If you follow 3D printing or medical news at all, you’re likely familiar with the many ways that 3D printing is changing medicine for the better. 3D printed anatomical models are helping surgeons better plan and execute surgeries, while 3D printed implants are being customized to patients for better comfort and longevity, just to name a couple of the major advancements of 3D printing in healthcare. While it may seem like things are happening quickly, however, the solutions don’t just appear and magically change the world; there are hurdles that must be addressed before these solutions can be truly widespread, particularly the dreaded R word – regulation.
In March last year, Materialise became the first company to receive FDA clearance for diagnostic use of its 3D printed anatomical model software. The company then launched an FDA-approved certification program that allows 3D printer manufacturers to have their products tested and validated for use with Materialise’s Mimics inPrint software, which converts medical images into 3D print-ready files.
3D-printed devices such as surgical instruments and implants offer treatment advantages for ASCs and hospitals but also entail liability risks if the device isn’t ‘manufactured’ properly, according to CNA Vice President of Underwriting Ryann Elliott.
The FDA defines a manufacturer as “any person who designs, manufactures, fabricates, assembles or processes a finished device.” Therefore, the FDA may be authorized to regulate and inspect healthcare facilities creating medical devices through 3D printing.
Facilities should implement these five strategies to mitigate risks:
1. Tracking. Implement procedures to track all 3D-printed products brought into the facility. Identify which physicians have the appropriate credentials and privileges to use the products.
Regulation is important in any industry, as are standards which ensure that every player in the industry is delivering products and processes up to a certain quality and consistency. There’s a fine line, however, between healthy regulation and unnecessarily strict standards that stifle innovation. At the beginning of July, the European Parliament adopted a non-binding resolution entitled “Three-dimensional printing: intellectual property rights and civil liability,” with 631 votes in favor, 27 against and 19 abstentions.
The resolution is largely a positive one in favor of 3D printing, pointing out the benefits of the technology for society and the economy and the need for new rules supporting faster certification of parts. That’s undoubtedly a good thing; one of the factors that holds up additive manufacturing from becoming a more prevalent production technology is the issue of getting bogged down in the part certification process. However, the resolution also calls for the European Commission to consider a revision of the Liability and Intellectual Property Rights (IPR) regulatory framework for 3D printing in the European Union.
The resolution starts by pointing out that 3D printing – also known as additive manufacturing – could be of great benefit to the European economy.
But the document mainly looks at the legal issues the technology raises. For example, it says more public awareness is needed to protect IP rights relating to 3D printing and calls on the European Commission to consider issues around civil liability. It even suggests the Commission could set up a specific liability regime.
According to the Parliament, the EU may have to adopt new, and amend existing, laws to take account of 3D printing. With the report claiming that Europe can play a leading role in additive manufacturing, it will be interesting to see how quickly the Commission moves to tackle the issues raised.
Hornick, who has been generous with his expertise in sharing his thoughts with us through previous interviews as well as thoughtful articles, has built up a strong background in intellectual property (IP) as it impacts the business of 3D printing. As an IP lawyer and highly regarded authorand speaker, Hornick has a well-established reputation as a thought leader; it was a pleasure to finally meet him face-to-face during the AMS summit last week. At the summit, Hornick spoke on a panel entitled “The Future of 3D Printing in Medical Markets” and moderated one called “Additive Medicine and Dentistry: Investment Industry and VC Perspective.” During these presenstations and in subsequent conversation, Hornick brought to the table a wealth of ideas regarding the future of 3D printing, as well as the customization and democratization of design and manufacturing allowed for through this advanced technology.
Day one was entitled 3D Printed Medical Devices. The opening keynote speaker was Lee Dockstader, Director of Vertical Market Development at HP Inc., whose thorough presentation set the stage for the entire conference. Dockstader wants to develop additive manufacturing in industries including Aerospace, Automotive, Medical, Dental, Life Sciences, Consumer and Retail.
Scott Dunham, Vice President of Research at SmarTech Markets Publishing, gave a comprehensive presentation that was particularly informative on the large production volumes occurring with certain non regulated low entry barrier products. The consensus estimate is that 300,000 low barrier medical devices are now 3D printed per day. Dr. Roger Narayan, Professor of Biomedical Engineering at UNC, gave a detailed presentation on the technical and regulatory aspects of additive medical markets. 3D printing has the potential to revolutionize business models and provides access to custom and functional prosthetic and orthotic medical devices.
FDA today offered a clearer picture of how it plans to regulate the 3D printing of medical devices – including in non-traditional settings such as medical facilities and academic institutions.
“In order to help ensure the safety and effectiveness of these products, we’re working to establish a regulatory framework for how we plan to apply existing laws and regulations that govern device manufacturing to non-traditional manufacturers like medical facilities and academic institutions that create 3D-printed personalized devices for specific patients they are treating,” FDA Commissioner Scott Gottlieb said in a statement.
Gottlieb also highlighted new guidance that clarifies what the FDA in the U.S. would like to see in submissions for 3D-printed medical devices. The guidance includes FDA regulators’ thinking on device design, testing of products for function and durability, and quality system requirements when it comes to 3D printing. FDA is describing the document as a “leapfrog guidance” because it offers initial thoughts on technologies emerging in the industry.
3D printing is revolutionizing manufacturing practices with wide-ranging uses from medical devices to automobile parts. But the ready availability of 3D printers, combined with the ease with which computer-aided designs (CADs) can be shared, makes 3D printing particularly vulnerable to easy reproduction and distribution without prior permission of designers.
In a recent article, Professor Peter Menell of the University of California, Berkeley and Professor Ryan Vacca of the University of Akron School of Law argue that regulating 3D technology successfully will depend on a combination of the industry’s strategic approach to enforcement and the willingness of courts to amend existing copyright laws to fit the particularities of 3D printing.
Over the past year, my email inbox has been consistently pinged by law firms advertising seminars and workshops that promise to help medical professionals understand what is noteworthy for 3D printed medical products, ranging from regulatory to IP concerns. Some of these have been quite alarming, seeming to indicate that as disruptive as 3D printing promises to be, there must be a corresponding disruption to how we work on regulatory compliance to protect our assets.
But if we step back and look at the actual Food and Drug Administration (FDA) communications, the pace of adoption of 3D printing and real intersections of 3D printing and business processes, it appears that little has changed. The only disruption is when 3D printing revolutionizes a commercial process.
The European Parliament, the second largest democratic electorate and largest trans-national democratic electorate in the world, met this week for the second Additive Manufacturing and 3D Printing European Conference, where it highlighted the pressing need for a common European strategy to advance 3D printing research, materials, education, market value and overall technological development.
At the 2015 Additive Manufacturing and 3D Printing European Conference, the need for a common, trans-national strategy became obvious. Now, at the 2016 Conference, high-level representatives from companies, institutions, and the machine tools sector gathered once again to put a plan into action.