Frontiers in Digital Health (Mar 2021)
A Crisis-Responsive Framework for Medical Device Development Applied to the COVID-19 Pandemic
- Marc-Joseph Antonini,
- Marc-Joseph Antonini,
- Marc-Joseph Antonini,
- Marc-Joseph Antonini,
- Deborah Plana,
- Deborah Plana,
- Deborah Plana,
- Shriya Srinivasan,
- Shriya Srinivasan,
- Shriya Srinivasan,
- Shriya Srinivasan,
- Lyla Atta,
- Lyla Atta,
- Aditya Achanta,
- Aditya Achanta,
- Helen Yang,
- Helen Yang,
- Avilash K. Cramer,
- Avilash K. Cramer,
- Jacob Freake,
- Jacob Freake,
- Michael S. Sinha,
- Michael S. Sinha,
- Sherry H. Yu,
- Sherry H. Yu,
- Nicole R. LeBoeuf,
- Nicole R. LeBoeuf,
- Ben Linville-Engler,
- Ben Linville-Engler,
- Ben Linville-Engler,
- Peter K. Sorger,
- Peter K. Sorger,
- Peter K. Sorger
Affiliations
- Marc-Joseph Antonini
- Greater Boston Pandemic Fabrication Team (PanFab) c/o Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, MA, United States
- Marc-Joseph Antonini
- Research Laboratory of Electronics, Massachusetts Institute of Technology, Cambridge, MA, United States
- Marc-Joseph Antonini
- McGovern Institute for Brain Research, Massachusetts Institute of Technology, Cambridge, MA, United States
- Marc-Joseph Antonini
- Harvard-MIT Division of Health Sciences and Technology Program, Cambridge, MA, United States
- Deborah Plana
- Greater Boston Pandemic Fabrication Team (PanFab) c/o Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, MA, United States
- Deborah Plana
- Harvard-MIT Division of Health Sciences and Technology Program, Cambridge, MA, United States
- Deborah Plana
- Department of Systems Biology, Harvard Ludwig Cancer Research Center and Harvard Medical School, Boston, MA, United States
- Shriya Srinivasan
- Greater Boston Pandemic Fabrication Team (PanFab) c/o Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, MA, United States
- Shriya Srinivasan
- Department of Mechanical Engineering, Massachusetts Institute of Technology, Cambridge, MA, United States
- Shriya Srinivasan
- Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, United States
- Shriya Srinivasan
- David H. Koch Institute for Integrative Cancer Research, Massachusetts Institute of Technology, Cambridge, MA, United States
- Lyla Atta
- Greater Boston Pandemic Fabrication Team (PanFab) c/o Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, MA, United States
- Lyla Atta
- Department of Biomedical Engineering, Johns Hopkins University School of Medicine, Baltimore, MD, United States
- Aditya Achanta
- Greater Boston Pandemic Fabrication Team (PanFab) c/o Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, MA, United States
- Aditya Achanta
- 0Harvard Medical School, Boston, MA, United States
- Helen Yang
- Greater Boston Pandemic Fabrication Team (PanFab) c/o Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, MA, United States
- Helen Yang
- 1Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, MA, United States
- Avilash K. Cramer
- Greater Boston Pandemic Fabrication Team (PanFab) c/o Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, MA, United States
- Avilash K. Cramer
- Harvard-MIT Division of Health Sciences and Technology Program, Cambridge, MA, United States
- Jacob Freake
- Greater Boston Pandemic Fabrication Team (PanFab) c/o Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, MA, United States
- Jacob Freake
- 2Fikst Product Development, Woburn, MA, United States
- Michael S. Sinha
- Greater Boston Pandemic Fabrication Team (PanFab) c/o Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, MA, United States
- Michael S. Sinha
- 1Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, MA, United States
- Sherry H. Yu
- Greater Boston Pandemic Fabrication Team (PanFab) c/o Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, MA, United States
- Sherry H. Yu
- 3Department of Dermatology, Yale University School of Medicine, New Haven, CT, United States
- Nicole R. LeBoeuf
- Greater Boston Pandemic Fabrication Team (PanFab) c/o Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, MA, United States
- Nicole R. LeBoeuf
- 4Department of Dermatology, Center for Cutaneous Oncology, Brigham and Women's Hospital, Dana-Farber Cancer Institute, Boston, MA, United States
- Ben Linville-Engler
- Greater Boston Pandemic Fabrication Team (PanFab) c/o Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, MA, United States
- Ben Linville-Engler
- 5System Design and Management, Massachusetts Institute of Technology, Cambridge, MA, United States
- Ben Linville-Engler
- 6Massachusetts Manufacturing Emergency Response Team (MA M-ERT), Massachusetts Technology Collaborative, Westborough, MA, United States
- Peter K. Sorger
- Greater Boston Pandemic Fabrication Team (PanFab) c/o Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, MA, United States
- Peter K. Sorger
- Department of Systems Biology, Harvard Ludwig Cancer Research Center and Harvard Medical School, Boston, MA, United States
- Peter K. Sorger
- 1Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, MA, United States
- DOI
- https://doi.org/10.3389/fdgth.2021.617106
- Journal volume & issue
-
Vol. 3
Abstract
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.
Keywords
