3DP/AM Revolution Is Also a Legal Revolution
Not since Henry Ford introduced the assembly line has there been such a watershed moment in manufacturing. Three-dimensional printing and additive manufacturing (3DP/AM) are rapidly expanding manufacturing capabilities and product commercialization. The freedom to create unique tradecraft from scratch has led to the wide use of 3DP/AM in disparate industries including jet engine manufacturing, medical devices, fashion, high efficiency tooling and even the preparation of food.
Poised to lead this movement are the medical device and aerospace sectors. The rapid response of 3DP/AM enables customized medical solutions feasible under both cost and scientific analyses. In aerospace, 3DP/AM dramatically reduces lead-times, tooling cost, and opens up new design possibilities. Despite the exciting potential applications of this technology, there are pressing legal and regulatory issues with respect to intellectual property and product liability. Companies that invest in this technical and creative opportunity, while preparing for inevitable legal and regulatory scrutiny, will be positioned for dramatic success.
Customization and the Freedom of Design
Thus far, the spotlight has been on implants formed from plastics and other bio-compatible material. In the past year alone, successful cranial, jaw, tracheal and hearing-aid implants have attracted significant attention, translating the science-fiction aspect of 3DP/AM to everyday life. Researchers around the world are regularly announcing tissues, organs, and surgical and teaching tools, as well as cardiovascular, orthopedic, prosthetic, and other devices generated by 3DP/AM.
There has been a lesser focus on metals, but metal additive manufacturing for jet engine manufacturers and air-framers is no less remarkable. In the traditional manufacturing sector, these advancements are also more translatable. Complex and highly efficient designs can now be realized with the help of additive manufacturing equipment that could not be manufactured using traditional techniques.
Dr. Rainer Hebert, head of the Pratt & Whitney Additive Manufacturing Innovation Center at University of Connecticut’s School of Engineering sees the application of this disruptive technology every day in real-world product development and manufacturing. He believes “greater opportunities will emerge if additive manufacturing technologies are combined with other innovations on the subtractive and 3D-scanning side of manufacturing.”
Dr. Hebert stressed that this technology is not just for the manufacturer with a billion-dollar R&D budget. Indeed, the recent launch of the National Additive Manufacturing Innovation Center (NAMII) in Youngstown, Ohio, and research hubs like UConn’s serve as catalysts for advancing additive manufacturing technologies beyond large aerospace or biomedical companies. Dr. Hebert is most excited “thinking about design, materials selection, and manufacturing—and the advantages that will emerge for those who will embrace and master those changes.” Although many companies lack the resources to capitalize on this technology today, they can still benefit from the growing availability of academic and consulting resources as they chart their path.
Navigating Uncharted Waters
Manufacturers can embrace the technology while protecting their intellectual property. Those serious about gauging the application and ramifications of 3DP/AM will want to consider their short- and long-term options for implementing powerful technology that may not always be used for noble purposes. How do you protect your patents and brands when someone else – a consumer, prosumer, or distributor – can control the manufacturing from a 3D scanner and 3D printer?
Resist the urge to declare 3D scanners and printers the world’s greatest piracy machine. Based on the scope of the product line and complexity of the brand’s needs, savvy business and legal teams should conduct patentability analyses, preliminary clearance reports, trademark analyses, and copyright analysis before exploring the opportunities of 3DP/AM. This groundwork will identify the products that translate best to 3DP/AM and examine anything currently in the market that may jeopardize the brand.
Manufacturers should also take into account that their products—including replacement parts—can be copied without authorization. As a result, they must adopt new strategies for product design and review the make-up and allocation of resources in their IP portfolios.
Disruptive innovation in manufacturing like 3DP/AM generates a concomitant disruption in product liability, raising many questions. The distribution channel from manufacturer to end-user will include entities the supply chain has never seen before. The approach to quality control, risk management, and consumer warnings must adapt. Manufacturing defects will again be a concern as more control passes from manufacturer to end-user. Ultimately, maintaining the integrity of the manufacturing distribution chain will require vigilance.
Perhaps looking at how the FDA may approach smartphone medical device applications provides a glimpse of the future. It has targeted the entities that create and control the software as the manufacturers of the app. Traditionally, manufacturers bear the exclusive liability for defects and compliance with regulations. However, the question, “Who is the manufacturer?” is now much more complicated. Besides software designers and programmers, manufacturers include the companies that develop the specifications for the apps and contract with others to perform the programming. In fact, the providers who link to a website may now also fall under the definition. Conversely, the FDA considers hardware manufacturers to be component manufacturers and they are not subjected to the same strict regulations.
If this analysis is extended to 3D printing, we can expect that every link in the chain may be designated as a manufacturer: that is, the design owner, the CAD software company, the company performing the 3D printing, the filament source manufacturer of titanium or nickel, and the prosumer/consumer could be identified as contributing to manufacturing and any associated product risk.
Like any opportunity, 3DP/AM comes with uncertainty. Risk should not deter companies from pursuing these technologies; delaying or ignoring this seismic shift is a far greater risk. The obstacles are simply problems to be solved before joining the revolution. Companies adopting these tools need to be aware, craft a reasonable plan for protection, and execute it with a legal team keen to the new issues. Analyzing the market, product lines and protections, as well as the transformative application potential of your products, is the first step.
About the authors:
Patrick J. Comerford is Special Counsel in the Products Liability Group of McCarter & English resident in the Boston office. He is the Founder and Head of the Advanced Manufacturing Practice Group at the Firm
Deborah M. Vernon, Ph.D. is a Partner in the Intellectual Property/Information Technology Group of McCarter & English resident in the Boston office. She assists clients in obtaining and enforcing intellectual property rights in both the U.S. and abroad. Her practice is focused on chemical and mechanical arts.
Maureen T.F. Reitman, Sc.D., is a Principal and Practice Director for Polymer Science & Materials Chemistry at Exponent, Inc in Bowie, Maryland.