3D printing has advantages in terms of cost, manufacturing, design and process, as well as the ability for mass customization.
The reason why everything is not 3D printed at this time includes but is not limited to laborious post processing, limited build sizes, and unknown regulatory pathways in healthcare and other sectors like aerospace and even consumer goods.
When a 3D printed product fails or something goes wrong with it, there is a potential for litigation. The uncertainty surrounding these potential issues was the focus of a recent webinar hosted by Exponent with presentations from Judd Day and Richard Underwood from Exponent, and Stephen Myersfrom Irwin Fritchie. Presented here are some interesting brain teasers for the future of 3D printing regulation.
Personalized test subjects?
The idea of mass customization is great. Personally, as a runner, I look forward to the soon future when personalized shoes for your feet are no longer just for professional athletes (or behind a very large price tag).
Our current shoes come in discrete sizing. While this may not work for people that are a size 9.25-wide (and you can only get a size 9-wide or 10-narrow) it enables manufacturers to perform quality testing on all the available designs. When there are potentially numerous size specifications and design aspects of shoes, how do you perform quality testing?
Another example given in the webinar was helmets. Do you create tests based on ‘standard’ head forms for product validation? What is a standard head?
In the medical device field, custom devices are for medical cases rare enough that testing cannot feasibly be performed (i.e., there are not enough people with the disease or condition to facilitate testing). With custom devices, there is generally an accepted range of specifications for a certain design that are allowed.
This is a similar idea to what was discussed in the webinar; setting limits to how variable the design of a product can be as a way to enable validation testing. In this way, there are fewer design variables to be test.
Who is liable in case things go wrong?
Photo credit to Annie Spratt
Traditionally, the manufacturer had the most information on a product; the design, materials used, manufacturing process, delivery method to the customer, etc. The parent company may not deal with each of these steps but is normally still responsible for the product’s performance (For example, if I buy a X-brand computer from a secondary reseller and the computer fails I will be redirected to X-brand for service).
With the 3D printing, it is more likely that the designer will not also be the manufacturer.
There are increasingly more commercial 3D printer services and at-home printers; the designer is providing the code to make something and not necessarily connected to the final product. However, the source code/design is not the only factor that affects a products quality; materials, printer, orientation (more for anisotropic materials) and location of the part on the 3D printer bed, as well as post-processing steps must also be considered. One or more people/machines may be responsible for implementing each of these steps.
Because of a decentralized digital manufacturing work flow, liability issues become more complex.
Did you deliver a product or a service?
During the webinar it was highlighted that, in previous court cases, computer code was not considered a product. If the distribution and use of something is the same as a traditional product then it may still be considered a product in the future.
How regulatory bodies will work with this has yet to be fully determined and will likely depend on the product type and industry. An additional layer to the complexity is that product liability law is dependent on where an issue is filed as well as where the product was made.
In design defect litigation, a case is usually won when the risks associated with a design as a whole are found to be greater than the benefits, or an alternative design with minimal change could have made the product less risky. The case is primarily lost when the new design is marginally more effective in one aspect but far less effective in others. With 3D printing, the delineation of benefits gained and risks incurred will be much more complicated since new designs are much easier to implement. For additional info on design defect litigation here is a more detailed piece.
There are wonderful possibilities that are enabled with 3D printing and many of us just want to shoot for the moon with our new toolkit!
Potential litigation and necessary testing issues may seem like a school teacher imposing new rules to a wonderful game. However, understanding the issues and coming up with solutions will enable a wider spread adoption of 3D printing and decrease potential dangers (as well as a lot less finger pointing and/or fights if something goes wrong in the design or manufacturing process).