Silicone saddle molded on
a polycarbonate connector
used as a component in a
drainage catheter (photo
courtesy of Rogan Corp.)
There are many “hot button” issues that are of concern to medical device manufacturers. Bring up infection control, the upcoming UDI rule, or the movement of healthcare from the hospital to the home and an
engineer should have something to say about at least one of those areas. It is
likely that any one of those issues is a current challenge with a project or will
be for the next product in development.
Since plastics are such a huge part of the design and manufacture of medical devices, the molders who work with the medical device OEM are doing
everything they can to address these same issues to help alleviate the challenges faced by engineers. Fortunately, getting the molder involved early in
the design process enables them to help “attack” these areas of concern.
Due to the change in the rules for reimbursement from healthcare associated (or hospital acquired) infections, hospitals and healthcare providers are
seeking solutions that will reduce the likelihood that germs can be spread.
As such, molders are offering several solutions to help device makers answer
“For materials used in the surgical suite, it is critical that they be able
to withstand harsh cleaning agents, gamma radiation, and the autoclaving
process. The focus on patient safety and infection avoidance is tightened each
day; materials must be able to meet the challenge,” explains Randy Pell, senior
staff design engineer at MackMedical/Mack Molding ( www.mack.com).
As more medical devices are used in the home by the patients themselves,
device manufacturers realize new factors that are necessary for their products
that can differ from those used in the hospital. The appearance of a device
becomes a much greater issue for the designer than perhaps previously.
Everyone wants a device to be designed well, but whereas the aesthetics may
have been much lower of a concern in the past, with home-based or mobile
products used on the go by the patient, appearance and discreetness is of
great importance. Fortunately, molders can aid with this as well.
Stephen Lee, business development manager at Pelham Plastics Corp.
( www.pelhamplastics.com) is aware of this trend and the needs of the
company’s customers as well as the patients. “As a custom molder and
component assembly company, we are focused on providing capabilities
Medefab has been making medical catheters and devices
OEM for over 20+ years. Extrusion has been a core
technology for our company. Medefab is competent and
competitive to make 100 or a million units of your next
extrusion requirement. We are experienced with single, multilumen, and micro extrusions in
PP, PE, TPE, PUR, Nylon, PEEK and Ultem.
What Extraordinary Extrusion can we do for you?
Call today 603-532-5656 for immediate assistance.
FDA Registered and ISO 13485, Medefab is exclusively a medical device OEM provider with all processes completed at our manufacturing facility in Jaffrey, NH.