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3D printing or additive manufacturing is the making of a three-dimensional object from a CAD model or a digital 3D model.
There are different techniques for the processes in which materials are deposited, joined, or solidified under computer control, and the material being added together (such as plastics, liquids, or powder grains being fused), layer by layer. This pre-feasibility report aims to assess the viability of 3D printing of bones as a business opportunity. AMTPL aims to manufacture 3D printing of bones for teaching and practical purposes, it will be helpful for the students and faculties for explanation and understanding purposes.
Market Analysis
The global 3D printing market is expected to reach USD 34.8 billion by 2024, according to a report by ResearchAndMarkets, the Indian 3D printing market is expected to grow at a CAGR of around 20% during 2021-2026. The medical industry is one of the fastest-growing segments in the 3D printing market. The market for 3D-printed bones is expected to grow significantly in the coming years due to the increasing demand for customized implants, the rise in the geriatric population, and increasing incidences of bone disorders.
Technical Feasibility
3D printing of bones is technically feasible with the use of biocompatible materials such as titanium and polyetheretherketone (PEEK). The process involves the creation of a 3D model of the bone using imaging techniques such as CT or MRI scans. The 3D model is then uploaded to a 3D printer, which produces the implant layer by layer. The 3D-printed implant is then sterilized and implanted into the patient.
Financial Feasibility
The initial investment for setting up a 3D printing facility for bones is high. The cost of a 3D printer ranges from ₹15000 to 200000 depending on the size and capacity of the printer. The cost of raw materials such as titanium and PEEK is also high. However, the cost of 3D-printed implants is significantly lower than traditional implants, which makes it a cost-effective solution for patients.
Regulatory Feasibility
The regulatory landscape for 3D-printed bones is still evolving, and there are no specific guidelines in place for the manufacturing and use of these implants. The FDA has released a draft guidance for 3D-printed medical devices, which provides some guidance on the regulatory requirements. However, it is important to ensure that the 3D-printed bones meet the safety and efficacy standards set by regulatory bodies.
Conclusion
Based on the market analysis and technical feasibility, 3D printing of bones is a viable business opportunity. While the initial investment is high, the cost-effective nature of 3D-printed implants makes them an attractive option for patients. The regulatory landscape is still evolving, but with the right processes in place, 3D printing of bones has the potential to revolutionize the medical industry.