Final Report Summary - IMPLANT DIRECT (Implant Direct)
Executive Summary:
The purpose of ImplantDirect was to create a cost-effective, faster manufacturing route for orthopaedic implants, tailored to the individual needs of patients. The overall project aims were to improve the quality of life for the patient and reduce the healthcare costs by improving the quality of the implant and reducing recovery time. This can be achieved by allowing surgeons to customise implants to the individual patients and the individual trauma, thus reducing the number of revisions, the length of surgery time and the recovery time of the patient.
Patient specific bone and joint replacement implants can lead to better functional and aesthetical results, however, conventional methods for extracting 3D shape information from patient images for designing and producing patient specific implants involve multiple surgeon-to-engineer interactions and laborious machining. The ImplantDirect project shows a combination of new design and manufacturing approaches that shortens the overall time significantly (7 days from 4 to 6 weeks).
Project Context and Objectives:
ImplantDirect has developed a cost-effective, faster manufacturing route for orthopaedic implants, tailored to the individual needs of patients. The overall project aims were to improve the quality of the implants, reduce the recovery time, improve the quality of life for the patients and reduce the healthcare costs.
This was achieved by allowing surgeons to design and personalise the implants to fit the patient and the individual trauma, thus reducing the need for revisions, the length of surgery time and the recovery time of the patient.
While the technology is available and can deliver the well-recognised benefits of using personalised implants, the number of clinical cases is still limited. The main reasons, that the technology has not been widely applied for treatment in hospitals, are the complexity of the delivery process, the high cost of implants and the lack of human and technological resources in the area of bio-modelling in hospitals. Especially, the multidisciplinary communication among radiologists, surgeons, and biomedical engineers, which is always needed during the design and manufacturing steps of a patient specific implant. In addition, the optimal solutions and funding for investment of hardware and software are not always available.
The work undertaken in ImplantDirect helped overcoming these issues by the realisation of two key innovations:
1) An innovative software solution that allows the surgeon to directly design the ‘best’ (not limited by existing manufacturing techniques) implant shape for his patients, based on CT-scan data, which will then allow implant creation using the flexible Additive Manufacturing (AM) process of Selective Laser Melting.
2) Development of the Selective Laser Melting process and post-processing necessary to deliver functional Ti6Al4V personalised implants within 3 days from receiving the designs from innovation 1.
Demand-driven innovation is motivating every part of the modern business, including the healthcare industry. More and more, direct customer input is driving every aspect of innovation, from the overall product concept to delivery times. In this emerging world of demand-driven innovation, the delivery time and cost play a crucial part: It must not only be resilient and cost-effective, it must also be able to respond directly to customer needs.
ImplantDirect provides an innovative supply-chain approach where customer data and needs (individual body anatomy) control all the quantitative and qualitative properties of the product, so the patient is treated faster and efficiently. The integrated design module will bring the design stage closer to the hospital and the surgeon, who will be able to directly communicate with the implant suppliers/manufacturers and easily provide input to the final product. It enables surgeons to plan and create 3D implant designs based on patient CT data with few interaction steps and without needing any engineering or CAD know-how. The software implements a design workflow developed in close collaboration with surgeons where users are guided step by step.
The advantage of using AM for fabrication and manufacturing parts in this field is that AM systems can produce parts of almost any geometrical complexity with minimal tooling cost and lead-time. The removal of tooling will reduce the cost at early stages of the product development process and avoid the lengthy lead times caused by tooling. Minor or substantial changes to part geometry are also possible during the course of design, since tooling is not involved.
AM systems can be used to produce physical models of parts of the human anatomy and biological structures to assist in surgery planning or testing. Three-dimensional printing systems are normally used to produce colour medical models to enhance teaching as well as research. It can be used to better illustrate the anatomy, allow viewing of internal structures and much better understanding of some problems or procedures.
Project Results:
The primary disadvantages of current manufacturing procedures for personalised implants are the time and cost required for the design and the possible need for a surgical robot to perform the bone resection. These disadvantages may be eliminated by the use of Additive Manufacturing (AM) technologies, especially the use of SLM technology for quick and economical fabrication of patient specific implant components.
Background
Patient specifically shaped implants for bone support or bone replacement are an emerging need in many surgical interventions. Implants in the facial area for example need to match the shape of the face in order to create an acceptable functional and aesthetical result. For many other indications, patient specific implants have a better surgical outcome or faster recovery times. Revisions of joint implants for example need a good interface from the implant to the patient’s remaining highly specific bone structure. Shape matching surfaces of patient bone and implant improve stability and preserve most of the patient’s remaining bone. Today, mainly two methods are used to customise bone implants.
One method is that the surgeon intra-operatively bends and cuts implants in order to match the desired shape. This procedure prolongs the operation time which is unfavourable for the patient’s health and ends up in high expenses regarding the time in the operation theatre. Further on, the bending adaptions weaken the metal structures and implants could easily break under biomechanical loads. Additionally, this surgical approach is never as accurate as a patient specific preoperatively produced implant.
Another approach of implant customisation starts by designing the implant pre-operatively based on the patient’s own computer tomography (CT) image data. This is conventionally realised by collaborating surgeons and design engineers but needs several interactions and iteration steps which take time and provide a risk for errors. After this, the implant is produced according to this design with conventional machining methods milling or turning. This is costly and time consuming because such production methods are designed and optimised for mass production.
ImplantDirect was building on current knowledge regarding the use of SLM, and developing the SME consortium into a fully functional supply-chain for the design, development and translation into the manufacturing of functional patient specific medical implants. In order to enable a successful supply chain, there were several key technical advances/results that needed to be achieved during ImplantDirect:
1. Patient CT or MRI scan data need to be ‘translated’ to develop suitable implant(s) designs. This required the development of a suitable software solution (InDri) which will allow surgeons (with minimum training and assistance) to design the optimised implant for the patient, without consideration/limitation of how the implant will be manufactured as a result of the design freedom offered by SLM. This also required feedback from surgeons and medical professionals.
The ImplantDirect project team aimed to develop a novel production chain, where the engineer is no longer the originator of the implant design. The surgeon himself becomes the designer of patient specific solutions while the classic design phase is eliminated and shorter lead-times can be reached. Additionally the use of SLM is ideal for low volume production.
The ImplantDirect process starts with the surgeon using highly automated and user friendly software. IMA developed the software solution for this project (EU-Project 2623859, http://www.implantdirect-project.eu/(s’ouvre dans une nouvelle fenêtre)). It enables surgeons to plan and create 3D implant designs based on patient CT data with few interaction steps and without needing any engineering or CAD know-how. The software implements a design workflow developed in close collaboration with surgeons where users are guided step by step.
After logging in to unlock the software, the surgeon starts the workflow by importing patient CT images. Uni-lateral 3D slice images that contain the hip cup and stem area with maximally 2 millimetres slice thickness and a gantry angle of 0 degrees are required.
After checking and complementing missing patient information, the surgeon marks anatomical properties like the patient’s leg axis or the hip centre in the patient images (fig. 1). This information is acquired on virtually generated 2D x-ray images that surgeons are already used to work with. 3D coordinates of the properties are gained by letting the surgeon work on two orthogonally oriented images.
In the next steps, the surgeon defines size and position of the implant based on the previously acquired anatomical properties. The last planning step requires the surgeon to define the area of the hip stem that will have a patient specific shape. A new algorithm then modifies standard implant geometry in the marked areas in order to match the automatically recognized cortical bone from the images.
2. An ‘On Demand’ manufacturing process or digital supply chain, which would incorporate the ‘translation’ (CT-CAD-SLM), which could be directly used to manufacture the implant(s) using SLM. This also required development of the manufacturing process, with special consideration on post-processing and mechanical properties of the implant; adhering to the respective standards required by the medical industry.
For the final check, the surgeon sees a 3D model of the patient specific implant, which he can inspect from all directions and in detail by rotating and zooming (fig. 2). A slice per slice overlay of implant contours on patient images allows verifying the surface match and the correct positioning. If the surgeon agrees to the design, he can export and upload it to the SLM manufacturer. The SLM operator then downloads the CAD file for SLM manufacturing preparation. A workflow for the stem and broach files was developed in order to reduce production time and ensure repeatability and quality of results.
At the manufacturing stages the 3D CAD file is downloaded through the online supply chain (fig. 3) and checked with regards to the requirements for the SLM process, the part is labelled and positioned on the build platform with the necessary support structures. In the meantime, the post-processing (heat treatment and post machining) are being planned. The manufacture of the implants takes 8 hours and the result is shown in figure 4.
3. Validation of the process to ensure that proposed system did enable a significantly faster production route for the manufacture of specific implants and could be used by hospitals in a practical manner. This task involved replicating case studies of ‘real life’ scenarios from the CT-scan time to implant delivery at the hospital.
Patient specific stem parts of hip joint prostheses served as example indication to build up and demonstrate the feasibility of the whole process chain. The design process started with the import of patient's CT scan datasets and ended up with the design of a patient-specific hips stem. This dataset was sent out to other project partners for production and post-processing. For validation purposes different surgeons were testing these individual implants along with pre-clinical trials.
The validation process was divided in two stages. First, the design software was validated. A questionnaire containing 22 questions in terms of usability and functionality was employed. Four individual surgeons filled out this questionnaire after using the software. Each question was rated with “very positive” “positive”, “medium”, “negative” and “very negative”.
The second validation step was the overall test of the whole process chain with an ex-vivo animal study. Twelve pig femur bones were scanned with CT. Using the ImplantDirect approach method, the patient specific implants were planned and produced. During the implantation step, patient specific cutting guides were used to help the surgeon to inter-operatively place the implants. Besides showing the feasibility of the approach, the implants’ stability was tested mechanically (fatigue testing). Post-operative CT scans were used to evaluate the fit and accuracy compared to the pre-operative planning result.
Main Results
1. Integrated supply chain solution, which enables the design and manufacturing of the personalised implants from CT scanning to implantation within 7 days.
2. Software solution, which enables the design of the personalised implants from CT scanning within 2 hours. It enables surgeons to plan and create 3D implant designs based on patient CT data with few interaction steps and without needing any engineering or CAD know-how. The software implements a design workflow developed in close collaboration with surgeons where users are guided step by step.
3. SLM process specification (list of process parameter and part orientation) for the manufacturing of titanium medical implants for achieving the required accuracy and material properties within 24 hours.
4. Post processing specification for heat treatment and finishing in order to meet the criteria of existing manufacturing processes.
The ImplantDirect approach allows an individual hip implant stem to be planned and designed within 10 minutes. The feedback from the surgeons revealed that 19 out of 22 questions were rated “positive” or “very positive” by the subjects. The remaining three goals reached “medium” rating from some of the participants. The “medium” answers were concerned about clarity of error messages, user instructions, and the performance of one particular workflow step. This was dealt with the creation of a user manual but it was also noted as a necessary step for commercialisation activities.
A working web platform (digital supply chain) for uploading the design file, tracking of implant production and delivery status was developed as well; similar a user manual was also created and disseminated within the consortium. The web platform was demonstrated successfully during the final project meeting and was also filmed for the creation of the ImplantDirect video.
Central to the ImplantDirect project was an integrated software platform accessing and monitoring every step of the process. This was an advanced software solution for project and process management within the design and manufacturing set-up. It enabled its users to monitor the manufacturing process, from order follow-up and data preparation, through platform scheduling and machine monitoring, to production planning and part tracking: this way the data-management software will record and store all projects and relevant data.
The pre-clinical validation of the ImplantDirect process chain indicated that the combination of design software, web platform and SLM production is succesful. Twelve implants were designed, produced and implanted into pig femurs (fig. 5). Post-operative CT scans of the femurs with implants were evaluated for implantation fit accuracy. The results showed that the insertion depths of the implants are within the tolerance. Improvements were suggested for the cutting guides in order to support the surgeon with the alignment of the neck part of the stem, this would also form part of follow on activities.
The successful demonstration and validation of the ImplantDirect process chain presents the feasibility and potential of the ImplantDirect approach. Taking manufacturing guidelines into account during the design phase (automatic labelling of parts and cutting lines) could further automate the process and thereby reduce production costs. A follow-up project for ImplantDirect is being discussed within the consortium and should address other indications while including increased manufacturing automation and further quality assurance steps and procedures.
Potential Impact:
The completion of the ImplantDirect project and validated results has enabled a supply-chain of SMEs with the potential to provide European benefit, creating significant competitive advantage by offering the following benefits:
• The use of SLM to allow total design freedom in customised implant designed for function (e.g. comfort of the patient, durability of the implant).
• Allowing a just in time, functional implant to be designed for a specific patient and delivered back to the hospital within 7 days (4-6 weeks currently required).
• Facilitation of the personalisation of medical implants, by enabling manufacture of otherwise uneconomical, small batches or ‘one-off’ implants.
• Provision of advanced mechanical properties of the metallic implants including the development of complex surfaces and structures (i.e. broach).
• The full integration of the SLM process into the manufacturing of fully functional implants.
• Flexibility in supply-chain development and manufacturing that will open up new opportunities in different markets and outside Europe.
Project results and exploitation strategy
1. A surgical software tool to enable the design and manufacturing of personalised primary hip stems from CT scanning to implantation within 7 days. More specifically, a software tool developed for surgeons based on the product portfolio of JRI.
This was a software prototype tool and will be protected via copyright (owner – JRI).
2. SLM process specification for the manufacturing of titanium medical implants.
This was a selection of guidelines and procedures for the manufacturing of functional Ti6Al4V implants and will be protected by secrecy (owners – LAY, JRI, RZR).
3. SLM processing and post processing specifed to meet medical device requirements.
This result included detail results and report regarding requirements and mechanical properties of SLM Ti6Al4V parts, to be protected by secrecy (owners – ALL project SMEs).
4. A web interface for delivering the supply-chain for the design, manufacturing and delivery of personalised titanium implants within a week.
This was a software prototype tool and will be protected by copyright (owners – ALL project SMEs).
5. Guidelines for clinical implant design and preparation for implantation
This result is related to both the design software and supply-chain tools, to be protected by copyright (owner – JRI).
Due to SLM and 3D printing being the focus of advanced manufacturing these days, the results and data from the project were not made publicly available. Also the area of AM is heavily patented and contested, and since some of the project’s main results are software tools, they will be protected by copyright.
Socio-economic impact
The market is driven by the ageing population, technological advancements in implant designs and materials which are resulting in improved durability and younger patients undergoing surgery in the future.
Musculoskeletal problems are strongly associated with age. As the body ages, the bones and muscle tissue start degenerating, thus giving rise to various indications manifested by pain in joints and the back. These problems are especially acute for developing countries, where the percentage of adults over 65 years in the total population is rapidly increasing. The World Health Organization (WHO) estimates that by 2050, there will be approximately 2 billion elderly people living worldwide.
A number of other factors are responsible for the growth in the incidence of musculoskeletal conditions. Urbanization and sedentary work have been linked with the rising incidence of back related problems. The lack of exercise and dietary changes are leading to a rise in the incidence of obesity, which is a major risk factor for the development of knee osteoarthritis and back pain. Smoking, to an extent, has also been associated with the loss of bone density, leading to an increased incidence of fractures.
The global orthopaedic implants market is forecast to grow to €33.6 billion by 2016 at the Compounded Annual Growth Rate (CAGR) rate of 7.8% during 2009-2016. Joint reconstruction will remain the largest orthopaedic implants category, which is expected to grow at 7.4% CAGR during 2009-2016 to reach €17.1 billion. The spinal surgery category is expected to grow steadily at 10.2% during 2009-2016, to reach €8.5 billion by 2016. The trauma or maxillofacial fixation category, which ImplantDirect is focussing on, is expected to grow to €5.75 billion at a CAGR of 6.0% during 2009-2016 (figure 6).
Main dissemination activities
The project has generated a website (figure 7) and a flyer (figure 8), which all partners have agreed to display in their facilities and also to disseminate in public events and exhibitions in both the AM and medical market. In the field of AM, the project has been made know through concept presentation in AM platform meetings (http://www.rm-platform.com/(s’ouvre dans une nouvelle fenêtre)) and flyers available through the partners in Euromold 2013 and 2014 (http://www.euromold.com(s’ouvre dans une nouvelle fenêtre)).
List of Websites:
http://www.implantdirect-project.eu(s’ouvre dans une nouvelle fenêtre)
The purpose of ImplantDirect was to create a cost-effective, faster manufacturing route for orthopaedic implants, tailored to the individual needs of patients. The overall project aims were to improve the quality of life for the patient and reduce the healthcare costs by improving the quality of the implant and reducing recovery time. This can be achieved by allowing surgeons to customise implants to the individual patients and the individual trauma, thus reducing the number of revisions, the length of surgery time and the recovery time of the patient.
Patient specific bone and joint replacement implants can lead to better functional and aesthetical results, however, conventional methods for extracting 3D shape information from patient images for designing and producing patient specific implants involve multiple surgeon-to-engineer interactions and laborious machining. The ImplantDirect project shows a combination of new design and manufacturing approaches that shortens the overall time significantly (7 days from 4 to 6 weeks).
Project Context and Objectives:
ImplantDirect has developed a cost-effective, faster manufacturing route for orthopaedic implants, tailored to the individual needs of patients. The overall project aims were to improve the quality of the implants, reduce the recovery time, improve the quality of life for the patients and reduce the healthcare costs.
This was achieved by allowing surgeons to design and personalise the implants to fit the patient and the individual trauma, thus reducing the need for revisions, the length of surgery time and the recovery time of the patient.
While the technology is available and can deliver the well-recognised benefits of using personalised implants, the number of clinical cases is still limited. The main reasons, that the technology has not been widely applied for treatment in hospitals, are the complexity of the delivery process, the high cost of implants and the lack of human and technological resources in the area of bio-modelling in hospitals. Especially, the multidisciplinary communication among radiologists, surgeons, and biomedical engineers, which is always needed during the design and manufacturing steps of a patient specific implant. In addition, the optimal solutions and funding for investment of hardware and software are not always available.
The work undertaken in ImplantDirect helped overcoming these issues by the realisation of two key innovations:
1) An innovative software solution that allows the surgeon to directly design the ‘best’ (not limited by existing manufacturing techniques) implant shape for his patients, based on CT-scan data, which will then allow implant creation using the flexible Additive Manufacturing (AM) process of Selective Laser Melting.
2) Development of the Selective Laser Melting process and post-processing necessary to deliver functional Ti6Al4V personalised implants within 3 days from receiving the designs from innovation 1.
Demand-driven innovation is motivating every part of the modern business, including the healthcare industry. More and more, direct customer input is driving every aspect of innovation, from the overall product concept to delivery times. In this emerging world of demand-driven innovation, the delivery time and cost play a crucial part: It must not only be resilient and cost-effective, it must also be able to respond directly to customer needs.
ImplantDirect provides an innovative supply-chain approach where customer data and needs (individual body anatomy) control all the quantitative and qualitative properties of the product, so the patient is treated faster and efficiently. The integrated design module will bring the design stage closer to the hospital and the surgeon, who will be able to directly communicate with the implant suppliers/manufacturers and easily provide input to the final product. It enables surgeons to plan and create 3D implant designs based on patient CT data with few interaction steps and without needing any engineering or CAD know-how. The software implements a design workflow developed in close collaboration with surgeons where users are guided step by step.
The advantage of using AM for fabrication and manufacturing parts in this field is that AM systems can produce parts of almost any geometrical complexity with minimal tooling cost and lead-time. The removal of tooling will reduce the cost at early stages of the product development process and avoid the lengthy lead times caused by tooling. Minor or substantial changes to part geometry are also possible during the course of design, since tooling is not involved.
AM systems can be used to produce physical models of parts of the human anatomy and biological structures to assist in surgery planning or testing. Three-dimensional printing systems are normally used to produce colour medical models to enhance teaching as well as research. It can be used to better illustrate the anatomy, allow viewing of internal structures and much better understanding of some problems or procedures.
Project Results:
The primary disadvantages of current manufacturing procedures for personalised implants are the time and cost required for the design and the possible need for a surgical robot to perform the bone resection. These disadvantages may be eliminated by the use of Additive Manufacturing (AM) technologies, especially the use of SLM technology for quick and economical fabrication of patient specific implant components.
Background
Patient specifically shaped implants for bone support or bone replacement are an emerging need in many surgical interventions. Implants in the facial area for example need to match the shape of the face in order to create an acceptable functional and aesthetical result. For many other indications, patient specific implants have a better surgical outcome or faster recovery times. Revisions of joint implants for example need a good interface from the implant to the patient’s remaining highly specific bone structure. Shape matching surfaces of patient bone and implant improve stability and preserve most of the patient’s remaining bone. Today, mainly two methods are used to customise bone implants.
One method is that the surgeon intra-operatively bends and cuts implants in order to match the desired shape. This procedure prolongs the operation time which is unfavourable for the patient’s health and ends up in high expenses regarding the time in the operation theatre. Further on, the bending adaptions weaken the metal structures and implants could easily break under biomechanical loads. Additionally, this surgical approach is never as accurate as a patient specific preoperatively produced implant.
Another approach of implant customisation starts by designing the implant pre-operatively based on the patient’s own computer tomography (CT) image data. This is conventionally realised by collaborating surgeons and design engineers but needs several interactions and iteration steps which take time and provide a risk for errors. After this, the implant is produced according to this design with conventional machining methods milling or turning. This is costly and time consuming because such production methods are designed and optimised for mass production.
ImplantDirect was building on current knowledge regarding the use of SLM, and developing the SME consortium into a fully functional supply-chain for the design, development and translation into the manufacturing of functional patient specific medical implants. In order to enable a successful supply chain, there were several key technical advances/results that needed to be achieved during ImplantDirect:
1. Patient CT or MRI scan data need to be ‘translated’ to develop suitable implant(s) designs. This required the development of a suitable software solution (InDri) which will allow surgeons (with minimum training and assistance) to design the optimised implant for the patient, without consideration/limitation of how the implant will be manufactured as a result of the design freedom offered by SLM. This also required feedback from surgeons and medical professionals.
The ImplantDirect project team aimed to develop a novel production chain, where the engineer is no longer the originator of the implant design. The surgeon himself becomes the designer of patient specific solutions while the classic design phase is eliminated and shorter lead-times can be reached. Additionally the use of SLM is ideal for low volume production.
The ImplantDirect process starts with the surgeon using highly automated and user friendly software. IMA developed the software solution for this project (EU-Project 2623859, http://www.implantdirect-project.eu/(s’ouvre dans une nouvelle fenêtre)). It enables surgeons to plan and create 3D implant designs based on patient CT data with few interaction steps and without needing any engineering or CAD know-how. The software implements a design workflow developed in close collaboration with surgeons where users are guided step by step.
After logging in to unlock the software, the surgeon starts the workflow by importing patient CT images. Uni-lateral 3D slice images that contain the hip cup and stem area with maximally 2 millimetres slice thickness and a gantry angle of 0 degrees are required.
After checking and complementing missing patient information, the surgeon marks anatomical properties like the patient’s leg axis or the hip centre in the patient images (fig. 1). This information is acquired on virtually generated 2D x-ray images that surgeons are already used to work with. 3D coordinates of the properties are gained by letting the surgeon work on two orthogonally oriented images.
In the next steps, the surgeon defines size and position of the implant based on the previously acquired anatomical properties. The last planning step requires the surgeon to define the area of the hip stem that will have a patient specific shape. A new algorithm then modifies standard implant geometry in the marked areas in order to match the automatically recognized cortical bone from the images.
2. An ‘On Demand’ manufacturing process or digital supply chain, which would incorporate the ‘translation’ (CT-CAD-SLM), which could be directly used to manufacture the implant(s) using SLM. This also required development of the manufacturing process, with special consideration on post-processing and mechanical properties of the implant; adhering to the respective standards required by the medical industry.
For the final check, the surgeon sees a 3D model of the patient specific implant, which he can inspect from all directions and in detail by rotating and zooming (fig. 2). A slice per slice overlay of implant contours on patient images allows verifying the surface match and the correct positioning. If the surgeon agrees to the design, he can export and upload it to the SLM manufacturer. The SLM operator then downloads the CAD file for SLM manufacturing preparation. A workflow for the stem and broach files was developed in order to reduce production time and ensure repeatability and quality of results.
At the manufacturing stages the 3D CAD file is downloaded through the online supply chain (fig. 3) and checked with regards to the requirements for the SLM process, the part is labelled and positioned on the build platform with the necessary support structures. In the meantime, the post-processing (heat treatment and post machining) are being planned. The manufacture of the implants takes 8 hours and the result is shown in figure 4.
3. Validation of the process to ensure that proposed system did enable a significantly faster production route for the manufacture of specific implants and could be used by hospitals in a practical manner. This task involved replicating case studies of ‘real life’ scenarios from the CT-scan time to implant delivery at the hospital.
Patient specific stem parts of hip joint prostheses served as example indication to build up and demonstrate the feasibility of the whole process chain. The design process started with the import of patient's CT scan datasets and ended up with the design of a patient-specific hips stem. This dataset was sent out to other project partners for production and post-processing. For validation purposes different surgeons were testing these individual implants along with pre-clinical trials.
The validation process was divided in two stages. First, the design software was validated. A questionnaire containing 22 questions in terms of usability and functionality was employed. Four individual surgeons filled out this questionnaire after using the software. Each question was rated with “very positive” “positive”, “medium”, “negative” and “very negative”.
The second validation step was the overall test of the whole process chain with an ex-vivo animal study. Twelve pig femur bones were scanned with CT. Using the ImplantDirect approach method, the patient specific implants were planned and produced. During the implantation step, patient specific cutting guides were used to help the surgeon to inter-operatively place the implants. Besides showing the feasibility of the approach, the implants’ stability was tested mechanically (fatigue testing). Post-operative CT scans were used to evaluate the fit and accuracy compared to the pre-operative planning result.
Main Results
1. Integrated supply chain solution, which enables the design and manufacturing of the personalised implants from CT scanning to implantation within 7 days.
2. Software solution, which enables the design of the personalised implants from CT scanning within 2 hours. It enables surgeons to plan and create 3D implant designs based on patient CT data with few interaction steps and without needing any engineering or CAD know-how. The software implements a design workflow developed in close collaboration with surgeons where users are guided step by step.
3. SLM process specification (list of process parameter and part orientation) for the manufacturing of titanium medical implants for achieving the required accuracy and material properties within 24 hours.
4. Post processing specification for heat treatment and finishing in order to meet the criteria of existing manufacturing processes.
The ImplantDirect approach allows an individual hip implant stem to be planned and designed within 10 minutes. The feedback from the surgeons revealed that 19 out of 22 questions were rated “positive” or “very positive” by the subjects. The remaining three goals reached “medium” rating from some of the participants. The “medium” answers were concerned about clarity of error messages, user instructions, and the performance of one particular workflow step. This was dealt with the creation of a user manual but it was also noted as a necessary step for commercialisation activities.
A working web platform (digital supply chain) for uploading the design file, tracking of implant production and delivery status was developed as well; similar a user manual was also created and disseminated within the consortium. The web platform was demonstrated successfully during the final project meeting and was also filmed for the creation of the ImplantDirect video.
Central to the ImplantDirect project was an integrated software platform accessing and monitoring every step of the process. This was an advanced software solution for project and process management within the design and manufacturing set-up. It enabled its users to monitor the manufacturing process, from order follow-up and data preparation, through platform scheduling and machine monitoring, to production planning and part tracking: this way the data-management software will record and store all projects and relevant data.
The pre-clinical validation of the ImplantDirect process chain indicated that the combination of design software, web platform and SLM production is succesful. Twelve implants were designed, produced and implanted into pig femurs (fig. 5). Post-operative CT scans of the femurs with implants were evaluated for implantation fit accuracy. The results showed that the insertion depths of the implants are within the tolerance. Improvements were suggested for the cutting guides in order to support the surgeon with the alignment of the neck part of the stem, this would also form part of follow on activities.
The successful demonstration and validation of the ImplantDirect process chain presents the feasibility and potential of the ImplantDirect approach. Taking manufacturing guidelines into account during the design phase (automatic labelling of parts and cutting lines) could further automate the process and thereby reduce production costs. A follow-up project for ImplantDirect is being discussed within the consortium and should address other indications while including increased manufacturing automation and further quality assurance steps and procedures.
Potential Impact:
The completion of the ImplantDirect project and validated results has enabled a supply-chain of SMEs with the potential to provide European benefit, creating significant competitive advantage by offering the following benefits:
• The use of SLM to allow total design freedom in customised implant designed for function (e.g. comfort of the patient, durability of the implant).
• Allowing a just in time, functional implant to be designed for a specific patient and delivered back to the hospital within 7 days (4-6 weeks currently required).
• Facilitation of the personalisation of medical implants, by enabling manufacture of otherwise uneconomical, small batches or ‘one-off’ implants.
• Provision of advanced mechanical properties of the metallic implants including the development of complex surfaces and structures (i.e. broach).
• The full integration of the SLM process into the manufacturing of fully functional implants.
• Flexibility in supply-chain development and manufacturing that will open up new opportunities in different markets and outside Europe.
Project results and exploitation strategy
1. A surgical software tool to enable the design and manufacturing of personalised primary hip stems from CT scanning to implantation within 7 days. More specifically, a software tool developed for surgeons based on the product portfolio of JRI.
This was a software prototype tool and will be protected via copyright (owner – JRI).
2. SLM process specification for the manufacturing of titanium medical implants.
This was a selection of guidelines and procedures for the manufacturing of functional Ti6Al4V implants and will be protected by secrecy (owners – LAY, JRI, RZR).
3. SLM processing and post processing specifed to meet medical device requirements.
This result included detail results and report regarding requirements and mechanical properties of SLM Ti6Al4V parts, to be protected by secrecy (owners – ALL project SMEs).
4. A web interface for delivering the supply-chain for the design, manufacturing and delivery of personalised titanium implants within a week.
This was a software prototype tool and will be protected by copyright (owners – ALL project SMEs).
5. Guidelines for clinical implant design and preparation for implantation
This result is related to both the design software and supply-chain tools, to be protected by copyright (owner – JRI).
Due to SLM and 3D printing being the focus of advanced manufacturing these days, the results and data from the project were not made publicly available. Also the area of AM is heavily patented and contested, and since some of the project’s main results are software tools, they will be protected by copyright.
Socio-economic impact
The market is driven by the ageing population, technological advancements in implant designs and materials which are resulting in improved durability and younger patients undergoing surgery in the future.
Musculoskeletal problems are strongly associated with age. As the body ages, the bones and muscle tissue start degenerating, thus giving rise to various indications manifested by pain in joints and the back. These problems are especially acute for developing countries, where the percentage of adults over 65 years in the total population is rapidly increasing. The World Health Organization (WHO) estimates that by 2050, there will be approximately 2 billion elderly people living worldwide.
A number of other factors are responsible for the growth in the incidence of musculoskeletal conditions. Urbanization and sedentary work have been linked with the rising incidence of back related problems. The lack of exercise and dietary changes are leading to a rise in the incidence of obesity, which is a major risk factor for the development of knee osteoarthritis and back pain. Smoking, to an extent, has also been associated with the loss of bone density, leading to an increased incidence of fractures.
The global orthopaedic implants market is forecast to grow to €33.6 billion by 2016 at the Compounded Annual Growth Rate (CAGR) rate of 7.8% during 2009-2016. Joint reconstruction will remain the largest orthopaedic implants category, which is expected to grow at 7.4% CAGR during 2009-2016 to reach €17.1 billion. The spinal surgery category is expected to grow steadily at 10.2% during 2009-2016, to reach €8.5 billion by 2016. The trauma or maxillofacial fixation category, which ImplantDirect is focussing on, is expected to grow to €5.75 billion at a CAGR of 6.0% during 2009-2016 (figure 6).
Main dissemination activities
The project has generated a website (figure 7) and a flyer (figure 8), which all partners have agreed to display in their facilities and also to disseminate in public events and exhibitions in both the AM and medical market. In the field of AM, the project has been made know through concept presentation in AM platform meetings (http://www.rm-platform.com/(s’ouvre dans une nouvelle fenêtre)) and flyers available through the partners in Euromold 2013 and 2014 (http://www.euromold.com(s’ouvre dans une nouvelle fenêtre)).
List of Websites:
http://www.implantdirect-project.eu(s’ouvre dans une nouvelle fenêtre)