Postmarket Surveillance - Medical Device Design: Innovation from Concept to Market - page 296

Once your device is in the marketplace (fully) it is the focus group that can help you to
decipher the clinical literature that is so important to your PMS.
12.4.3 Courses and Conferences
Hopefully, once your device has been released, it will gain a life of its own and end-users
will start to produce their own clinical investigations using your device - often without you
knowing it. The one major venue where this information will be presented is a conference.
It is therefore a very good idea to keep a watchful eye on relevant conferences and their
respective conference programs. If there is anything of interest you should do your best to
attend, watch, and learn.
The second point of interest is that the authors of the conference papers are probably going to
be very useful members of your focus group!
In addition to conferences another potential vehicle for intelligence collection is a short
course. Many clinical colleges run courses on a regular basis. The colleges are always looking
for subjects (and sponsors) - why not be that partner? 4 Furthermore, clinical schools in
universities and colleges are also always looking for similar partnerships - again, why not be
that partner? At the end of the day the students going through these programs are going to be
the end-users of the future.
12.5 Vigilance
Every regulatory body expects you to have an appropriate and active system to collect and
analyze complaints. This process should be able to detect complaints that are not critical
to your device's safety and those that provide a risk to the end-user, the patient, or anyone
else associated with it. It is beyond the scope of this topic to describe how your vigilance
procedure should operate; however I am duty bound to tell you that you should make sure you
have one in place. As usual the FDA and MHRA websites have guidelines to help you.
12.6 The Good, the Bad, and the Ugly
The phrase “the good things in life” always passes people by. We spend so much of our
lives looking for what has gone wrong that we forget to look at what has gone right. Just
like little Polyanna, 5 we should learn to play the “glad” game and find the things that have
gone well.
4 A word of warning - take care that any partnership with training of end-users does not put you into any breach of
laws regarding “undue influence,” or worse, bribery. A rule of thumb to avoid this is always try and partner with
at least one other company: but this alone does not give total protection.
5 Along with Little Women and The Railway Children this is one of my wife's favorite films; she is always telling
me, and the children, to play the “glad” game too.