With the current paradigms of personalised medicine, various methods have surged to improve the aesthetic results of cranioplasties [22,35,6,25,5,33,13,20,21,32,19]. This revolution in modern practice occurs due to the 3D printing of biomaterials and its disruptive applications in the twenty-first century medicine. Correction of cranial defects is a perfect example of this technological application: a closed, rigid, and immovable compartment with a defect that can be corrected by overlapping a simple prosthesis.
Although autogenous bone flaps are still the best option for defect correction, they are frequently unavailable for several reasons [12, 23, 1, 22, 27, 28]. Various studies have shown the advantages and disadvantages of every material used for cranioplasty [29, 22]. Infection rates may vary among patients receiving custom implants, and infection is still the most common complication in cranioplasty surgery with variable incidence rates. Regardless of the selected method, the timing of cranioplasty, patient’s performance, choice of the material, and surgical running time affect the risk of complications [12, 16, 23, 1, 30, 22, 9]. PMMA often exhibits low complication rates in cranioplasty [16, 6, 7, 33, 15, 8, 26, 3]. Infections or complications in the 11 patients from this study were not observed.
The inflated costs for a high-quality custom template [20, 31, 24] may be directly associated with bureaucracy, health systems limitations, and the lack of specific certified manufacturing processes in Brazil. Several studies have demonstrated the feasibility of producing low-cost custom implants, offering significant potential for cost savings and improving aesthetic results and patients’ quality of life [25, 13, 32, 11, 33, 2, 17]. However, solutions that match the prominent level of medical technology available with optimised costs are still required.
Interdisciplinary collaboration between engineering and neurosurgery is an evident starting point. This concept, as previously described [13, 32, 19, 2, 17], favoured the creation of the mould. The use of 3D images facilitated the integration between medical staff and engineering. As observed in several articles [30, 6, 7, 25, 5, 33, 13, 20, 21, 32, 19], the various CAD/CAM techniques offer safe and satisfactory aesthetic results regardless of the implanted biomaterial, provided that an appropriate scientific methodology is followed. In our experience, the ideal algorithm for mould production was observed when the surgeon adequately expressed his/her need to the engineering team via a medical phantom.
Following technological development, there are complex and rigorous regulatory issues specific to a particular country. Accessibility and regulatory compliance for 3D custom implants still lacks proper validation in Brazil. This makes the use of modern biomaterials temporarily unfeasible, which are still pending approval by the Agência Nacional de Vigilância Sanitária. This is a bureaucratic step that involves long-term efforts and needs to be fulfilled.
While the regulation of some biomaterials does not occur, the confection of 3D printed moulds for customised PMMA implants has been described as an alternative solution [26, 11, 2, 14]. In the manufacturing process, the cost of material to produce moulds is similar to that of the prosthesis. By automating the interdisciplinary design of implants during their manufacture under validated systems, the application of 3D printing could be routinely used in clinical practice while continuously overcoming the limitations [20, 21, 34]. Product production, whether mould or implant, is achievable in less than 14 days. For the present article, up to 7 days from image acquisition to sterilisation has been fully possible.
The fight against bureaucracy and overpricing has become the next challenge. In the current Brazilian model, there is often an intermediary responsible for supplying products, adding a significant increase in the final value. In early 2017, three possible suppliers for custom cranioplasty templates were listed at our institution. None had legal regulations consistent with the use of biomaterials or appropriate specifications regarding implant production. The final cost to the patient or to the health insurance ranged from 14,000 dollars (70,000 reais) to 44,000 dollars (220,000 reais). Even considering Brazilian taxes, such prices are 2 to 7 times more expensive than expected in other countries [4, 18, 10] and often evolve into judicialization, harming all parties involved, specifically the patient. In the proposed method, a cost of less than 8,000 dollars was achieved.
We advocate that a high-quality solution under the scientific method can be cost-effective. If intermediary supplier bias is excluded, the entire system can benefit from reduced costs. Therefore, such technology could continue to evolve, focusing on welfare.