Custom IMD consortium unveils new e-medicine platform with special patients’ privacy protocol in Tarnowskie Gory-Poland
22 September 2010 - 22 September 2010
The Custom IMD consortium, a European R&D Project in the field of industrial technologies for the manufacturing of fully customized medical implants, has developed a platform for managing the whole production process on-line, from patients’ data collection, to part design and delivery of the implant sterilised and ready for surgery. Following the latest trend in e-medicine, the platform, developed by the consortium, includes a special protocol to ensure the confidentiality of patients’ personal information throughout the process.
This and other results will be presented this Thursday and Friday, the 23rd and 24th of September, during the 7th General Custom IMD Meeting, which will take place in Tarnowskie Gory (Poland).
Mainly developed by the partner ENTE (Gliwice, Poland), the tool is an e-collaborative platform, enabling integration between healthcare centres and industry. In other words, it provides industry with design requirements obtained from the patient data acquisition process.
This ensures manufacturing fully customized medical devices according to patients’ physical characteristics. The system also encompasses a final logistic step, responsible for delivering the spinal, cranial or dental implant in a short timeframe.
“We have identified a great interest in the platform within the Polish dental market”, says Adam Koniecksky, project manager at ENTE. “It’s a tool which facilitates the communication and simplifies the work of dental prosthetic clinics when collaborating with the design labs”, he adds. The communication is performed through a secure webpage. All clients (e-collaborators) can access it through any type of internet connection, at any time, enabling integration and communication throughout the whole process chain. In order to comply with data protection regulations, the system uses an encryption protocol, ensuring patient’s privacy. Moreover, only strictly necessary data is transmitted to those partners within the supply chain whose work depends on it.
BIOCOMPATIBILITY AND STERILISATION
Another result to be presented during the meeting in Poland reveals the safety of materials used in the fabrication of the main demonstrators produced in the framework of Custom IMD project.
In-vitro trials carried out by partner Lasmed (Lodz, Poland) ensures the appropriate biocompatibility of PEEK polymer, for cranial implants; the combination of aluminum and zirconium oxides, for dental restorations; and TPU (thermoplastic polycarbonate urethane), for the spinal disc implant. All these materials can be processed through additive manufacturing or injection molding processes representing no risk of rejection.
“All tests have been performed according to the international standards to ensure the safety and the lack of long-term side effects of the project implants once they are placed in the body”, explains Alicja Olejnik, expert in in-vitro biocompatibility assessment at Lasmed.
In the case of the cranial implant, Lasmed has also applied a technique of sterilization of the final part based on electron beam irradiation:
The cranial implant combines a PEEK material with compounded bioresorbable polymer and calcium phosphate. This formulation enhances bone growth for quick tissue regeneration after the surgery.
“Sterilization processes are critical for those biomaterials designed to be biodegradable within the body, because it has to be ensured that the sterilization process is not damaging the material”, says Radoslaw Wach, specialist in the sterilisation effects on polymers at Lasmed.
This and other results will be presented this Thursday and Friday, the 23rd and 24th of September, during the 7th General Custom IMD Meeting, which will take place in Tarnowskie Gory (Poland).
Mainly developed by the partner ENTE (Gliwice, Poland), the tool is an e-collaborative platform, enabling integration between healthcare centres and industry. In other words, it provides industry with design requirements obtained from the patient data acquisition process.
This ensures manufacturing fully customized medical devices according to patients’ physical characteristics. The system also encompasses a final logistic step, responsible for delivering the spinal, cranial or dental implant in a short timeframe.
“We have identified a great interest in the platform within the Polish dental market”, says Adam Koniecksky, project manager at ENTE. “It’s a tool which facilitates the communication and simplifies the work of dental prosthetic clinics when collaborating with the design labs”, he adds. The communication is performed through a secure webpage. All clients (e-collaborators) can access it through any type of internet connection, at any time, enabling integration and communication throughout the whole process chain. In order to comply with data protection regulations, the system uses an encryption protocol, ensuring patient’s privacy. Moreover, only strictly necessary data is transmitted to those partners within the supply chain whose work depends on it.
BIOCOMPATIBILITY AND STERILISATION
Another result to be presented during the meeting in Poland reveals the safety of materials used in the fabrication of the main demonstrators produced in the framework of Custom IMD project.
In-vitro trials carried out by partner Lasmed (Lodz, Poland) ensures the appropriate biocompatibility of PEEK polymer, for cranial implants; the combination of aluminum and zirconium oxides, for dental restorations; and TPU (thermoplastic polycarbonate urethane), for the spinal disc implant. All these materials can be processed through additive manufacturing or injection molding processes representing no risk of rejection.
“All tests have been performed according to the international standards to ensure the safety and the lack of long-term side effects of the project implants once they are placed in the body”, explains Alicja Olejnik, expert in in-vitro biocompatibility assessment at Lasmed.
In the case of the cranial implant, Lasmed has also applied a technique of sterilization of the final part based on electron beam irradiation:
The cranial implant combines a PEEK material with compounded bioresorbable polymer and calcium phosphate. This formulation enhances bone growth for quick tissue regeneration after the surgery.
“Sterilization processes are critical for those biomaterials designed to be biodegradable within the body, because it has to be ensured that the sterilization process is not damaging the material”, says Radoslaw Wach, specialist in the sterilisation effects on polymers at Lasmed.