Medical Device Hardware Out of Box Failure Rate

1 Reply

Medical Device Hardware Out of Box Failure Rate

Posted by Michael Webb on Jan 11, 2019 8:10 am

Doing some bench marking and appreciate your thoughts.  What is best in class OOBF rate for medical device hardware first 5 years after release, and after 5 years when manufacturing is more mature?  I know 0 is the target, but what is realistic?  Thanks

Re: Medical Device Hardware Out of Box Failure Rate

Posted by James Shore on Feb 13, 2019 9:31 am

This is a great question!  

The reliability of a device/lifetime of a device should be set in the design phase of the program, at least before the release to commerialization.  The type of device and its use varies so I'm not sure how to answer it without knowing the type of device.

If you are not already a member of the ASQ Biomedical Division, please join. If so, you can post your question on this page:  https://www.linkedin.com/groups/1027567/

Regards,
Jim Shore
Chair, Biomedical Division 2019