3D printing is playing prevalent role in a number of industries. Is it the future of rapid prototyping? What are the risks? How is 3D printing effecting the medical industry and medical device manufacturers?If you Google the term “3D printing”, limitless articles and advertisements abound. From 3D printed houses to a catalog of 3D printed body parts or an open-source site for 3D printed robotic prosthetics, it seems that 3D printing is at everyone’s fingertips. You can even order a 3D printer on Amazon. So how can this phenomenal and continually-evolving technology be regulated in myriad industries? More importantly; how will it effect medical manufacturing?
In his article, 3D Printed Injection Molding – the Future of Rapid Prototyping, Jim Pomager, executive editor of Med Device Online writes, “3D printing has fundamentally changed the way medical devices are prototyped and tested. The technique turns out sample parts much more quickly and cheaply than conventional manufacturing methods, enabling designers to significantly shorten iteration cycles and speed time to market for their products. As the cost of equipment has fallen, the technology has improved, and the range of applicable materials has expanded, 3D printers have become a fixture in design departments — even the smallest of medical device companies is investing in these rapid prototyping tools.” With 3D printers readily available to anyone from the consumer shopping on Amazon to highly regulated medical device manufacturers, and everything inbetween, is 3D printing the future of rapid prototyping?
Anthony Joseph, a Labroots writer says, “With the 3D printing industry becoming so advanced, the world is finding multiple uses to put the technology to work. One of the largest foreseeable needs for 3D printing to date is the medical industry, which will call for replacement parts for patients.” In his article, he cites, “The latest to receive a 3D-printed bodily replacement, a 54 year-old Spanish Cancer patient, has reportedly received a titanium 3D-printed replacement for a portion of his ribcage.” You can see the technology at work here on CSIRO’s YouTube Channel.
What’s the FDA’s Take on 3D Printing Medical Devices? Read the MDD Online article by Jamie Hartford that states, “Medical device manufacturers that have been hesitant to move forward with 3-D printing due to regulatory uncertainty seemingly got a green light today from the director of CDRH’s applied research arm.”
What about the need for regulation worldwide? The challenges with EU regulation are addressed in the article, Innovation Outpacing EU Regulation, The Case for Medical 3D Printing, “This lack of regulation for 3D-printed, patient-specific medical devices can be seen in the current version of the EU’s regulatory framework. The EU has been working for many years on an update to the Medical Devices Directive. This proposed legislation has many noble attributes in addition to overcoming the flaws and gaps of the existing Medical Devices Directive, such as supporting technology and science innovation while simultaneously strengthening patient safety.”
3D printing is still in the early stages of what is sure to be a lasting and evolving technology. Do you use 3D printing applications in your field? Have you seen any enlightening data that you'd like to share? Leave a comment to share your thoughts and experience.