DNV GL, a global certification and risk management firm, has released a new 3D printing service specification document aimed at supporting additive manufacturing in the oil and gas industry.
Specification DNVGL-SE-0568 defines DNV’s additive manufacturing qualification scheme and provides details on how to obtain and retain a number of the company’s 3D printing-related certificates. This includes certificates that endorse facilities and digital manufacturing services, and certificates that qualify manufacturers, build processes, 3D printers, parts, and personnel.
The document was developed in accordance with industry standard DNVGL-ST-B203, which DNV previously created for metallic components in the energy sector. As such, the specification is ultimately intended to help the industry in adopting metal 3D printing in a safe and efficient manner.
The maritime sector is one of the more overlooked segments in 3D printing, with only a handful of companies really taking advantage of the opportunities there. A new business involved in 3D printing for naval uses has made itself known, Austal Australia, who, along with its partners, AML3D (ASX:AML) and Western Australia’s Curtin University, has 3D printed an aluminum personnel recovery davit. The device has been verified by DNV, the world’s largest classification society at its Global Additive Manufacturing Technology Centre of Excellence in Singapore.
According to international and naval specifications, Austal, AML3D and Curtin University produced a three-meter-long crane, also known as a davit, designed for personnel recovery. The assembly was then tested to support over two times its intended working load. This was followed by non-destructive and destructive testing. The testing process included microanalysis of the microstructure of the aluminum parts, with mechanical and corrosion properties compared to those of traditional marine grade materials.
Honeywell Aerospace, the aerospace division of conglomerate Honeywell, has received a Federal Aviation Administration (FAA) certification for its first 3D printed flight-critical engine component. The part in question – a #4/5 bearing housing – is a key structural component of the ATF3-6 turbofan engine found in the Dassault Falcon 20G maritime patrol aircraft. The part is already in production and has been installed in an operational Falcon unit, with dozens more expected to be printed by the end of the year.
Jon Hobgood, Vice President of Manufacturing Engineering at Honeywell Aerospace, states: “This is a major milestone for Honeywell because it demonstrates the maturity of our Additive Manufacturing operations and paves the way for us to print more certified, flight-critical parts in the future. It also is a major win for the additive industry, as flight-critical parts face heavy scrutiny and high standards for qualification and installation on aircraft, but this shows it can be done.”
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.