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.
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.
“Following our series of studies – the most extensive to date on 3D printer emissions – we are recommending additional investments in scientific research and product advancement to minimize emissions and increased user awareness so safety measures can be taken,” said Marilyn Black, vice president and senior technical adviser at UL.
UL Chemical Safety and the Georgia Institute of Technology recently announced a body of research that explored the impact of 3D printing on indoor air quality. Following an in-depth, two-year research period with Georgia Tech, UL Chemical Safety found that many desktop 3D printers generate ultrafine particles while in operation, which may be a health concern since they are the size of nanoparticles and may be inhaled and penetrate deep into the human pulmonary system. The research also revealed more than 200 different volatile organic compounds, many of which are known or suspected irritants and carcinogens, are released while 3D printers are in operation.
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.
“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.
With 3D printing moving towards broader adoption many companies are now entering our market. One of these is Deloitte. The professional services firm that does everything from accounting to tax and M&A also wants to guide firms into the 3D printing world. We interviewed Vinod Devan, Product Strategy and Operations Lead at Deloitte Consulting to see what the firm’s plans are in 3D printing and how it hopes to help customers.
Why is Deloitte entering the 3D printing market?
Additive manufacturing (AM) is a critical component of the Industry 4.0 digital transformation.AM technology is finally at the point where companies are starting to realize significant, tangible, new value for themselves and their customers. Deloitte is making significant investments in 3D printing knowledge and capabilities so that we can advise and join with our clients as they revolutionize supply chains, product portfolios, and business models.
Indian law prohibits owning a firearm without a proper license. Similarly, the US law forbids the purchase of guns by convicted felons.
On May 6, 2013, a video surfaced on the internet showing a young man in blue jeans and a black polo shirt firing a single bullet from an off-white, plastic 380 single-shot pistol called “the Liberator”, fabricated by him with a Stratasys 3D printer bought on eBay. That young man was Cody Wilson – a Texan law student, who overnight turned into a cult figure and garnered headlines worldwide. After test firing, Wilson published the blueprints of the gun’s design online, which was downloaded in excess of 120,000 times in two days. Following this, the US Department of State clobbered a restraint order against Wilson and his company ‘Defense Distributed’ which was overturned in August this year, allowing him to once again freely publish designs of 3D printed guns and share the same with one and all on the internet.
These blueprints would potentially allow anyone with a 3D printer to make an untraceable, unregulated gun at home. The 3D blueprints are today also available on several CAD (computer-aided design) repository sites and can also be downloaded for free from torrent sites. Thirty seconds of googling are all one would need to fish out these files. It’s kind of creepy to envisage that in our country today, we have no clue as to how many of our citizens possess a 3D printer, how many of them have downloaded the blueprints of 3D guns and how many of them are in possession of 3D printed guns?