The urge to help in times of crisis is often countered by harsh realities, and this dichotomy is coming to light as the additive manufacturing (3-D printing) industry continues to churn out ideas and designs for aid in the fight against the spread of COVID-19. On-demand manufacturing made possible through digital manufacturing technologies such as 3-D printing is providing stop-gap supplies in this time of need, especially for personal protective equipment (PPE) and other medical equipment in short supply.
Community response is high, but also in short supply is often the knowledge of exactly what will help, and how and where to deploy that help. 3-D printing random designs found online might feel helpful, but if those designs don’t meet usage criteria or aren’t produced in satisfactory environments, ultimately it’s often just a waste of plastic. Fortunately, the 3-D printing community is learning important lessons in appropriate crisis response and leaders are emerging among industry participants.
More fortunately still, oversight is also emerging at a quickening pace.
The US FDA has been engaged with the additive manufacturing industry for years now, working actively with industry participants for outreach and direct involvement.
“What I really want to accomplish, and think we’ve built into our program, is this outreach we’re building with the industry. To make sure we can foster innovation in a way that is beneficial for everybody, and that the FDA is helping to advance things rather than reacting,” FDA senior research engineer Lieutenant Commander (LCDR) James Coburn, the lead for a core FDA 3-D printing research facility, told me in a 2018 interview shortly after the FDA released guidance on Technical Considerations for Additive Manufactured Medical Devices.
The FDA is a Gold Member of America Makes, the National Additive Manufacturing Innovation Institute. America Makes and the FDA are now partnering, they announced this week, “to help ensure the additive manufacturing industry can effectively and safely meet the needs of America’s health care workers on the front lines of the Coronavirus crisis.”
3-D printing work from the VHA Innovation Ecosystem
While many industry partnerships have arisen to provide aid, this one will prove pivotal in the use of 3-D printing technologies through the connection of manufacturers and healthcare personnel to meet specific needs for designs that meet medical standards.
On the heels of America Makes’ initial announcement of its partnership with the FDA, the latter released further insight into regulatory efforts and expanded collaboration. The FDA, the Department of Veterans Affairs (VA), the National Institutes of Health (NIH), and America Makes have formed a COVID-19 response public-private partnership. The FDA, VA Innovation Ecosystem, and NIH 3D Print Exchange will be sharing data and coordinating on open-source medical products for pandemic response, working with America Makes to connect those doing the 3-D printing with those healthcare providers in need.
“FDA recognizes that many stakeholders are interested in designing and producing 3D printed devices during the COVID-19 public health emergency. We are also aware that stakeholders often do not know what device designs to choose or how much to print,” the FDA notes.
To that end, important connections will be able to be made more easily between those who can do and those who have need. The FDA is addressing specific 3-D printing questions in a thorough FAQ with both historical perspective and insights into COVID-19-specific matters.
America Makes' flow chart of responses with the FDA, VA, and NIH to coordinate COVID-19 response
The VA Innovation Ecosystem and America Makes have both created sites to connect 3-D printing providers with healthcare personnel. For its part, the NIH 3D Print Exchange offers a model repository for COVID-19-related designs. Importantly, this collection contains only “authorized, validated, or otherwise tested designs that can be used by manufacturers to fill gaps in the supply chain.”
The conversation will continue as all these entities provide ongoing information as the situation progresses. Tomorrow, Monday, March 30, at 12pm ET, America Makes Executive Director John Wilczynski will offer a briefing on the repository in a one-hour informational webinar entitled “Review of the COVID-19 Capabilities and Needs Repository.”
Oversight and connections from both public and private entities is ramping up for quick, appropriate response in manufacturing during this pandemic. Such oversight will ensure that the right goods are made in the right way by the right teams to get to the right healthcare providers — and hopefully help to see viral spread go right down.
