Since its advent more than 30 years ago, the 3D printing market has grown, and will continue to expand for a myriad of reasons, including sustainability and reduced energy consumption. As the process, including the applicable technology, becomes more cost-effective, its widespread use continues to increase across many industries, such as aerospace and defense, energy, architecture and construction, automotive, food/culinary, consumer products and health care.
However, with innovation comes legal risk throughout the entire product lifespan, from the manufacturer and supplier of the printer and materials, the purchaser of the printer, the designer and seller of the prototype product and the creator of the computer-aided design (CAD) blueprint, to the printer of the product and the distributors and sellers. As a result, there are many potential product liability pitfalls in this emerging field. For example, a digital design file could be defective or become corrupted upon download. A CAD blueprint or digital design could have a defect. The material used to create the 3D printed product could be deemed defective and there is always a possibility of human error when operating a 3D printer.
Laws and guidelines regarding the manufacture, sale and use of 3D printing and 3D printed products are evolving slowly, with discussions regarding possible IP/copyright protections, particularly involving use of proprietary CAD files. Regulation of weapons, specifically guns created by 3D printing is also a well-discussed issue. In the health care/pharmaceutical/medical device arena, the Food and Drug Administration (FDA) has regulatory authority over 3D printed medical devices and pharmaceuticals. In fact, the FDA already has approved hundreds of 3D printed devices to market as well as a number of 3D printed pharmaceutical products.
Further, in recognition of increased industry use of the technology, the FDA issued a Draft Guidance document for 3D printed medical devices in 2016, and in December 2017 issued another Guidance document to assist industry and staff. This guidance points out a number of helpful considerations for companies using additive manufacturing, including:
- Recognition of Dimensional Specifications. Dimensional specifications of a final device will be different than the design created. Pixelation of features in a design must be considered and accounted for, so that once a full-sized device is created, it can successfully and reliably exist and accomplish its function.
- File Compatibility. Creating a product using additive manufacturing usually involves interaction between differing software packages, which requires file compatibility across different applications. The American Society of the International Association for Testing and Materials (ASTM) offers a standard file format that can be purchased on their website, astm.org/Standards.
- Layer Thickness. Layer thickness should be documented and reflect awareness of the bonding and curing of each layer, the surface texture of the device and its sensitivity to power fluctuations.
- Build Path Consistency. Consistency in the build path of identical devices and components is essential if a difference in the path could affect the device’s performance. The ‘build path’ refers to the direction in which the delivery system sweeps as it creates the device, layer by layer.
- Starting Material. Careful documentation of starting material is essential because in the additive manufacturing process, this material may undergo significant physical or chemical changes.
- Labeling. For patient-specific products in particular, additional labeling is recommended and should include a patient identifier, the device’s use, and the final design iteration or version used to produce the device.
The FDA’s guidance document includes many more issues that can reduce a manufacturer’s potential product liability concerns when using additive manufacturing. A touchstone of the FDA’s guidance is careful documentation at all steps of the complex design and manufacturing process. The guidance describes the overall process of additive manufacturing and encourages manufacturers to apply quality systems to all steps of the manufacturing process. The FDA also clarified that any recommendations it is making in regards to 3D printing and 3D printed products are likely to continue to evolve as the technology develops.
When using emerging technology such as 3D printing, it is important for manufacturers to remain competitive. As always, however, it comes with legal and regulatory considerations that should impact decision-making and the implementation of new processes or protocols.