mentation will reduce risks associated
with sterilization, patient infection and
product traceability, the specialized nature or customization of these instruments can make single-use or disposable
components less practical or affordable.
“Many of our customers are interested in
achieving longer useful lives of the instrumentation, rather than going the disposable route,” said Beatty.
One way to make surgical instruments
lighter weight, reusable and more cost-effective is improving presentation and performance by replacing metal with plastic.
“We have been able to assist clients with this
effort and have produced some exceptional
results, especially for joint reconstruction,”
said Cory Colman, executive vice president
of business development for Paragon Medical Inc., a provider of cases and trays, surgical instrumentation and implantable
components based in Pierceton, Ind.
High-temperature engineered polymers
are especially suitable for multiple sterilization cycles. One of the biggest challenges in
going from metal to plastic is redesigning
tooling strategies and being certain that
performance is not compromised.
“An issue that is becoming more visible
in the delivery system area is compliance
with the reduced weight of the delivery sys-
tem, as well as being compatible with de-
creased sterilization and drying cycle times,”
continued Colman. “The product must be
compatible with current parameters within
the hospitals and surgery centers.”
Some OEMs also are starting to mod-
ify the design of their single-use devices
so they can be reprocessed more easily. A
typical third-party medical device re-
processor of single-use devices is regis-
tered with the FDA, which requires a
510(k) for each specific product it re-
processes. Devices go through disinfec-
tion/cleaning, testing, refurbishing to
“like new”functionality and sterilizing to
10-6 sterility assurance level.
“Some OEMs continue to design to
prevent reprocessing,” said Connor.“Oth-
ers are thinking in terms of designing de-
vices that can be used for multiple aspects
of a procedure for a given patient or for re-
processing. All these emerging require-
ments will have an impact on the design,
manufacture, and validation of many
Technology Leads the Way
Quality system expectations and basic
economics are driving OEMs to look for
key suppliers that can provide a broader
range of services. This means having cur-
rent technologies in place that will in-
crease operational efficiencies and speed
time to market.
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