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Daniel Daryaie, Materialise, discusses the extreme to the mainstream and the 3D printing revolution in personalised healthcare
Nearly every day we hear of another exciting case where 3D printing played a significant role in a patient’s treatment. Whether it’s a custom implant, drill or cutting guide, or an anatomical model; 3D printing is revolutionising the medical landscape on many levels.
The value of 3D printing was recognised early in the hearing aid market resulting in over 10 million 3D printed hearing aids in circulation worldwide (according to Phil Reeves, Econoloyst). The size of hearing aids, material property requirements, cost of the traditional manufacturing methods and clear benefits to patients when they are created in a patient-specific manner made them ideal for 3D printing. The question today is what other procedures or devices could benefit from the technology, how to address the regulatory concerns and how to get reimbursed.
Materialise, a Belgian-based company began in 1990 as a specialist in additive manufacturing and has grown into a key player for 3D printing, software for medical image processing and digital CAD software. In addition to its own 3D-printed medical devices it brings to the market its Mimics Innovation Suite software package that allows companies and hospitals to convert patient-specific medical image data (CT and MRI) into 3D models for anatomical quantification, FEA simulations, medical device size selection, custom implant design, virtual surgical planning, and, of course 3D Printing.
Materialise’s customers are the heroes of advanced medical applications of 3D printing and are innovating ways to improve clinical outcomes by pushing the limits of the technology. Scott Hollister and Glenn Green from the University of Michigan made headlines with their bioresorbable trachea splint which has already saved several children with life-threatening tracheobronchomalacia. By combining the ability to design custom devices based on each patient’s unique anatomy with the ease of 3D printing and the latest advancements in materials; they hit the trifecta for maximising the technology’s capabilities in an entirely new way.
Another area where 3D printing is invaluable is the planning of complex surgeries of congenital heart disease. Kosair Children’s Hospital was presented with a case of a 14 month old with four congenital heart defects. The complexity of the defects made planning the surgery difficult without a physical model and 3D visualisation. Materialise’s software was used to accurately represent the child’s cardiovascular anatomy, scale it for better visualisation and section the model into three pieces so that internal structures could be analysed as well. Thanks to the 3D-printed model, the surgeons planned a simplified approach to repairing the defects. Not only was the procedure effective, it also minimised the post-operative recovery.
Any discussion on the value of 3D printing in the medical world wouldn’t be complete without highlighting how ideal the technology is for cranio-maxillofacial procedures. Head and neck surgeries not only require removing and repairing anatomy but also symmetry and aesthetically pleasing results. Companies like OBL are using the Mimics Innovation Suite to mirror a patient’s healthy anatomy as a reference for repairing their defect. By 3D printing in porous titanium, resulting implants are light, strong and perfectly match the patient’s anatomy.
In 2013, medical implant manufacturer Oxford Performance Materials (OPM) became the only company to receive FDA clearance to manufacture 3D-printed, patient-specific polymeric implants for its cranial implant line. Its OsteoFab Patient-Specific Facial Devices (OPSFD) are designed with Materialise’s 510(k) cleared software, which was beneficial for OPMs regulatory submissions as scrutiny of software in custom device design is increasing.
With concerns regarding insurance and reimbursement, many surgeons are still hesitant to use 3D-printed medical devices according to data collected by the research and consulting firm GlobalData. Until insurance companies incorporate these cutting-edge methods into their reimbursement systems, the innovative solutions for hopeless cases, improved clinical outcomes and even reduced overall treatment costs that 3D Printing can offer may be artificially limited.
Fortunately, the doctors at Boston’s Children’s Hospital haven’t been deterred and used a soft, plastic, 3D-printed replica of an infant’s brain which included the blood vessels in a contrast color to practice a hemispherectomy, an extremely complex and rare procedure that involves disabling one cerebral hemisphere of the brain from the other. Thanks to the surgeons’ ability to plan and practice on the 3D-printed model, surgery was successful and the child is now seizure-free.
It’s exciting to see the evolution of 3D printing as the technology is reaching new levels and redefining what’s possible. As we move from 3D printing training models, to implantable devices and eventually organs from a patient’s own biomaterials; a ‘better and healthier world’ is clearly on the horizon.