Periodic Reporting for period 2 - BioImplant ITN (European Training Network to develop Improved Bioresorbable Materials for Orthopaedic andVascular Implant Applications)
Reporting period: 2021-01-01 to 2023-06-30
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.
The BioImplant project has successfully trained the next-generation of industry and academia leaders in the area of bioabsorbable medical device development and innovation. The activities of the project contributed to providing excellent career prospects to its ESRs through (i) advanced technical expertise (via ESR projects spanning the Supply Value Chain, high quality industry secondments and technical network-wide training events delivered), (ii) transferrable skills (through the transferable skills network-wide training events delivered and local training availed of), (iii) international industry experience of up to 36 months in duration and (iv) training in clinical engagement. Through its research programme, the project achieved enhanced mechanical properties of polymer-based bioabsorbables through novel processing technologies. A range of novel processing technologies were used to create new bioabsorbable materials and devices. These included extruded and stretch-blow moulded samples, wire-braided structures and warp knitted polymer components. The project achieved controlled degradation rates of magnesium-based bioabsorbable materials with the implementation of plasma electrolytic oxidation (PEO) coatings that were used to introduce a ceramic layer on Mg specimens that resulted in a 3-fold enhancement of corrosion behaviour. Other polymer based coatings were also developed that provided additional enhancements to behaviour. The project developed novel metal- and ceramic-based polymer composite bioabsorbables. Several magnesium wire and PLA composite materials were developed that showed enhanced mechanical properties and superior corrosion behaviour compared to uncoated magnesium. The degradation and long-term mechanical performance of implanted bioabsorbable devices was predicted through the development and implantation of a novel surface-based corrosion model framework that fully captured the onset and evolution of pitting corrosion on magnesium samples, in addition to predicting the associated mechanical performance. Finally, a range of prototype devices were developed as part of the BioImplant programme. These included extruded PLLA tubes, nitinol stents, WE43 dog bone scaffolds, extruded and L-PBF bone plates, PLA-PLA and PLA-PCL composite plates, machine braided PLLA stents, PLA and P4HB warp knitted textile scaffolds and 3D printed flat dog bone scaffolds.
Project results were disseminated through 23 open access journal publications in high impact journals including Bioactive Materials, Frontiers in Medical Technology, Biomaterials Science and Polymers. There have been 46 national and international conference presentations, in addition to participation in public engagement events (e.g. Science Week in Madrid, Falling Walls Lab MSCA Competition, Soapbox Science and engagement with students). To maximise the impact of the BioImplant ITN, exploitation by industry, clinical and academic/researchers was considered using various channels which include making results available through open source platforms, continued internal use of results in the involved industry/academic institutions, use of results within education in the form of teaching tools and encorporation into graduate/postgraduate modules, and use of results for further research and funding applications.
Project results were disseminated through 23 open access journal publications in high impact journals including Bioactive Materials, Frontiers in Medical Technology, Biomaterials Science and Polymers. There have been 46 national and international conference presentations, in addition to participation in public engagement events (e.g. Science Week in Madrid, Falling Walls Lab MSCA Competition, Soapbox Science and engagement with students). To maximise the impact of the BioImplant ITN, exploitation by industry, clinical and academic/researchers was considered using various channels which include making results available through open source platforms, continued internal use of results in the involved industry/academic institutions, use of results within education in the form of teaching tools and encorporation into graduate/postgraduate modules, and use of results for further research and funding applications.
The European medical technology industry has continued to grow during the BioImplant ITN and now directly employs more than 800,000 people. 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 has targetted new processing solutions that enhance the mechanical behaviour of bioabsorbable polymers themselves and has integrated 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 has enhanced 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 has enhanced career development and employability of ESRs within the Medical Technology sector and promoting their development into leading innovators in the European Medical Technology sector.