Clinical robotics and other emerging technologies are profoundly reshaping the way in which medicine is practiced. One of those technologies, additive manufacturing—also known as 3-D printing—is helping usher in a new era of innovation and customization unlike anything that we have ever seen. But with this promising innovative technology also come many novel challenges, as both the industry and the law try to keep up with new developments. As 3-D printing becomes more widely adopted in the clinical robotics arena, an important question arises: What steps can traditional manufacturers take to lessen or eliminate their potential liability when using 3-D printing in the production process?
Earlier this month, Stephen Feller from UPI.com reported that scientists at Brigham Young University are taking cues from NASA and, with the help of a 3-D printer, are adopting origami techniques to scale down certain surgical tools that are used with Intuitive Surgical’s da Vinci Surgical System. According to Mr. Feller, the scientists’ ultimate goal is to shrink surgical tools to the extent that they would require such small incisions that they could heal by themselves without the need for sutures.
But the benefits of 3-D printing are not limited to such quicker and cheaper prototyping capabilities. This revolutionary technology holds many other promises for the medical field. For example, 3-D printing will allow manufacturers to more quickly and easily build complex devices with fewer moving parts. Additionally, because this manufacturing process permits the fabrication of a wide variety of different types of objects without significant upfront investment, the cost of product customization nearly disappears, making it more feasible to develop patient-specific products that will offer an added level of safety and efficacy. Finally, because 3-D printing permits smaller manufacturers to produce products of a caliber that was once the exclusive domain of larger manufacturers, it will allow easier marketplace penetration, thus incentivizing ingenuity.
Yet as with every emerging technology, there is still great uncertainty as to how liability will be allocated among the various market actors. Although many forward thinkers have already theorized about how 3-D printing may affect the various theories of liability available against manufacturers incorporating 3-D printing into their production process, very few have actually suggested concrete steps that manufacturers can take to lessen or eliminate their liability. And so, given all this uncertainty, what is a manufacturer to do? I suggest the following:
- Where traditional supply chains exist, manufacturers should seek defense and indemnification from CAD file designers;
- All manufacturers should establish quality control mechanisms and protocols that are narrowly tailored to their respective 3–D printer products and take into account the specific failure modes associated with this production process;
- Manufacturers who modify existing CAD files should institute clear design modification protocols and maintain comprehensive design history files documenting the extent and exact parameters of the modifications. This will be helpful when a question arises as to whether purported injuries or harm came about as a result of the original CAD design or the manufacturer’s modifications;
- When dealing with products that lack clear differentiation (such as screws or other interchangeable parts), manufacturers should consider adding tracers that will allow for differentiation from competitors’ products. This could include anything from physical microscopic marks, to miniature RFID chips, to unique chemical tracers embedded in the bulk material. In the event of litigation, such tagging would permit positive identification that could show that an allegedly defective product was not produced by a particular manufacturer; and
- Manufacturers should proactively engage with insurers to take into account the unique risks posed by the 3-D printing process.
While such steps are not guaranteed to completely eliminate liability, they do constitute a wise first step in the right direction. And as the law plays catch-up and more cases make their way through our courts, it is likely that those manufacturers who were forward-thinking before litigation ensued will fare much better than their less proactive peers.