3d Printing and Why Lawyers Should Care
| Publication year | 2019 |
| Pages | 28 |
by Bob Lambrechts
Additive Manufacturing refers to a process by which digital three-dimensional design data is used to build up a component in layers by depositing material. The term "3D printing" is increasingly used as a synonym for Additive Manufacturing. Instead of milling a workpiece from a solid block, for example, 3D printing builds up components layer by layer using materials such as metals, plastics, composites, pharmaceuticals and even human tissue.
As with any advance in technology, 3D printing gives rise to myriad legal issues. How, for example, will intellectual property rights be enforced if anyone with a 3D printer can create replicas of objects, such as sculptures and patented devices? Do 3D printed guns run afoul of U.S. federal law that prohibits firearms that are not detectable by walk-through metal detectors? And who will be held liable if objects created with 3D printing technology are distributed to consumers and other users, and those objects turn out to be defective and unreasonably dangerous? This article will provide an overview of a few of the major business sectors that are being impacted by 3D printing and the legal implications of this new technology.
BACKGROUND ON THE TECHNOLOGY
In August 1984, Charles Hull, co-founder and chief technical officer of 3D Systems (at that time, in Valencia, California), applied for a U.S. patent titled Apparatus for Production of Three-Dimensional Objects by Stereolithography, which was granted in March 1986.[1] Hull’s 1986 patent describes a process of photo-hardening a series of cross sections using a computer-controlled beam of light. Stereolithography utilizes an acrylic-based material known as a photopolymer. Expose the liquid photopolymer to an ultra-violet laser beam, and the polymer instantly changes phase to a solid piece of plastic making it possible to fabricate complex parts, layer by layer, in a fraction of the time it would normally take.
3D printing uses a machine to turn digital blueprints into physical objects.[2] For 3D printing, physical objects reside in digital form in .amf[3] format, or the older and more widely used .stl[4] format. These files “can be thought of as the object equivalent of a .pdf file—they are universally printable by 3D printers and allow objects to be transferred digitally around the world.”[5] As noted above, the 3D printing process starts with a digital file. The computer aided design (“CAD”) file may be created with a CAD program on a computer, producing a virtual 3D model of an object. The CAD design process replaces the need for prototypes allowing a designer to create a model, freely manipulate a design, and save it as a file.[6] In the alternative, a 3D scanner can create a CAD design by scanning an existing object.[7] Regardless of which process is used to create it, once a CAD design exists it can be distributed like any other computer file.
Until 2009 3D printing was mostly limited to industrial uses, but then the patent for fused deposition modeling, one of the most common 3D printing technologies expired.[8] As more and more manufacturers have entered the 3D market, what once cost hundreds of thousands of dollars suddenly became available for a few thousand dollars, and the consumer 3D printing market took off in 2009.[9] Tree-dimensional printer sales have been growing ever since, and as 3D printing patents continue to expire, more innovations can be expected in the years to come. It is estimated that over 455,000 3D printing units were shipped in 2016 and that 6.7 million units will be shipped globally in 2020.[10]The 3D printing industry has seen a remarkable 21 percent growth as the industry is expected to exceed $7.3 billion in revenues in 2018.[11]
Traditional manufacturers make the same standardized product to put on the market, but 3D printing allows products to be tailored to meet an individual’s specific needs, tastes, and measurements.[12] 3D printing is making unparalleled advancements in industries including healthcare, automobiles, aviation, construction and even firearms.[13] The impact of 3D printing in each of these five sectors is discussed below in greater detail to give context to the advances and challenges this technology is bringing forth.
AVIATION INDUSTRY
The aviation industry in Kansas employs over 77,000, roughly 4.1 percent of all jobs in Kansas, and the industry has an economic impact of $17-1 billion.[14] Aircraft design and construction is changing rapidly and to maintain leadership, Kansas industry must invest in innovation. 3D printing's suitability for complex parts, short production runs, weight reduction, and fewer tooling changes are reducing costs and turnaround times. 3D printing has enabled aviation companies to create complex components previously impossible with traditional techniques.[15] The capabilities of 3D printing fosters innovation while reducing costs and turnaround times in a complex, highly-regulated environment.[16]
Because of the limited number of parts fabricated in an aviation production run, the aviation industry is a prime candidate to benefit from 3D printing. The technology provides companies with the flexibility to print specific parts for short production runs without the substantial cost of tooling changes. While 3D printing has entered the aviation industry focusing on smaller-scale parts, it is possible that entire aerospace frames could be 3D printed in the future. This advancement is already underway in drones, such as the SoleonAgro.[17] Intended for biological pest control in agriculture, the drone was developed using 3D printing for rapid prototyping, testing, and design verification to reduce the cost of product development.[18]
There are challenges to further implementing 3D printing in the aviation industry. Aircraft components often need to be certified to meet rigorous standards and must undergo a First Article Inspection which is a design and design history verification and a formal method of providing a reported measurement for a given manufacturing process.[19] A First Article Inspection Report (FAIR) requires among other criteria, printer and third-party material qualification. The FAIR evaluation requirements, not only applicable to 3D printing, consist of comparing supplier and purchaser results by measuring the properties and the geometry of an initial sample item against given specifications, such as a drawing.[20] The rationale for this comprehensive testing of aircraft components is the need to meticulously document a process control methodology and the need to verify the stringent federal requirements for delivering a new product within such a heavily regulated space.
The FAA has understandably expressed concerns with 3D printing to include the potential for material defects in 3D printed parts which could lead to a part lacking in airworthiness; the unknown mechanical properties of metal 3D printed parts; a lack of understanding as to "failure modes" and their connection to key production parameters for 3D printed parts; and the susceptibility of 3D printed parts to environmental conditions.[21]Likely only with the passage of time and the amassing of performance data will the FAA come to acknowledge the acceptability of 3D printing technology.
AUTOMOTIVE
3D printing is no stranger to the automotive industry when it comes to both prototypes as well as finished parts. Among others, many Formula 1 racing teams have been using 3D printing for prototyping, testing and ultimately, creating custom car parts that are used in competitive races.[22]
3D printing also has the potential to revolutionize the auto repair industry, making it easier to obtain spare parts. 3D printing technology also allows automakers to afford-ably customize vehicles and develop stronger, more efficient, lightweight designs. It can simplify both complex and small production, enabling manufacturers to print a single component on demand. One machine can support unlimited product lines.[23] Before long, local auto shops may be able to print parts for repairs. In fact, for years Jay Leno has relied on a sophisticated scanner and 3D printer to replace obsolete parts in his collection of antique cars.[24]
HEALTH CARE
It is a good bet that no industry has embraced or benefited more from advances in 3D printing technology than the healthcare industry. The FDA has reviewed over 100 medical devices currently on the market that were made with 3D printers,[25] including orthopedic and cranial implants, surgical instruments, dental restorations, and prosthetics. Many of these products are customized to fit each patient. The FDA has also granted emergency exemptions for devices not yet approved.
In 2012, the FDA granted an emergency exemption for the implant of a 3D-printed trachea into a six-week-old infant.[26] A year later, the FDA again granted an emergency exemption for a man to have 3D-printed plates replace 75 percent of his skull.[27] Analysts from iData Research estimate that the 3D-printed trauma device market will be worth $8 billion by 2020.[28]
Pharmaceutical companies are using 3D printing technology to develop medications and the FDA has approved the first drug produced on a 3D printer. In 2015, the FDA approved Spritam®, a drug for treatment of epilepsy[29]The FDA website provides that "tailoring size, drug release profile and dosage form shape can be particularly useful for special populations with unique or changing medical needs."[30]In addition, the FDA provides that "children, for instance, may need special or smaller doses beyond what is conventionally available, or they may need unique dosage forms other than the standard pill, which can be difficult to swallow."[31]Due to certain illnesses or resulting from taking multiple medications older adults may have various...
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