In today’s fast paced environment, it is tempting to short cut the risk-based design and development process. Unfortunately, this can place humans in jeopardy of injury or death. This is true whether it is medical devices, airplanes, building design, or any number of disciplines where humans use the end product. It is never too early to consider design risks and consequences and it is critical that a company culture exists where this is a priority and everyone involved can weigh in. This starts with user and product requirements, risk management strategy, design, and carries through manufacturing, documentation and training. In this presentation, we will cover our risk-based design and development process and give examples of where it has been successfully used, and where it was not implemented leading to serious consequences.
Bob Benkowski is the President and CEO of DesignPlex Biomedical. With extensive experience in the medical device and biologics industry, he and his team are ready to help you with any part of the design, regulatory, or manufacturing process. When not at work, Bob enjoys building hotrods – and anything else that has a motor.