FDA Regulations (or Lack Thereof) of 3D Printed Medical Devices
$1.6 billion is estimated to be invested in 3D printing in 2015. More staggering is that the amount of investment is predicted to escalate to $13.4 billion by 2018. Indeed 3D printing seems to be the future of manufacturing. To date, the FDA has approved 85 3D printed medical devices for production.
The production of 3D printed products generally involves designers, software engineers, manufacturers, and distributors. However, each of these parties operates without specific regulatory guidance with respect to the 3D printing process. Currently, the FDA has opted to regulate 3D printed medical devices in the same manner that any other medical product would be regulated. See fedscoop.com/how-the-fda-regulates-3-d-printed-devices. Unfortunately, 3D printing requires software specifications and material specifications that are stricter than the typical specifications of a traditionally manufactured device.
The FDA has provided little guidance on the development of 3D printed products or the limits within which software developers should work when creating 3D printable product digital files. Most importantly, the FDA has not addressed the question, “Who is the manufacturer?”
Consider a scenario in which Medical Device Co. designs a prototype of a novel orthopedic implant. Software Co. is then hired to create a digital file of the prototype. The digital files are sold to Hospital Co., who prints the implants on site and on demand. Prior to delivering the digital file to Hospital Co., Software Co. is hacked and the digital file is corrupted. Unaware of the hack, Software Co. delivers the corrupted file to Hospital Co. Next, during a fitting for the implant, a clinician at Hospital Co. modifies the digital file to accommodate the special needs of the patient. An implant is then printed on site at Hospital Co. using the modified digital file. Unfortunately, the modified product lacks the durability of the originally designed product. Additionally, Hospital Co’s. stock of powder for the 3D printing process has been contaminated resulting in a finished product that lacks the strength required for the implant. The product later fails, resulting in severe injury to the patient.
Hospital Co. has operated without specific guidelines from the FDA on how to maintain 3D printing materials or the limits within which a clinician can modify the design of the implant. Software Co. has operated without specific guidelines for developing and maintaining digital files. Lastly, under current FDA regulations, it is uncertain who should be considered the manufacturer of the implant. A defendant to product liability is required to be “engaged in the business of selling such a product.” Restatement Second of Torts §402A(1)(a) (1965). Despite the involvement of Software Co. and Hospital Co., the seller of the product could be considered Medical Device Co. Additionally, Software Co. and Hospital Co. have not violated any FDA regulations despite the mistakes they have made. Despite the lack of involvement in the failure of the device, Medical Co. Device could be held responsible for the product’s failure.
This is a scary scenario for medical device companies since much of the 3D printing process may be out of their control. A bit of foresight could prevent disaster down the road. Given the uncertainty surrounding 3D printing and the eventual uses to which 3D printed products will be put, it is imperative that medical device companies contract with their customers concerning such issues as product production quality parameters, limits on modification of the digital files, security of the files, operator training, indemnification, and insurance requirements. While it may be possible to contract away some of the liability, it is especially important that medical device companies consult counsel and continue the careful practices that the company applies to its normal non-3D printed products.
In the above scenario, Medical Device Co. may mitigate its damages by explicitly holding Software Co. and Hospital Co. responsible for breaches of security. Likewise, by placing restrictions on Software Co.’s and Hospital Co.’s ability to modify the digital files, at least some of the damages may be passed on to Hospital Co. and Software Co. Explicitly regulating Hospital Co.’s retention and use of materials used to print Medical Device Co.’s products could also prevent the contamination of the powder materials and, once contamination occurred, shifted additional liability onto Hospital Co.
Medical device companies require specialized advice and guidance concerning design, protection, manufacture, and sales of their 3D printed products. To discuss the necessary protections that your company may require, please contact an Ice Miller LLP Additive Manufacturing Practice Group member.
This publication is intended for general information purposes only and does not and is not intended to constitute legal advice. The reader must consult with legal counsel to determine how laws or decisions discussed herein apply to the reader's specific circumstances.