Mark McCourtney, director of sales and marketing at JunoPacific, was a part of the staff written article, “Molders Address Biggest Device Issues.” He took time to present a full array of responses that were not able to be included in the article, so they are presented here.
Q: How can medical molders help device designers achieve compliance with the upcoming UDI rule?
McCourtney: RFID tags and laser etching seem to be the best methods for creating unique identifiers. For high volume applications, RFID tags can be insert molded with automation. Laser etching can be effective for low volume products such as surgical instruments where pressure-sensitive labels can prove cumbersome. We have equipment at Cretex Medical’s sister company, rms Surgical, that is capable of laser marking plastics in contrasting colors that are highly visible.
Q: What features are most important to device designers to achieve through molding material selection?
McCourtney: Impact resistance for hand-held devices that are likely to get dropped, bio-compatibility, melt-flow for thin wall and micro molded components and flexibility for snap and press-fit assembly. Designers should also consider pre-colored vs. colorant as colorants can affect flow and biocompatibility. There are also fillers, such as glass fiber/bead and carbon fiber, etc. Fillers can add strength and conduct electromagnetic energy, etc.
Q: How are the capabilities realized through micro molding changing medical device design?
McCourtney: Whether talking about minimally invasive surgical devices or implantable devices, smaller is better. Medical OEMs are striving for miniaturization, lighter weight and component cost reduction. Micro molding of components can accomplish all the above as resins, tooling and molding machine technology continue to evolve. Molded components are replacing metal injection molded and machined components in many devices as micro molding can produce net shape parts on a highly repeatable basis thereby lowering cost.
Q: What type of molding technique is gaining more interest with medical device engineers?
McCourtney: We are doing more with insert molding and multi-shot molding recently. Insert molding on a micro level is a way to add stiffness to plastic components that are micro molded. One of our Cretex Medical sister companies, Meier, does a great deal of machining to stamping conversions. They can create “reel-to-reel” inserts that we index through the molding process. This creates an opportunity to lower cost through conversion of manufacturing processes and elimination of labor at the molding machine. With multi-shot molding, we are able to combine multiple components in one molding process thereby lowering the cost to manufacture. At the same time, we can build in ergonomic and aesthetic features.
Q: How are molders addressing the movement to more patient-based devices?
McCourtney: Lower cost tooling methods capable of producing cavities quickly and inexpensively are required.
Q: How are material advances impacting the capabilities offered with implantable devices?
McCourtney: Materials do not seem to be advancing enough in terms of higher flow for micro molding. Engineers seem to be specifying the same resins they have been for years when it comes to implantables, namely; PEEK, Tecothane, PPSU, etc…
Q: Where is medical molding headed over the next five to ten years?
McCourtney: We will continue to see a push for smaller components, faster development time and manufacturing cost-downs. Medical device companies are driving toward devices that are less invasive, disposable and lower net cost. I think we will see a major shift in manufacturing technology with the development of high resolution 3D printing equipment for metals and plastics. The ability to produce “one-off” custom components/devices without tooling will drive the patient-based device market. This equipment can also produce cavities for tooling to reduce lead times and cost. I also believe OEMs will outsource more to conserve resources in light of healthcare reform. This should create opportunities for medical device contract manufacturers that are capable of delivering on every aspect of the product development cycle and are FDA registered.
Q: Any thoughts/comments on molding or another related area that you would like to share with medical device manufacturers to aid them?
McCourtney: Now more than ever, with manufacturing technologies advancing at an accelerating rate, it is important to bring your contract manufacturer into the early stages of product development and work together to achieve your new product goals.