The era of individualized medicine is just starting to dawn and no other technology has demonstrated this concept more than 3D printing. The technology has made it possible for doctors to translate CT and MRI scans into patient-specific, 3D-printed implants and presurgical models. One company, however, sees 3D printing as just an important component to the larger trend of individualized medicine, working to implement a host of technologies to transform healthcare from a one-size-fits-all model to a model that really places the patient at the center of the treatment process.
In an interview with ENGINEERING.com, David Ryan, vice president of product development and marketing for Medicrea, discussed the past, present and future of Medicrea’s unique approach to patient-specific medical devices. As crucial as 3D printing will be to this field, Ryan was able to shine a light on the larger picture through the company’s additional work in patient-specific spinal rods and patient data.
While companies like Materialise are focused on translating patient CT and MRI scans into 3D models for 3D-printable transplants, Medicrea entered into the field of patient-specific medicine through its patient-specific software analytics and personally tailored spinal rod implants. Those outside of the field of spinal surgery may be shocked to learn just how the traditional process is performed when not utilizing Medicrea’s UNiD technology.
In the case that a patient requires spinal fusion—due to scoliosis, fractures, degenerative disc disease or any number of causes—the surgeons will actually prepare the spinal rod while the operation is taking place. Standard rods are provided in straight incremental lengths, so the surgeon will often use a pair of medical-grade shears to cut a mass-manufactured rod to the appropriate length, while the patient’s back lies open on the operating table. Next, the surgeon will use a handheld device called a rod bender to manually curve the device to align with the shape of the patient’s spine before implanting it.
This manual process may seem quite brutal and lo-fi, which is exactly why Medicrea developed a technology for automating this process. As Ryan explained, “It is medieval and quite amazing that, in the United States, over 350,000 individuals are operated on every year using spinal rods, and, unfortunately, still a lot of them have a rod that was bent [manually] during the operation. When you bend something by hand, you simply cannot replicate the precision and efficiency that is possible with specialized software and machinery developed using the latest clinical data on what the optimal curvature for the patient should be.”
Just five years ago, according to Ryan, Medicrea began work on a proprietary piece of equipment that automatically bends these rods specifically for a patient based on X-rays and other medical data that is analyzed by a specially trained team of biomechanical engineers using a Medicrea software tool. The entire procedure is performed ahead of the surgery, saving the surgeon not only work in the operating theater, but also valuable time. Ryan described the process by saying, “We use that equipment to curve the rods without creating any type of notch or stress, which is yet another one of the problems in today’s practice when surgeons are bending rods.”
Medicrea performed its first operation with a patient-specific rod in Europe in September 2013. As Ryan said, “This was the first time we actually produced a patient-specific device and the first time in the history of spinal devices that a patient-specific implant was designed and produced.” Since then, patient-specific spinal rods have been Medicrea’s main patient-specific service. The rods were subsequently cleared in the United States at the end of 2014, and, this April, the company received clearance for its cervical spinal rods from the FDA. The video below further illustrates just how important these devices might be from a surgical perspective:
As Ryan mentioned, the procedure focuses on analytical services and industrial contouring methods to provide individualized surgical treatment, not 3D-printed devices. That, however, is the next step for the company. Medicrea began working with 3D printing in 2014, when they designed a custom interbody device for an operation in France. In other words, Medicrea has already collaborated with a surgeon to produce a 3D-printed patient-specific implant for spine. The firm has since acquired the 3D printing equipment and built a team of 3D printing technology experts to handle production itself, which Ryan said is key to Medicrea’s approach to manufacturing medical devices.
“As a company, Medicrea is fully integrated,” he explained. “We perform design and production and sell our products ourselves. We have a strong engineering background. We like to really master and understand, inside and out, the technologies we use, which is why we bought the equipment to do the 3D printing of titanium ourselves.”
This initially helps with one specific patient. However, as the data begins to accrue, Medicrea can provide further information about all of the patients a surgeon has operated on. The outcomes of every operation and the shape of every rod, for instance, might then inform the doctor in crafting subsequent implants. In this way, Medicrea is looking into not only patient-specific devices, but also surgeon-specific services, something it plans to further develop in the future.
“The same surgeon could look at 20 patients and look into all of the information and data that we provide him or her,” Ryan explained. “This can allow surgeons to maybe see differently the results they were obtaining and impact the way they are operating on patients.” Ryan added, “Having a growing collection of data allows our lab engineers to look into improving the algorithms we use to analyze and apply the surgeon’s preoperative plan and determine what rods should be produced for an individual patient, which is very new and exciting for the future,” Ryan added.
All of this, Ryan said, is tied to a more active role on the part of the patient as well. The antiquated nature of some medical procedures, such as crafting spinal rods, is now becoming palpable to those introduced to Medicrea’s products. “For the first time in our history of developing spinal devices, the basic methodology is accessible to surgeons and patients alike,” Ryan elaborated. “When we explain to anybody how things have been done for the past 20 years and how things can be done today using our personalized services and devices, everybody understands the benefits to healthcare entailed.”
As Medicrea preps to launch its 3D-printed spinal devices, using the expertise gained with its UNiD line of rods, the company has already begun demonstrating that the medicine of tomorrow will look very different from the medicine of yesterday. Through increased access to information for all parties involved, patients may be placed at the center of health care in more ways than one.