The Medical Devices & Equipment industry is highly diversified and produces a range of products designed to diagnose and treat patients in healthcare systems. Correctly speaking, Medical Equipment is interchangeable with Medical Device, but frequently the term “equipment” is used to describe ex-vivo devices such as MRI, CT or Ultrasound scanners, Dialysis machines, or ICU Life Support Systems. In the industry one frequently refers to a Medical Device for implanted devices, such as stents, heart valves, blood pumps, or pacemakers.
The simulation and CAE in medical devices is very important as it can save millions of dollars for the industry, e.g. by reducing the number of required benchtop test, clinical trials, or by accelerating the regulatory approval process. The FDA and other regulatory agencies worldwide are supporting the collaboration effort in the simulation field driven by industry.
In recent years, the industry has seen increased use of simulation on Medical Equipment like MRI, CT scanners and lab equipment, and also for personalized equipment (health trackers, blood pressure measurement devices).
Medical Devices for Cardio and Neuro Applications
Medical Device makers spend a lot of R&D dollars on Cardiovascular Disease treatment devices. Such devices include pacemakers, heart valves, various stent types, stent grafts (for bypasses), catheters, filters, balloons and blood pumps.
First, benchtop test are supported by simulation to increase the learning achieved by modelling and allow for device optimization in the experimental environment.
Later, implanted devices are modelled, based on anatomical data sets, to show the full benefit of simulation, reducing the clinical trial workload.
Cardiovascular Device Design is historically involving many iterations between experimental lab work on the benchtop and animal trials before a device gets approved for human/clinical trials. FEA simulation has become more prevalent in recent year, followed by CFD and FSI modelling.
Simcenter STAR-CCM+ is a CFD (Computational Fluid Dynamics) solution. Its core is the ability to predict the behaviour of fluids (e.g. air, water, blood, and spinal fluid), heat transfer and particle modelling. Additional multi-physics can be included such as structural stress.
STAR-CCM+ is the tool of choice for many of these applications involving fluid flow, but also various Multiphysics applications such as Heat Transfer, EMP, Particle Interaction, and even Acoustics and EMAG.
Since many devices interact in various ways with the surrounding tissues and fluid flow, FSI is exceedingly used for device design in-silico modelling using anatomical data sets based on MRI or CT scans. FSI coupling between STAR-CCM+ and Abaqus, and STAR-CCM+internal FSI capabilities are industry leading solutions.
Blood pump, Photo credit: Siemens Digital Industries Software
Drug Delivery Applications
Most CFD modelling around drug delivery was related to respiratory models, like mouth or nasal inhalers. However, success applications showed good potential also in cardiovascular, cerebral and spinal drug delivery.
Our technology has been demonstrated to work well for infusion pumps and syringe models. Frequently, FSI coupling to model interacting tissue is industry required.
In the respiratory field the goal is to eventually reduce the amount of clinic trials, e.g. to determine the drug transport into the lungs or nasal cavities. This leads to optimization of e.g. powder particle size distributions, inhaler design but can also be used to diagnose, to study respiratory disease.
Again, step one will be to support current benchtop tests and subsequently apply the models to anatomical data.
Inhaler (left) and Drug Delivery Catheter, Photo credit: Siemens Digital Industries Software
Medical Equipment, Lab Instruments
Diagnostics as well as therapy equipment from the lab to the hospital can benefit from CAE, simulation and predictive engineering.
Below some examples for equipment simulation with STAR-CCM+Diagnostic:
X-ray, CT scan source, sensor design & optimization, thermal, electronics
MRI -electro-optics, thermal, electronics
Tissue heating during diagnostic processes
O2 monitoring systems
Real time inhomogeneity (tumor) detection from imaging data (inverse radiation modelling)
Therapy
Chemotherapy - dose, spread determination
Laser surgery e.g. lasik -power, wavelength, pulse width, material removal determination
Laser ablation of tumors - dose, spread
Dental root canal, implant cement filling
Photo credit: Siemens Digital Industries Software
Microfluidics Devices
From developing medical test strips, analyzing implanted sensors and drug delivery, developing lab-on-a-chip models, to prototyping new concepts or designing PCR bioreactors, advanced simulation can accurately and cost-effectively simulate the motion of minute amounts of fluids and bubbles within the micro-scale environment. The development of microfluidic devices for the life sciences industry has a promising future and numerical simulations have become critical for pinpointing key requirements for successful implementation through both prototyping and design exploration.
Microfluidics: Hemodynamic Focusing (left), and Particle Separation on a Microfluidic Chip, Photo credit: Siemens Digital Industries Software
Our Engineering team has the experience and the ability to leverage the most advanced technologies in test and simulation to help medical device companies meet their demands.
Whether exploring early design concepts, conducting more detailed engineering efforts later in the development cycle or troubleshooting issues that arise in the field, our Engineering has successfully delivered engineering solutions that bring proven value to our customers.
The services of our Engineering support the medical device companies to transform multi-domain system simulation, detailed 3D analysis and test-based engineering into a streamlined development process from concept modelling to physical prototype evaluation.
“This helps medical device manufacturers bring innovative, high-quality designs to market faster than the competition. ”
Clinical Trials costs are soaring, and CFD modelling can help in many cases to reduce experimental iterations and lab work. Examples include implanted blood pumps, heart valves, coronary and aneurysm stents, aneurysm treatment (stenting, coiling), catheter and filter (blood clots) development etc. But also external devices can be developed and designed "better and faster", like dialysis machines, external blood pumps, syringes etc.
The challenges of rising Clinical Trial costs are compounded by traditional design methods.
Medical Device design for many devices requires extensive benchtop, animal and human testing in order to obtain regulatory approval.
While these requirements will remain in place for many years to come, eventually, clinical trial times will be reduced by running extensive trials in a virtual environment before starting actual animal and human trials.
Medical device companies will increase their productivity with:
Integrated solution. Accelerating production with a unified CAD/CAM/CAE system
Innovative software. Increased programming efficiency with automation.
Proven technology. Producing parts reliably with a full range manufacturing technology.
Applying the virtual twin approach with our 3D CFD and Multiphysics simulation to work in parallel with experimental testing is an effective way to deal with the challenges.
Tying simulation/CAE toLife Cycle Management and improving regulatory reporting is supporting the industry trend towards Digital Clinical Trials.
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