3D printing – or additive manufacturing – is big news in healthcare these days, with no shortage of stories about the creation of body parts customized to meet the anatomical dimensions of specific patients, from dental crowns to replacement hip joints. The stories of patients who have benefited from the technology are inspirational, and the science is already changing how care is delivered. But healthcare has always been about new life-saving technology, from miracle drugs to exoskeletons controlled by implanted sensors that help move paralyzed limbs. In my opinion, 3D printing will be far more disruptive to the healthcare supply chain, as a result of changing where and when medical devices are manufactured and by whom. In other words, hospitals are increasingly becoming the site where manufacturing occurs, which changes the logistical equation. Hospitals could also become the primary manufacturer of record, which raises a whole series of regulatory requirements and questions.
I disagree with the doomsday predictions that say community hospital-based printing of custom prosthetic implants, as an example, is bad news for big name global implant manufacturers. Yes, it will change how they do business; after all, if the product is custom-made one at a time, on site, and on demand, many of the costs associated with packaging, labelling, transporting and storing products will go away. But it will not put these companies out of business, at least not those who are willing and able to keep up with the changes their customers and patients will demand.
A number of hospitals are already using additive manufacturing to create three-dimension models of patient body parts. For example, Mayo Clinic created an exact model of a patient’s hip using data from a CT scan and a 3D printer. The surgical team used the model to practice a hip replacement procedure for a particularly challenging case. Once the procedural process was perfected, Mayo Clinic sent the model to a manufacturer to make a customized replacement joint for the actual surgery. In other cases, hospitals generate the data to design the product but leave the actual printing of the model to outside manufacturers who specialize in this kind of work. That was the case for physicians at New York Presbyterian/Morgan Stanley Children’s Hospital who sent a CT scan of a newborn with congenital heart disease to a manufacturer that sells the models as Class I medical devices to clients in the US and Europe. For these surgeons, the technology is a game changer. Without it, the surgical team would have had to stop the child’s heart momentarily to take a look before deciding how to proceed with the operation.
In 2013, a bioengineering professor at Arizona State University, Vincent Pizziconi, conducted a show and tell of some of these products during a panel discussion at the Supply Chain Insights inaugural global summit. I recently had a chance to catch up with Dr. Pizziconi to learn about advances that have been made since he literally pulled a prototype hip and a model of a pediatric patient’s heart out of his pocket during the panel discussion. The heart had been produced for a team of pediatric surgeons at Phoenix Children’s Hospital, where 3D printing of models is now routine. One of Dr. Pizziconi’s graduate students, Justin Ryan, runs the hospital’s 3D Print Lab that utilizes three separate printers and has produced well over 200 hearts.
Dr. Pizziconi, meanwhile, is on the cutting edge of research around the biofabrication of human tissue and organs. Dr. Pizziconi explained that the majority of the human body is made up of cells that like to anchor to a surface upon which they grow into the tissue type for which they have been biologically programmed. While we may not yet understand fully how those biological markers are established or communicated, advances have been made toward creating the correct anatomical substrate upon which the tissue can grow and the proper micro environment in which cells harvested from patient populations can regenerate. At least one healthcare system is already preparing for the day when this science is operational, by building what are essentially manufacturing facilities that regenerate tissue using cells archived from patient populations according to the U.S. FDA’s Good Manufacturing Practice (GMP) regulations.
The FDA is currently accepting (through August 8, 2016) comments on its draft guidance on 3D printing for medical device manufacturers, but that document does not yet address 3D printing involving cells or human tissues. That kind of manufacturing, according to the FDA, raises “additional technical considerations.” The FDA recognizes the value of producing medical products that are “anatomically-matched,” which is keeping with the White House’s initiative on personalized or precision medicine. But the agency also warns of challenges around making sure the manufacturing process is designed in such a way to produce devices as intended. Hospitals, unlike traditional manufacturers, are not as familiar with quality system validation and will need to ensure they have expertise in this area and/or partner with traditional manufacturers or third parties to ensure compliance.
3D printing of body parts, whether from naturally occurring/man-made materials or human cells/tissue, will also require mechanisms to track their performance. The FDA has been busy in recent years rolling out requirements for unique device identification, which requires manufacturers of medical devices to assign unique device identifiers (UDIs) to their products, to label those products with UDIs in human and machine readable formats, and to publish data about those products to the FDA’s Global UDI Database (GUDID). While you cannot easily slap a label on a 3D printed product (nor would you necessarily want to given that it is not being shipped, received or stored), we still need to collect information on the use of 3D products in patient care, along with pertinent information on their production and composition, and, in the case of regenerative tissue, the source of the cells.
Innovation in medical science never ceases to amaze me. Applications for 3D printing in healthcare will change how clinicians work and how patients are cared for and in some cases cured of debilitating injury, disease or congenital defects. Now, it is up to those of us who are responsible for the healthcare supply chain to match that innovation, with new ways of thinking about the product lifecycle and the relationships between the various players, new and old.