Integrating digital evidence to achieve design excellence

Human factors engineering plays a large role in the design of medical devices. The goal is to minimize use errors and risks so physicians can use the devices safely and effectively to treat patients. The FDA acknowledges the need for simulation as digital evidence. FDA regulations for medical devices help the industry standardize verification and validation (V&V) of simulation and modeling to provide better outcomes.

By generating digital evidence in V&V testing, medical device manufacturers can ensure a safe and efficacious product. Learn more about how using digital evidence can achieve design excellence.

Creating a true digital twin for greater design value

With each patient being so different, one-size-fits-all devices are simply not enough. Today, companies are expected to create individualized designs. Wearable devices now use imaging and data tracking to provide specific patient data. Personalization and patient data are on the rise, but so are healthcare costs.

To keep project costs low and increase design freedom, manufacturers need to use computer modeling and simulation for digital evidence. Adopting design simulation for medical devices helps improve design choice, reduces costs and time, and establishes a model-based competitive advantage.

The ability to simulate a product, design variation and its environment accurately and under real-world conditions is the key to achieving a true digital twin. Companies then can accurately simulate a range of problems that can help develop a more successful medical device.

Read the infographic to learn more about Digital Evidence as part of our Design Excellence solution for medical devices.

The power of simulation for medical devices

Breathing is an act that comes naturally for most, and something we often take for granted. However, when the COVID-19 pandemic hit in 2020, the need to breathe was crucial. Healthy individuals were having difficulties breathing, and people of all shapes and sizes were being hospitalized. The global medical technology manufacturer Vyaire Medical sought to minimize the effort of breathing for those patients and to help enhance and extend their lives. Vyaire worked hard to bring ventilator equipment to hospitals to treat patients.

By integrating Simcenter into their design process, Vyaire Medical was able to introduce patient-specific data into their simulations. Now, the medical manufacturer can use scans of real human heads to capture patient features and incorporate lung structures using a variety of breathing profiles to help all patient populations. The ability to automate simulation reduces development times to produce more high-quality products for better patient outcomes.