Accelerating Innovation and Elevating Patient Care with Personalized Devices

Healthcare is often considered to be one of the most dynamic industries. The speed at which innovation is occurring—from the way surgeries are performed to the development of new therapies and how medical devices are manufactured—is moving ever more rapidly. While the adoption of additive manufacturing (AM) is accelerating across a breadth of industries, it is fundamentally transforming how healthcare is delivered through the innovation of new treatments and associated medical devices. The power of additive manufacturing solutions can be seen in the development of patient-specific surgical plans and devices that include instruments and implants. By designing a unique plan and devices for each patient, it is possible to improve surgical outcomes, reduce operating time and cost,^1-4 and elevate the patient experience.

Personalized instruments and implants are becoming more common for a variety of surgical procedures. According to a research report released by Facts and Factors in May 2021, the global orthopedic implants market is expected to surpass $73 billion by 2026.⁵ A large percentage of this growth can be linked to the increased use of personalized implants that are additively manufactured. Advances in materials, technology, and software are revolutionizing the manufacture of devices, allowing for improved customization and complexity of designs (such as predetermined engineered porous structures) in a more efficient, cost-effective manner. This process is not only transforming the devices, they are also transforming the way surgeons think about treating patients. Developing the right device for the patient begins with developing the right surgical plan for the patient.

Patient-Specific Models
Patient-specific models and tools improve accuracy and efficiency.^6-8 To create patient-specific anatomic models and surgical instruments, the clinician must begin with medical imaging data of the patient’s anatomy (e.g., a CT scan). Utilizing controlled and proven workflows, a patient’s medical imaging scans are segmented and converted to a digital 3D model of the patient’s anatomy. This is accomplished using FDA-cleared software that relies on unique automatic segmentation tools driven by deep learning algorithms. Having this 3D, digital representation of the patient facilitates collaborative virtual surgical planning between medical practitioners and biomedical engineers, allowing surgeons to perform the surgery digitally before entering the operating room. Following the online session, the 3D models, in combination with the pre-surgical plan, facilitate creation of personalized surgical tools, instruments, and implants designed for use within the sterile field.

This step in the process is accomplished using 3D design software that includes advanced design tools for working with complex, organic shapes like patient anatomy. This software—in combination with a haptic device—facilitates intimate and accurate interaction with the digital representation of the patient to create precise fitting devices. The ability to visualize the surgical devices and anatomy in a 3D environment allows the surgeon to see the design and fit of the instrument or implant prior to moving forward with production and make alterations based on clinical need at any time during the design process. Following the completion and approval of the design, the device is produced using additive manufacturing in an FDA-registered, ISO-13485-certified facility.

With the ability to provide a device designed specifically for one patient and one procedure, benefits such as improved fit and reduced operating time contribute to improved patient outcomes and decreased procedural costs.

Partnerships Expanding Patient-Matched Solutions
As the evolution for providing patient-specific solutions continues, partnerships between medical device manufacturers and companies specializing in patient-matched workflows are emerging. For example, 3D Systems recently announced a collaboration with Exactech to provide personalized surgical instruments designed to prepare the patient’s ankle anatomy to receive Exactech’s total ankle replacement system. The Vantage Ankle PSI includes pre-surgical planning from patient CT data and design of patient-specific 3D-printed instruments that guide resections in the tibia and talus for total ankle replacement surgery using Exactech’s Vantage Total Ankle System.

As part of the company’s VSP surgical planning workflow, 3D Systems’ team of engineers complete the imaging segmentation, pre-surgical planning, and design process with interactive feedback from surgeons, if needed. The surgeon will then receive a kit that includes anatomic models to confirm the fit of the patient-specific guides, which increases surgeon confidence during the procedure⁹. Vantage Ankle PSI cutting guides are uniquely designed to allow the surgeon to cut through the saw slots on each nylon guide, reducing the number of operative steps per case.

Patient-specific orthopedic instruments are an enabling technology that helps surgeons prepare the skeletal anatomy to receive an implant. These devices are designed to improve surgical efficiency by pre-planning the patient’s unique surgical approach while reducing the number of steps required to prepare the anatomy with a patient-matched 3D-printed instrument set.

The Future of Personalized Medical Devices
With the expanded use of patient-specific planning and instrumentation for a variety of surgical procedures, the use of personalized implants is the next large market growth segment. However, the process for clearing a 3D-printed surgical device or implant is relatively new, and the FDA continues to evolve its guidance for patient-matched devices and implants.

With clinical evidence supporting the improved outcomes and resultant lower cost of care, we can expect to see an increase in the number of patient-matched devices. With increasing demand, 3D Systems collaborates with its device manufacturing partners to devise ways to expedite delivery and lower costs. We are also working directly with health systems to set up point-of-care centers to print patient-specific implants and instrumentation on site.

Finally, we see additional opportunities for innovative patient-specific devices in orthopedic, craniomaxillofacial, and cardiovascular applications as the costs and lead times of additive manufacturing continue to decrease. Personalized medicine is just getting started. 

References

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2. Hanasono M, Skoracki R: Computer-assisted design and rapid prototype modeling in microvascular mandible reconstruction. Laryngoscope 123(3): 597-604, 2013.
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