By Lisa Larrimore Ouellette, Nicholson Price, Rachel Sachs, and Jacob Sherkow
Health systems worldwide are facing shortages of crucial medical supplies, including personal protective equipment (PPE), diagnostic testing components including kits and nasal swabs, and even ventilators or ventilator parts. Enter 3D printing. A growing network of hobbyists, small-scale makers, 3D printing firms themselves, and even larger companies with some 3D printing capacity are using the technology to help address ongoing shortages in the COVID-19 response.
What kinds of COVID-19-related products are being 3D printed?
3D printing, also called additive manufacturing, involves building a 3D form from the bottom up by adding one thin layer of material at a time. (Here’s a handy Congressional Research Service overview.) Many materials can be used, including plastic, metal, or resin. The printer is controlled by a computer which prints based on a computer-assisted design (CAD) file. 3D printers have been used for rapid prototyping or by hobbyists for years, but are more recently being used at larger scale.
3D printing is being used to create a host of products potentially relevant to COVID-19. PPE is perhaps the most common example; many people are producing the headbands of protective face shields; some are printing masks. Nasal swabs are also being printed in substantial numbers (the swabby bit at the end is a bristled resin structure, not cotton fibers like you’d find in a Q-Tip), and have been evaluated by, among others, Beth Israel Deaconess Medical Center. Printing has also been used for more complex components of medical devices, such as ventilator valves or splitters so that patients can share a ventilator—or even most of the components of emergency open-source ventilators.
How does the FDA regulate these 3D-printed products?
3D printing has some applications for drugs and biologics, but the examples above all fall under the broad umbrella of “medical devices” regulated by the FDA’s Center for Devices and Radiological Health (CDRH). In December 2017, the FDA issued guidance on the design, production, and testing of 3D-printed devices, while noting that the wide range of applications makes generalized guidance difficult. In general, a 3D-printed medical device is subject to the same regulatory requirements as the non-3D-printed version. Those requirements vary with medical risk: high-risk devices (e.g., artificial heart valves) are subject to a rigorous premarket approval requirement; moderate-risk devices (e.g., N95s with antiviral agents) only need a 510(k) premarket notification to show “substantial equivalence” to an existing device, and low-risk devices (e.g., tongue depressors) are exempt from 510(k) requirements.
As we have previously written, the FDA has relaxed regulatory burdens to address medical device shortages during the pandemic, including for diagnostic tests and N95 respirators, through Emergency Use Authorizations (EUAs). In its FAQs for COVID-19-related 3D printing, the FDA highlights the role 3D printers can play in addressing device shortages. And some EUAs could include 3D-printed devices, such as the March 24 EUA for ventilator tubing connectors and accessories or the April 9 EUA for face shields. The agency cautions, however, that some devices are not easily 3D printed and that “3D-printed PPE are unlikely to provide the same fluid barrier and air filtration protection as FDA-cleared surgical masks and N95 respirators.”
The FDA is also coordinating with NIH, the Veterans Healthcare Administration, and America Makes (a public-private partnership focused on accelerating 3D printing) to collect designs related to the COVID-19 supply chain and to connect 3D printers with healthcare providers in need of supplies.
Are there IP concerns regarding 3D-printed products?
Recently, some have raised the concern that patents might be used to limit 3D printing of medical device components important to tackling COVID-19. The (debunked) rumor of volunteers at an Italian hospital being sued for 3D-printing patented ventilator valves has been the basis of numerous calls for patent reform. We are unaware of any case of actual or threatened patent litigation delaying access to COVID-19-related technology. Nonetheless, it is worth noting that 3D-printing patented medical device components would be an act of patent infringement as a new “making.” Contrary to popular belief, there is no meaningful research exemption or public health emergency exception. The statutory exception under § 271(e)(1), which protects infringing acts “solely for uses reasonably related” to submitting information to FDA is also unlikely to immunize 3D-printers since the supplies being printed aren’t being “solely used” to submit any information to the agency. And, even assuming that the 3D-printed material is simply a component of a larger patented device, that may still constitute an act of infringement under a different section of the patent statute, § 271(c), which generally proscribes the sale of “a component of a patented machine” if it is “especially adapted for use in an infringement of such patent.” (It’s an open question whether use in a health care setting that’s then billed to patients or insurers would be a “sale.”)
But these legalities concerning infringement aside, the reality is that patent owners are unlikely to be able to block 3D printing of medical devices related to the pandemic. For one, patent holders may avoid suit altogether given that the median patent lawsuit lasts 2.5 years—hopefully by which point the COVID-19 crisis will resolve itself. Second, even without a judgment, a preliminary injunction is unlikely to be available to patent holders to stop accused infringers because the equitable factors—namely, irreparable harm, balance of hardships, and the public interest—are unlikely to tip in patent holders’ favor. Third, 3D printing presents some challenges to the traditional mechanics of patent infringement; Lucas Osborn at Campbell University has written a series of articles highlighting challenges such as the difficulty detecting and suing distributed infringers. And fourth, even if a patent owner could overcome these challenges, the backlash to the non-existent patent suit in Italy illustrates the substantial public relations risk a firm would face. So: while 3D printing patented medical materials is likely an act of patent infringement, it’s doubtful that patents will block providers seeking to alleviate the COVID crisis.
Beyond patents, there are also trade secrets. For 3D-printed materials, many companies guard their CAD files as such. But small components, especially simple ones like swabs, are easily reverse engineered, a defense to claims of trade secrecy misappropriation. In other cases, the component may be so simple that simply eyeballing it yields how it can be 3D-printed. If so, the instructions to 3D-print the component may not be a trade secret to begin with because they would be “readily ascertainable.” Thus, while trade secrets can—and do—protect materials helpful for combatting COVID-19, like patents, infringement suits are unlikely to afford much relief.
Can 3D-printed products be reimbursed in the same way as more traditionally produced products?
Prior to the current crisis, billing systems had been developed for at least some 3D-printed products. For instance, in 2019, individual billing codes were established for individually-prepared 3D-printed models to assist surgeons in planning for operations. Although payment systems for 3D-printed medical products are still in their early stages, it does not appear that traditional reimbursement models have posed substantial barriers to the acquisition of 3D-printed products for addressing the pandemic. In part, this may be because many of the people producing COVID-19-related products are looking to donate these materials to clinicians rather than being paid.
In other cases, the types of products being made would not commonly be reimbursed individually. As we discussed last week in our blog post on the shortage of N95 respirators, PPE is often not reimbursed on a per-unit basis, and may be folded into other hospital charges. In this crisis specifically, states have begun to access pools of federal emergency funds enabling them to purchase supplies including PPE, lessening the need for formal reimbursement codes for 3D-printed versions of typical products.
Similarly, the Paycheck Protection Program and Health Care Enhancement Act, signed into law last week, includes $25 billion to expand state and local testing capacity, including “the manufacturing, procurement and distribution of tests, testing equipment and testing supplies.” Healthcare facilities encountering issues regarding traditional reimbursement for new 3D-printed swabs could seek to access these funds.
More generally, the traditional models of reimbursement for drugs and devices may apply less forcefully in the context of COVID-19, given the state-level coordination efforts and large national injections of funds into the testing and treatment process. It is possible that reimbursement may pose a barrier to the access and distribution of 3D-printed products, but as yet it does not appear to have created obstacles.
What are the limits to the use of 3D printing in this context?
3D printing can be especially useful in a few different situations where the traditional supply chain isn’t working well. Sometimes, a sudden ramp-up in supply is needed, such as the scenario in Italy concerning replacement ventilator valves. Sometimes the supply chain for products breaks down; one of the world’s largest manufacturers of nasal swabs is located in Lombardy, at the heart of Italy’s outbreak. In either case, 3D printing can nimbly help increase capacity, with the added benefit that the printing capacity is often local to the need.
But while 3D printing can help address supply chain shortages, it is largely a stopgap measure (at least for now). Most importantly, some 3D printed products are clearly emergency products not suitable for regular or long-term use. Take respirator masks. There’s a reason they’re hard to make; the melt-blown fabric filters catch tiny particles, and 3D-printed masks simply don’t provide the same protection. The 3D-printed materials are often more porous, making them both less protective and harder to disinfect.
There are also concerns about the supply chain for 3D printing itself. 3D printing requires its own supplies—the powders or plastic or resins that are made into the finished product. And of course 3D printing requires 3D printers. There are a lot of them out there—around 600,000 consumer-grade printers were sold in 2018 alone—but 3D printing generally can’t operate at the same scale as traditional manufacturing. 3D, as currently practiced, is largely an ad-hoc network of small-scale makers who are filling in for gaps in the supply chain—a decentralized, relatively uncoordinated response. It is inspiring, and it is a tremendously useful stopgap. But for sustained national and international response, a more coordinated and industrially based effort will be required.