Postmarket Surveillance - Medical Device Design: Innovation from Concept to Market - page 297

This quirk of human nature is just the same with our products. When the medical devices
regulations discuss PMS they actually force us to look in a negative direction by using terms
such as vigilance and complaints . However, now that we are clever designers we can turn
things to our advantage. Instead of only using the PMS structure to collect details of faults,
etc., let us use it to collect details of good practice and items of excellence in our products.
Doing this we not only learn from our mistakes, we learn from our successes too.
For example, your clinical end-users may be telling your sales staff how the “knob” is just
right. When they are in a panic the knob is just the right size and feel to work how it is
supposed to. If this is the case why not use this design for all of your other knobs? Certainly,
if this piece of information is not captured then you will never get to know.
You have probably spotted the issue. In the event of a complaint or a hazard the end-user
will contact you directly - you can count on that. However, do you think they will ring you
up to tell you about how good something is? No, that's highly unlikely. Hence this sort of
information only comes through your relationships with your end-users; and this normally
means your sales force. You must insist that any information (good, bad, or ugly) gets back
to you. With modern Internet-based communications this is easily achieved using a good
contact management system (CMS) that forces the sales force to produce a report of any visit
or meeting.
12.7 Summary
This chapter intended to demonstrate to you that your part in the life of a design does not
end once it has been released. Rather, the work has only just begun! Several tools have been
presented to help your PMS become an active design tool rather than it being a reactive tool to
act on complaints. This chapter also emphasized the need for you to have an active complaints/
vigilance procedure in place - and that this is mandatory not selective.
References
Carter, A. D. S. (1986). Mechanical reliability . Basingstoke: Macmillan Education.
Further Reading
Bicheno, J., & Catherwood, P. (2005). Six sigma and the quality toolbox . Buckingham: Picsie Books.
DEC 2012., Medical evices Vigilance. MEDDEV 2.12/1 Rev 7.
FDA 2006., Post Market Surveillance under section 522 of the Federal Food, Drugs and Cosmetics Act.