So Im testing out a new printer...

[bigj1972]

IS there an issue (with regard to patient safety) from a workflow standpoint? Curious to know how you will determine if the material has been cured to the proper level so that biocompatibility is not compromised- this is what concerns me about the future of 3D printing in medical applications, people disregarding testing/analysis to ensure their process meets/exceeds acceptability standards to save some $$.

Sadly that philosophy has been abandoned since insurance write-offs.

 

[Foggy_in_RI]

At Formlabs we do validation and regulatory submission quite a lot with 3rd party and internally manufactured biocompatible resins. If there is not complete workflow validation with the printer manufacturer in coordination with the resin manufacturer it is no longer a biocompatible validated part or appliance.

If someone wanted to do their own validation it costs tens of thousands of dollars for the testing and the documentation is crazy AND with all that you need to submit it to the regulatory body (FDA or EU Cert). It is not easy.

It really only makes sense to use a 3D printer that has biocomp validation and workflow for the resin you want to use or know that anything outside of the validated hardware or workflow is off label (non-biocomp) and you should be ready for that potential risk.

Some people are not worried about the risk but, last point here, photopolymers that are not made correctly can be very toxic...

I hope this is helpful!

Yea, makes perfect sense. Good to know that there are some manufacturers out there trying to lead horses to water and work with a system that is validated. Patient safety should be above all else IMO.

 

[JMN]

FDA 's Technical Considerations for Additive Manufactured Medical Devices

https://www.fda.gov/media/97633/download