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 We write something up, get it signed, and a couple of weeks later, project plans lie quietly buried and already outdated in a design history file.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.
I’m not going out on much of a limb when I say that, as an industry, medical device companies are not particularly strong in project management. A tool (like Microsoft Project) is not a management technique. Program management offices abound in larger companies, but rarely do you find a systematic approach to defining the activities of project management. The Critical Chain approach has advantages over a traditional Gantt chart, but at the end, it’s still only a tool. We’re really stuck in last century thinking.
At Fractyl we’re building an amazing team – the best I’ve ever worked with. Our team is super smart, highly productive, and absolutely dedicated to our mission. We see the big picture but we aren’t afraid to sweat the details. We also know how to have fun.
Great teams start with great recruiting. Recruiting best practices are important, but not enough. Read on to learn how we’ve built best team in medical devices.
Lots of great individual contributors ask to become managers. They reach a point in their career where a management role seems like the next logical step up. The management path appears to offer more authority, and probably more money.
Unfortunately, success as an individual contributor is no guarantee of success as a manager, and many high-performing individuals find out later that they hate the responsibilities of management. They hate the amount of time they spend in meetings. They dread the planning and budgeting. They can’t stand dealing with personnel issues. They find themselves putting off work on performance reviews. They don’t effectively delegate tasks, because they can more easily perform the tasks themselves.
So, how do you know if you’re cut out to be a manager? Here are a few telltale signs: Continue reading →
Every once in a great while I read something so well stated that I put down my book/ipad/kindle and just reflect.
So when I recently read a post from Mike Sellers on Quora, I had to share it with you. Mike was responding to the question “As first time entrepreneurs, what part of the process are people often completely blind to?”
Mike wrote beautifully about software companies (read his original post here).
I’d tweak his words slightly for medical devices. Here’s my modified version of Mike’s post: Continue reading →
My colleague Chris recently noted: “the right way to do things is often a pain in the butt.” No question that most engineers see protocols as a pain in the butt – yet another file to sherpa through the document approval process.
There’s an important logic behind the practice of doing protocols. Imagine doing an experiment on humans (aka a clinical study) without one. But “good product development practice” isn’t the only reason star medical device engineers write protocols. Believe it or not, star medical device engineers view protocol writing as a key element of team leadership and team effectiveness.