Accelerating time to market is high on the priority list of most manufacturers. Medical device OEMs are no different, but, in addition to the design and manufacturing challenges that all companies must overcome, they also must satisfy FDA requirements.
"When we examined how we could better support our clients in quickly getting products to market, we identified two bottlenecks in the commercialization process: tooling and the FDA regulatory pathway," says Derek Mathers, Business Development Manager at Worrell, a design bureau in Minneapolis, MN. By integrating 3D printing and injection molding in its design process, Worrell has been able to help customers save considerable time and money.
Tooling is a pain point for medical device manufacturers because they invest multiple weeks and significant capital in each mold needed to produce prototypes, says Mathers. Moreover, the molds often require multiple iterations before the design can be finalized.
"Each time a design is fine-tuned, another mold must be cut, representing another significant investment of time and money for our clients," says Mathers. To minimize potential iteration risks and reduce tooling costs, Worrell 3D prints molds using PolyJet technology from Stratasys and processes them to achieve a desired surface finish. The mold is then used with an in-house injection molding press to produce a prototype in the same material that will be used for the finished device.
Says Mathers, 3D printing allows Worrell to create high-fidelity molded parts for prototypes and streamline development by soliciting user feedback. By accelerating this phase of the design and development cycle, FDA clearance can be achieved sooner.
3D printed molds can be finished in two days, compared with the six-week lead time that is typical of traditional tooling processes. "So, you're saving time and cost at the tooling stage," says Mathers. By contrast, aluminum molds are rarely perfect the first time, he adds. "Adjustments always need to be made to the design and tooling. With our technique, you can do the testing and sterilization on a functional part without investing in tooling."
Mathers cites a recent medical device project as a concrete example of the cost and time savings that can be realized. "During validation and functional testing on a series of 3D-molded prototypes, we were able to identify several important design changes that needed to be made," says Mathers. "Instead of going back and making a large capital investment in tooling again, we simply printed the revised molds and were able to run molded parts the next day. Using conventional technology, these critical observations would not have surfaced until much later in the design process, adds Mathers.
Few design firms have the infrastructure or the willingness to make the investment that is necessary to achieve this level of integration to benefit their medical device customers, says Mathers. "We have integrated 3D injection molding into our design process, enabling us to help clients get their products to market faster and maximize ROI," he adds.
In business for 37 years, Worrell has collaborated with many of the leading medical device manufacturers on product design and development projects. It is also active in the consumer products and technology sectors, and has expertise in industrial design, engineering, user experience, and branding and packaging.