Periodic Reporting for period 1 - BioImplant ITN (European Training Network to develop Improved Bioresorbable Materials for Orthopaedic andVascular Implant Applications)
Berichtszeitraum: 2019-01-01 bis 2020-12-31
BioImplant Innovative Training Network (ITN) is a European Industrial Doctorate (EID) programme that is providing world-class multidisciplinary skills to 12 Early Stage Researchers (ESRs) through an integrated research & training programme in the area of bioabsorbable medical implant development. Bioabsorbable materials are a category of biomaterial that gradually degrade when implanted in a biological environment. They have the potential to form the basis for the next-generation of vascular and orthopaedic medical implants as they can reduce the need for revision surgeries and avoid biocompatibility issues associated with conventional permanent implants. However, several issues relating to poor mechanical properties and/or uncontrollable degradation behaviour of current materials has presented significant technical challenges to the medical device sector. Furthermore, the stringent regulatory requirements associated with a “step-change” technology in the industry has formed a barrier to innovation in the field of bioabsorbables.
The programme vision of the BioImplant ITN is to develop improved bioabsorbable materials for medical implant applications and deliver technical, interdisciplinary and transferrable skills training to the ESRs throughout all stages of the development process. The multidisciplinary training programme delivered to ESRs during the BioImplant ITN programme will enhance career development and employability, promoting their development into leading innovators in the European Medical Technology sector. The training objectives of BioImplant ITN are centred on upskilling the ESRs in core technical skills across all elements of the Supply Value Chain, delivering advanced technical skills through industry-led network-wide training events, providing key transferable and interdisciplinary skills, as well as promoting international mobility of ESRs through inter-sectoral secondments.
The scientific objective of the BioImplant ITN is to develop and implement improved bioabsorbable materials for vascular and orthopaedic implant applications, by focussing on key areas such as enhancing the mechanical properties of polymer-based bioabsorbable material, controlling degradation rates of magnesium-based bioabsorbable materials and developing novel metal- and ceramic-based polymer composite bioabsorbables. The development of these innovative biomaterials will represent a major advancement on the current state-of-the-art in bioresorbable materials and maximise commercial potential in vascular and orthopaedic applications.
The programme vision of the BioImplant ITN is to develop improved bioabsorbable materials for medical implant applications and deliver technical, interdisciplinary and transferrable skills training to the ESRs throughout all stages of the development process. The multidisciplinary training programme delivered to ESRs during the BioImplant ITN programme will enhance career development and employability, promoting their development into leading innovators in the European Medical Technology sector. The training objectives of BioImplant ITN are centred on upskilling the ESRs in core technical skills across all elements of the Supply Value Chain, delivering advanced technical skills through industry-led network-wide training events, providing key transferable and interdisciplinary skills, as well as promoting international mobility of ESRs through inter-sectoral secondments.
The scientific objective of the BioImplant ITN is to develop and implement improved bioabsorbable materials for vascular and orthopaedic implant applications, by focussing on key areas such as enhancing the mechanical properties of polymer-based bioabsorbable material, controlling degradation rates of magnesium-based bioabsorbable materials and developing novel metal- and ceramic-based polymer composite bioabsorbables. The development of these innovative biomaterials will represent a major advancement on the current state-of-the-art in bioresorbable materials and maximise commercial potential in vascular and orthopaedic applications.
In Period 1, 12 ESRs were recruited to four academic beneficiaries, located in the National University of Ireland Galway (Ireland), Queens University Belfast (United Kingdom), RWTH Aachen (Germany) and IMDEA Materials (Spain). In Period 1, all 12 ESRs started their international secondments with their industry partner, including Boston Scientific Limited (Ireland), Vascular Flow Technologies (Scotland), Meotec GmbH (Germany) and ITA GmbH (Germany). Between these academic and industry collaborations, work has been carried out within the areas of materials development (Work Package 1), manufacturing (Work Package 2), characterisation (Work Package 3) and applications (Work Package 4).
Within Work Package 1, an extensive literature review was completed to identify the most suitable materials and processing methods to be used throughout the project. A series of recommendations were provided by the review to inform each material technology under development (i.e. polymer processing, magnesium/coatings and composites).
Within Work Package 2, different advanced manufacturing technologies were investigated with the aim to set the basis for the manufacturing of the next-generation bioabsorbable orthopaedic and vascular devices. Specifically, manufacturing of reinforced composites, warp knitting of spacer fabric and additive manufacturing for bone implant applications, as well as different braiding technologies and the manufacturing of nanoparticle-reinforced tube for stent applications have been widely performed.
Within Work Package 3, three different applications of numerical modelling were developed, in order to assist and inform the characterization processes of device development. These numerical models help to visualize, predict, and optimize degradation behaviour and mechanical properties of the medical devices over time. Also in this Work Package, different characterisation techniques were used within both polymer and metal applications. The focus here has been on the influence of varying manufacturing settings, sterilization techniques and the degradation behaviour, on the material.
Within Work Package 4, a number of prototypes have been designed and developed for vascular and orthopaedic applications in Period 1. In terms of vascular devices, this includes a braided polymer-based stent for coronary applications. In terms of orthopaedic devices, warp knitted bone scaffold, 3D printed magnesium-polymer composite plates, 3D printed magnesium bone scaffolds and magnesium-fibre reinforced bone plates have been developed.
In Period 1, excellent progress has also been made in the BioImplant Training Programme. An extensive range of transferable skills training has been delivered to ESRs in the areas of presentation skills, academic writing, report writing, management skills, leadership skills, discussing research with the public through storytelling, unconscious bias and US and EU regulatory affairs training for biomedical devices. Advanced technical skills training has also been delivered to ESRs across topics including current developments in bioabsorblae materials and state-of-the-art polymer, magnesium and composite materials manufacturing technologies.
Within Work Package 1, an extensive literature review was completed to identify the most suitable materials and processing methods to be used throughout the project. A series of recommendations were provided by the review to inform each material technology under development (i.e. polymer processing, magnesium/coatings and composites).
Within Work Package 2, different advanced manufacturing technologies were investigated with the aim to set the basis for the manufacturing of the next-generation bioabsorbable orthopaedic and vascular devices. Specifically, manufacturing of reinforced composites, warp knitting of spacer fabric and additive manufacturing for bone implant applications, as well as different braiding technologies and the manufacturing of nanoparticle-reinforced tube for stent applications have been widely performed.
Within Work Package 3, three different applications of numerical modelling were developed, in order to assist and inform the characterization processes of device development. These numerical models help to visualize, predict, and optimize degradation behaviour and mechanical properties of the medical devices over time. Also in this Work Package, different characterisation techniques were used within both polymer and metal applications. The focus here has been on the influence of varying manufacturing settings, sterilization techniques and the degradation behaviour, on the material.
Within Work Package 4, a number of prototypes have been designed and developed for vascular and orthopaedic applications in Period 1. In terms of vascular devices, this includes a braided polymer-based stent for coronary applications. In terms of orthopaedic devices, warp knitted bone scaffold, 3D printed magnesium-polymer composite plates, 3D printed magnesium bone scaffolds and magnesium-fibre reinforced bone plates have been developed.
In Period 1, excellent progress has also been made in the BioImplant Training Programme. An extensive range of transferable skills training has been delivered to ESRs in the areas of presentation skills, academic writing, report writing, management skills, leadership skills, discussing research with the public through storytelling, unconscious bias and US and EU regulatory affairs training for biomedical devices. Advanced technical skills training has also been delivered to ESRs across topics including current developments in bioabsorblae materials and state-of-the-art polymer, magnesium and composite materials manufacturing technologies.
The current state-of-the-art in bioabsorbable medical implants has seen, for the most part, polymer-based biomaterials implemented clinically. However, their large-scale commercial production relies on traditional processing strategies, such as injection, compression or extrusion moulding. The BioImplant ITN is in the process of (i) targeting new processing solutions that enhance the mechanical behaviour of bioabsorbable polymers themselves and (ii) integrating high stiffness magnesium- and ceramic-based reinforcements with polymer biomaterials to produce novel hybrid/composite bioabsorbables with optimised mechanical and degradation performance. The development of these innovative biomaterials, in addition to a novel predictive framework for polymer- and metal-based degradation, will have a major impact on the advancement of the current state-of-the-art and maximise the commercial potential of bioabsorbable materials for implant applications.
Outside the realm of providing the next generation of bioabsorbable medical devices, the BioImplant ITN is enhancing career development and employability of ESRs within the Medical Technology sector and promoting their development into leading innovators in the European Medical Technology sector.
Outside the realm of providing the next generation of bioabsorbable medical devices, the BioImplant ITN is enhancing career development and employability of ESRs within the Medical Technology sector and promoting their development into leading innovators in the European Medical Technology sector.