Mission Statement

Coordinated by the Harvard-MIT Center for Regulatory Sciences (Harvard University) a not-for-profit 501(c)(3) educational institution.

PanFab was established to meet the urgent needs for medical supplies and equipment arising from the COVID19 pandemic. It is focused initially on the Greater Boston area but anyone is free to join and use its work products. We aim to continue this even after the immediate COVID-19 outbreak has passed so that key lessons can be learned and applied to future crises.

Mission:

PanFab is a group of volunteer scientists, engineers, clinicians, and concerned citizens dedicated to helping healthcare professionals, first responders and patients respond to pandemic disease (currently to COVID19) by using innovative approaches to alleviate shortages in medical products, coordinate product testing, and promote hospital uptake of innovative solutions.

License:

We aim to share PanFab work products without restriction to expedite reuse by others. Unless explicitly stated otherwise, the work products developed by PanFab are made available under a permissive Creative Commons CC BY 4.0 license.

Goals:

1) To serve the needs of patients and front-line medical professionals during the COVID-19 crisis, with an initial focus on the Greater Boston Area

• Provide a source of engineering, scientific and manufacturing expertise for individuals and institutions facing unprecedented shortages in medical equipment and supplies and support health care professionals and first responders at the front line of COVID19 response.

• Advance solutions to specific engineering and fabrication problems to increase the capacity of the healthcare system and, when possible, fabricate innovative solutions and subject them to rigorous testing.

2) To serve the national and global community of clinicians, engineers, and volunteers responding to the COVID-19 outbreak

• Study the problems raised by COVID19 response from a rigorous scientific and engineering perspective and document findings in peer-reviewed publications.

• Share and amplify lessons learned from our work to better assist others embarking on similar efforts to reduce redundancy in responding to this and future crises.

Affiliations:

PanFab is supported administratively by the Harvard-MIT Center for Regulatory Sciences but we are a volunteer organization that does not represent any institution. The opinions expressed in PanFab documents and Slack Channels are those of the individual contributors. All contributors commit to providing the best possible advice as they see it, given limitations in knowledge, the rapidly changing nature of the COVID19 response and the “fog of war” that attends any fast moving emergency.

We have ongoing collaborations with hospitals in the Greater Boston area, including Brigham and Women's Hospital and Massachusetts General Hospital.

Intellectual property:

PanFab coordinators take no position on the patentability or patent-related restrictions on any designs or methods discussed in its forums or documents. The coordinators do not intend to make any intellectual property claims with respect to PanFab work products. However, designs and methods described in PanFab may be subject to patents and other IP claims originating outside the group.

Testing devices:

Before any device can be introduced into a healthcare setting it needs to be tested, in many cases on patients. For ethical reasons, testing is a tightly controlled activity overseen by Institutional Review Boards (IRBs). To participate in testing, individuals must have appropriate and documented training. Not all of the activities involved in clinical testing can be shared with the general public in real time, and the names of patients who are involved will always be kept confidential (de-identified). However, the procedures used and the outcomes of such studies are made publicly available via peer-reviewed publication and IRBs themselves are made up of healthcare professionals, ethicists and local community leaders. The PanFab team strongly promotes the publication of both positive and negative results (see below). Members of the PanFab team include translational and clinical scientists with experience in the conduct of clinical trials.

Caveats and cautionary statements for medical professionals:

Much of what is described in PanFab involves medical devices regulated by the FDA; other devices, face shields for example, are not FDA-regulated but still must pass standards put forward by NIOSH, OSHA or TUV. FDA regulates Class I devices such as swabs and Class II devices such as respirators. Unless otherwise specified, none of the designs and methods described PanFab have been submitted for FDA review by the PanFab group and documents have not been subjected to formal peer review. They should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.

Caveats and cautionary statements for participants:

Many PanFab volunteers are putting a lot of time and effort into this and other aspects of COVID19 response. Please do not forget to care for yourself and your own mental and physical health! We have only partial understanding of what is unfolding around us and will inevitably be involved in many activities that do not succeed, either for technical, political or economic reasons. It is also increasingly obvious that many problems with the current COVID19 response (particular in the US) are failures of leadership, planning and vision - not technical failures - and thus we can expect institutions to be less than fully transparent. It is important not to become cynical under these circumstances. Citizen science is here for all citizens, not just for the leadership.

The role of scientific and engineering publications in PanFab activities:

The way in which scientists and engineers investigate and report their activities for the larger (international) community is via peer-reviewed publication. When you publish, you attempt to be as objective as possible, you subject your ideas to public scrutiny and you declare any conflicts of interest. Research papers are durable products that are also the basis of changes in Federal policy. It is the intention of the PanFab group to document as many of its findings as possible in a peer-reviewed format. For this reason, we will need to record whether members of the group wish to be authors on resulting papers: both unwanted inclusion and unintended exclusion are dangers.

We anticipate that multiple papers will arise through the efforts of PanFab members, based either on independent research or research covered in our forums. We encourage these activities and ask that authors send us links to papers, most of which are likely to be posted on preprint servers such as BioRxiv and MedRxiv, and to acknowledge the contributions of the Greater Boston Pandemic Response Consortium (membership found at panfab.org/consortium-members). In addition, PanFab coordinators intend to publish at least one paper involving as many PanFab members as wish to be included (and have actively participated in the forum as indicated by posting on Slack or other settings). We will actively solicit members for authorship on this manuscript in mid-April.