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.
LONDON (ICIS)–The true take off for 3D printing is on the horizon but a lack of machinery capable of production is holding the technology back, according to Evonik’s head of new 3D technologies.
Sylvia Monsheimer said that, while the company is happy with the growth it has seen in the 3D printing industry in the last 20 years, there is a lack of machinery capable of production available on the market.
Plastic recovered from discarded fridges is being re-purposed into a resilient material that can be used in the 3D printing of scale models and similar outputs. The development follows a partnership between two Dutch specialist, Coolrec, a subsidiary of Renewi, and filament manufacturer Refil.
Refil already makes a range of different coloured filaments from recycled car dashboards and PET bottles. Now it is taking the interior of fridges supplied by e-scrap specialist Coolrec to make High Impact PolyStyrene (HIPS) filament that has a neutral off white colour which is easy to paint or glue, making it a perfect material for the 3D printing of scale models. The filament comes in the two standard diameters of 2.85mm and 1.75mm and has successfully been tested on 3D printers.
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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.
With the rapid rise of the additive manufacturing sector, it has become increasingly possible for industry players to make spare and replacement parts in a cost-effective manner. What’s more, the sector lends itself especially well to the fabrication of parts for the customisation of existing products and equipment. As such, all parties in the supply chain need to be acutely aware of the very real risks of IP infringement in this evolving space, says Jason Teng, partner and patent attorney at leading full service IP law firm, Potter Clarkson.
As things stand, different considerations apply depending on the type of IP rights covering a particular part or a complex product that includes the part. For instance, the manufacture of a whole patented product would normally constitute patent infringement, unless certain exceptions apply such as private non-commercial use. On the other hand, the manufacture of a spare/replacement part for incorporation into a patented product could either constitute an infringing “making” of the patented product or a non-infringing “repair”, which would vary on a case-by-case basis. On this note, some guidance can be found in a 2011 Supreme Court decision in the Schütz v Werit case.
CECIMO believes the current 3D printing intellectual property rights framework is fit for purpose.
CECIMO, the European Association of the Machine Tool Industries, has said the European Parliament risks stifling 3D printing innovation by introducing premature regulatory measures to protect Intellectual Property.
The European Parliament recently released a non-binding resolution entitled ‘Three-dimensional printing: intellectual property rights and civil liability’, with 631 votes in favour, 27 against, and 19 abstentions. It called for sterner parameters surrounding IP infringements and has suggested a potential revision of the Liability and Intellectual Property Rights (IPR) regulatory framework for 3D printing within the European Union, and has also raised the feasibility of national copyright levy systems.
Gas turbines are complex components to manufacture, but additive manufacturing has been successfully utilized to accelerate design cycle times, reduce development test times, provide better test data and reduce the overall time to the release of the final component. It also allows for testing to be performed earlier, as early as the concept or preliminary design phases. This means that there is less likelihood that the entire component will have to be redesigned, as problem areas can be detected and eliminated early.
In a recent case study, a Siemens Energy SGT-A05 industrial gas turbine engine line was manufactured, and additive manufacturing was used for aerodynamic development testing within the preliminary design phase for boundary condition definition of new compressor static flow path components.
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.