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Emerging Technology Series: The FDA Guidance for 3D Printed Medical Devices

  • September 4, 2018
  • KBA Attorneys
  • No Comments

As part of our focus on emerging technology series, we have covered drones a couple times and we have discussed 3D printing. This technology raises interesting issues related to product liability and personal injury lawsuits. This is particularly true with respect to medical devices.

We are medical device attorneys and therefore keep an eye out for development at the United States Food and Drug Administration (“FDA”). The FDA has increased its attention to 3D printing in recent years. When discussing 3D printing in recent posts, we noted that FDA approved a drug that involves 3D printing, SPRITAM, which treats patients suffering from epileptic seizures. We are now coming up on the one year anniversary of another important milestone in FDA-3D printing history.

In December of 2017, FDA has issued a guidance document related to 3D printing and medical devices. A guidance document “represents FDA’s current thinking on a topic. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.” This guidance document is limited in scope. It concerns “technical considerations specific to devices using additive manufacturing, the broad category of manufacturing encompassing 3-dimensional (3D) printing. The guidance defines Additive manufacturing as “a process that builds an object by sequentially building 2-dimensional (2D) layers and joining each to the layer below, allowing device manufacturers to rapidly produce alternative designs without the need for retooling an to create complex devices built as a single piece.”

The FDA gives a good overview of the current state of this technology with respect to medical devices.

“While many AM technologies exist, at the time of publication of this guidance, the most commonly used technologies in medical devices are powder bed fusion, stereolithography, fused filament fabrication, and liquid-based extrusion. Powder bed fusion systems rely on an energy source (laser or electron beam) to selectively melt or sinter a layer of powder, either a metal or polymer, which is then refreshed to create the next layer. Stereolithography systems use a vat of liquid material that is selectively cured using light, either through a laser or projection system, and create new layers by moving the build surface. Fused filament fabrication systems melt a solid filament at the point of deposition, after which the material solidifies in place, and new layers are created by moving the build surface away from the heat source. Liquid-based extrusion systems eject a liquid, which then solidifies (method of solidification could include light exposure, solvent evaporation, or other chemical process), and new layers are created by moving the build platform away from the deposition tip.”

Additive Manufacturing Create Surgical Instruments

This AM technology brings the promise of being able to create anatomically matched devices and surgical instrumentations. In other words, things that are specific to each individual, accounting for the unique curves and other features that set eac,h of us apart. Additionally this technology can result in the creation of complex geometric structures or shapes more easily than using existing technology. The FDA notes further that despite the promises, the unique aspects of the AM process and relative lack of experience and clinical history (use in living beings), pose challenges. Accordingly, FDA’s guidance specifically addresses “Design and Manufacturing Considerations (Section V) and Device Testing Considerations (Section VI).” FDA is similarly working to provide assistance on the drug side.

We expect to see more 3D printing involved in the pharmaceutical and medical device industries in the coming years. Thus, this will be an emerging area of product liability that we will be involved within for many years to come. In the meanwhile, we continue analyzing the legal implications of this emerging technology.