How To Manage a Medical Device Project

Aug 27, 2019 | Product Development, Quality + Regulatory

It’s a complex, challenging thing, developing a medical device. And it’s littered with opportunities for pain. Opportunities that good project management helps minimise. But, what does good look like?

If you had a sense of what you needed to do, to take care of this, what would you then do?

After watching this video, you may want to think about how you’ll put what you learn into action.


In this bite-size video, we’ll continue our exploration of the map of medical device development. We’re taking a look at the Project Management track.

The Project Management track of Medical Device Development

In the time available to us, we can’t go into great detail, so please get in touch to find out more.

There’s a straightforward way to do this, which benefits your device throughout development and beyond. It starts with:

Project Definition – every successful project begins with the end in mind. Understand who has influence over it’s success and create with them a clear and shared view of what the end point looks, sounds and feels like. Think about the risks you might face and get everyone on the same page about what you’re doing together.

Work on agreeing shared objectives, project roles and responsibilities. We’ve pulled together a toolkit of effective ways to achieve all this.

You should create a Project Plan to capture shared understanding and use as a reference throughout the actual work. Outline the big chunks of activities that you’ve defined together. The rule of thumb here is to plan for the “big picture”, resisting the urge to delve into detail until the next phases. This’ll be tough as we feel a strong pull to “get on with doing”.

How long should this take? It depends upon the size, complexity and novelty of the project, however we’ve found it invariably is done in less than 1 day!

As your project progresses, you start to put flesh on the bones of this plan, phase by phase, buttoning tasks down so there’s less opportunity for scope creep. Learn from what did, and didn’t, work for previous projects, incorporating this knowledge within your evolving plan.

Design Review – Confirm you’re on the right track and make sound project decisions based on concrete data (search for our video “4 w’s of Design Review” to learn more about these)

Manage Project – You’ll want to be clear about how you, the project team, work together, procedures you’ll follow in day-to-day execution of your project plan. Many project teams schedule regular reviews, to check they’re on course, that the data supports continuing along that path. Pause, take stock of where you’ve got to.

Issue Resolution – Consider how you’ll deal with changes and issues, how will they be described, decisions made and actions implemented? Issues won’t just be design related, things like changes in the skills, people and resources you’ve got, will also impact upon project delivery. It typically looks something like this:

  • Understand what the issue/change really means
  • Assess its scope, and drivers
  • Examine the impact upon your end-point and planned activities
  • Identify any additional things that will need to be done as a consequence
  • Decide whether to accept the change or reject it, as well as if it results in returning to an early project phase.

Transfer of Design – At some point, you’ll take your device design forward to production. That transfer is what this stop is all about. In reality, it starts at an early stage in development, but comes to its conclusion at this point in your journey. It takes your design outputs and turns them into a product. That’s why you will have involved people from production from project definition onwards.

Issue Resolution – We spoke about this stop earlier, the principles continue to apply throughout your project

Launch Preparation – everything involved with completing your regulatory submission, manufacturing, assembling, packing finished product, ready for distribution and sale once you get the green light.

Of course, Issue Resolution continues to be relevant.

Project Closure – The evaluation of what led to your project being successful is often overlooked. Yet, this is how people, teams and organisations learn, so it should be an integral part of how you do business. Look back over the project to recap on how well you achieved what you set out to do, what worked well,what you achieved, would be done differently.

A couple of the things we’ve found work well here:

  • knowledge cafes,
  • case studies,


As you watched this video, you’ll have started to think about how you can go about addressing each of these stops properly, making the best of each step of your journey. You may now want to get some guidance to turn your thoughts into concrete actions.

Maybe something in this video struck a chord, felt familiar, perhaps you saw the whole picture. Then you’ll want to come along in 6 September, to the two day public training course in central London, UK that we’re running in collaboration with MDTI.

Clients tell us they love our practical, engaging approach to training, training that’s helped over 1000+ people so far.

Here’s another way to find out more, right now – we’ve written an Amazon bestselling book that’s a practical down to earth guide to great project management. It’s called “How To Build An Ark”, you can get your copy from Amazon, right after watching this video.

And there’s more! Our toolkit includes a couple of invaluable checklists:

  • The project triage and symptom treatment
  • The project leadership checklist.

Now that we’re coming to the close of this video, subscribe to our YouTube channel, or follow us on social media (the links are just below), so you’re the first to know when new content is available.

Thanks for watching, remember to send us your feedback and comments.