Recently, my colleagues Colin Kelly, Caroline Gieser, Michael Polatsek, and I thought about the role that additive manufacturing (3D-printing) is playing in today’s brave new world.  As COVID-19 continues to cause critical manufacturing shortages while also increasing demand for emergency medical and protective equipment, the government and private industry are coming together with the help of 3D-printing technology to tackle both problems simultaneously. Manufacturers large and small are arming themselves with 3D-printing to produce much-needed medical and protective products that are in high demand but short supply. The list of critical COVID-19-related products being manufactured through 3D-printing include nasal swabs, ventilators, face shields, gowns, masks and even respirators. Yet additive manufacturing is still a relatively new process and certain technical and practical limitations remain. Indeed, as the U.S. Food and Drug Administration (FDA) noted in a March 26, 2020, communication, “3D-printed PPE are unlikely to provide the same fluid barrier and air filtration protection as FDA-cleared surgical masks and N95 respirators.”

Up until very recently, discussions about the risks associated with 3D-printing have been mostly hypotheticals reserved for academics and product liability lawyers, but COVID-19 has now raised the question: Will well-intentioned additive manufacturers (large and small) face personal injury claims for helping address COVID-19-related spikes in demand for medical and protective equipment?
Continue Reading COVID-19: Will 3-D Printing Medical Supplies and Protective Products Expose You to Liability?

It’s not hard to imagine a time in the not-too-distant future when physicians start using 3-D printing technology to produce tools for their robotic surgery systems that are based on existing copyrighted models but customized to address patient-specific needs. But what happens when the copyright holders of those existing models start attributing depressed bottom lines

YouTube is a great educational resource. By watching a few videos, one can learn just about anything, from how to tie a fancy knot to how to assemble an internal combustion engine. The website also features numerous videos concerning various do-it-yourself medical procedures. Recently, my colleague Amy Foust and I viewed a fascinating video about an inexpensive surgical robot built by Designer Frank Kolkman using off-the-shelf components and easily accessible technologies like 3-D printing and laser cutting. This got us thinking: Is do-it-yourself surgery using homemade robots really a good idea?
Continue Reading The Do-It-Yourself Surgery Genie is About to Escape the Bottle

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?
Continue Reading Five Steps Robotic Manufacturers Can Take to Limit Liability When Using 3-D Printing