Medical device manufacturing guide
The medical device development process can be lengthy, complex, expensive, and fraught with risk. New technology is rapidly opening up new therapies and medical device applications. Demand is growing.
Product lifecycles are accelerating. A recent survey within the healthcare industry found medtech production cycles had become 50% faster over the past five years.
Meanwhile, regulation is tightening to ensure proper control of new and cutting-edge technology. In 2021, there were 2,607 FDA product recalls, affecting millions of units.
Medical device developers need to move fast, but they also need to ensure their approach to compliance is robust and bulletproof. Right now, though, there are not many companies that can achieve this on their own.
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