FDA Guidance for Custom Medical Products (e.g. Printed Devices)

[mplishka]

Interesting guidance from the FDA.  It will cover 3d printing custom devices.

http://www.dicardiology.com/article/fda-changes-rules-custom-medical-device-exemptions?eid=323035710&bid=1562576

 

 

[Dr. Mike]

3D printing has huge potential in medicine. Traditionally identical devices were mass produced, but everybody's body is unique. So these standardized devices went into non-standardized bodies. As technology makes 3D printing cheaper and better, the trend will be for customized devices for each non-standard body.

[kopachini]

I just realized that I have opened new topic regarding materials for custom made implants.

My original post was:

 

Hi everybody.

As title says, what material do or would you prefer for 3D printing of custom made implants. I know that titanium is mostly used and surgeons are used to titanium  because all of osteosintetic material is made of it, but BIG minus is the PRICE of the print. I was considering Cobalt-Chrome/Cobalt-Chrome-Molibden alloy and/or Stainless Steel (316L), too, because of the very similar material properties (biocompatible, inert, MR compatible etc.) and lower price than titanium which is, unfortunately, big factor.

But compare to all of these metals and prices of their print, what about PEEK (which is FDA approved)? It cost much less than metals (around 400$ for 2 pounds), FFF printers are used to print it (if extruder is modified to heat up to 400*C) with great precision, it can be sterilized in autoclaves, it is biocompatible, inert, MR safe, very similar elastic modulus as bone...

And there is PMMA (bone cement) with similar properties as PEEK, but  it can't be printed (molds of implant are printed), exothermic reaction during polymerisation and risk of tissue necrosis, risk of pulmonary embolism...)?

 

Kind Regards,

Vjekoslav.

[DJB]

Hello everyone,

 

I just stumbled across this site and was surprised at some of the topics.  I actually work for a company that 3d prints metal parts for medical applications among others and we are ISO 13485:2003 certified.  We print in Titanium Ti64 and Ti64 ELI along with stainless steels (15-5 17-4 316L) Cobalt Chrome, Inconel, Aluminum and tooling steel. 

 

I am curious to hear about what the medical community thinks about us 3d printing custom implants as well as surgical tools.   I have always just done prototypes but now getting into the implants arena and very interested to see what the thoughts are out there.

 

Look forward to being part of the discussion

 

DJ Butenschoen

djb@gpiprototype.com 

[Dr. Mike]

In general, I think customized surgical implants and tools will be the norm in the future. The challenge now is clearly identifying applications for the technology, conducting adequate research to prove efficacy, and overcoming regulatory hurdles.