We currently see wide applications of 3D printing and custom solutions in orthopaedics – pre planning surgery models in complex trauma and revision surgeries, patient specific guides for accurate implant positioning or for precise resections and tailor-made implants for complex reconstructions.
Human anatomy is the most complex and unique for every individual. Now since every patient’s bone is different and unique, it demands for the customized solution for that specific patient and that is where 3D Printing plays a vital role.
However, there are few things that needs to be addressed or rather analysed,
- Is it not possible to make a custom-made device every single time for every single patient? Is there a way to standardize this customization?
- Selection criteria for customized solution
- Challenges in the process of delivering a customized solution.
AM Chronicle also organised a Webinar on Medical 3D Printing – Opportunities and Challenges where I shared detailed insight on the Use of 3D Printing in Orthopaedics.
In other industries sizes are very common and are standardized based on specific geographic location. Standardization in orthopedics is no different. In other words, Patient specific medical devices are truly valuable in complex cases, but group specific (eg. population or disease specific) medical devices are also to be looked at to address a larger volume of cases.
Virtual Patient Computational Modelling is key to standardization in Orthopedics. Globally, we see that many medical device companies like Stryker, DJO, Materialise, rely on different population anatomical data and statistical shape modelling to optimize and improve the implant design and manufacturing requirements. These huge individual anatomical data from all across the world can help in designing “population specific” or “disease specific” implants. Of course, here one needs to take into account large amount of data acquisition required and creating of this database
How do we really qualify and choose the right customized solution for orthopedic surgeries. To understand this, one must also understand various types of orthopedic surgeries and the device that it demands.
Trauma cases dealing with the accident cases, malunions from previous surgeries, articular deformities, pelvi acetabular cases etc have lot more variation in the defects and complexity in the reconstruction/restoration due to nature of the cases. Here a patient specific device customised to address the individual’s need can be a good option.
On the other hand, Joint replacement surgeries – arthroplasties (hip, knee, shoulder etc) are common among certain group of patients with similar defects mostly. So, precision and accuracy are utmost priority to restore functional joints. A standard device based on statistical shape modelling, might address this better and impact larger population.
It’s important to understand the applications along with technical and commercial factors affecting the product for making it standard or customized device.
Manufacturing a customized medical device for patients has its own challenges right from the input, processing stages and final output. Data transfer, Communication, Designing, Manufacturing materials, certifications and regulations etc are just few to name.
We are seeing very few companies which have focused their attention in solving these issues. With the same aspiration, we at Jajal Medical, have built our own proprietary service platform – MySegmenter.com which helps in bridging these known gaps.
The portal allows user to upload the scan data and visualize 3D models and customized medical devices for the case. Surgeons can communicate, plan virtual surgery and co-create the designs. A link to print allows user to choose the material/technology best suited for the application. And finally hassle free payment online on the portal!
Currently, there are various technologies like SLS, SLA, FDM, DLP, EBM, DMLS etc offering plastic and metal outputs in wide range of materials and one should select the right material for intended application.
An anatomical model of the patient’s defect is a good visualization and planning tool and necessary does not have to be in biocompatible material. However, a surgical guide material coming in contact with the bone/tissues has to be in USP Class VI compliant. Same thing applies for implants – medical grade regulated metal and alloys.