Ignore 3-D Printing at Your Peril

When it comes to medical devices, 3-D printing is growing up. Worrell Design's Derek Mathers explains how 3-D printing will evolve the next generation of medical technology. 

Derek Mathers, Worrell Design

Carbon 3-D printing
Google invested $100 million in Carbon to commercialize its high-speed CLIP (Continuous Liquid Interface Production) process, which uses ultra high-performance urethanes. Johnson and Johnson has already forged a medical device partnership with the company. (Image courtesy of Carbon)

A village in Haiti needs to provide umbilical cord clamps for pregnant mothers, but cannot afford a 10,000-unit minimum purchase order. An orthopedic surgeon, sick of long, arduous ACL repair procedures identifies the need for a complex tool to simplify and accelerate surgery. A Chinese man diagnosed with a rare sacral cancer needs a bespoke, durable implant to replace the tumorous bone matter once removed.

Derk Mathers Worrell
Derek Mathers

For scenarios like these, 3-D printing is the perfect method of manufacturing, and is quickly becoming a mainstream technique for producing medical devices, prosthetics, and drugs. The greatest opportunity for 3-D printing exists when the designer can "grow" a component to create complex surfaces and to match a patients' anatomy. This digital revolution of physical healthcare products is driven by three trends: the building of clinical evidence for 3-D printing of medical devices, the introduction of new 3-D printing platforms using functional materials, and the FDA's new framework for ensuring safety and quality.

One of the biggest challenges facing innovators in the medical 3-D printing space is not technological, but rather financial. Despite the fact that the FDA has approved over 85 3-D printed medical devices and drug forms (as of January 2016), reimbursement for the use of 3-D printing in medicine has largely been an afterthought. In order for 3-D printing applications to receive reimbursement, industry and academia must work together to create a unified body of clinical evidence that demonstrates both patient benefit and cost control. Key factors to identify in these clinical studies include overall improvement in patient outcomes, the total cost of procedures using 3-D printing for planning and devices, revision rates, and invasiveness. The United States and Europe are already falling behind in this space. Recently, Japan's Ministry of Health announced full coverage for the use of 3-D printed pre-operative models in most surgical procedures. The next 3-D printing applications in medicine will be powered by two factors: objective clinical evidence for reimbursement purposes, and a promising new generation of 3-D printing platforms.

See Mathers discuss 3-D printing's use in medical devices at MD&M Minneapolis, September 21-22.

In the past year, two technology titans have made big bets on the 3-D printing industry, resulting in compelling new platforms. Google invested $100 million in Carbon to commercialize its high-speed CLIP (Continuous Liquid Interface Production) process, which uses ultra high-performance urethanes. Hewlett Packard split its $110 billion business into two divisions--one focusing primarily on consumer hardware and 3-D printing, and the other focusing on enterprise servers and storage. Many believe that this strategy was developed to help commercialize its Multi-Jet Fusion 3-D printing process, which has the ability to create SLS-quality parts at a fraction of the time and cost. CLIP and MJF platforms are engineered to pursue the $12 trillion manufacturing industry, whereas Stratasys and 3-D Systems are primarily focused on the $10 billion global prototyping industry.

Johnson & Johnson recently announced exclusive partnerships with both HP and Carbon, and many competitors are expected to follow suit. As medtech designers begin to select high-speed and high-performance 3-D printing processes, it is inevitable that a tidal wave of new 3-D printing applications will be invented and commercialized. In order to ensure patient safety and performance in this brave new world, FDA realizes it must be at the forefront of medical 3-D printing technology to create guidance frameworks by which the rest of us can operate.

FDA has recently been vigilant in understanding the design, material control and quality control necessary for mass customization using 3-D printing. Last month, the administration released a draft guidance specific to 3-D printed medical devices (and follow-up article) outlining the additional information necessary for premarket submissions, including key technical considerations around the device design, the software workflow (from DICOM to 3-D CAD), material controls, and testing considerations. The Worrell team is excited by this draft guidance because it gives us framework to apply our world-class human factors engineering team to new problems within personalized medicine for our clients. 

The human body is an electrical, chemical, and mechanical organism that requires structurally-tough and complex architectures to perform properly. 3-D printing will soon have the ability to utilize low-cost and functionally strong materials that create high-resolution isotropic parts. The next generation of 3-D printers will demand better software for handling organic structures, as well as use algorithms to personalize patient-matched devices. Bolstered by solid clinical evidence and a new draft guidance, this industry is poised to become an attractive new solution for insurers to reduce the cost of healthcare across the board. For the patient, this implies a future of aesthetically pleasing, biomimetic 3-D printed devices built for a human being's specific anatomy, ultimately extending life and eradicating suffering throughout the process. We are excited to be working on the front lines of this technology at Worrell.

Derek Mathers is director of R&D at Worrell Design (Minneapolis).

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