Early Planning, Future Reward
Proper product development involves taking
proactive steps to avoid pitfalls that may
come when potential risks are not
Erik Swain • Contributing Writer
In the medical device product development process, the most risk lies at the beginning, where mistakes and omissions can be made that fester into large and expensive problems as the
product gets closer to market, and even after it is introduced.
Risk assessment and risk management are processes often associated with the later stages of product development, but they
need to be employed in the earlier stages as well, so potential
problems can be addressed before a design is finalized, after which
changes take longer and cost more to make.
Medical device OEMs that outsource all or part of product development need to work with their partners to ensure that these early-stage pitfalls are avoided. Luckily, there are a number of contract
developers that are experienced enough to know how to do that.
What follows is a discussion of some of the most common mistakes that lead to unnecessary early-stage risk, and some tips for
ensuring that they are not made.
Firms shouldn’t be making as many potential mistakes in early
product development as they used to, assuming that they’re following a process that’s compliant with U.S. Food and Drug Ad-minstration (FDA) quality system practices, said Paul Mulhauser,
president of Factors NY, a New York, N.Y.-based design and development company with an emphasis on human factors. This is
because most of the more common pitfalls have been well-pub-