages in personal protective equipment (PPE) and other medical supplies. These shortages catalyzed local efforts to use nontraditional, rapid manufacturing to meet urgent healthcare needs. Here we present a crisis-responsive design framework designed to assist with product development under pandemic conditions. The framework emphasizes stakeholder engagement, comprehensive but efficient needs assessment, rapid manufacturing, and modified product testing to enable accelerated development of healthcare products. We contrast this framework with traditional medical device manufacturing that proceeds at a more deliberate pace, discuss strengths and weakness of pandemic-responsive fabrication, and consider relevant regulatory policies. We highlight the use of the crisis-responsive framework in a case study of face shield design and production for a large US academic hospital. Finally, we make recommendations aimed at improving future resilience to pandemics and healthcare emergencies. These include continued development of open source designs suitable for rapid manufacturing, education of maker communities and hospital administrators about rapidly-manufactured medical devices, and changes in regulatory policy that help strike a balance between quality and innovation. |
---|---|
Bibliography: | ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 Deborah Plana orcid.org/0000-0002-4218-1693 Shriya Srinivasan orcid.org/0000-0002-2508-1324 Ben Linville-Engler orcid.org/0000-0002-1251-8275 Sherry H. Yu orcid.org/0000-0002-1432-9128 Lyla Atta orcid.org/0000-0002-6113-0082 Helen Yang orcid.org/0000-0002-9455-5300 Peter Sorger orcid.org/0000-0002-3364-1838 Reviewed by: Niamh Lennox-Chhugani, TaoHealth Research, United Kingdom; Milena B. Cukic, Amsterdam Health and Technology Institute (AHTI), Netherlands This article was submitted to Health Technology Innovation, a section of the journal Frontiers in Digital Health ORCID: Marc-Joseph Antonini orcid.org/0000-0002-9774-1483 These authors have contributed equally to this work Edited by: Björn Wolfgang Schuller, Imperial College London, United Kingdom Aditya Achanta orcid.org/0000-0002-7610-3538 Nicole R. LeBoeuf orcid.org/0000-0002-8264-834X Avilash K. Cramer orcid.org/0000-0003-0014-8921 Jacob Freake orcid.org/0000-0002-5198-835X Michael S. Sinha orcid.org/0000-0002-9165-8611 |
ISSN: | 2673-253X 2673-253X |
DOI: | 10.3389/fdgth.2021.617106 |