Speaker
Description
Introduction
Medical devices are being revolutionized with the development of new materials and manufacturing processes. Nowadays, technology enables accurate biofabrication of patient-specific parts, which, while holding high potential for providing the best solutions for patients, presents challenges in designing regulatory-approved devices. This becomes even more challenging once the medical device changes its properties over time of use. For example, biodegradability of devices, which can be encouraged by several mechanisms as enzymatic and hydrolysis, will most likely reduce the mechanical properties; 3D lattices that allow tissue ingrowth change their performance according to the rate, characteristics, and maturity of the regenerated tissue. These mechanisms must be monitored in in-vivo studies examining the state of the implant, ingrowth tissue, and the native tissue’s reaction.
Recent advancements in computational software and hardware provide quality in-silico tools, leading the main regulatory affairs (RA) to accelerate their efforts in embracing Computational Modeling and Simulation (CM&S) as an alternative to physical tests and to animal studies in the longer term [1, 2]. The impact of incorporating computational tools on reducing the amount of in-vivo testing is significant, translating to reduced development time and cost, and the number of animals to be sacrificed. The potential of CM&S has been covered by RA guidelines for the past two decades, highlighting that a credible in-silico tool can answer a variety of questions of interest already in the early stages of product development.
CollPlant’s pioneering development in the field of regenerative medical devices has been rapidly advancing in recent years, enabling the manufacturing of unique lattice-based scaffolds for various applications. The core material of the bioink used to 3D print such products is based on CollPlant’s plant-based recombinant type I human collagen (rhCollagen). The collagen-based bioinks offer a range of mechanical properties depending on the selection of additional components of the formulation and their concentration (e.g., biodegradable polymers, photoinitiator, photoblocker). CM&S tools were incorporated within the design workflow, optimizing both the geometry of the lattice and the material selection, taking into consideration initial and advanced degradation-regeneration states.
Methods
CM&S workflow was developed based on commercial design and Finite Element (FE) software. ‘Digital-Twin’ models were created, mimicking the implant’s geometry, material’s hyperelastic response, boundary conditions, and the expected loadings. An iterative design based on the mechanical in-silico performance was performed. Comparison of Finite Element Analysis (FEA) results with physical tests was conducted as part of the verification and validation process.
Results and Discussion
The gross performance of the implants was calculated using FEA and compared against experimental measurements. Stresses, strains, and displacements were tracked by generating field distribution, highlighting potential regions with localized distortion, buckling, and stress concentration. Insights from the simulation results guided the design of the product, leading to improved mechanical properties while maintaining its adaptability for tissue integration and scaffold degradation mechanisms.
References
[1] Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions, FDA, November 2023
[2] Plan to Phase Out Animal Testing Requirement for Monoclonal Antibodies and Other Drugs, FDA, April 2025
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