Thanks to the global availability of additive manufacturing and 3D printing (3DP) and to the easy sharing of 3DP designs, a teenager in Iowa with a 3D printer can print face shields based on a design uploaded only minutes earlier by an engineer in France. Indeed, in only a few weeks, the world has seen the 3DP community come together and quickly produce items – like face shields – that are desperately needed in the fight against COVID-19 and that would take weeks or months to manufacture using traditional approaches. Medical equipment has been in such short supply that the CEO of Massachusetts General Hospital called on those with 3DP capability to help make masks for his hospital’s staff.
In case any doubt remained, these recent activities show that 3DP has advanced far beyond a plaything for home hobbyists and is now a globally distributed tool for quick-turnaround manufacture. These recent activities also provide an opportunity to consider the 3DP community at large and also raise important legal considerations for those with 3DP capabilities.
Citizens can contribute at an individual level. In a 21st-century version of a community garden, citizens with their own 3DP systems (e.g., at-home 3D printers) can essentially grow protective gear for use by medical workers. This empowers individual citizens to contribute to their communities’ needs with the items that are most needed simply by downloading a set of shared 3DP printing instructions to their home printing device.
Groups can contribute at a community level. At a second level, groups of citizens with 3DP design knowledge have collaborated on designs for 3DP parts and have quickly placed those parts into production. As one example, after a hospital in Brescia, Italy, was faced with a shortage of necessary ventilator valves (which normally cost $11,000 each), a group of volunteers responded by delivering a 3D printer to the hospital and designing and printing new valve components in only a few hours. Social media groups with thousands of members collect, vet and post 3DP printing instructions for needed medical products, and even the National Institutes of Health has posted 3DP printing instructions for certain medical items.
Institutions can contribute at an industrial level. Institutions are also repurposing their 3D printing capabilities, as schools and colleges are able to switch over from printing student projects to making face shields, with the switch taking place in only a few hours. In this way, corporations that possess 3DP capabilities that are not used or needed for the corporation’s traditional products can quickly pivot from manufacturing their traditional products to manufacturing products that are more urgently needed.
Matchmaking and incentivizing. In an effort to speed design and delivery of needed items, various industry groups have undertaken efforts to match needs with 3DP capacity. Private individuals have likewise organized design competitions for medical products, including the Co-Vent19 challenge, a global effort to design a rapidly deployable ventilator.
Takeaways. The rapid proliferation of 3DP products and designs raises a number of legal issues for those in the 3DP community and for those who are impacted by 3DP activity.
Are those who print products based on downloaded designs committing infringement? A designer who posts their design for community use in a time of crisis is unlikely to later accuse community members of infringement, as public opinion does not favor those seen as trying to profit from a crisis. At the same time, those making 3DP parts should, as always, be mindful of intellectual property rights, as intellectual property rights may – even unintentionally – be incorporated into crowdsourced designs.
Who owns a 3DP design? This question can be difficult to answer, as some 3DP designs are the product of input from many individuals. So long as all contributors agree, a design can be freely distributed – but if not all contributors agree, a design could in theory be held up by a contributor who objects. For this reason, it may be worthwhile to determine who contributed to a given 3DP design and to confirm that all contributors agree on how the design will be distributed and used.
Are product designers surrendering intellectual property rights by posting their designs online? The answer to this is “sometimes – yes,” as a public disclosure of a technology can impact the innovator’s ability to secure future patent rights to that technology. Those who have developed a 3DP product or design would do well to consider some form of intellectual property protection (e.g., provisional patent application, copyright or design patent) for their technology so as to protect future rights in that innovation, even if the designer does not intend to enforce those rights at the present time.
Will those who lack 3DP capabilities be left behind? Those with 3DP capabilities can pivot quickly from making automotive parts to making medical equipment and to implementing successive designs for that equipment in only a few hours. Those who lack 3DP capabilities and rely on traditional techniques are unable to quickly update their product line and are thus unable to participate in quick-pivot opportunities. Further, those who rely on traditional manufacturing can be more susceptible to supply chain disruption, while those who utilize 3DP need only the plastic feedstock for their 3DP systems and do not need molds or the other supplies used in traditional manufacturing.
Will those who make or sell 3DP parts for COVID-19 applications be subject to normal product liability in these times of crisis? 3DP parts can be produced and distributed quickly, and sometimes do not undergo the usual testing regimen for medical devices, which raises the question of manufacturer liability for these quickly made parts. The Department of Health & Human Services recently issued a notice regarding exceptions from liability for products that are considered “countermeasures” to COVID-19, so those who make or sell 3DP parts for COVID-19 applications may wish to consider whether such parts qualify under this notice.
Bottom line. The 3DP community’s response to the COVID-19 crisis confirms that the quick manufacture of new products is key to responding to the challenges of today’s world and can even be lifesaving. At the same time, the relatively non-traditional paradigm of 3DP activity still faces the very traditional legal issues of intellectual property and product liability. For this reason, those who engage in 3DP activity should take the opportunity now to consider the intellectual property, product liability and other implications of their work.