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The saga at Boeing is portrays a very different mindset from my
experience with makers of medical devices.</p>
<p style="margin-bottom: 0in; line-height: 100%">Every one is very
aware that patients lives are effected for bettor or worse by the
company product. If that isn’t enough, bad outcomes result in lots
of lawyers. I’m sure you have seen ads on television, “If you or
a family member was injured...”</p>
<p style="margin-bottom: 0in; line-height: 100%">First every
significant step in the development from original requirements to
production testing must be carefully documented. Makes it very easy
to go back and figure out what happened. If the company does not
have a good documentation system, FDA will not approve the product.
The whole design process will need to be repeated with better
documentation.</p>
<p style="margin-bottom: 0in; line-height: 100%">Another important
part of the process is FMEA, Failure Modes and Effects Analysis.
Lots of brainstorming to try to list every possible thing that could
go wrong, the consequences and how severe it is to the patient.
Items with any small possibility of serious problems to the patient,
the doctor or the equipment must be analyzed and ways found to
mitigate it.
</p>
<p style="margin-bottom: 0in; line-height: 100%">To use a
hypothetical example from the airline industry. Some planes have a
thing called angle of attack sensor. If the sensor just gives an
indication to the pilot, and the plane has lots of other
instruments, perhaps pilot training can tell him when to ignore AoA
and how to use other information to safely fly the plane. And the
documentation system will track the training requirement to the
actual training.</p>
<p style="margin-bottom: 0in; line-height: 100%">Just speaking, not
that this would happen, but suppose the AoA sensor was connected to
an automated flight control system and a bad sensor input could
possibly, under remote circumstances, cause the plane to crash. This
is not acceptable.
</p>
<p style="margin-bottom: 0in; line-height: 100%">Mediation would
require multiple sensors, using different technologies. There might
be an undiscovered weakness in one kind of sensor. Software will
have a requirement that a bad sensor input will not cause the plane
to crash. Maybe the requirement includes checking the altitude
before pointing to the ground. Again the documentation system will
track this from software requirements to final validation.</p><br clear="none"></div></div></div><div id="ydp1f899ebeyahoo_quoted_3209447985" class="ydp1f899ebeyahoo_quoted"><div style="font-family:'Helvetica Neue', Helvetica, Arial, sans-serif;font-size:13px;color:#26282a;">
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