M. Tichem
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19 records found
1
Development of a Regulatory Process Model for Non-Active Class III Cardiosurgical Medical Devices
Integrating EU MDR Requirements, Regulatory Documentation, and Institutional Stakeholders from Concept to Post-Market Activities
The process model was developed through an iterative, document-based approach and structured into nine interconnected development domains. It was evaluated by twelve multidisciplinary experts using a mixed-methods validation combining quantitative assessment with qualitative feedback. The quantitative evaluation indicated that experts generally considered the model complete and regulatory accurate, with the validation criterion Completeness receiving the highest mean score (4.15/5) and Regulatory Accuracy a mean score of 3.88/5. In contrast, Clarity and Interpretability received the lowest mean score (2.73/5), which identified the visualization of the process model as important areas for further development. Qualitative findings supported these results: experts recognized the potential value of the model as an integrated overview and guidance tool, while also identifying opportunities to improve its visualization, usability, and representation of regulatory and development relationships.
Overall, the resulting regulatory process model provides a foundation for supporting early-stage medical device developers and for further development towards a more accessible and interactive regulatory guidance tool. ...
The process model was developed through an iterative, document-based approach and structured into nine interconnected development domains. It was evaluated by twelve multidisciplinary experts using a mixed-methods validation combining quantitative assessment with qualitative feedback. The quantitative evaluation indicated that experts generally considered the model complete and regulatory accurate, with the validation criterion Completeness receiving the highest mean score (4.15/5) and Regulatory Accuracy a mean score of 3.88/5. In contrast, Clarity and Interpretability received the lowest mean score (2.73/5), which identified the visualization of the process model as important areas for further development. Qualitative findings supported these results: experts recognized the potential value of the model as an integrated overview and guidance tool, while also identifying opportunities to improve its visualization, usability, and representation of regulatory and development relationships.
Overall, the resulting regulatory process model provides a foundation for supporting early-stage medical device developers and for further development towards a more accessible and interactive regulatory guidance tool.
By making use of specialty inks, such as conductive inks and photopolymer inks, it becomes feasible to construct embedded electronic circuits in 3D solids, a concept referred to as structural electronics.
Several aspects of this process remain challenging, however: there is a wide variety of printable photopolymers, each with different printing requirements and material characteristics. Likewise, although conductive inks are commercially available, many formulations require intense post-processing or offer limited conductivity. Furthermore, there is an absence of open software tools dedicated to the design and integration of structural electronics for inkjet-3D-printing.
In this thesis, the use of a TPGDA photopolymer in combination with a silver nanoparticle ink is investigated for the application of printing structural electronics. The materials are printed using a PIXDRO LP50 Inkjet printing platform equipped with Dimatix printheads. The TPGDA is cured with UV light, which results in accurate, millimeter-scale structures, although artifacts are present due to fluid interactions of the liquid photopolymer.
The silver nanoparticle ink, NovaCentrix Metallon JS-A211, is printed on the polymer substrate and sintered with intense UV light, a process known as photonic sintering. Circuit traces are consistently printable with a minimum width of 0.3mm, and a sheet resistance of 0.21 Ohm per layer has been achieved.
To support the fabrication process, a software tool is developed for pre-processing files for inkjet-3D-printing, and for designing and embedding electronic circuits. This tool is used to design a series of print tests, where the structural and conductive materials are combined to form structural electronics. In these print tests, the ability to incorporate electronic vias into the printed circuit is demonstrated. Additionally, electronic components are successfully soldered to the fabricated designs, and the ability to embed these components into the structural material is achieved. ...
By making use of specialty inks, such as conductive inks and photopolymer inks, it becomes feasible to construct embedded electronic circuits in 3D solids, a concept referred to as structural electronics.
Several aspects of this process remain challenging, however: there is a wide variety of printable photopolymers, each with different printing requirements and material characteristics. Likewise, although conductive inks are commercially available, many formulations require intense post-processing or offer limited conductivity. Furthermore, there is an absence of open software tools dedicated to the design and integration of structural electronics for inkjet-3D-printing.
In this thesis, the use of a TPGDA photopolymer in combination with a silver nanoparticle ink is investigated for the application of printing structural electronics. The materials are printed using a PIXDRO LP50 Inkjet printing platform equipped with Dimatix printheads. The TPGDA is cured with UV light, which results in accurate, millimeter-scale structures, although artifacts are present due to fluid interactions of the liquid photopolymer.
The silver nanoparticle ink, NovaCentrix Metallon JS-A211, is printed on the polymer substrate and sintered with intense UV light, a process known as photonic sintering. Circuit traces are consistently printable with a minimum width of 0.3mm, and a sheet resistance of 0.21 Ohm per layer has been achieved.
To support the fabrication process, a software tool is developed for pre-processing files for inkjet-3D-printing, and for designing and embedding electronic circuits. This tool is used to design a series of print tests, where the structural and conductive materials are combined to form structural electronics. In these print tests, the ability to incorporate electronic vias into the printed circuit is demonstrated. Additionally, electronic components are successfully soldered to the fabricated designs, and the ability to embed these components into the structural material is achieved.
In this study, the effects of UV light exposure on feature accuracy and mechanical performance is systematically investigated. It is observed that for the rigid material, Anycubic High Clear, sample sizes increase and void features shrink when the exposure to UV light increases. For the soft material, Liqcreate Elastomer-X, shrinkage rates after swelling due to IPA absorption are compared under different conditions, revealing that shrinkage occurs more rapidly with a heat source than at ambient temperature.
Mechanical properties are further evaluated through tensile testing of four sets of printed dogbones, showing that extended UV exposure enhances mechanical properties such as the Young's modulus, ultimate tensile strength and strength at break. Elastomeric materials assessed in this study demonstrate an optimal measurement accuracy within a strain range of 10% to 50%. The influence of print orientation is assessed for the hard material. This experiment is executed for layer thicknesses from 10 µm to 200 µm across horizontal, vertical, and diagonal orientations, with vertically printed samples being closest to the intended dimensions.
A comprehensive multi-material 3D printing protocol based on the existing "print-pause-print" technique and utilizing the software UVTools is presented. Finally, a microfluidic Quake valve is designed and optimized for 3D printing, its performance is analyzed through finite element (FEM) simulation and analytical calculations.
The results of this study offer valuable insights into the optimization of multi-material 3D printing for microfluidic applications, highlighting several critical parameters that affect feature resolution and mechanical performance. The proposed protocol and findings serve as a foundation for future advancements in the fabrication of complex microfluidic devices. ...
In this study, the effects of UV light exposure on feature accuracy and mechanical performance is systematically investigated. It is observed that for the rigid material, Anycubic High Clear, sample sizes increase and void features shrink when the exposure to UV light increases. For the soft material, Liqcreate Elastomer-X, shrinkage rates after swelling due to IPA absorption are compared under different conditions, revealing that shrinkage occurs more rapidly with a heat source than at ambient temperature.
Mechanical properties are further evaluated through tensile testing of four sets of printed dogbones, showing that extended UV exposure enhances mechanical properties such as the Young's modulus, ultimate tensile strength and strength at break. Elastomeric materials assessed in this study demonstrate an optimal measurement accuracy within a strain range of 10% to 50%. The influence of print orientation is assessed for the hard material. This experiment is executed for layer thicknesses from 10 µm to 200 µm across horizontal, vertical, and diagonal orientations, with vertically printed samples being closest to the intended dimensions.
A comprehensive multi-material 3D printing protocol based on the existing "print-pause-print" technique and utilizing the software UVTools is presented. Finally, a microfluidic Quake valve is designed and optimized for 3D printing, its performance is analyzed through finite element (FEM) simulation and analytical calculations.
The results of this study offer valuable insights into the optimization of multi-material 3D printing for microfluidic applications, highlighting several critical parameters that affect feature resolution and mechanical performance. The proposed protocol and findings serve as a foundation for future advancements in the fabrication of complex microfluidic devices.
Photoacoustic imaging is a technique capable of providing real-time visual feedback. Integrating photoacoustic capabilities into existing Radiofrequency ablation catheters poses a significant challenge, which this thesis addresses. The proposed integrated solution employs optical fibers for light delivery and an ultrasound transducer for signal reception.
This work investigates the design of two light delivery systems for integrated photoacoustic-guided surgery. Monte Carlo simulations are employed to study three-dimensional light propagation in tissue, informing the catheter design specifications. Optimal fiber distances and orientations within the catheter are determined based on normalized fluence values and illumination spot size—critical parameters for assessing the amount of delivered light, its area of coverage, and depth of penetration. The methodology presented applies to various photoacoustic applications.
The simulation study was able to successfully inform design specifications and it was able to establish a relation between design variables and the evaluation criteria such that it can be referred to for future designs. The comparative study yielded a better-performing design configuration and its optimal specifications were found out. This proves the use of a simulation-based evaluation to design a photoacoustic intracardiac catheter. In the final phase of this research, an experiment is set up to validate the light delivery of the design, which provides a clear outlook for the future of these designs into fabricated products. ...
Photoacoustic imaging is a technique capable of providing real-time visual feedback. Integrating photoacoustic capabilities into existing Radiofrequency ablation catheters poses a significant challenge, which this thesis addresses. The proposed integrated solution employs optical fibers for light delivery and an ultrasound transducer for signal reception.
This work investigates the design of two light delivery systems for integrated photoacoustic-guided surgery. Monte Carlo simulations are employed to study three-dimensional light propagation in tissue, informing the catheter design specifications. Optimal fiber distances and orientations within the catheter are determined based on normalized fluence values and illumination spot size—critical parameters for assessing the amount of delivered light, its area of coverage, and depth of penetration. The methodology presented applies to various photoacoustic applications.
The simulation study was able to successfully inform design specifications and it was able to establish a relation between design variables and the evaluation criteria such that it can be referred to for future designs. The comparative study yielded a better-performing design configuration and its optimal specifications were found out. This proves the use of a simulation-based evaluation to design a photoacoustic intracardiac catheter. In the final phase of this research, an experiment is set up to validate the light delivery of the design, which provides a clear outlook for the future of these designs into fabricated products.
Machining cost estimation in topology optimization for 2.5-axis CNC milling
Adapting a new-school design method to an old-school manufacturing process
This estimation model was implemented in a generic topology optimization algorithm in five steps of complexity. The behaviour of the model was evaluated at each step by means of a set of experiments, showing how the addition of the cost estimation influences the optimization results.
The most promising results from the experiments are validated with Autodesk Fusion 360, with which the designs were programmed to be machined on a CNC mill. The machining times from this software were used to calculate the actual machining costs and these were compared to the machining costs estimated by the optimizer.
Two formulations of the method were found to be useful for estimating the machining cost of designs. A simple formulation that uses the shape factor and the differentiation between internal and external pockets to estimate the cost resulted in a cost saving of 13% at the expensive of a compliance increase of 9%. The more complex formulation uses multiple pocket domains to evaluate pocket-specific properties. This allowed a more accurate estimation of the costs, but did not result in a better performing optimization. The cost saving was comparable at 12%, but the compliance increased by 16%.
It was concluded that there is a use for both methods. The simple formulation allows to find cheaper designs, but does not allow much control in the cost estimation. The complex formulation however can be used to fine-tune the method for a specific situation, which could enable it to perform better that the simple formulation. ...
This estimation model was implemented in a generic topology optimization algorithm in five steps of complexity. The behaviour of the model was evaluated at each step by means of a set of experiments, showing how the addition of the cost estimation influences the optimization results.
The most promising results from the experiments are validated with Autodesk Fusion 360, with which the designs were programmed to be machined on a CNC mill. The machining times from this software were used to calculate the actual machining costs and these were compared to the machining costs estimated by the optimizer.
Two formulations of the method were found to be useful for estimating the machining cost of designs. A simple formulation that uses the shape factor and the differentiation between internal and external pockets to estimate the cost resulted in a cost saving of 13% at the expensive of a compliance increase of 9%. The more complex formulation uses multiple pocket domains to evaluate pocket-specific properties. This allowed a more accurate estimation of the costs, but did not result in a better performing optimization. The cost saving was comparable at 12%, but the compliance increased by 16%.
It was concluded that there is a use for both methods. The simple formulation allows to find cheaper designs, but does not allow much control in the cost estimation. The complex formulation however can be used to fine-tune the method for a specific situation, which could enable it to perform better that the simple formulation.
Contactless positioning of thin flexible substrates
Demonstrator design and validation of opposed air film actuators
Computational efficient robustness analysis of aircraft component distortion
Accounting for stochastic pre-stressed stock material in reductive manufacturing processes
(10^-15 L) volumes, and studies on mechanical interaction with single cells. The main fabrication method of these devices is by standard clean room micro/nano fabrication techniques, however, they are inherently planar, thus limiting three dimensional design, and the required masks make prototyping time-consuming and expensive. In this work maskless 3D-printing by two-photon polymerization (2PP) was used to fabricate hollow microfluidic cantilevers. A novel fluidic interfacing approach was developed by directly 2PP-printing the cantilever on a stereolithographic microfluidic device for handling and connecting to the external world. Several 350 µm long cantilevers with an aperture of 25 µm were mechanically characterised by laser Doppler vibrometry and the fundamental frequency was measured at 99,6 kHz, with a quality factor of approximately 174 in air. A hydraulic model was constructed and fluidic functionality was demonstrated. The non-optimised printing time of the full device was approximately 2.5 hours, performed by only two automated maskless fabrication steps. This printing method enables rapid prototyping of ready-to-use suspended microfluidic devices. ...
(10^-15 L) volumes, and studies on mechanical interaction with single cells. The main fabrication method of these devices is by standard clean room micro/nano fabrication techniques, however, they are inherently planar, thus limiting three dimensional design, and the required masks make prototyping time-consuming and expensive. In this work maskless 3D-printing by two-photon polymerization (2PP) was used to fabricate hollow microfluidic cantilevers. A novel fluidic interfacing approach was developed by directly 2PP-printing the cantilever on a stereolithographic microfluidic device for handling and connecting to the external world. Several 350 µm long cantilevers with an aperture of 25 µm were mechanically characterised by laser Doppler vibrometry and the fundamental frequency was measured at 99,6 kHz, with a quality factor of approximately 174 in air. A hydraulic model was constructed and fluidic functionality was demonstrated. The non-optimised printing time of the full device was approximately 2.5 hours, performed by only two automated maskless fabrication steps. This printing method enables rapid prototyping of ready-to-use suspended microfluidic devices.
Membrane fouling
Study on fouling inside an Organ on a Chip
In this research a microfluidic flow cell is produced and used to explore fouling within the OoC. Static and dynamic fouling experiments are executed on membranes having pore sizes ranging from 0.4 to 5 μm.
Scanning electron microscope (SEM) images indicate that standard blocking and cake layer formation are dominating fouling mechanisms.
Membranes with 1 μm pore size are the most susceptible to standard blocking. Further a decrease in pore area of 0%, 11% and 20% and a decrease in uncovered amount of pores of 27%, 34% and 80% for Glycine, BSA and λ-DNA respectively are measured after one week of fouling.
Cake layer formation is seen after fouling for a shorter duration for BSA (one day) than for Glycine (one hour) and a higher concentration of BSA particles is permitted through all tested membranes than Glycine, therefore the conclusion is drawn that BSA causes less fouling than Glycine.
...
In this research a microfluidic flow cell is produced and used to explore fouling within the OoC. Static and dynamic fouling experiments are executed on membranes having pore sizes ranging from 0.4 to 5 μm.
Scanning electron microscope (SEM) images indicate that standard blocking and cake layer formation are dominating fouling mechanisms.
Membranes with 1 μm pore size are the most susceptible to standard blocking. Further a decrease in pore area of 0%, 11% and 20% and a decrease in uncovered amount of pores of 27%, 34% and 80% for Glycine, BSA and λ-DNA respectively are measured after one week of fouling.
Cake layer formation is seen after fouling for a shorter duration for BSA (one day) than for Glycine (one hour) and a higher concentration of BSA particles is permitted through all tested membranes than Glycine, therefore the conclusion is drawn that BSA causes less fouling than Glycine.
MEMS-based sample carriers became a breakthrough for in-situ TEM where they function as a micro-sized laboratory and enable dynamic studies. The Nanoreactor allows for manipulation of samples by simultaneously applying heat and gas stimuli, through which real-time studies of solid-gas interactions are enabled inside the TEM. Many challenges are still to be faced in further optimization of Nanoreactors. Especially because the tiny scale and the extreme conditions at which these devices must operate, limit the number of suitable tools to characterize and help understand their behavior.
In this project, the electro-thermo-mechanical behavior of the Nanoreactor is characterized using various microscale analytical techniques. The obtained results are used to model the Nanoreactor with finite element analysis, including electric current, mechanical stability, heat transfer, gas flow, and their interdependence. Using the acquired knowledge and the model, an optimized Nanoreactor design is proposed that improves membrane deflection, spatial sample drift, temperature homogeneity, temperature stability, gas flow speed and gas switching time. ...
MEMS-based sample carriers became a breakthrough for in-situ TEM where they function as a micro-sized laboratory and enable dynamic studies. The Nanoreactor allows for manipulation of samples by simultaneously applying heat and gas stimuli, through which real-time studies of solid-gas interactions are enabled inside the TEM. Many challenges are still to be faced in further optimization of Nanoreactors. Especially because the tiny scale and the extreme conditions at which these devices must operate, limit the number of suitable tools to characterize and help understand their behavior.
In this project, the electro-thermo-mechanical behavior of the Nanoreactor is characterized using various microscale analytical techniques. The obtained results are used to model the Nanoreactor with finite element analysis, including electric current, mechanical stability, heat transfer, gas flow, and their interdependence. Using the acquired knowledge and the model, an optimized Nanoreactor design is proposed that improves membrane deflection, spatial sample drift, temperature homogeneity, temperature stability, gas flow speed and gas switching time.
This thesis presents the different aspects of the conceptualisation and creation of the actuator for an all polymer conducting polymer microfluidic valve. The proposed system uses the widely studied multi-layer bending beam actuator, commonly used as an artificial muscle or soft actuator. The actuation of the all polymer system is the result of the different expansion rates during an electrochemical reaction.
The system consist of three polymer layers. The first layer is the flexible base layer that also functions as a fluid barrier in the microfluidic system. The second layer is the electrode material that is used as an electrode in both the fabrication and actuation of the expanding layer. The final layer is the electrochemically polymerized layer of expanding conducting polymer.
The all polymer actuator can eventually form the basis for new opportunities regarding the miniaturisation and commercialisation of Lab on Chip devices ...
This thesis presents the different aspects of the conceptualisation and creation of the actuator for an all polymer conducting polymer microfluidic valve. The proposed system uses the widely studied multi-layer bending beam actuator, commonly used as an artificial muscle or soft actuator. The actuation of the all polymer system is the result of the different expansion rates during an electrochemical reaction.
The system consist of three polymer layers. The first layer is the flexible base layer that also functions as a fluid barrier in the microfluidic system. The second layer is the electrode material that is used as an electrode in both the fabrication and actuation of the expanding layer. The final layer is the electrochemically polymerized layer of expanding conducting polymer.
The all polymer actuator can eventually form the basis for new opportunities regarding the miniaturisation and commercialisation of Lab on Chip devices
Surface Self-Assembled Colloidal Crystals
For the use in Pattern Replication by Hot Embossing
comprehensive overview of the aspects of the fabrication of colloidal crystals, the most influential parameters and how they can be qualified. Offering a basis for future research on microscale replication by colloidal crystals and resulting in development of a method for the fabrication of colloidal crystal, which can be used as a master to replicate microscale patterns through Hot Embossing. ...
comprehensive overview of the aspects of the fabrication of colloidal crystals, the most influential parameters and how they can be qualified. Offering a basis for future research on microscale replication by colloidal crystals and resulting in development of a method for the fabrication of colloidal crystal, which can be used as a master to replicate microscale patterns through Hot Embossing.