Spinal fusions — a treatment option for fractures, deformities, or instability in the spine — typically involve pedicle screws for extra strength and support. However, if placed incorrectly, patients could experience critical injuries, including spinal cord damage. While robotic solutions can alleviate errors associated with freehand pedicle screw insertion, such technology is expensive and has a steep learning curve.
After 11 years of using additive manufacturing to enhance and produce spinal technologies and medical devices, Mighty Oak Medical is no stranger to the benefits of 3D printing or the pain points associated with spinal surgeries. To alleviate the errors associated with freehand pedicle screw insertion and eliminate the challenges and complexity of robotic systems, they had to rethink the surgical workflow.
This year, the company partnered with HP to 3D-print medical models and surgical guides using HP’s Jet Fusion 5200 3D printers. With its cornerstone FIREFLY solution — a patient-specific pre-surgical planning and navigation platform — Mighty Oak Medical produces FDA-cleared and CE-marked products to improve operating room efficiency and make spine surgery safer.
FIREFLY provides surgeons with concierge pre-surgical planning, which is accurate to the millimeter and done in 3D on a virtual rendering of patients’ spines. Then it supplies 3D-printed anatomical models and 3D-printed disposable guides that surgeons use to drill, tap, and place pedicle screws quickly and safely. With HP’s industrial Multi Jet Fusion technology, FIREFLY is streamlining and reducing printing turnaround time so that more patients can benefit from an elevated level of personalized care.
“It was important for us to maintain our focus on the spine and develop innovative solutions that make surgical procedures safer and more efficient,” said Heidi Frey, president of Mighty Oak Medical. “We have always viewed 3D printed, patient-specific solutions as an ideal way to achieve those two objectives, and now, the healthcare industry is undergoing a massive transformation in terms of the solutions, patient experience, and outcomes new 3D printed medical devices can provide.”
Before installing HP’s Jet Fusion 5200 printers directly onto its factory floor, Mighty Oak Medical outsourced its production. At the time, the models and guides were made using stereolithography (SLA) and a white photopolymer material. While it closely matched the color of bone, the material was very reflective, which made it difficult to read the markings on the surgical guides. Lack of contrast with the bony anatomy also made guide fit difficult to see in the operating room.
Now, the models and guides are manufactured using HP’s nylon PA-12 material for its strength, detail, and surface finish. Each part is embossed with a unique patient identifier number and marked to allow the surgeon to easily find and place them in the right location on the spine. The models can even be personalized with the name of the hospital or physician. HP’s nylon PA-12 material features a mineral gray color that makes such markings easier to read in an operating room environment. It also offers higher contrast, allowing the surgeon to check for anomalies and gaps.
“Surgeons are always looking for better results,” said Rob Bronersky, VP of operations at Mighty Oak Medical. “Additive manufacturing is becoming more widely adopted because it helps them achieve that mindset. It’s being embraced because it helps them deliver superior outcomes.”
To streamline the presurgical planning and guide the design process, Mighty Oak Medical uses sophisticated analytics based on data collected from previous cases. For each new case, trajectories and guides are automatically generated depending on patient demographics, with only minor manual review and modification required by the engineering team. Mighty Oak is further developing these analytics into machine learning algorithms using their ever-expanding pool of data to further improve analytics and efficiency.
Mighty Oak Medical