A new dimension is coming to medical device manufacturing — a third dimension, if you will. It’s the marriage of 3D printing and plastic injection-molded medical devices, and it’s revolutionizing the entire med-tech industry.
The reason is simple: production time. Now engineers can design a medical part in an application like SolidWorks one day, 3D print its mold over night, then start producing clinical test-ready plastic parts the next day. It’s a breakthrough of staggering proportions in an industry where that process typically takes weeks, or even months to complete.
Experts say the medical device industry is facing tight budgets and even tighter time constraints to determine if a product is even going to be marketable. A rigorous regulatory process adds to the difficulty. Consequently, any process which overcomes all those hurdles is a game changer.
It’s not just about making faster prototypes, these observers say, it’s about expanding printable material options and reducing their costs. You can thank the new digital world we live in for this huge leap forward in efficiency.
But there’s a further advantage to 3D printing prototypes: you can use the same machine to make the molds themselves. And because 3D systems can print these molds from the bottom up, layer by layer, they can be printed in complex slides, pick outs and ejection systems with no increase in cost.
Medtech manufacturers are especially excited about the prospect of molding the part in its final, specified material, then proceed immediately into pre-clinical testing and usability/human factors testing to establish safety and efficacy. It’s all because of the ease with which design iterations can be made.
The technology is not perfect, however. Production runs are typically limited to 100 or less before the mold wears out — a run that is laughably small by traditional, aluminum mold standards. And the surface quality of the parts won’t come close to parts manufactured by an aluminum mold. Today, 3D printing molders are overcoming that deficiency by sanding the molds to remove layer lines at a 30-micron printing resolution. There are also limitations due to print beds and shot size. And while a range of materials can be 3D-printed, the process is not compatible for high-melt polymers such as PEEK and Ultem.
Still, the 3D-printing sector has tripled in value in the past four years, reaching $4.1 billion, according to the industry press, a growth rate which will only accelerate as the technology matures. Tellingly, that spectacular growth is being driven by the use of 3D printers to create functional, end-use parts, not rapid prototyping, which is what originally made the process famous.