The recent inaugural Additive Manufacturing Strategies summit, hosted with SmarTech Markets Publishing, brought together experts in medical and dental 3D printing alongside legal and business leaders to share thoughts on the future of additive manufacturing in human healthcare. The event, rich in expertise, filled two days with insightful presentations and conversations in Washington, D.C., allowing for a unique opportunity to network and learn from leading minds in technology and regulation. When we initially announced the summit back in September, one of the first names added to the agenda was one familiar throughout the legal and 3D printing fields: Finnegan Partner John Hornick.
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.
From Charles Goulding at 3dprint.com
I had the privilege of attending a two-day Future of 3D Printing in Medicine and Dentistry conference on January 22nd and 23rd in Washington, D.C. at the Army and Navy Club. The Additive Manufacturing Strategies summit was sponsored by SmarTech Markets Publishing and 3DPrint.com.
3D Printing Medical Devices
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.