- FDA approved software?
3D printing is an idiosyncratic, software based technology. Idiosyncratic means that typical 3D additive manufacturing systems rely on different software programs, from multiple vendors and have an absolute requirement that they all talk to each other.
We’ve seen this movie before.
Patient imaging software, design manipulation software, digital point clouds and meshes, machine-readable files—different standards, coordinates and parameters.
So, what happens when there are the inevitable file conversion errors?
The FDA’s answer is to ask manufacturers to verify the final 3D product critical attributes and performance criteria as part of the software validation process.
And, any software changes anywhere in the process flow would require revalidation.
The FDA is also asking companies to archive and maintain final printing device files and store all 3D printing/AM-specific information so that the information can be retrieved in case…
- Validating a moving target.
The FDA is asking 3D device producers to validate their device geometry, dimensions, material characteristics, mechanical properties AND how the 3D/additive manufacturing process affects them.
The FDA is also asking suppliers to validate parameters, process steps, and raw material properties—which is like non-3D production requirements.
One major difference will be when there are process parameters which are specific to 3D additive manufacturing trigger a need for revalidation—like software updates or changes.
Other triggers include: changes in material (e.g., supplier, incoming material specification, reused powder, new formulation), material handling, device spacing or orientation changes, changes to the software workflow or physically moving the machine to a new location. With traditional manufacturing machines, moving to a new location is a huge effort. With desktop printing, it’s an event that could occur almost routinely.
- Labeling “Henry’s Implant”.
Does Mother Nature need a label? Allograft implants, for example, are “labeled” for what they are. Bone is bone and is intended to be used as a structural implant and bone void fill. Logically simple and obvious.
With regards to patient-specific and anatomically matched 3D implants, the FDA is asking suppliers to create a patient-specific label.
Labeling, suggests the FDA, should have a patient identifier, intended use (e.g., left distal femoral surgical guide), and some descriptor of the final design iteration or version used to produce the device.
In addition, the FDA is suggesting an expiration date for a patient-matched device label. That expiration date, says the FDA, can be driven by the patient imaging date or the design finalization date—since, of course, tissues change over time.
Or patients may experience events between the time of imaging and surgery (e.g., additional trauma) which would affect the ability of the implant to match and perform as intended.
Therefore, the FDA is recommending that 3D suppliers add a precaution to the device label which says that the patient should be surveyed (by the physician? Clinic? Hospital?) for potential anatomical changes prior to the procedure.
