By Matthew Jacobson, Reed Smith LLP
Last month, legal practitioners, industry, and academics gathered at The Legal, Regulatory and Business Conference on 3D Printing to discuss the legal, regulatory, and business issues that arise when products are manufactured using 3D printing or additive manufacturing techniques, rather than traditional manufacturing methods.
During the conference, 3D printing was described as the digital revolution, the fourth industrial revolution, a game-changer, and a disruptive innovation. Although the conference focused on all different types of 3D-printed products and uses, it is safe to say that the printing of medical devices falls under each of these descriptors, and may comprise some of 3D printing’s most innovative uses.
During the conference, several themes, or “lessons,” developed, which are important considerations for medical device companies currently in the 3D printing space, or those thinking about venturing into it.
Developing one set of 3D printing standards and test methods that can be applied to 3D-printed medical devices around the world is helpful because it provides continuity and ensures that devices are safe, reliable, and of good quality.
The American Society of the International Association for Testing and Materials (ASTM) implemented an international committee on additive manufacturing technologies in 2009, which goes by its committee name: F42. The Committee’s membership has steadily increased since that time, and is now at approximately 400 members. The ASTM standards focus on several different categories, including general standards (e.g., terminology, test methods, safety), process and equipment standards, application-specific standards (including medical uses), feedstock material standards, and fished part standards. The standards for 3D printing are built off of existing standards to the extent possible, and modified for 3D printing when necessary.
The International Organization for Standardization (ISO) also has a committee devoted to 3D printing, appointed in 2011: Technical Committee 261 Additive Manufacturing (ISO/TC 261). Twenty-two countries participate in this initiative, including the United States, and nine countries observe the developments. ISO and ASTM partnered to develop a common roadmap and organization structure for 3D printing standards, with the ultimate goal of creating one set of worldwide standards. The American National Standards Institute (ANSI), which is the U.S. representative to the ISO, has partnered with America Makes to coordinate the development of industrywide 3D printing standards in the U.S. This knowledge will likely be helpful in creating the ISO standards.
Creating one set of standards for 3D printing is ideal, but it does not come without challenges. Other organizations are simultaneously developing standards, which creates the risk of inconsistencies and duplication. Additionally, because medical devices are regulated by each country, one set of standards may not fit within each country’s regulatory framework. For example, even if a unified, global standard is established, that does not mean the U.S. Food and Drug Administration (FDA) has to recognize it.
Adhering to standards also does not alleviate product liability concerns. Compliance is an incomplete defense. If the standards are adopted by a statute or FDA, for example, then some states may find that compliance with these governmental regulations shifts the burden of proof that the product is not unreasonably dangerous, but does not mandate dismissal. While compliance with industry standards may not be a total bar to recovery, if a manufacturer does not comply with the standards, then the plaintiffs’ bar will raise issues that the manufacturer should be held liable simply for not conforming to industry standards. Thus, standards — and more importantly, compliance with those standards — adds another tool for manufacturers to use in potential litigation.
Despite these challenges, the collaborative effort to create a single, cohesive set of published standards and test methods for 3D printing will certainly help guide the technology and legal issues going forward.
To date, FDA has approved more than 100 medical devices, and one prescription drug, that involve 3D printing. Regarding 3D printing of medical devices, FDA has been working to provide a more comprehensive regulatory pathway, while at the same time making sure these products are safe and effective.
Although FDA has not yet changed its current regulatory pathway, it issued in December 2017 a guidance for 3D printing medical device manufacturers, Technical Considerations for Additive Manufactured Devices. The guidance is a “leap-frog” guidance intended to share FDA’s “initial thoughts regarding technologies that are likely to be of public health importance early in product development.” While the guidance is not meant to be a comprehensive document to address all regulatory requirements, it highlights the technical considerations and recommendations for design, manufacturing, and testing of medical devices that include at least one fabrication step using 3D printing.
The guidance is split into two categories of considerations: (1) design and manufacturing, and (2) device testing. Both sections overlap in substance, and the device testing section provides strong recommendations regarding what a device manufacturer should include in a premarket submission for a device that uses 3D printing. The guidance should help 3D printing medical device manufacturers make their way through FDA’s 510k pathway.
The FDA has yet to issue any guidances or regulations on premarket approval (PMA) of 3D-printed medical devices, point-of-care (POC) manufactured devices, or bio-printed devices. Those products would be novel, and would likely change FDA’s existing regulatory framework.
As it relates to 3D-printed medical devices, or really any 3D-printed product, the law surrounding product liability is still relatively unknown. However, the current body of product liability law will serve as a guide to suggest what could stay the same, and what set of rules may need created. As more hospitals, physicians, and patients buy into this technology, legal issues will undoubtedly be created, especially if POC manufacturing (i.e., printing medical devices at hospitals or in a doctor’s office) becomes more routine.
Currently, there is an open issue whether computer-aided design (CAD) files or other software used in the creation of 3D-printed medical devices will be considered “products.” If they are considered products, then the companies involved in creating the design files or software may be subject to strict liability type claims. Even if they are not considered products, FDA could conceivably treat them as “labeling,” since FDA’s definition is broad. The FDA could require CAD files to include the same warnings and other information that must accompany the physical device. The companies involved with creating the design files and software should be aware of these potential new legal issues.
POC manufacturing also could lead to FDA considering hospitals or physicians as “manufacturers,” subjecting these care providers to the inspection, quality control measures, and record-keeping requirements already faced by traditional medical device manufactures. Traditionally, doctors and hospitals have been viewed by courts as service providers. But, if they become “manufacturers,” they may be subject to strict products liability. There may also be a blurring of lines related to who is required to provide warnings to the patient, and what defenses may be available going forward.
To date, because all 3D-printed medical devices on the market have been cleared by FDA as “substantially equivalent” to prior, non-3D printed devices, they have not had an impact on product liability preemption. Once 3D-printed devices receive a PMA from FDA, preemption will depend on whether FDA has imposed any “requirements” on 3D printing.
Unless and until FDA adopts 3D printing regulations, the imposition of FDA “requirements” will be by way of FDA’s consideration of premarket applications, the specifications of which become “requirements” after FDA approval. Thus, to potentially shield the 3D printing process from state-law litigation, manufacturers of such devices should include specifications for the 3D printing in their PMA applications.
Although FDA has not issued any guidance or regulation related to bio-printed medical devices, and that technology has yet to reach market, for product liability purposes, human cells and tissue have traditionally not been considered products under the Restatement (Third) of Torts. The Uniform Commercial Code (UCC) also treats blood or tissue as a service — not as a product. Historically, states have blood shield laws, finding that the sale of blood is a service for public policy reasons. This may change as bio-printed medical devices are determined to be products by either FDA or the courts.
Testing also becomes a concern, since 3D-printed medical devices can be customized. Customization of products makes it nearly impossible to test every product’s shape and size, because 3D-printed medical devices could theoretically be printed in an infinite number of specifications. Testing may have to occur at the materials stage, if it cannot take place when the end product is created. FDA also requires that certain data be stored, so a product can be remanufactured later for testing purposes, which may raise issues of confidentiality and cyber-security.
As 3D-printed medical devices become more mainstream, courts will likely be faced with these product liability issues, which will help create a body of law and more predictability going forward.
To mitigate risk, a 3D printing medical device manufacturer needs to identify the risks. Many questions need to be asked to determine these risks, such as: Who is doing the printing? What is the product? Where is the product being manufactured or printed? Who designed the product?
Identifying risks early can help with potential liability concerns if a third party claims they have been injured by a 3D-printed device. Lawyers, engineers, senior executives, and anyone else involved with decisions in the company 3D printing medical devices should partner early to help identify and mitigate potential risks.
Medical device manufacturers also should adhere to established and emerging manufacturing and safety standards. Again, compliance with standards is not a complete defense, but it will help avoid the pitfall that a manufacturer did not comply with known standards.
Medical device manufacturers using 3D printing technology also should have an open dialogue with their insurers early on. These products’ long-term strength and durability are a concern, especially for medical devices, which by their nature have safety concerns. The raw materials used, and how they are altered by the printing process, also is a concern. Underwriters likely will require proof that these issues have been addressed, and that quality control and postmarket surveillance measures are put into place — maybe beyond what FDA requires.
To the extent that doctors and hospitals are operating on-site 3D printers and are concerned with strict product liability, or liability extending beyond professional negligence, they should enter into indemnification agreements or other contractual agreements with others in the supply chain. Hospitals and doctors also may consider creating separately incorporated entities to perform 3D printing of the devices.
Regulations, standards, and best practices for 3D-printed medical devices will be slow to develop and achieve consensuses. However, the technology will continue to outpace these controls. Medical device manufacturers in the 3D printing space should be aware of inadequacies and uncertainties in the law so they can protect themselves from liability. Discussing the legal, regulatory, and business issues early, whether in collaborative groups — such as this conference — or within a company, will help alleviate potential problems before they develop.
About The Author
Matt Jacobson is an associate in Reed Smith LLP’s Life Sciences Health Industry Group and a member of the firm’s 3D Printing taskforce. He focuses his practice primarily on product liability litigation for medical device companies. Matt can be reached at email@example.com