Dissertation committee:
Παναγιώτης Παπαγγελόπουλος, Καθηγητής, Ιατρική Σχολή, ΕΚΠΑ
Θεόδωρος Παπαϊωάννου, Καθηγητής, Ιατρική Σχολή, ΕΚΠΑ
Όλγα Σαββίδου, Καθηγήτρια, Ιατρική Σχολή, ΕΚΠΑ
Ανδρέας Μαυρογένης, Καθηγητής, Ιατρική Σχολή, ΕΚΠΑ
Κωνσταντίνος Στεργίου, Καθηγητής, Τμήμα Μηχανολόγων Μηχανικών, ΠΑΔΑ
Βασίλειος Κοντογεωργάκος, Αναπληρωτής Καθηγητής, Ιατρική Σχολή, ΕΚΠΑ
Ολυμπία Παπακωνσταντίνου, Αναπληρώτρια Καθηγήτρια, Ιατρική Σχολή, ΕΚΠΑ
Summary:
The theme of this Thesis is the Point-of-Care (PoC) utilization of emblematic 3D technologies (3D digital design, 3D Printing (3DP), Virtual/Augmented/Mixed Reality (xR)) that enable the realization of scientifically amalgamated inter-epistemic schemes in a medical setting to simplify orthopaedic operations by complex pre-operative planning and (bio)mechanical engineering, thus delivering fast high-quality (in)tangible customized solutions to improve individualized patient healthcare.
The Thesis is structured in eight sections and many sub-sections to ultimately transition from the general to the specific part, whilst the reader is presented with a plethora of visual material. All required software and hardware means to develop individualized orthopaedic services and products at the PoC are covered and many details, step-by-step guidelines, and notes are provided to enable the fabrication of patient-specific orthopeaedic solutions featuring optimized biomimetic structures.
The state of the art is unfolded in the first section. The characteristics of individualized orthopaedic rehabilitation, inter-epistemic synergy and enabling technologies, and PoC 3D Units are covered.
In section two, the theme, approach, and structure are impressed, and the hypothesis is introduced, suggesting that inter-epistemic workflows exploiting the triad of 3D digital design, 3DP, and xR technologies could be disruptive for individualized orthopaedics, especially if routinely applied at or near the PoC.
Section three provides a critical literature review on the use of biomaterials in modern reconstructive orthopaedics and Tissue Engineering (TE) for regenerative medicine. Emphasis is given on manufacturing and 3DP techniques, including bibliography, historical background, features of 3DP technologies, process flow chain for 3DP, their characteristics, and potential. The adoption of advanced 3D digital design tools and 3DP for PoC 3D Units and their impacts on orthopaedics are highlighted. The potential of 3DP for boosting the design and materialization of optimized forms as well as associated challenges and issues are analyzed; biomimetic designs, architected endo and exo-structures, and meta-(bio)materials-by-design for mechanical and biological superiority. xR technologies and applications in orthopaedics are also discussed.
In section four, the research rationale is justified and the methodology to approach the initial hypothesis is set. A de-novo 15-step role-based end-to-end systematic inter-epistemic patient-specific orthopaedic product design workflow is created and applied to solve selected case studies at the PoC.
Two scenarios for PoC 3D Unit establishment and associated topics are discussed for distributed and localized manufacturing in section five; organizational structure and framework, online platform for data exchange, regulations and quality management system, hardware and software equipment, infrastructure and layout, and costing. A small hypodigmatic pilot PoC 3D Unit was established as per the available resources.
In section six, selected case studies are solved at the pilot PoC 3D Unit as per the 15-step inter-epistemic workflow set, utilizing advanced 3D digital design and optimization techniques, xR, and 3DP. Five oncological case studies about pelvic and sacrum tumor resection and reconstruction using patient-specific instrumentation and custom-made artificial endo-prostheses are presented. Anatomical structures, surgical instruments, and endo-prostheses were visualized digitally, virtually, and physically before issuing the final documentation for approval to enable the materialization of the collaboratively developed solutions. The first case is analytically described step-by-step whilst justifying each selection and decision, and alternative design options are also being explored. For the other oncological cases, the final solutions are demonstrated. A case study on patient-specific orthotic devices using 3D scanning is also carried out.
The results are discussed in section seven and the conclusions and future work in section eight. The developed patient-specific solutions were successfully prototyped at the pilot PoC at acceptable clinical times and costs, whereas the end polymer and metallic parts that required industrial-grade machines were outsourced to external partners for production. 3DP of polymer anatomical models, surgical guides, and implant prototyping, along with xR systems for pre-operative planning and intra-operative (non-navigation) purposes can be implemented at relatively low initial capital investments and operating and maintenance costs. A plethora of trade-offs can be made for PoC 3D Units in terms of software and hardware equipment, layout, personnel, etc. It is orthological for interested healthcare facilities to commence with in-house 3D design and 3DP only for prototyping and outsourcing the end parts, and only if sufficient demand exists to implement in situ final manufacturing and increase their capacity. Investments should be rationalized and driven by clinical needs so that the collaboratively developed solutions are clinically and scientifically relevant and ultimately beneficial for each unique patient. Non-technical challenges (regulatory compliance, lack of directives, standards and quality management systems, need for skilled personnel) and technical limitations still hold 3D technologies from springboarding and should be addressed. As necessity drives invention and innovation, once the readiness of 3D technologies stops remaining under question and their costs in tandem with the required medical device development time will be further reduced, their PoC incorporation will accelerate orthopaedics into intelligent formats capable of unlocking mass-customization with high-quality end-results and increased patient satisfaction.
Healthcare was traditionally a non-engineering design and non-manufacturing sector as neither design nor manufacturing has been taking place in situ. As 3D design and manufacturing technologies are now being adopted, the transformation of healthcare facilities into decentralized design and/or manufacturing sites is viable. PoC 3D Units aiming at medical device development should be established accordingly to facilitate the symbiosis of healthcare professionals with skilled (bio)mechanical engineers to develop patient-specific devices at the PoC within acceptable lead times and costs. (Bio)mechanical engineers could enable orthopaedic surgeons to actively participate in medical device making at or near the PoC for clinical applications. Novel approaches by advanced 3D digital design and optimization, coupled with the freedom offered by 3DP should be embraced to architect (bio)meta-materials-by-design and develop smart medical devices for reconstructive orthopaedics, though there is a need to shift towards TE for regenerative medicine and other smart and innovative approaches.
Although related pitfalls are known to engineers, an increased awareness is suggested to explore and exploit the full potential of the 3D design-3DP-xR triad that introduces entirely new abilities for delivering medical devices at the PoC with greater customization, innovation in design, cost-effectiveness, and high quality.
