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Note: Medical Design Technology first published this blog at www.mdtmag.com in July 2016.

The widespread adoption of modeling and simulation in life sciences on clinical and trial studies is at an embryonic stage, but that could soon be changing.  

Cardiovascular device design historically involves many iterations from experimental lab work on the benchtop to animal trials before a device gets approved for human/clinical trials. Finite element analysis (FEA) simulation has become more prevalent in recent years, followed by computational fluid dynamics (CFD) and fluid-structure interaction (FSI) modeling.

In the United States, the Food and Drug Administration (FDA) is very supportive of this development and works closely with the American Society of Mechanical Engineers Verification and Validation 40 committee to create guidelines on how to use and document simulation to achieve fast approval times. Industry and academia also have come together in consortia, like the Medical Device Innovation Consortium (MDIC) and Avicenna, to promote and drive the development of simulation for clinical trial support.

In general, the rest of the world watches and follows the activities of the FDA very closely. Also, the medical device design industry is still largely dominated by US companies.

In many cases, CFD simulation can help to reduce experimental iterations and lab work. Examples include implanted blood pumps, heart valves, coronary and aneurysm stents, aneurysm treatment (stenting, coiling) and catheter and filter (blood clots) development. Eventually, clinical trial times will be reduced by running extensive trials in a virtual environment before starting actual animal and human trials. But also external devices can be developed and designed "better and faster," like dialysis machines, external blood pumps, syringes, and more.

STAR-CCM+® software is the tool of choice for many of these applications involving fluid flow, but also various multiphysics applications such as heat transfer, Eulerian Multiphase (EMP), particle interaction and even acoustics and electromagnetic (EMAG). Since many devices interact in various ways with the surrounding tissues and fluid flow, FSI is exceedingly used for device design in-silico modeling using anatomical data sets based on Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) scans. FSI coupling between STAR-CCM+ and Abaqus, and Siemens PLM Software's internal FSI capabilities are industry leading solutions.

While the adoption and proliferation of modeling and simulation on clinical and trial studies in this field are at the beginning stages, their potential impact is obvious. In fact, the potential of using Product Lifecycle Management (PLM) integration of simulation in the clinical trial framework suggests this area is on the verge of major breakthroughs for customers and vendors alike.

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Kristian Debus is the Director of Life Sciences at Siemens PLM, a global provider of multidisciplinary engineering simulation and design exploration software.

 

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