When newborn Jemma Starks struggled to breathe, her worried parents rushed her to Phoenix Children’s Hospital where a cardiologist delivered alarming news. The two-day-old infant had only half a heart. What followed was a blur of explanations and sketches of hearts and arteries that never opened, and a right ventricle that failed to form. “It was helpful, but nothing he said made sense to me,” said Jemma’s mother, Stephanie Starks.
That all changed following Jemma’s first open heart surgery when cardiologist John Nigro showed the parents a color-coded 3D-printed model of their daughter’s heart. “Now, all of a sudden we could see what she was missing, what she was dealing with,” Starks said. “It really changed the game for us.” Since then, Jemma, now 2 and a half years old, has had two more open heart surgeries, each aided by 3D printing.
3D models are also changing the game for physicians, who can study and practice on exact replicas of patients’ organs before they ever go into the operating room, leading to shorter surgeries, reduced anesthesia exposure and fewer complications. At Phoenix Children’s Hospital, which teamed up with Arizona State University to build a 3D print cardiac print lab, surgery times have declined by two hours, said Justin Ryan, a research scientist who runs the lab.
Over the past four years ago, the lab has branched out to print models of orthopedic conditions and brain tumors, Ryan said.
Whether for modeling difficult surgeries or constructing prostheses, a growing number of physicians and hospitals are embracing 3D printing. The global 3D printing healthcare market is expected to grow at a compound annual growth rate of 26.2% over the next four years, totaling $2.3 billion by 2020, according to a new report by Allied Market Research.
Customized external wearable devices will lead the market due to growing numbers of amputees, patients with hearing loss, dental issues, and greater availability of biocompatible materials, the report says. But 3D printing is also being used in surgical modeling, and as an alternative to animal testing in biopharmaceutical development, reducing time to clinical trials and overall costs.
Within the world of 3D printing, polymers account for about half the market, while ceramics — at 32.1% CAGR — is the fastest growing segment. Medical and surgical centers comprise two-thirds of the market’s end users, while tissue engineering applications represent the fastest growing use, forecast at 31.7% CAGR over the four-year period. 3D Systems Corp. and Stratasys Ltd. currently lead a pack of about 10 major manufacturers in the 3D-printing healthcare space.
Medical devicemakers are also jumping onto the 3D-printing wagon. Stryker announced plans to build a state-of-the-art 3D printing facility this year. The lab will focus on new and innovative products, rather than on replacing existing products, CFO William Jellison told a Q4 earnings call late last month. The Kalamazoo, MI-based company already markets a 3D-printed tibial base plate, patella and revision cones for the knee and is about to launch a 3D-printed titanium interbody device for spines. All of the products are porous to allow for bony ingrowth.
Stryker CEO Kevin Lobo said 3D-printed products will add only incremental growth in the near term, but could benefit the company in other ways, such as reversing a lag in revision sales. “It’s an extra shot in the arm,” he said. “Now that we have what we consider to be best-in-class revision cones, not only do we keep that business… but [that surgeon] has something they can talk to other surgeons about.” Over the long term, Lobo sees 3D printing as a sustainable business venture, comprising a significant portion of overall sales.
Yet while 3D printing’s promise seems indisputable, high costs, patent and copyright issues, and a lack of regulatory and reimbursement frameworks could limit future growth.
Phoenix Children’s Hospital paid $55,000 for its first printer, a full-color resin printer made by 3D Systems. It has since acquired three secondary printers that work with a variety of materials. Together, they’ve produced about 200 to 250 model hearts, Ryan said. “We definitely see the benefit as we keep doing it, but ultimately, in order to get reimbursed, we need to show that it’s helping patients get better outcomes and reduces costs.”
To do that, Phoenix — in conjunction with Children’s National Medical Center in Washington, D.C., and Children’s Hospital of Philadelphia — are launching a randomized, single-blinded clinical trial this month to demonstrate the quantitative impact of 3D printing in healthcare. The study will enroll 400 patients at 14 sites, split into two cohorts — traditional surgical planning and 3D printing.
“We hope to see a reduction in surgical time and surgical morbidity,” said Ryan, adding the data will be used to lobby the American Medical Association to create the insurance codes needed to get reimbursed. “Ultimately, that’s going to be the tool to get 3D-printing technology into all hospitals,” he said.
For parents like Jemma’s, the benefits of 3D printing are clear. “Every heart is different, and to know that the doctors actually held her heart in their hands, they practiced before they ever got to her, has been very empowering,” Starks said.