SimuTech Group Engineers Contribute to New Handbook on Medical Device Validation and Uncertainty Quantification

SimuTech Group Engineers Contribute to New Handbook on Medical Device VVUQ



SimuTech Group recently revealed the publication of a significant chapter in an open-access handbook dedicated to verification, validation, and uncertainty quantification (VVUQ) in computational modeling for medical devices. This pivotal chapter, co-authored by two of their principal engineers, Mark Goodin and Ertan Taskin, sheds light on blood pump simulation. The chapter is part of a multi-author volume funded by Ansys and Johnson & Johnson, aimed at enhancing the credibility of models used in medical device applications.

On September 10, 2026, Goodin and Taskin will share insights from their work in a live webinar titled Modeling Blood Flow and Blood Damage in Medical Devices. This session will delve into crucial applications illustrated in their chapter.

Within the handbook, the authors detail methodologies necessary to substantiate the credibility of blood pump models. They illustrate concepts applicable to various blood-contacting devices, including blood oxygenators and artificial kidneys. By providing guidance on how simulation informs design decisions at every stage—from initial concept development to regulatory submission—the chapter aims to improve the development process of medical devices.

A core theme in the chapter emphasizes the interplay of computational simulation and physical testing throughout the lifecycle of medical device development. Goodin elaborates, stating that during the early stages of product development, simulation serves to inform the design. As the project progresses to regulatory submission, empirical test data becomes paramount to ascertain the device's safety and efficacy. This dynamic shifts reliance from simulations to tangible data, increasing the rigor required to define computational model credibility in scenarios where test data is unavailable.

Taskin, who has a robust background in blood pump design, reinforces the vital importance of carefully evaluating risks tied to medical device development at each juncture. His extensive experience highlights how each decision impacts patient welfare, thereby necessitating a comprehensive approach utilizing all available resources.

Drawing from decades of combined expertise in medical device simulation, the authors stress the significance of their work. Goodin, with nearly 30 years in the field and notable contributions to ventricular assist and artificial heart projects, underscores the profound sense of accomplishment that comes from enhancing patient care.

In conjunction with the outlined principles, the webinar will address strategies on how blood flow and damage modeling influence design choices within the medical device lifecycle. It will guide attendees on establishing credibility in computational models and how they can implement the chapter's insights into their projects.

To attend the upcoming webinar, registration is available at this link. Additionally, interested parties can access the published chapter at this link and the full open-access volume at this link.

SimuTech Group has garnered an impressive reputation, with over 40 years of experience supporting clients in realizing innovative products through simulation. Serving over 4,000 clients, the company continues to enhance product performance and reliability through its comprehensive services, including sales, support, consulting, and training. SimuTech's engineering specialists empower organizations to tackle complex challenges in research and development, fostering swift and productive outcomes.

Topics Health)

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