Medical Device Testing
tasks could result in serious harm.”
“In the last couple of years, regulatory bodies have been re-
quiring clearer [testing] data. Years ago, manufacturers could
send in their raw data showing the results of the tests they did,”
Eddington said.“The FDA and other regulatory bodies now don’t
want just raw data, they want manufacturers to interpret what
they are doing, explain why they are doing it, and convince them
the testing they conducted is safe. They want the rationale behind
the tests being performed.”
Producing such justification can be challenging for medtech
manufacturers without the resources or expertise to perform the
required verification for their products. Partnering with contract
testing service providers can fill that knowledge gap and help
companies meet higher regulatory expectations for rigor and
defensibility in validation testing, and broaden their design risk
mitigation strategies.
The increasing complexity of medical device development is
driving the need for more rigorous, reliable, and reproducible
testing. Tackling test method validation early in the product development process can help manufacturers avoid costly delays in
commercializing their devices.
“One of the things we recommend is designing for X-ray
[inspection],” affirmed Gil Zweig, CEO of Glenbrook Technolo-
gies Inc., an X-ray imaging technology developer in Randolph,
N.J.“If, for example, you’re making an injection-molded catheter
hub with lumens, you would want to be able to see inside that
catheter hub for the possible presence of blood-collecting voids.
There are certain materials you can use to make the hub more
radiopaque. It’s better to know that kind of information at the
beginning of the product development process.”
Certainly, designing for testing is an important attribute to
consider when partnering with a contract testing service provider.
Perhaps more critical, though, is the desire to establish a long-
term relationship for the sake of patients.
“It is important to have a partner that takes the time to understand the customer’s unique needs, interests, and operational
strategies,” observed Christopher Scott, vice president of medical device testing at Eurofins Medical Device Testing, an international laboratory services company which provides a broad range
of testing capabilities to the medical device industry.“Companies
will benefit from aligning themselves with a testing laboratory
that is committed to maintaining a long-term relationship, not
simply conducting a transactional test. When a true partnership
is established between manufacturer and testing lab, both parties
share the desire to celebrate the successful commercialization of
a safe and effective medical device.” v
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