Greeting Everyone:

I am wondering how are medical device manufactures performing design validation for implants, in this case a class 2 device Vertebral Body Replacement device (intended for use in the thoracolumbar spine (T1-L5). Device has been tested to the required performance standards (design verification). FDA has approved 510K (As substantially equivalent) But I am unsure how to do design validation. Clinical or animal studies are not cost effective and have significant timeline constraints, I cannot find any computer simulation software program available. Any recommendations or comments you might have will be greatly appreciated.

Thanks for everyones comments

Maxwell,

Sorry I have not posted anything sooner. Honestly, though, I am not sure I have anything of interest to you.

Do you take X-rays of the piece you are going to simulate? How do you come up with dimensions for making your part?

Will this be stainless steel, and do you have information regarding rejection rates of the material?

Anyway, possibly you could team up with a local university that has some simulation systems, and graduate students just looking for such a program.

If you have the input parameters (the size to manufacture it) and the tolerance/ specification you have for making it, with a 3 D system they could perform some simulations to develop best case, realistic, and worst case scenarios. Then within your worst case, you could justify the rejection possibility and patient impact.

This may be totally not feasible, but thought I would give it a try.

Brad M
Thanks for the information, The device is made from titanium ELI and meets ASTM F136 standard specification for implant applications. We have defined the inputs and outputs, Fabricated prints with dimensions and tolerances established. The prototypes have been manufactured and tested to FDA required performance standards and the device has been reviewed and approved (510k) by FDA. It's the design validation that I am having issues with.CFR 820.30 (G) Design validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions.

.....shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions.

I was just thinking maybe you could do some simulation studies with the human body and the device. Some of those simulation labs are amazingly detailed and precise. At least you would have something to support that the device was properly designed for it's intended purpose.

As bad as it pains me to say this, it might be worth contacting some validation consultants for this area. I would also be interested in seeing what level of design validation occurs with knee/hip replacements.

Sorry I could not be more help.