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The $14 billion joint replacement market is made up of competitors manufacturing off-the-shelf joint implants and other devices. ConforMIS has now developed advanced imaging software to design new implants based on the shape of the patient’s knees. Their new 41,000-square-foot manufacturing plant has rows of 3-D printers that produce custom instruments used by orthopedic surgeons to fit implants. Eventually, the printers will be used to produce the implants as well.
“No one else has this kind of truly customized implant that re-creates the shape of a patient’s natural anatomy,” said ConforMIS chief executive Phillip Lang, 53, a German-born radiologist who practiced at Brigham and Women’s Hospital in Boston. “Patients are highly variable in their shapes.” With orthopedic surgeons performing an estimated 700,000 knee replacements in the United States alone each year, “there’s a lot of room for us to grow,” Lang said.
Companies like Biomet Holdings, Stryker Corp., Johnson & Johnson’s DePuy Synthes, and Smith & Nephew have started to introduce customized instruments, but still mainly deal in implants in specific shapes and sizes. However, some orthopedic physicians question how quickly the demand for customized implants will take hold given improvements in surgical instruments as well as the ability of doctors to better manage patients’ post-surgery pain injections and other therapies.
“With the current system of implants, where you have multiple sizes and shapes, the instruments are so accurate that you can customize the knee during surgery,” said Dr. David A. Mattingly, chief of joint reconstruction at New England Baptist Hospital in Boston.
ConforMIS chief executive Lang cites a recent company study involving 295 patients at seven US sites. The patients receiving ConforMIS’s customized knee replacements were 1.7 times more likely to have better functional outcomes than those getting competing products. “Patients can walk significantly faster with this than with an off-the-shelf replacement,” he said.
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