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Simulation Benefits For The Healthcare Industry - Part 1

Simulation for Healthcare | FEA CFD Electronics Consulting
July 25, 2017 By: Chris Mesibov

Healthcare is important to everyone.  It is more personal to us than many other industries – It impacts all of our lives. Every product either directly improves quality of life, or keeps people alive.  In this 4-part blog series I will explore how simulation can benefit healthcare product development.

In the healthcare industry, companies seeking to improve ROI are looking for ways to manage risk and control development costs. Typical worries include; the potential of product failure, which could lead to legal problems; the cost of the FDA approval process; and repetitive clinical testing, in order to adequately represent human variability. Companies are also looking to position themselves for growth; to that end they are identifying new pathologies and chronic diseases in elder care and preparing new products to help address these issues. They are also dealing with replacement of previously implanted devices and managing elderly patients who are faced with a persistent lack of nursing resources. For these patients, companies are looking for ways to help them live more self-sufficiently. 

At the same time, companies face immense pressure to reduce costs. Cost reduction in product design is a way to lower material costs and streamline the product manufacturing process without sacrificing product quality. The other cost reduction scenario comes later, by monitoring patients’ recovery in order to shorten hospital stays and minimize nursing costs. The development of devices for this application is of rising demand.

Medical device manufacturers and the healthcare industry as a whole are turning to simulation to meet these challenges. Simulation effectively creates a virtual Human Laboratory, creating a “digital twin” of the laboratory environment.  This virtual lab enables medical device developers to test new concepts earlier in the development process.  Also, by establishing feasibility of feature and cost targets early, it opens the door to more development investment. Moreover, developing and expanding the virtual lab, In Silico testing validates the prototypes and collects data that is usable as part of clinical data collection. The simulation results can then be used as part of FDA and CE approval submission.

Through the creation a Virtual Human Laboratory, the simulation becomes a “relief valve” for the prohibitive cost of trying new creative ideas. Otherwise, it is difficult for development teams to achieve sustainable competitive advantages. As part of testing the device, developers need to know quickly how the product will interact with the body. In order to do this, patient data is integrated into the simulation. For example:

  • Patient data is obtained from the patient as the patient participates in daily activities.
  • Unique patient information can be integrated into the Human Body Model (HBM) to test the interaction with the device.
  • This enables the developers to account for human variability over a large population of patients.

By performing a structural analysis, patient data and the device can be simulated under real world conditions to see how the product performs. Some examples are walking, riding and other transient scenarios that provide device performance data not easily attainable by other means. Other simulations could also include coronary and pulmonary simulations to analyze blood and air flow.

The importance of simulation in medical product development cannot be understated.  I hope that this post helps you understand why simulation is an important tool to utilize as part of the development process. In my next post, I will expand on the role that simulation can play in the regulatory approval process.