What to Do When Standards Don't Exist

It is a fact that technology typically evolves faster than standards. A regulatory specialist provides advice on what to do when developing a technology not covered by a specific standard.

Brian Buntz

Regulation can sometimes lag behind the development of novel medical technologies but standards can be even slower. "Stent grafts were approved way before standards related to them existed," said Brandon Davis of MED Institute at MD&M West on February 9.

An example illustrating this is ASTM F2942-13 for stents. It was published in 2013 but stent makers have been running these tests for many years.

In cases like this, it is up to the manufacturer to come up with a methodology for the test. There are a few strategies that medical device professionals can use.

The first is to get directly involved with the appropriate standard committee. "There are several advantages to working with committees--the main being you can collaborate with folks who are struggling with the same issues you are. It also reduces regulatory risk," Davis said. "The main disadvantage is it takes time. It can take two to five years to get a new standard approved."

(MED Institute is at Booth #962 at MD&M West, February 9-11, 2016 in Anaheim, CA.)

Another option is to modify a current standard. Medical device companies can reach out to standard organizations if they realize that a given standard may be updated and proactively make suggestions on how to update it.

Finally, the third strategy is to establish a new non-standard test methodology. This method entails some risk because the regulatory bodies haven't seen the test methodology, and the standard organizations are likely not familiar with it either. "But you can validate the non-standard test methodology to gain confidence that the method is appropriate, that the data generated are reliable and repeatable, and to develop a critical assessment of the method," Davis said.

It is also a good idea to validate the repeatability and the reproducibility of your test protocols when working towards developing new standards, Davis said. The former can be ascertained by evaluating the variability under tight controls. Robustness, conversely, can be determining, for instance, by measuring how sensitive a test is to operator skill.

Davis also recommended doing calibration checks. "An example of this is stereo microscope calibration. We learned that, with our microscopes, if you zoom in and zoom out and zoom back in, there was a problem with calibration because the knobs were a little worn out," Davis said.

To summarize, developing novel medical devices requires more than just solid engineering but also learning to get a sense of where the appropriate standards are headed and, if necessary, playing an active role in developing those standards. 

(MED Institute is at Booth #962 at MD&M West, February 9-11, 2016 in Anaheim, CA.)

Brian Buntz is the editor-in-chief of MPMN and Qmed. Follow him on Twitter at @brian_buntz. 

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