The benefits of 3D models and 3D surgical guides, created in 3D printed plastic have been widely demonstrated, their value has also been shown in numerous publications that have been increasing since 2017. The benefits claimed by these publications and surgeon’s experience are: reduction of risk, reduction of surgical time, use for pre-sizing implants, shorter hospital stays, quicker recoveries, and so on. Additionally, the use of 3D printed anatomical models and surgical guides has proven a greater impact in complex cases and with surgeons with less training.
The technological advancements in additive manufacturing (AM) along with the evolution of 3D printing materials such as plastics, polymers, metals and ceramics have significantly impacted the medical sector. Beyond the usage for surgery training and surgeon education as opposed to generic models or cadaveric surgeries, being both cost-effective and easily implementable, patients exposed to the anatomical models also claimed to be more satisfied with the surgeon's interpersonal skills.
3D printing technology in healthcare domain has been divided into Binder jetting, Wire Direct Energy Deposition (laser metal deposition using wire), Powder Injection Technology Laser Engineered Net Shaping, Direct Metal Deposition) and the most extensively used Powder Bed Fusion (Selective Laser Melting, Electron Beam Melting, Direct Metal Laser Sintering). This empowering innovation is driving the 3D printing and advanced manufacturing industry and is carrying them forward with better solutions [1].
In terms of material, PLA is the most widely used 3D printing plastic filament in the world. It is the recommended 3D printing plastic material to be used for most of the desktop 3D printers. PLA is considered as the easiest 3D printing material to work with at the initial stage. It is one of the eco-friendliest 3D printing materials available and requires less temperature and energy to process. PLA processing is both easier and safer to use and provides smoother and shinier appearance. PLA can achieve a superior level of print and is less prone to warping.
There is an interest in these technologies to become more widespread, to do so it is proposed that manufacturing of 3D-printed devices becomes more decentralized. A sign of this is the rising number of U.S. hospitals with 3D printing facilities, more than 100 by 2019. This is still a very small number compared to the 6,090 hospitals the AHA has in its lists, but the stage is set for staggering growth.
Large academic hospitals have implemented in-house 3D printing programs. Radiologists and surgeons are teaming up to discover every possible detail about complex cases, before the operation, by printing thousands of models every year [3]. Nevertheless, the cost of these programs makes it difficult for programs in smaller hospitals, ambulatory surgery centers, and private practices to implement these solutions.
As the technology evolves, this point-of-care (POC) model may become even more widespread. Considering this, FDA has shown interest in regulating the medical products made via 3D printing like patient-matched anatomical models, prosthetics, and surgical guides.
Beyond regulation, there are four new CPT codes that will finally allow radiologists and other clinicians to seek reimbursement for 3D printing services. This is a key milestone on the journey towards widespread adoption of 3D printing in healthcare.
List of CPT® Category III Codes Medium Descriptors
0559T ANATOMIC MODEL 3D PRINTED 1ST COMPNT ANTMC STRUX
0560T ANATOMIC MODEL 3D PRINTED EA ADDL COMPONENT
0561T ANATOMIC GUIDE 3D PRINTED 1ST ANATOMIC GUIDE
0562T ANATOMIC GUIDE 3D PRINTED EA ADDL ANATOMIC GUIDE
Considering our company's mission of making custom the new standard, our proposal is to mitigate current cost associated with point-of-care models to promote 3D printing usage routinely in a more general surgical setting.
For a Hospital to implement an in-house 3D printing solution, there are several visible and hidden costs that need to be addressed. Especially significant fixed costs associated with software and talent necessary to use the 3D reconstruction and design software. There are also significant hidden costs and quality risks associated with the qualification and quality assurance of these solutions.
We can make POC printing a lot more accessible and provide additional value by the pooling of some of the most expensive resources and providing use of the TECHFIT surgical planning platform for better 24/7 interaction with engineers and case planners.
We can make POC printing a lot more accessible and provide additional value by the pooling of some of the most expensive resources and providing use of the TECHFIT surgical planning platform for better 24/7 interaction with engineers and case planners.
In this model, the POC can subscribe to the TECHFIT Service that includes the installation of the hardware, all of the qualification activities and a maintenance and support service. TECHFIT will remotely monitor the status of consumables and replenish the stock automatically.
The health care facility would be responsible for printing the product within the validated parameters, and for using the product for its approved intended use. The staff at the facility would also receive a complete training on the operation and quality assurance of medical 3D printing.
How would it be to get familiar with different, complex or unknown pathologies, train residents and start discussions about approaches, procedures, implants in a more efficient way?.
References
[1] BIS research. (n.d.). Global 3D Printing Plastics Market – Analysis and Forecast, 2018–2023: Focus on Types (PLA, ABS, PEEK, Nylon/Polyamide, PETG, and PC), Forms, Technologies, and End User (Healthcare, Automotive, Aerospace and Defense, Consumer Electronics, and Others). Retrieved June 1, 2021, from https://bisresearch.com/industry-report/global-3d-printing-plastics-market.html
[2] PEW. (2020, October 5). What Is Medical 3D Printing—and How Is it Regulated? What Is Medical 3D Printing—and How Is It Regulated? https://www.pewtrusts.org/en/research-and-analysis/issue-briefs/2020/10/what-is-medical-3d-printing-and-how-is-it-regulated#:%7E:text=Because%20this%20type%20of%20manufacturing,cranial%20implants%2C%20and%20dental%20restorations.
[3] Mayo Foundation for Medical Education and Research. (n.d.). 3D Anatomic Modeling Laboratories - Overview. Mayo Clinic. Retrieved May 5, 2021, from https://www.mayoclinic.org/departments-centers/anatomic-modeling-laboratories/overview/ovc-20473121
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