A Crisis-Responsive Framework for Medical Device Development Applied to the COVID-19
      Pandemic

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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.

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Most cited references 64

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The rise of 3-D printing: The advantages of additive manufacturing over traditional manufacturing

Mohsen Attaran (2017)

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Face shields for infection control: A review

Raymond Roberge (2016)

ABSTRACT Face shields are personal protective equipment devices that are used by many workers (e.g., medical, dental, veterinary) for protection of the facial area and associated mucous membranes (eyes, nose, mouth) from splashes, sprays, and spatter of body fluids. Face shields are generally not used alone, but in conjunction with other protective equipment and are therefore classified as adjunctive personal protective equipment. Although there are millions of potential users of face shields, guidelines for their use vary between governmental agencies and professional societies and little research is available regarding their efficacy.

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Towards an understanding of resilience: responding to health systems shocks

Johanna Hanefeld, Susannah H. Mayhew, Helena Legido-Quigley … (2018)

Abstract The recent outbreak of Ebola Virus Disease (EVD) in West Africa has drawn attention to the role and responsiveness of health systems in the face of shock. It brought into sharp focus the idea that health systems need not only to be stronger but also more ‘resilient’. In this article, we argue that responding to shocks is an important aspect of resilience, examining the health system behaviour in the face of four types of contemporary shocks: the financial crisis in Europe from 2008 onwards; climate change disasters; the EVD outbreak in West Africa 2013–16; and the recent refugee and migration crisis in Europe. Based on this analysis, we identify ‘3 plus 2’ critical dimensions of particular relevance to health systems’ ability to adapt and respond to shocks; actions in all of these will determine the extent to which a response is successful. These are three core dimensions corresponding to three health systems functions: ‘health information systems’ (having the information and the knowledge to make a decision on what needs to be done); ‘funding/financing mechanisms’ (investing or mobilising resources to fund a response); and ‘health workforce’ (who should plan and implement it and how). These intersect with two cross-cutting aspects: ‘governance’, as a fundamental function affecting all other system dimensions; and predominant ‘values’ shaping the response, and how it is experienced at individual and community levels. Moreover, across the crises examined here, integration within the health system contributed to resilience, as does connecting with local communities, evidenced by successful community responses to Ebola and social movements responding to the financial crisis. In all crises, inequalities grew, yet our evidence also highlights that the impact of shocks is amenable to government action. All these factors are shaped by context. We argue that the ‘3 plus 2’ dimensions can inform pragmatic policies seeking to increase health systems resilience.

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Author and article information

Journal

Journal ID (nlm-journal-id): 101771889

Journal ID (pubmed-jr-id): 50009

Journal ID (nlm-ta): Front Digit Health

Journal ID (iso-abbrev): Front Digit Health

Title: Frontiers in digital health

ISSN (Electronic): 2673-253X

Publication date Nihms-submitted: 15 April 2021

Publication date (Electronic): 22 March 2021

Publication date (Print): March 2021

Publication date PMC-release: 23 April 2021

Volume: 3

Electronic Location Identifier: 617106

Affiliations

[1 ]Greater Boston Pandemic Fabrication Team (PanFab) c/o Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, MA, United States,

[2 ]Research Laboratory of Electronics, Massachusetts Institute of Technology, Cambridge, MA, United States,

[3 ]McGovern Institute for Brain Research, Massachusetts Institute of Technology, Cambridge, MA, United States,

[4 ]Harvard-MIT Division of Health Sciences and Technology Program, Cambridge, MA, United States,

[5 ]Department of Systems Biology, Harvard Ludwig Cancer Research Center and Harvard Medical School, Boston, MA, United States,

[6 ]Department of Mechanical Engineering, Massachusetts Institute of Technology, Cambridge, MA, United States,

[7 ]Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA, United States,

[8 ]David H. Koch Institute for Integrative Cancer Research, Massachusetts Institute of Technology, Cambridge, MA, United States,

[9 ]Department of Biomedical Engineering, Johns Hopkins University School of Medicine, Baltimore, MD, United States,

[10 ]Harvard Medical School, Boston, MA, United States,

[11 ]Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, MA, United States,

[12 ]Fikst Product Development, Woburn, MA, United States,

[13 ]Department of Dermatology, Yale University School of Medicine, New Haven, CT, United States,

[14 ]Department of Dermatology, Center for Cutaneous Oncology, Brigham and Women’s Hospital, Dana-Farber Cancer Institute, Boston, MA, United States,

[15 ]System Design and Management, Massachusetts Institute of Technology, Cambridge, MA, United States,

[16 ]Massachusetts Manufacturing Emergency Response Team (MA M-ERT), Massachusetts Technology Collaborative, Westborough, MA, United States

Author notes

AUTHOR CONTRIBUTIONS

M-JA, DP, SS, NL, BL-E, and PS: article conception. M-JA, DP, SS, LA, AA, HY, JF, MS, BL-E, and PS: writing. M-JA, DP, SS, LA, AA, HY, AC, JF, MS, SY, NL, BL-E, and PS: editorial feedback. DP, HY, and PS: Greater Boston Pandemic Fabrication Team (PanFab) Consortium Coordination. All authors contributed to the article and approved the submitted version.

[* ] Correspondence: Peter K. Sorger, peter_sorger@ 123456hms.harvard.edu ; sorger_admin@ 123456hms.harvard.edu , Ben Linville-Engler, benle@ 123456mit.edu

Author information

Marc-Joseph Antonini http://orcid.org/0000-0002-9774-1483

Deborah Plana http://orcid.org/0000-0002-4218-1693

Shriya Srinivasan http://orcid.org/0000-0002-2508-1324

Lyla Atta http://orcid.org/0000-0002-6113-0082

Aditya Achanta http://orcid.org/0000-0002-7610-3538

Helen Yang http://orcid.org/0000-0002-9455-5300

Avilash K. Cramer http://orcid.org/0000-0003-0014-8921

Jacob Freake http://orcid.org/0000-0002-5198-835X

Michael S. Sinha http://orcid.org/0000-0002-9165-8611

Sherry H. Yu http://orcid.org/0000-0002-1432-9128

Nicole R. LeBoeuf http://orcid.org/0000-0002-8264-834X

Ben Linville-Engler http://orcid.org/0000-0002-1251-8275

Peter K. Sorger http://orcid.org/0000-0002-3364-1838

Article

Manuscript ID: NIHMS1692348

DOI: 10.3389/fdgth.2021.617106

PMC ID: 8064560

PubMed ID: 33899045

SO-VID: 80a4278f-0920-41e3-92b7-0e58841b866e

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This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

A Crisis-Responsive Framework for Medical Device Development Applied to the COVID-19 Pandemic

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Novel Coronavirus Disease COVID-19

Most cited references 64

The rise of 3-D printing: The advantages of additive manufacturing over traditional manufacturing

Face shields for infection control: A review

Towards an understanding of resilience: responding to health systems shocks

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