5 Project management Rules for the Success of your Medical Device Launch

5 Project management Rules for the Success of your Medical Device Launch


     July 19th, 2013    1 Comment

At LSO, we typically manage 50-55 new product launches a year. This doesn’t include helping existing customers with product revisions and follow on work.  This is a launch rate that far surpasses that of many multi-billion dollar medical device companies. Our volume is driven by our focus on the start-up market and our willingness to manage any product regardless of its size. Due to the high volume of product launches we’ve developed an expertise in project management. We wouldn’t be able to keep up with the volume if we didn’t.  So based on our extensive experience we’ve created a list of the top 5 ways to manage a project successfully.

1. Know your Role

Project management is all about identifying tasks, assigning responsibility, and then holding people accountable. Task assignments need to be clear, and those who are responsible need to focus on their task not on anyone else’s.  For example, we recently worked on a project where our client’s quality managers wanted to play an active role in the package design. They had little package design experience, and were throwing ideas around that made no sense in the overall scope of the project. Portions of conference calls were spent explaining why their ideas wouldn’t work.  Also, the lack of focus by those individuals leads to delays in reviews of the protocols, and approvals of drawings.  This simple want of a couple individuals to play in a space which wasn’t assigned to them cost the project 3-4 days, time that is incredibly valuable when bringing a project to market.  Stay on your task, do it well, and expect those around you to do the same.

2. Balance your Focus

Critical path items are always the key to a project launch, but I cannot tell you how many times we have seen a missed deadline due to a minor item not being taken care of quickly enough. One project we worked on required a full suite of validations and the assembly of a device comprised of over 30 components. We missed the launch date due to the client not being willing to specify the maker of the O-ring they wanted to use. The O-ring was a minor component and only cost a couple cents to purchase, but the vendor they ended up choosing went on back stock, when the client was expecting a 2-3 day lead time. It is so important to stay in front of every item, even as you place the majority of the focus on the critical path. It is as simple as reviewing the entire project list once a week and tracking progress.

3. Projects are Multi-Level

Every task of a project has multiple elements that must be accomplished to complete that task. To track a project at those component levels can be incredibly cumbersome, and can turn a project list into a nightmare to maintain. Tracking needs to be done at the top level task, but everyone on the team needs to understand that each task has its own project list that the responsible party needs to achieve. An example would be label design. One may assume that label design is as simple as designing a single label and releasing that label into the quality systems. That release typically requires multiple approvals which can lead to all sorts of revisions. Label stock needs to be found, bought, and approved. Sample labels need to be run and inspected for abnormalities, and the labels need to fit on the package and meet the regulatory requirements, enhance the brand of the company and make the product look like a high cost medical device.

4. You are Not Alone

Multiple people are involved in every project launch. There are folks on the project team, managers of the people on the project team, operations and quality people who will be responsible for handling the project after the launch, etc.  Also, each task of the project is dependent on a task being completed prior to its initiation, and has a task waiting for its completion. Don’t forget that you and your task are not alone. People and the project are depending on you completing your task on time. On the flip side, if you are having issues, don’t neglect to reach out to the project manager to get the support of those around you. Many people, many of which are not the project team, are highly vested in the success of the project’s completion. If you need help, you will get it. Just don’t miss your deadline.

5. Communication

This is the most obvious one, but it is also the most important. Weekly meetings are a must, as is communicating through continually updated tracking mechanisms, like project sheets or Microsoft project documents. Daily updates via email, are a great tool as well. I can’t tell you how many times people come to me asking for a weekly meeting to be pushed off as there was nothing to report, only to get on the call and spend an hour and a half dealing with issues no one remembered were important. It is imperative that people are constantly updating the group on where they stand, issues they are facing, and areas that are ahead of schedule. You are not alone in this project, many people are relying on you, each step has multiple components, minor items need to be cared for. There are so many moving pieces that if you don’t communicate status constantly something will be dropped.

I’ll finish with a simple analogy of a football team on offense. Think of how each person on the field has an assignment. The guards don’t run the ball, the quarterback doesn’t block. They each have an assignment and that is their focus. The center is communicating with his line and with the quarterback, the receivers and running backs are signaling to the quarterback, the quarterback is communicating with everyone. It seems like chaos right before the snap, and then everything moves. The teams that are the best are the ones that know their roles, balance their plays, understand the complexities of theirs and other requirements, have individuals that depend on each other while being dependable, and communicate constantly.

If you follow these rules, you will do everything you can to have a successful project, and with a little luck you may actually get it completed ahead of schedule.


One Response to “5 Project management Rules for the Success of your Medical Device Launch”

  1. The points are applicable for those who are willing to start or have an idea to launch a medical device. Also there are certain regulations to be followed by the FDA for the approval for the new innovation. Because whatever the innovation is going to be launched, is definitely to help patients with the best possible solutions to increase quality of life.

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