Customization is Crucial

Being able to design and 3D print your own, custom cellphone case is cool. Being able to have a pair of earphones designed exclusively to fit your ears and custom printed in a few days is amazing. But being able to create custom prosthetics, implants and patient-specific surgical models are life-changing, and in some cases, life-saving applications of 3D printing.

Every day, medical professionals are using 3D printers to create customized, personalized solutions for an array of medical problems, and there’s more to come. Research firm IDTechEx expects the dental and medical market for 3D printers to expand by 365% to $867 million by 2025. Transparency Market Research predicts the medical 3D printing market will grow at a compound annual growth rate of 15.4% to reach $965.5 million in 2019.

Pushing the Boundaries

Researchers are already pushing beyond the initial medical 3D printing applications like spinal braces, knee implants and dental molds. For example:

• Oxford Performance Materials (OPM), which develops poly-ether-ketone-ketone (PEKK) materials used in 3D printing implants, is working with Yale University on 10 projects involving direct tissue attachment for cranial and facial surgery, prostheses for rib replacement, and 3D-printed PEKK devices to deliver therapeutics and antibiotics.

• A research team led by scientists at Dalhousie University and the Nova Scotia Cancer Center has investigated the use of 3D printing as part of modulated electron radiation therapy to create custom devices that shield some areas from the cancer treatment, but also to ensure an even distribution of radiation in the targeted area.

• Researchers at Brigham and Women’s Hospital are developing a method that allows for the creation of viable blood vessels in 3D-printed organs.

• Researchers at Drexel University have begun to use 3D printers to artificially manufacture cancerous tumors. Doctors intend to use the tumors for medical testing and drug trials.

• A team of scientists used 3D printing to create a membranous sleeve that can surround a heart to provide monitoring and cardiac assistance.

The list of 3D printing medical research goes on and on. (See this article and Rapid Ready Tech for more.) To bring that research out of the labs and into hospitals will require the usual development cycle all new products go through, plus meeting extensive safety regulations. In the U.S., regulators are well aware of the promise of 3D printing.

Government Support

There are a number of online exchanges that allow anyone to download a model they can then 3D print. The National Institutes of Health (NIH) has launched the NIH 3D Print Exchange because “few scientific 3D-printable models are available online, and the expertise required to generate and validate such models remains a barrier,” according to the site. The Exchange enables searching, browsing, downloading and sharing of biomedical files of cells, bacteria, viruses, molecules and anatomical models that can be 3D printed. The site also includes downloadable video tutorials and instructions on how to use 3D modeling software, and illustrated workflows to create 3D-printable models from data.

Last fall the U.S. Food and Drug Administration (FDA) hosted a public workshop called “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” The workshop brought together representatives from the FDA, medical device manufactures, additive manufacturing companies and academia. The agency used the workshop to seek input on how to evaluate 3D-printed medical devices. (On-demand webcasts and transcripts are available here).

At a medical conference last year, Steven Pollack, director of the Office of Science & Engineering Labs at the FDA, said the agency wants to be aware of the challenges involved in 3D printing and won’t regulate things that don’t need regulation, but does need to know where to “take a deeper dive.”

The U.S. Department of Health and Human Services is awarding up to $3 million in grants in 2015 through the Eunice Kennedy Shriver National Institute of Child Health and Human Development to advance the use of 3D printers for the production of medical devices. The grants are specifically intended to support research to develop 3D printers, polymers and processes to produce premature- and neonatal-specific devices.

As with any innovation, government regulations can be a hindrance to widespread adoption or provide a boost to acceptance. The federal government’s initial efforts show that it intends to support 3D printing as an avenue toward high-quality, personalized health care.