Project management is a key to successful medical device product development. Sounds cliche, I know. But it is true.
When project management is good, you know it. And of course, when project management is bad, you know this too. The trouble is we all experience poor project management more often than good project management.
When you hear the term “project management”, what thoughts come to mind? I suspect you instantly think of things like work breakdown structures, Gantt charts, and MS Project. You might also think of organizations like the Project Management Institute and the PMBOK.
Yes, these are all pertinent references for project management.
When I refer to “project management”, I’m referring to something more basic. I’m referring to a process of getting things done.
Project Management Certification?
I think the Project Management Institute does a good job of conveying the principles of project management. Their Project Management Body of Knowledge (PMBOK) guide reduces the concepts of project management down to a science. And Yes, PMI offers certification for project management.
But what does being a certified project manager really mean?
I mean does earning this certification mean you are a good project manager?
I’ll let you ponder the answer to this question.
I’ll just share that I do not have project management certification. And I guess you’d have to work with me as a project manager to determine if I’m good at it.
Becoming certified as a project manager does not make you good at it.
Good project management is more than just a set of tools and philosophies. It’s very much about mindset. Project management is about leadership and providing direction.
As I stated above, project management needs to be about getting things done.
When Project Management Is Missing . . .
So what happens when you work on a project and there is little to no project management? How does this feel?
In a word: chaos.
We’ve all been part of efforts with poor project management. Let me share a recent experience to illustrate.
No Project Management = Chaos
A couple weeks ago, we had an interesting experience with a client. They are in the midst of this mad push to launch a couple of new products by the end of the year. Yes, there is still a great deal to accomplish for these products to launch. There is plenty to do, and a lot of moving parts. And a whole team of people trying to do everything that needs to get done in the mean time.
My story takes place right in the middle of the chaos. This project lacks something critical. It lacks project management.
The project has some direction: get it done and ready to manufacture by the end of the year.
The project has some leadership: the CEO says get the project done by the end of the year.
Okay, that’s not entirely fair. The CEO is very involved in the details, when needed. But he leaves the day to day actions up to the engineers involved. He steps up and steps in when needed and when he feels something needs his attention.
But there is no sense of project management. Meaning, there is no sense of getting things done. Mostly because the team does not necessarily know what to do.
I’ll illustrate further with more specifics.
The product being developed involves some machined components. The company recently acquired the necessary equipment to machine in house. Plus, they have an experienced machinist on board to establish the processes and make the parts.
But the equipment had been on site and sitting idle for a few weeks. Finally, the CEO stepped in and told the machinist to make parts. Specifically, the machinist was to make 250 of each part while the CEO was away on a business trip.
I was aware of this request. Our role is RA/QA. I communicated to the same machinist that in addition to making the parts, all the drawings, work instructions, inspection criteria, etc. also needed to be established.
The CEO wants the parts in order to hit the timeline. I want the supporting documentation in order to hit the timeline. The CEO and I are in sync and on the same page.
The machinist communicated to the CEO and me, separately, that the parts would be made and documentation established. He assured each of us that he understands how to manage projects like this and has been doing so for over 10 years.
Experience Does Not Equal Project Management
As the week for machining began, I checked in with our machinist friend. He gave me solid reassurance that making these parts and establishing the documentation during the next few days would be no issue.
I suspected otherwise based on my own project management experience and based on previous interactions with the machinist.
I asked the machinist to send over the documentation, even if in process and incomplete. I offered to review documents in parallel to his efforts. He shrugged it off. No need, he assured me.
I checked in the next day and day after. And the tune was starting to change. The machinist started telling me he was unable to spend time on the documentation because he needed to deliver the 250 parts requested by the CEO. He assured me that once the parts were made, he would get the documentation caught up soon after.
The machinist was giving updates to the CEO too. He told the CEO that he was delayed in making parts because he had to work on the documentation. However, the CEO and I spoke daily, and we compared notes.
By the end of the week, the machinist had neither made the parts nor finished the supporting documentation.
Why the Disconnect?
There are probably plenty of reasons our machinist friend failed to deliver. And I won’t go into all the reasons.
I’ll instead focus on the project management aspects of this story.
This project lacks project management! There is no real sense or attitude that things need to get done. The machinist never got this message. I think his ego might have gotten the best of him. Or he might have had some delusions about what needed to happen. He thought he was good at project management, especially because it related to his “expertise” of machining.
Yet the project does have leadership. The CEO is pushing, and he has a goal in mind. The CEO would not claim to be a project manager. However, he would say he is managing this project.
It’s not that he is keeping anything from this machinist or the rest of the team. In fact, quite the opposite. He has been very clear about what the product needs to do and when it needs to be done.
But typically, he’s not a micromanager. He lets the team members lead and drive.
Which means everyone is driving, at times.
However, the mindset of the team members is sometimes off. They are not focused on getting things done.
Jon Speer has been in the medical device industry for over 16 years. In 2007, Jon started Creo Quality to help medical device companies with project management, quality systems, and regulatory submissions. As a result of his experience in the medical device industry, Jon had an idea to develop a software solution to improve how companies handle Design Controls. Because of this greenlight.guru was born. You can find him on Google+, Twitter, and LinkedIn.