James Beck is the senior life sciences policy analyst at Reed Smith. James is specialized in product liability, personal injury, especially in very large and very complex cases. Active in law for over thirty years he has been involved in cases U.S. District Court for the Eastern District of Pennsylvania, the U.S. Court of Appeals, Third Circuit and the Supreme Court. He is involved in mass torts, many amicus curiae briefs he is an award-winning expert in his chosen fields who writes often about the law. Over the past few years, James has taken an active interest in 3D Printing, especially with regards to product liability. He is part of Reed Smith’s 3D Printing team who take an active interest in all things printed. Reed Smith itself is a 1500 lawyer law firm with 28 offices around the world and over a billion dollars in revenue. It is both nice and significant when people like that take an active interest in our industry and technology. We interviewed James to find out more about 3D printing and the law, specifically product liability.
As a result, Sigma Labs will enable in-process quality monitoring for additive manufacturing systems at the MTC’s National Centre for Additive Manufacturing through its software; the company will also participate in MTC’s member-sponsored programs with a focus on qualification and certification of the additive manufacturing process.
“With Europe at the forefront of many innovative and major developments in the metal AM industry, we believe this agreement, our second major research alliance with a European center of excellence, holds great promise for us and the future of AM,” said John Rice, CEO of Sigma Labs.
If a group of people was asked about the legal concerns associated with 3D printing, most would likely mention 3D printed guns. But the moral and legal debate the technology raises is much broader
If a group of people was asked about the legal concerns associated with additive manufacturing, also known as 3D printing, most would likely mention 3D printed guns. More specifically, the fear that nefarious individuals will print undetectable firearms in the privacy of their own home for nefarious purposes. In fact, as recently as this past summer, a U.S. Senator introduced draft legislation to prevent just such an occurrence by criminalizing attempts to proliferate the software blueprints for guns.
3D printing is not a young technology per se. The basic technology has been around for decades, but it has experienced a resurgence of innovation over the past couple of years. There are many different methods for 3D printing, but most involve the use of computer-aided design software (CAD) to instruct a digital fabricating machine that extrudes materials, via a layering pattern, to form objects. The technology is relatively unlimited in the materials it can print with, and in the complexity or size of the objects. 3D printers range broadly in cost and use from the industrial to home-based, and even to child-oriented devices. Notably, 3D printing is likely seeing this resurgence because of the expiration of foundational patents in the field that previously prevented too much innovation.
The use of 3D printing is becoming more common in the US Air Force’s supply chain for its fifth-generation aircraft. In December 2018, a metallic 3D printed part was installed by 574th Aircraft Maintenance Squadron maintainers on an operational F-22 Raptor during depot maintenance at Hill Air Force Base, Utah.
Robert Lewin, 574th Aircraft Maintenance Squadron (AMXS) director said, “One of the most difficult things to overcome in the F-22 community, because of the small fleet size, is the availability of additional parts to support the aircraft.”
The use of 3D printing is growing mainly because it gives maintainers the ability to acquire replacement parts on short notice without minimum order quantities. This not only saves money, but also reduces the time the aircraft is in maintenance.
A special interest group of the Radiological Society of North America (RSNA) has posted a set of guidelines, suggesting standard approaches for 3D printing in healthcare.
Recognizing the need for evidence-based recommendations in the sector, these guidelines have been developed over a period of two years, in review of over 500 recent papers published on the topic.
As the abstracts states, “The recommendations provide guidance for approaches and tools in medical 3D printing, from image acquisition, segmentation of the desired anatomy intended for 3D printing, creation of a 3D printable model, and post-processing of 3D printed anatomic models for patient care.”
This is the second of a two-part conversation with Gary Gereffi, director of the Global Value Chain Center at Duke University, on the future of global supply chains. In the first piece, we looked at the impact that protectionism is having on global value chains. Today, we focus on the impact of technology and the changing U.S.-China relationship.
BRINK: You’ve talked about how we should be thinking of value chains and supply chains in regional rather than global terms. Why?
Gary Gereffi: In complex industries, no single country has the capabilities to produce all of the parts of a product. If you take something like an automobile that has about 20,000 parts, the most efficient industries are actually set up on a regional basis. For example, the U.S. automobile industry is really a North American industry, where U.S. companies are very tightly intertwined with suppliers in Mexico, Canada and even Central America to form a regional supply chain that can produce a very large share of the components needed.
A new Additive Manufacturing (AM) Process Simulation solution for predicting distortion during 3D printing was announced by Siemens (Frankfurt, Germany). The product is fully integrated into the company’s end-to-end Additive Manufacturingsolution, which assists manufacturers in designing and printing useful parts at scale.
Building on Siemens’ comprehensive digital innovation platform and the Simcenter portfolio, the AM Process Simulation solution uses a digital twin to simulate the build process before printing, anticipating distortion within the printing process and automatically generating the corrected geometry to compensate for these distortions. This simulation is paramount for constructing a “first-time-right” print and necessary for achieving the efficiencies required of a fully industrialized additive manufacturing process.
Contributing to the company’s Additive Manufacturing Execution System (AMES) & Additive Workflow Software, the Post Processing work management and scheduling tools are designed to optimize downstream manufacturing processes within a 3D printing supply chain.
“With dynamic routing and smart scheduling algorithms, Link3D aims to drastically improve the operational efficiency of additive production, particularly for OEM’s looking to adopt series production,” said Vishal Singh, Co-Founder and CTO of Link3D.
3-D printing famously endured a “hype cycle” circa 2012-2015, when popular media took note of the technology and ran with it. Common headlines of the time dubbed 3-D printing a technology right out of Star Trek while many consumer publications and tradeshows (including mainstay CES) cried out for placement of a 3-D printer in every home. This straight-out-of-sci-fi solution would let kids make their own Christmas presents! Rockstars became brand ambassadors. 3-D printing was The Next Big Thing.
Until it wasn’t.
The crash followed and it hit hard, with the resulting whiplash changing the headlines: suddenly 3-D printing wasn’t a savior, it was “dead.” Kids didn’t know how to design their own toys to make, parents had problems calibrating print beds and cleaning material jams and the consumer craze fizzled. With many a token Yoda head landing in trash cans, 3-D printing was laid to (popular) rest.
According to product liability law in the European Union, producers of products are subject to strict liability if products are defective and this leads to violations of certain legal interests (life, body, health, privately used objects). Persons other than producers are only liable under additional conditions.
“Producer” is therefore a key term in product liability law. If products are manufactured using 3D printing, the roles existing in the conventional value chain (supplier-producer-dealer-user) may change. Wholesalers and retailers may not be part of it, but other players may be added, such as the creator of the CAD file that contains the individual commands for controlling the 3D printer, and the person printing out the end product (a private or commercial user or an additional service provider). Product liability law – this applies to Germany, but equally to all other EU Member States – is based on the conventional value chain, however, and contains provisions which, unmodified, do not take account of these changed roles. For reasons of correctly offering incentives (those who are able to prevent or minimize risks should be given incentives to do so, within economic reason), but also for considerations of fairness, a broad interpretation of the term “producer” is therefore advisable. On the other hand, it seems appropriate to limit the liability of the persons so included to areas that they are controlling.