Periodic Reporting for period 1 - ASURI (Advanced Surgical Implants (ASURI))
Reporting period: 2016-07-01 to 2016-12-31
The ASURI project at DO3D Innovations Ltd. aims to enter the patient specific 3D –printed medical implant and surgical guide market with a 3D printing service that integrates the whole patient specific medical implant and surgical guide design and manufacturing process. We provide a scientific evidence based design process and a cost effective manufacturing solution which results in significantly cheaper end products that may be easier financed by private or public health insurance organizations and make patient specific surgical guides and implants accessible to patients. Medical Implants Market is expected to grow to EUR 90 billion by 2022, while global 3D Printing Healthcare Market was valued at EUR 445 million in 2014, and is expected to grow to EUR 1.8 billion by 2020, registering a CAGR of 26.2% during the forecast period 2015-2020. Patient-specific implants, protheses and surgical approaches provide faster recovery and implants match better with the bones around them than traditional implants and conventional surgical techniques. This results in a lower overall healthcare cost (better succes rates for surgery, less recovery time) for healthcare financers. The clinical and economical value of patient-specific surgical approach and implant use is significant in othopedics, where a remarkable part of the surgeries are unconventional ones due to their complexity (e.g. a spinal deformity surgery), extension (e.g. resection of a musculosceletal tumor) or the difficult anatomy (e.g. a revision surgery). Due to its technological superiority the healthcare market for 3D printing is expected to expand ca. EUR 3 billion by 2020. DO3D Innovations foresees a large growth of the personalized medical implant markets as a consequence of the aging societies, therefore we want to make personalized implants and surgical guides accessible to more people.
Our objective is to continue working on our project and proceed to Phase 2 of the SME Instrument.
Our objective is to continue working on our project and proceed to Phase 2 of the SME Instrument.
The Feasibility study (FS) summarises how DO3D Innovations Ltd intends to develop patient specific surgical guides and implants from the current level (TRL6) to industrial readiness and how prepares for the market entry.
TECHNICAL VIABILITY: Our planned service and products were compared to other existing solutions on the market. Possible development alternatives and technical solutions were investigated with respect to the aimed TRL level (trl 9).
IP EVALUATION: The freedom to operate search has been carried out with the result that the planned service does not violate any valid patent in Europe.
LEGAL AND REGULATORY ISSUES, NECESSITY OF CLINICAL RESEARCH: We concluded that it is necessary to carry out clinical trials for patient specific surgical guides and implants. The result of the clinical trials will be a presumably approved CE mark approval by the end of the Phase 2 project.
PHASE 2 project definition has been done during the feasibility study, which embraces a 24 month period. The project overall budget is planned at 1.853 thousand EUR.
MARKET RESEARCH AND BUSINESS PLAN: We evaluated primary and secondary market information. Results of the competitor analysis show that spinal and shoulder applications are the least frequent among competitors.
The main conclusion of the survey conducted was that spinal surgeons are open to use 3D printing techniques, however there is a strong perception that these techniques and tools are not affordable, and therefore they do not use it at the moment. DO3D Innovations will provide patient-specific surgical instruments, guides and implants, as well as surgical models and orthosis focusing on the spinal area of the body. Targeted users of the service will be orthopaedic surgeons, with a special focus on spinal surgeons. Large efforts will be devoted to convincing the spinal clinician community that tools using the 3D printing technology can be availably priced. The business plan assumes a revenue of EUR 4 million for year 3 of the business plan.
TECHNICAL VIABILITY: Our planned service and products were compared to other existing solutions on the market. Possible development alternatives and technical solutions were investigated with respect to the aimed TRL level (trl 9).
IP EVALUATION: The freedom to operate search has been carried out with the result that the planned service does not violate any valid patent in Europe.
LEGAL AND REGULATORY ISSUES, NECESSITY OF CLINICAL RESEARCH: We concluded that it is necessary to carry out clinical trials for patient specific surgical guides and implants. The result of the clinical trials will be a presumably approved CE mark approval by the end of the Phase 2 project.
PHASE 2 project definition has been done during the feasibility study, which embraces a 24 month period. The project overall budget is planned at 1.853 thousand EUR.
MARKET RESEARCH AND BUSINESS PLAN: We evaluated primary and secondary market information. Results of the competitor analysis show that spinal and shoulder applications are the least frequent among competitors.
The main conclusion of the survey conducted was that spinal surgeons are open to use 3D printing techniques, however there is a strong perception that these techniques and tools are not affordable, and therefore they do not use it at the moment. DO3D Innovations will provide patient-specific surgical instruments, guides and implants, as well as surgical models and orthosis focusing on the spinal area of the body. Targeted users of the service will be orthopaedic surgeons, with a special focus on spinal surgeons. Large efforts will be devoted to convincing the spinal clinician community that tools using the 3D printing technology can be availably priced. The business plan assumes a revenue of EUR 4 million for year 3 of the business plan.
As a result of the Phase 1 project, we are confirmed that we pursue of the project. A huge added value of the feasibility study was the much deeper knowledge of the medical devices regulation and necessary standards. The phase 1 project also provided an opportunity to work with a range of partners, who could be long term business partners for our enterprise.