Astero StarFish

9 ways Project managers make or break Medical Device development

PM MeetingHaving the help of a project manager (PM) is critical for medical device development, and manufacture.  Otherwise the project would blow up and take 3x longer.   Without a good PM, the design and development team wouldn’t systematically go after the high risk items. They wouldn’t know when it’s good enough and when to focus on something else.

It’s easy to spend time on things that don’t matter too much.  PMs make sure the project team spends its energy in an efficient way– solve problems deeply enough, but not too deeply.  They enable you to get to a result that’s highly effective and cost effective.  It’s almost impossible to be in the trenches, working away at the details of some tricky problem while simultaneously organizing the rest of the project team towards the bigger outcome.

Keep the requirements in front of the technical team. When you start to engage in some of the system technology challenges, you need someone to say, “Hey, guys, don’t forget this piece. What are we doing about this? Have we thought about that?” Bringing it in front so you are converging toward the appropriate solution. You would make something, but whether it met any of the requirements would be pure luck. Meeting the right requirements.

Often things will come up from a user risk standpoint that could stop things in their tracks. Project Managers assess all the usability requirements right up front and early to keep things cost effective and mitigate risk.

Solve the right problems. That’s a core value at StarFish Medical. It’s alright to get off track. It may lead to a really cool idea.  But we need to come back to the big picture and what is right for the device and the client.  That’s why early in the project managers keep asking the client, “What is your intended use?” If the answer is “Oh, we’re still working on that”.  That’s very dangerous. Not just for regulatory, but functional issues.  You can get a long way down the path and realize that’s not what you want. ”

The project manager is the glue or the quarterback. If a project manager has an electronic background, and the project is 80-90% electronic, then you can maybe get away with a lot of things.  But, in the real world if there is electronics, there is also software and mechanical stuff, so you’re going across the realm of disciplines. The project manager ties everything together to make sure everyone is working to achieve the same goals.

Project managers become the voice of the client.  As a project manager, you become a bit of a third party when having design meetings because you represent the client internally.  On the flip side to the client, you’re representing the whole design team. So you help them see what’s coming down the line, resolve issues they may not be aware of, and leverage the development team’s experience.

Provide a critical communication path—especially on larger design teams with 4, 5, or 6 designers with a lot of interactions.  A project manager glues the team together and represents the client internally. A project manager also forecast issues out to the client so they know what to expect and what to do with the next critical item.

Often the PM acts as a systems engineer. That’s a huge point.  If you as an electronics person, need a bigger chip and have reorganized your board, or need a bigger board that generates more heat, which has implications for the enclosure. Maybe it needs a fan now, maybe it has an interaction issue, or perhaps the shape changes.  Because of that, maybe you need to get other people involved. Or because of the extra features, the user interaction may be more complicated.  No individual on the team is going to recognize that. Only the project manager is going to see all those pieces together and make appropriate decisions.

PMs help with Risk management, managing skills, managing scope creep.  In the trenches, a client often asks, “Can you add this little feature?”  As you start carrying the request out, it may have huge implications for the team, schedule, and cost.  You have to stop and ask: “Is it worth doing?”

Client communication. The client bonds tightly with the PM.  They want to make sure that nothing gets changed for them.  The relationship they’ve come to depend on is something they can look forward to. The day-to-day business corporate relationship is managed by the project manager and often eliminates the need to escalate issues to a higher level.

A normal occurrence on the front lines is something electronic you expect to happen doesn’t work.  You have a fall back option you hope will work.  But a good project manager will communicate to the client that the risk profile has changed.  When you switch from pretty confident it will work to hoping it will work and the client is not informed, it becomes a dangerous thing.  Project managers are in a position where they are responsible for something out of your control.  Clients understand that problems arise which are difficult to prevent or mitigate beforehand, but Project Managers make sure that these problems are communicated and that the necessary corrective actions take place.

PMs make sure that Quality Assurance (QA) and regulatory are involved when needed.  Project managers know when to bring QA in.  They are in charge of making sure all regulatory documentation gets done.  QA checks on the project to make sure it has been done, but the PM makes sure it get done.  It’s much easier for QA to walk into a room and talk to one person.

Astero StarFish is the attributed author of StarFish Medical team blogs.  We collaborate on our medical device development projects, so it’s fitting that we also collaborate on creating content.

Usability Engineering

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