Of all the important elements of medical device new product development (NPD), project planning and management gets the least attention and is the most poorly performed. Full stop.
We expend tremendous product development effort to deliver patient safety, product performance, and physician ergonomics. We design for cost, manufacturability, and reliability. We agonize over the wording and acceptance criteria of every requirement. Our drawings are exquisitely toleranced. No spec is left unverified or unvalidated. Instruments and fixtures are IQ’d, OQ’d and PQ’d. Manufacturing processes are thoroughly validated. We justly take pride in these achievements. One medtech engineer told me that he sleeps better at night knowing his risk analysis was well-done.
Yet when it comes to planning a project, our attention wanders. We put in some effort, get frustrated by the complexity and ambiguity of the project tasks and dependencies, and call it “good enough.” We don’t put nearly the effort into planning that we put into FMEA’s or inspection instructions. We write something up, get it signed, and a couple of weeks later, project plans lie quietly buried and already outdated in a design history file. Most of the time, we don’t know how to make the plan any better, even if we wanted to.
Sound familiar? Software companies have shown us that there is a better way.
Continue reading “Top Five Reasons Why Tech and Software Companies Abandoned Traditional Project Planning” →