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Due to their intricate design and lifesaving nature, developing cardiac rhythm management devices is challenging. Manufacturers must ensure the device functions as indicated throughout its intended lifetime without interfering with normal bodily functions. It must also withstand the harsh conditions of the human body and resist possible cybersecurity threats. Plus, no two patients are the same, with anatomies and diseased areas of the heart differing from person to person. Given their critical role in sustaining life, regulatory agencies around the world have very strict requirements that must be met before market entry.
Manufacturers can use computational modeling and simulation (CM&S) to help overcome the complex design and regulatory challenges associated with these devices while still maintaining the highest possible safety. CM&S enables device manufacturers to effectively iterate on designs while ensuring safety and reliability, accelerating the approval process and time to market.
Read the e-book to learn how CM&S can accelerate and optimize the cardiac rhythm management device development process.
