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Working Toward a Prescription for AM in Medical

By: Louis A. Kren

Thursday, October 20, 2016
 

With this issue of 3D Metal Printing, we take a closer look at how this maturing yet revolutionary technology is impacting the medical industry. A simple country doctor making the rounds of a small town and the surrounding countryside, armed with a stethoscope and a black bag with rudimentary instruments and medicines, is medicine of long ago. But the capabilities of additive manufacturing (AM) hold promise to make medical practices of just a few years back seem nearly as quaint.

I was fortunate recently to visit GPI Prototyping, an independent service bureau and one of the largest, with 10 3D metal printers (see the article beginning on page 29 to find out how GPI got into the business and what’s made it successful.) The Illinois company supplies prototypes, one-offs and limited volumes of implants and replacements to medical suppliers. Medical devices produced via 3D printing include orthopedic and cranial implants, surgical instruments, dental restorations and external prosthetics. GPI, its customers and suppliers have been working together to iron out myriad issues with AM to deliver these often life-critical products.

For example, how many times can a material be used to produce implants and still provide the composition, properties and characteristics required? Once, twice, 10 times? Many factors, including the type and makeup of the material, various process parameters, and even the design of the product impact that number. Equipment providers and material producers have teamed to study and measure, and find answers. Recently, builders such as GPI have joined the effort, bringing manufacturing knowledge and experience into the equation. The talent and knowhow so prevalent in these service bureaus are a rich resource for the industry, which is a major reason why large traditional manufacturers have been gobbling them up.

Efforts also are being made to more closely control and measure the processes themselves, layer by layer in real time. Such study has enormous quality implications. The ability to measure density and other part attributes constantly during build mean that products are guaranteed to meet spec and perform as intended. That is a must in medical, and the same holds true in producing critical parts for aerospace and other applications. As time goes on and data are gathered and disseminated, the AM community can arrive at the proper recipes —materials, machines, designs, etc.—to ensure success with every build.

Keeping a close eye on progress along this front is the U.S Food and Drug Administration. Seeing the potential of the technology, the FDA, through America Makes for example, is partnering on projects with the AM community.

Through the end of 2015, the FDA had cleared more than 85 3D-printed medical devices, and going beyond metals, sees potential in AM for biologics and drugs. For example, this past March it approved the first-ever 3D-printed drug, which relies on AM technology to rapidly disintegrate in a patient's mouth, thus making it easier to swallow. For biologics, researchers are looking into 3D printing as a means of manufacturing cell and tissue products.

"AM has the advantage of facilitating the creation of anatomically matched devices and surgical instrumentation by using a patient's own medical imaging,” reads an FDA position paper. “Another advantage is the ease in fabricating complex geometric structures, allowing the creation of engineered porous structures, tortuous internal channels, and internal support structures that would not be easily possible using traditional manufacturing approaches.”

Today, industry and the FDA are working toward acceptable guidance on patient-matched products, where 3D printing can produce implants, skull plates and more, specifically matched to a patient, printed on demand and immediately used on that patient. Key to achieving this are the needed advancements in process control and real-time quality measurement.

It all ties together, and if companies such as GPI and industry partners can deliver, the future’s unlimited for AM in medical.

 

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