Simulation Best Practices for Medical Devices Design and Development

February 2, 2024 Conrad Magalis

Simulation Best Practices for Medical Devices Design and Development

In recent years, the integration of in silico simulations has revolutionized medical device design and development. This blog explores the impact of utilizing Ansys simulation software in medical device product development.

The Impact of In Silico Clinical Trials

Two years post the release of a medical product, statistics reveal a significant reduction in the number of patients involved in clinical trials – a remarkable 256 fewer individuals. This reduction has resulted in a substantial cost-saving of $10 million. Moreover, over the same period, 10,000 patients were successfully treated with the product.

Engineering Goals and Requirements for Medical Devices

Safety, Time, and Cost – The Triad of Excellence

The engineering goals for medical devices focus on safety, time efficiency, and cost reduction. Achieving extreme reliability, shorter development cycles, and reduced clinical trials are crucial milestones. An emphasis on staff efficiency and patient safety is complemented by accelerated regulatory approval through adherence to ASTM and ISO standards.

The incorporation of in silico testing has seen a phenomenal increase – 10,000 more tests performed virtually, saving three months out of twelve in the development cycle and leading to a remarkable $10 million cost reduction for a single product. The multidisciplinary approach and adherence to EU-MDR and REACH standards have resulted in a Return on Investment (ROI) of over 500%.

Positive Business Outcomes Ansys Customers Realize

Unleashing the Power of Simulation

Ansys, a leader in simulation solutions, has empowered its customers with remarkable outcomes:

  • Increased Accuracy: Up to 90% more accurate delivery of drugs to target sites.
  • Accelerated Development: Elimination of typical testing times.
  • Cost Reduction: $10 million reduction in clinical trial costs.

Review the Ansys source materials here for more information about the statistics mentioned in the above sections.

How We Do It – Multidisciplinary Medical Device Total Product Lifecycle

The holistic approach to medical device design and development involves increased collaboration, faster innovation, customized workflows, optimization, and the integration of cloud and high-performance computing.

Design

In the realm of medical devices, self-expanding stents pose unique challenges. Ansys provides a solution that encompasses fast 2D to 3D geometry setup, ensuring open occluded vessels with minimal damage. The benefits include reduced stent fractures, minimized restenosis, and a 10% reduction in the cost of physical testing.

Blood Pumps

Understanding flow patterns and pressures in blood pumps is critical. Ansys offers a solution with accuracy, ease of use, and speed through turbulence models and extensive turbomachinery design tools. The results include maximized performance and efficiency, optimized patient implantation strategies, enhanced biocompatibility, and streamlined bench testing.

Dry Powder Inhalers

Optimizing device design for pressure drop and particle size distribution is achieved through multiphase flow models. Ansys' solution provides insights into powder dosing, capsule emptying, particle de-agglomeration, and device delivery efficiency. The benefits include reduced time to market and improved reliability.

Clinical Applications

MRI Safety

Ensuring patient safety during MRI scans is paramount. Ansys' solution involves coupled electrothermal simulation capability, electromagnetic field modeling, and human body models. This approach is not only accurate but also speeds up MRI safety evaluations, leading to lower costs by minimizing bench testing.

Spinal Interbody Fusion Device

Optimizing implants for patient-specific physiological loading requirements involves biomaterial models, material model calibration tools, and dynamic spine-implant interactions. Ansys' solution results in optimized implant structures, increased range of motion, faster recovery times, and decreased operating time.

Regulatory Affairs

Ensuring regulatory compliance is a key aspect of medical device development. Ansys provides tools for simulation process and data management, workflow automation, and quality assurance test suites. The benefits include automated model report generation meeting regulatory guidance requirements, a proven track record supporting approved regulatory applications, and active collaboration with global regulators.

Quality Assurance

Materials Intelligence

To address the evolving landscape of medical devices, Ansys offers solutions for time-critical responses to material queries, preventing disruptions due to material obsolescence, and accessing historical data for faster new product development. The benefits include traceability, time savings, and reduced need for product testing.

Watch the Rand Simulation Medical Device Webinars

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Partner with Rand Simulation for Medical Device Simulation

Rand Simulation, as an Ansys partner, offers consulting and product sales. Leveraging Ansys' 50-year expertise and gold-standard solutions, Rand Simulation contributes to the transformation of medical device design, ensuring safety, efficiency, and cost-effectiveness in the industry. With a focus on innovation, Rand Simulation aligns with Ansys to shape the promising future of medical device development through crucial simulation applications in healthcare. Contact us to get started.

About the Author

Conrad Magalis

Conrad Magalis is responsible for the adoption of advanced digital engineering practices at Rand Simulation. Conrad has a broad range of experience within manufacturing and industrial industries. His acumen is focused on progressive business and engineering decisions, with practical outcomes.

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