May 1, 2015
By Kristian Debus, CD-adapco
The group of industries known as Life Sciences is experiencing an unprecedented change in how new medicines and medical technologies are being developed. Visionary companies in the sector are increasingly deploying modeling and simulation to reduce costs, mitigate risks and increase innovation. Ultimately, this results in better medicines, medical products and improved patient outcomes.
Medical Design and Simulation
In their day-to-day work, medical professionals are often required to provide fast and simple answers. The “yes” or “no” decisions doctors are forced to make could ultimately lead to the life or death of a patient. For example, when trying to predict whether an aneurism will rupture, doctors inspect blood flow patterns and wall thicknesses. CFD (computational fluid dynamics) and FEA (finite element analysis) could be used to run many simulations and provide correlations that suggest whether a particular set of circumstances might lead to a rupture.
While extensive research and development is required before modeling simulation is able to consistently provide a fast, accurate and reliable tool for clinical diagnostics, steady progress has been made recently, enabling some pioneering companies to begin offering these services to the medical community.
Where Are We Today?
To use computational modeling and simulation effectively, we need to close the gap between experiments, benchtop tests, clinical trials and engineering design, by automating the workflow process. For clinical trial support, that means direct import from major CAD packages, integrated with anatomical data sets from CT or MRI scans, followed by state-of-the-art meshing to enable rapid turnaround time of complex geometries.
From a software vendor’s perspective, this requires the introduction of methods to enable integration of device and patient-specific data. In addition, software vendors need to offer visualization tools that help deliver simulation results in a way that is easily understandable by physicians and patients.
Most importantly, simulation-based product development and virtual prototyping are increasingly being recognized by the FDA as valid tools to supplement experimental testing and, clinical trials, and accelerate regulatory approval. Initiatives like the ASME V&V 40, MDIC or Avicenna drive and guide these efforts and lobby for the increased usage of simulation for the support of benchtop and clinical trials in the medical device industry.
Similarly, in pharmaceuticals, consortia like CSPOS are promoting the move from batch to continuous manufacturing. This represents a great opportunity to integrate the use of simulation early when redesigning processes, and offering the best possible chance of maximizing ROI.
When Will It Go “Mainstream?”
So how will this shared vision of a revolution in Life Sciences simulation become a reality? Part of the challenge is in developing solver technologies and process improvement tools. Another is the provision of advanced use cases that give potential users confidence in the technology for the particular applications.
Yet, with the advancement of simulation technology, and following the buy-in and support by the regulatory bodies, the most essential ingredients — expertise and manpower — have to come from the customer. The leading medical device design and pharma companies have realized the investment is required in terms of recruitment as well as the technology. They also require the integration of modeling and simulation into clinical trial studies or the fine-tuning and modernizing of manufacturing processes in “big pharma.”
To facilitate this substantial change in the industry, modeling and simulation expertise cross-pollinated from industry sectors such as automotive or communications and power will have to be considered. To maintain the momentum that MDIC or CSOPS have created, we need to reach out to the end-users to help overhaul process engineering in big pharma and integrate new design and testing modalities within medical device companies.
There has been a lot of planning, talking and investigating around modeling and simulation in the Life Sciences sector — many are finally taking action; others will have to catch up later.
Kristian Debus is the director of Life Sciences at CD-adapco. Send email about this article to [email protected].
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