Medical Device Development Cycle

In contrast implanted medical devices may undergo dynamic changes in function and safety over years or even decades.

Medical device development cycle.

Adnan ashfaq is a quality regulatory validation specialist with almost 20 years of experience in medical device biotech and pharmaceutical industries. Implanted medical devices capable of undergoing dynamic changes in function and safety are continuously analysed. Share product design feb 8 2018 jordan hobbs. It only gets more complicated when you want to enter various marketplaces.

These factors have a major impact on the medical device development cycle which can be broken down into five major stages. All these factors have major impact on development cycle of medical device. The outcomes of each stage have a direct effect on subsequent ones. Medical device design and development is a complex process rife with regulations specifications application requirements and end user needs all of which must be balanced and adhered to for a successful product.

Aside from the conceptualization and manufacturing there s a ton of paperwork that needs to be done to see any success. Adnan founded pharmi med in 2011 and has since been supporting medical device companies around the labyrinth of regulations and assisting them in flying through successful audits. New product development is a crucial process for innovation in dynamic and competitive business environment. If your device lacks usability market share will suffer but if your device doesn t meet regulatory guidelines it won t make it to the ultimate guide to medical device.

5 phases in development process of medical devices.