Project Management and Execution in Medical Device Development

As part of a OneMedRadio series, MPR Associates takes us through the process of medical device development. Below, Ralph Paul and Eric Claude discuss the importance of project management and execution.





Click below to hear full audio interview and see transcript that follows.

Matthew Margolis:    Greetings from OneMedRadio in New York City. I’m Matt Margolis. Today, we’re joined by Ralph Paul and Eric Claude, senior managers of the product development group of MPR Associates, a leading international design and engineering firm. Today, we’re discussing the value of project management and execution in rapid medical device development and commercialization as part of our series on shortening time to market in med tech development. Mr. Paul and Mr. Claude, thank you for joining us.

Eric Claude:    It’s a pleasure thank you.

Ralph Paul:     Thank you.

MM:   So Ralph, I want to start with you. You’ve discussed the need for rigorous project management approach, what is the most important aspect of project management that leads to successful development projects?

RP:     Well, the single most important thing is to have a single empowered project manager who’s accountable for the entire project. That may seem very obvious, but it’s not always obvious and there’s many cases we’ve run into where organizations have made multiple individuals accountable for different elements of a project, and inevitably that leads to miscommunication and problems and an inability to make decisions when they need to be made. That contributes to schedules that are late, budgets that are overrun and just an inability to get to a final product that’s going to meet all the needs of the stakeholders.

MM:    Sure. I can see how a strong project manager is important, how can a single person be knowledgeable enough to make all the right decisions throughout the development?

RP:   Well, it’s true that a single person can’t be an expert in everything and if you try to do that, you will certainly fail. But as a project manager, what you need to do is surround yourself with people that fill those roles and that you trust and that will be accountable to you and you need to take all that information in from these various people and make your decision. So you can’t work in a vacuum, it really never works that way. But you need to involve all these stakeholders and in some cases you may need stakeholders to either be highly involved or even make certain critical decisions. One of the key things is if that’s true and if you need a key stakeholder to be a part of the final decision process, you need to include that in your plan. You need to have that known upfront so that everyone involved understands that that’s how the project is going to be run and how that decision is going to be made. When you do that upfront, it’s very clear and you have a clear way to have accountability on those decisions.

EC:    I would just add to that that I think in our experience what’s critically important is to have a well-organized project team with clear division of responsibilities between the team members. Where the project manager of course has overall authority and accountability, but additional people with the right expertise are on the team to assist with technical direction of the project and execution of the work. The project manager one of the key roles that that person fills is really being the communication conduit of information to keep the flow moving at the right pace.

MM:      And so maybe you can go into just a little bit of detail about what particular things that project manager, what kind of challenges can arise and what things a project manager really needs to be in control of, communicate properly.

RP:   Well, really there’s all matter of things that can go wrong during a project. In fact, to a large degree, a project manager’s whole job is risk management. So as a project manager, you should constantly be asking yourself what else is going to go wrong, what’s going to go wrong next. If you take that approach, you’re basically always thinking ahead to the next things happening in your project and you think ahead as to what could go wrong, what could cause any of those things to not be done on time or on schedule or be done in a way that’s going to meet your requirements and you come with contingencies.

So in a couple of examples in many of the projects, you have resources, you have people on your team that are doing work for you. You can have unforeseen problems with those resources. You have a resource that has to get pulled away for some other critical function and suddenly your team is down a person who is really needed to get a certain task done so what do you do about that? You need to think ahead and be planning to have team members that are understanding of each other’s work and so that you can have somebody fill in it in the last second if you need to. So that’s an example of something that can go wrong.

You can have an external organization say or working with a key supplier of a component who is critical to the function of our device and that supplier fails to meet their schedule and not only fails to meet their schedule but when they finally do ship products, it doesn’t meet the specification, what do you do? So if you haven’t planned ahead, you’re going to be caught flat footed and when that occurs you’re going to be well behind and really not have a way to recover. So in thinking through, you have to know where your risks are. If that supplier is somebody you’ve only just started working with, maybe you should have a second supplier who’s working in parallel so that you have two options. That’s another way to mitigate your risk. So these are some things that you can be doing throughout the project to constantly be trying to identify where things are going to go off plan and come up with ways to mitigate those before they happen.

EC:    Let me just add a little bit there. We put a lot of effort upfront into developing a really sound project plan for our development activities and that’s really the foundation of being able to do these risk management activities that Ralph discussed. It’s a little bit like for example making up a flight plan to fly from point A to point B, you’ve got to have that plan so that you can think about what might happen if there are thunderstorms in Atlanta and I have to deviate from the plan. So we’ve put a lot of effort upfront into looking at what has to come together for a project to be successful because that gives you a baseline that you can use to then look at the potential risks to success.

MM:  So it sounds like we’re talking a lot about sort of mitigating disaster, kind of rolling with the punches here. So what actually does make for a successful plan?

RP:   Well, at first as Eric mentioned, it needs to be comprehensive and detailed. You need to really capture everything that you’re doing as a part of the project. Both describing what you’re doing but also have key responsibilities and roles defined, key deliverables defined so it’s very clear what is going to be done, when it’s going to be done, and what the outcome will be. That’s the first step.

Now as you get into this detailed plan, you’re going to be identifying activities that have to get done in order to achieve these end results. Another critical thing is that these activities have to be defined in a way that people can be accountable. So they need to have clear start and finish dates, clear expectations on how much time and effort it’s supposed to take to do these activities and most importantly the activities should have a single owner. Again, one person who’s going to own that task and make sure it gets done and be accountable for the outcome and really again that builds on everything else. If you plan your work in a way that individuals are empowered to be accountable to get the work done and the team works well together, you will end up meeting your goals.

Where it breaks down is when that doesn’t happen and communication is not clear. So people think, one person thinks somebody else is really going to do some element of the task, but they aren’t doing that, you get a breakdown then you get to an endpoint or a certain point in the work and that activity never got done. So it’s really important to use this plan as a way to ensure that it’s communicated very clearly to everyone involved, all the stakeholders. When you do that, that leads to a successful project.

EC:   That’s an important point. Using the plan as a communication tool is so important because one of the interesting and challenging aspects of medical device development is the multidisciplinary nature of these kinds of projects. You have investors, you have legal folks from an IP standpoint, clinicians, regulatory people so there’s lots of communication interfaces that need to be managed.

MM:  At what point do you find the communication breaks down most often and what, you know, part of the project I guess?

RP:    Realistically, that can happen in all parts. You can’t oversell the importance of communication. You know, where when you have a very good working team, I’d say a lot of times you can avoid those breakdowns. So it’s the places where you don’t have good careful close communications that’s going to cause the biggest issues.

So for example, say you’ve got again a partner who’s either supplying a critical component or maybe developing a part of the system but external to your own organization, that is a critical interface. It’s a place where communication or information needs to be over communicated because that’s a place where you’re going to get a breakdown.

The other place we’ve seen it is things of the nature if you’ve got a marketing group who cares about certain elements of the product and they understand what the end users need and you’ve got an engineering team who’s developing the product. A lot of times you can get a breakdown between what the engineers think they’re developing versus what the marketing really knows the users want. So that’s a place where careful communication is needed. There’s many more examples but I would say it’s looking for these interfaces where you don’t have people that are working closely together on a daily basis. If you don’t have that, then you better make sure your communication links are strengthened.

MM:   Now, we’ve spent a lot of time talking about project management, I’m curious what makes this idea different in the medical device space as compared to other projects and other ventures?

EC:   Well, you know, that’s a great question and one that I think has a couple of answers. One, as we’ve discussed, medical device development projects are so multidisciplinary with so many different organizations involved. You know, we’ve talked about the communication points that are so important that adds to the challenge from that standpoint. You know, this is all happening under a timeline that generally has quite a bit of pressure to bring a new product to market quickly so that’s a challenge and that’s all compounded by the regulatory issues that have to be addressed. You can’t back fit regulatory compliance, design controls, risk management, these kinds of things into development after it’s done. They have to be tightly integrated with the development process. So all of those reasons combine to make the discipline of managing a medical device development project a little more challenging than many others.

MM:   You mentioned a little bit about the regulatory constraints, I was curious if you could just talk a bit about why we’ve seen a tighter leash whether we are seeing more difficulties in getting these things through and any explanations for that really.

EC:    Sure. Well, I think that FDA has I would say increased their level of expectations in certain areas particularly around risk management, around human factors, and designing to prevent the possibility of use error, those kinds of things. I think particularly when you look at the human factors issues, I think there’s some justification there to be concerned about those issues. So I think the expectations have increased there in those areas and we’ve got to be ready to meet those expectations.

MM:    We are talking shop with Ralph Paul and Eric Claude, senior managers of the product development group at MPR Associates, once again, a leading international design and engineering firm. Thank you guys for your time, I appreciate it and please readers stay tuned for more of our series on shortening time to market in med tech development.

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