Technology is advancing in leaps and bounds, with almost dizzying speed. Technological advances can bring great benefits, but sometimes the pace of development outstrips planning for liability issues. It can be difficult, and essential, to anticipate and minimize risks from implementing new technology in a production process. A relevant example of this involves liability issues in 3D printing.
Charles "Chuck" Hull invented 3D printing in 1984, barely 30 years ago, while working for a small business that manufactured coatings for tables using ultraviolet lamps. The first 3D printer was invented in 1992, and in 1999, the first 3D organ was created. Just ten years later, in 1999, "do it yourself" kits for 3D printers were entering the marketplace. A few years after that, the first 3D printed car and robotic aircraft were created, and 3D printers capable of using multiple materials appeared. By 2014, the first 3D printed robotic exoskeleton appeared, followed, in 2015, by the first FDA approval of a 3D printed prescription pill. It is clear that 3D printed consumer products will only continue to become more widely available.
Among the products currently being 3D printed for consumer use are shoes, foods, prescription pills, prosthetics, body parts, jewelry, automotive parts, and construction materials. As the technology continues to improve, this list will grow much longer.
First, computer aided design system software creates a 3D design of a product. Next, the design is converted into an electronic format that the 3D printer is capable of reading. Then the materials to be printed are loaded into the 3D printer either automatically or by hand. The printer receives the electronic file, reads it, and prints the object. The object is removed or dispensed from the 3D printer, at which point it may be further refined by hand or by traditional mechanical means.
There are definite advantages to the use of 3D printing as a prototyping tool. It allows individuals and companies to innovate more rapidly, by being able to see and touch a three-dimensional model of a prototype rather than a drawing. By the same token, being able to examine an object in three dimensions allows designers and engineers to identify design flaws earlier in the process. 3D printing also allows for the customization of products for large groups of consumers.
These advantages come, naturally, with risks. These include product liability risk: who owns the printed object—the owner of the material, the owner of the template, or the owner of the printer itself? Who is liable for a failure of the object?
There are technological risks as well. If you are printing an object, do you own the software or the design template for it? If not, who does? If you do own the software, have you considered cybersecurity issues? If the software is stolen, the thief could counterfeit and market inferior, even dangerous, goods. This could lead to litigation in which your company would likely become embroiled. It is essential to plan for the protection of your designs and formulas.
Other concerns include operations issues, such as adequate training of printer operators and ensuring an adequate supply of materials. Naturally, there can be supply chain issues, as with any product. If you cannot rely on a steady supply of the materials you need for 3D printing from one supplier, do you have alternatives?
Last but not least, risks to individuals and the environment must be considered. Some materials being used in 3D printing may be toxic; are handlers sufficiently well-trained to avoid unnecessary exposure? Is exhaust being properly vented? What about the heat printers can generate? How will waste materials be disposed of?
There are many companies involved in the printing of a single 3D item: the producer of the printer, materials, manufacturer of the product and retailers. Who is liable for a defective or injurious product? It's critical for each company involved in the production of 3D printed products to establish contractual risk transfer controls to clarify liability issues. The risks of 3D printing, and the process of mitigating those risks, will evolve along with the technology.