With patient welfare hanging in the balance, product failure is not an option in healthcare. Applying engineering simulation throughout development can make all the difference in meeting safety standards and product deadlines.
When you build reliability into the design process, it improves compliance with tightening FDA regulations — and saves lives. Since clinical testing can’t address every possible situation, medical device companies adopt engineering simulation (in silico testing) to systematically identify and resolve worst-case scenarios.
Implantable cardiovascular devices — stents, coils, heart valves and pacemakers — are complex as a result of exacting product and regulatory (FDA) specifications. The study of hemodynamics is critical to cardiac device engineering, which can benefit greatly from engineering simulation and advanced fluid–structure interaction modeling.
As life expectancy rises, orthopedic researchers are extending the life of joint implants and developing innovative replacement therapies for aging hips, knees, shoulders and spines. Successful companies invest heavily in engineering simulation to develop the best possible design while ensuring implantable product reliability.
Regulatory approval includes subjecting products, procedures and services to the extreme conditions they will encounter during use — over a large patient population. ANSYS technology helps minimize the chance that a medical device will fail, not just for regulatory testing but throughout its lifetime.