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Questions and Answers
Testing & Simulation Medical Device Development Need Design & Prototyping Preclinical Clinical Mechanical strength ______
Testing & Simulation Medical Device Development Need Design & Prototyping Preclinical Clinical Mechanical strength ______
Functionality
Testing & Simulation Approval Launch Testing – what and how?Thrombogenicity Gas transfer Durability ______
Testing & Simulation Approval Launch Testing – what and how?Thrombogenicity Gas transfer Durability ______
Inflammation
Testing & Simulation Standards & Guidelines ISO: International Organization for ______ − DIN (German Institute for Standardization) participates as member
Testing & Simulation Standards & Guidelines ISO: International Organization for ______ − DIN (German Institute for Standardization) participates as member
Standardization
Device-specific standards − Cardiovascular implants - Cardiac valve prostheses – ISO 5840 − Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) – ISO 7199 − ______ - Active implantable medical devices – ISO 14708 ▪ Part 5: Circulatory support devices −…
Device-specific standards − Cardiovascular implants - Cardiac valve prostheses – ISO 5840 − Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) – ISO 7199 − ______ - Active implantable medical devices – ISO 14708 ▪ Part 5: Circulatory support devices −…
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Definition Biocompatibility is the ability of a material to perform with an appropriate host response in a specific application Mandatory tests depend on − Nature of body contact (e.g.
Definition Biocompatibility is the ability of a material to perform with an appropriate host response in a specific application Mandatory tests depend on − Nature of body contact (e.g.
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Biological systems are highly complex ➔ Impossible to understand w/o ______
Biological systems are highly complex ➔ Impossible to understand w/o ______
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Virtual exploration of many scenarios ➔ Impossible to do ______/in vivo
Virtual exploration of many scenarios ➔ Impossible to do ______/in vivo
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Mechanistic understanding of a system ➔ Therapies, devices etc. Regulatory pipeline medical devices 44 Testing & ______
Mechanistic understanding of a system ➔ Therapies, devices etc. Regulatory pipeline medical devices 44 Testing & ______
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Hemocompatibility tests are challenging but provide lots of information about blood-material ______
Hemocompatibility tests are challenging but provide lots of information about blood-material ______
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In-vitro tests reduce ______ trials
In-vitro tests reduce ______ trials
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Testing is highly important for artificial organs and any medical ______
Testing is highly important for artificial organs and any medical ______
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The duration of contact for biocompatibility testing can be limited (≤ 24 h), prolonged (24 h – 30 d), or ______ (> 30 d)
The duration of contact for biocompatibility testing can be limited (≤ 24 h), prolonged (24 h – 30 d), or ______ (> 30 d)
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The interaction of blood components with artificial material is a key aspect of ______
The interaction of blood components with artificial material is a key aspect of ______
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Hemolysis leads to the destruction of red blood cells and the release of cell ______ hemoglobin
Hemolysis leads to the destruction of red blood cells and the release of cell ______ hemoglobin
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The '3R' principle in pre-clinical animal trials stands for Replace, ______, Refine
The '3R' principle in pre-clinical animal trials stands for Replace, ______, Refine
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Hemodynamic testing assesses the impact of high shear rates, regions of stasis & turbulences, and ______
Hemodynamic testing assesses the impact of high shear rates, regions of stasis & turbulences, and ______
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The cardiovascular implants and artificial organs standard ISO 5840 is specific to cardiac valve ______
The cardiovascular implants and artificial organs standard ISO 5840 is specific to cardiac valve ______
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The efficiency of a blood pump is measured using the formula: Efficiency = Power/Flow × ______
The efficiency of a blood pump is measured using the formula: Efficiency = Power/Flow × ______
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Blood pump hemolysis can be assessed using the Normalized Index of Hemolysis (NIH) and the Modified Index of ______
Blood pump hemolysis can be assessed using the Normalized Index of Hemolysis (NIH) and the Modified Index of ______
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Biocompatibility testing includes evaluation of cytotoxicity, sensitization, irritation, and material-related ______
Biocompatibility testing includes evaluation of cytotoxicity, sensitization, irritation, and material-related ______
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Biological systems are highly complex ➔ Impossible to understand w/o ______
Biological systems are highly complex ➔ Impossible to understand w/o ______
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Virtual exploration of many scenarios ➔ Impossible to do in vitro/in ______
Virtual exploration of many scenarios ➔ Impossible to do in vitro/in ______
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Mechanistic understanding of a system ➔ Therapies, devices etc. Regulatory pipeline medical devices 44 Testing & ______
Mechanistic understanding of a system ➔ Therapies, devices etc. Regulatory pipeline medical devices 44 Testing & ______
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The interaction of blood components with artificial material is a key aspect of ______
The interaction of blood components with artificial material is a key aspect of ______
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Testing is highly important for artificial organs and any medical ______
Testing is highly important for artificial organs and any medical ______
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Modeling, Discretization, and Iterative solutions are used to compute CFD Flow field numerically by ______
Modeling, Discretization, and Iterative solutions are used to compute CFD Flow field numerically by ______
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Results of CFD Flow field computation are strongly dependent on ______ conditions
Results of CFD Flow field computation are strongly dependent on ______ conditions
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Spatial and temporal resolution, including mesh and timestep, are important for the ______ model
Spatial and temporal resolution, including mesh and timestep, are important for the ______ model
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Validation and verification are ______ for the development of CFD Flow field computation
Validation and verification are ______ for the development of CFD Flow field computation
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George E.P.Box cleverly said, “All models are wrong, but some are ______”
George E.P.Box cleverly said, “All models are wrong, but some are ______”
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The interaction of blood components with artificial material is a key aspect of ______
The interaction of blood components with artificial material is a key aspect of ______
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Mechanical strength ______
Mechanical strength ______
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Durability ______
Durability ______
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The duration of contact for biocompatibility testing can be limited (≤ 24 h), prolonged (24 h – 30 d), or ______ (> 30 d)
The duration of contact for biocompatibility testing can be limited (≤ 24 h), prolonged (24 h – 30 d), or ______ (> 30 d)
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Hemodynamic testing assesses the impact of high shear rates, regions of stasis & turbulences, and ______
Hemodynamic testing assesses the impact of high shear rates, regions of stasis & turbulences, and ______
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CFD stands for Computational ______ Dynamics
CFD stands for Computational ______ Dynamics
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Turbulence in flow: chaotic changes in pressure/velocity caused by disturbance of the flow field laminar ➔ transitional ➔ turbulent ______ (eddies) on various spatial scales big ➔ smaller ➔ smallest ➔ heat turbulent free jet (CFD Calculation)
Turbulence in flow: chaotic changes in pressure/velocity caused by disturbance of the flow field laminar ➔ transitional ➔ turbulent ______ (eddies) on various spatial scales big ➔ smaller ➔ smallest ➔ heat turbulent free jet (CFD Calculation)
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The cardiovascular implants and artificial organs standard ISO 5840 is specific to cardiac valve ______
The cardiovascular implants and artificial organs standard ISO 5840 is specific to cardiac valve ______
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The '3R' principle in pre-clinical animal trials stands for Replace, ______, Refine
The '3R' principle in pre-clinical animal trials stands for Replace, ______, Refine
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The duration of contact for biocompatibility testing can be limited (≤ 24 h), prolonged (24 h – 30 d), or ______ (> 30 d)
The duration of contact for biocompatibility testing can be limited (≤ 24 h), prolonged (24 h – 30 d), or ______ (> 30 d)
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The interaction of blood components with artificial material is a key aspect of ______
The interaction of blood components with artificial material is a key aspect of ______
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Results of CFD Flow field computation are strongly dependent on ______ conditions
Results of CFD Flow field computation are strongly dependent on ______ conditions
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The efficiency of a blood pump is measured using the formula: Efficiency = Power/Flow × ______
The efficiency of a blood pump is measured using the formula: Efficiency = Power/Flow × ______
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Hemolysis leads to the destruction of red blood cells and the release of cell ______ hemoglobin
Hemolysis leads to the destruction of red blood cells and the release of cell ______ hemoglobin
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Hemodynamic testing assesses the impact of high shear rates, regions of stasis & turbulences, and ______
Hemodynamic testing assesses the impact of high shear rates, regions of stasis & turbulences, and ______
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Mesh resolution may affect the entire flow field. Unrealistic velocity distribution. Development of vortices in wake region. Even “simple” numerical setups might be more intriguing than you think. ______ Fine Flow through squeezed tube
Mesh resolution may affect the entire flow field. Unrealistic velocity distribution. Development of vortices in wake region. Even “simple” numerical setups might be more intriguing than you think. ______ Fine Flow through squeezed tube
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Mesh strongly influences the results of the simulation. Important step in the verification process. Know what output is of interest for you. Gradient based outputs (shear stresses) need very fine ______
Mesh strongly influences the results of the simulation. Important step in the verification process. Know what output is of interest for you. Gradient based outputs (shear stresses) need very fine ______
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Recall of CFD theory 1st step: Modeling ✓ 2nd step: Discretization ✓ 3rd step: ______
Recall of CFD theory 1st step: Modeling ✓ 2nd step: Discretization ✓ 3rd step: ______
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Errors/assumptions along the pipeline affect our result. Solution errors: Equations are solved numerically ➔ Are just approximations!!! Mathematical algorithms to solve the system of equations (PDE) Use convergence plots to see if solution algorithm “works” Not ______?
Errors/assumptions along the pipeline affect our result. Solution errors: Equations are solved numerically ➔ Are just approximations!!! Mathematical algorithms to solve the system of equations (PDE) Use convergence plots to see if solution algorithm “works” Not ______?
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Results of CFD Flow field computation are strongly dependent on ______ conditions. Hemodynamic testing assesses the impact of high shear rates, regions of stasis & turbulences, and ______
Results of CFD Flow field computation are strongly dependent on ______ conditions. Hemodynamic testing assesses the impact of high shear rates, regions of stasis & turbulences, and ______
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Rotational velocity (top), absolute velocity (bottom).Ψ/Φ: Dimensionless numbers pressure/flow 54 Testing & Simulation Example I: CFD based design optimization Homogeneous velocity distribution Stagnation area prone to thrombus formation High velocities at blade outlets Initial and modified design of an RBP and its effect on velocity and ______
Rotational velocity (top), absolute velocity (bottom).Ψ/Φ: Dimensionless numbers pressure/flow 54 Testing & Simulation Example I: CFD based design optimization Homogeneous velocity distribution Stagnation area prone to thrombus formation High velocities at blade outlets Initial and modified design of an RBP and its effect on velocity and ______
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Reduction of ______ rates Example I: Parameter based design exploration β1 β2 many variations in β1 and β2 Parameter based design exploration.left: initial design, center: meta-model, right: optimal design
Reduction of ______ rates Example I: Parameter based design exploration β1 β2 many variations in β1 and β2 Parameter based design exploration.left: initial design, center: meta-model, right: optimal design
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FDA Round Robin initiative – Let’s test CFD/PIV around the world FDA Round Robin Pump curve/pressure head ➔ hydraulic vs.CFD Velocity distribution ➔ PIV vs.CFD Hemolysis ➔ in-vitro blood vs. ______
FDA Round Robin initiative – Let’s test CFD/PIV around the world FDA Round Robin Pump curve/pressure head ➔ hydraulic vs.CFD Velocity distribution ➔ PIV vs.CFD Hemolysis ➔ in-vitro blood vs. ______
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The '3R' principle in pre-clinical animal trials stands for Replace, ______, Refine
The '3R' principle in pre-clinical animal trials stands for Replace, ______, Refine
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Validation and verification are ______ for the development of CFD Flow field computation
Validation and verification are ______ for the development of CFD Flow field computation
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Spatial and temporal resolution, including mesh and timestep, are important for the ______ model
Spatial and temporal resolution, including mesh and timestep, are important for the ______ model
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The efficiency of a blood pump is measured using the formula: Efficiency = Power/Flow × ______
The efficiency of a blood pump is measured using the formula: Efficiency = Power/Flow × ______
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The duration of contact for biocompatibility testing can be limited (≤ 24 h), prolonged (24 h – 30 d), or ______ (> 30 d)
The duration of contact for biocompatibility testing can be limited (≤ 24 h), prolonged (24 h – 30 d), or ______ (> 30 d)
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Results of CFD Flow field computation are strongly dependent on ______ conditions
Results of CFD Flow field computation are strongly dependent on ______ conditions
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Modeling, Discretization, and Iterative solutions are used to compute CFD Flow field numerically by ______
Modeling, Discretization, and Iterative solutions are used to compute CFD Flow field numerically by ______
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