How do you complete a new project on time and within budget while maintaining company goals and objectives? Simple. Work on the project scope and plan a new project effectively before executing it. Easier said than done, you say. I hear you.
In medical device project management, it’s common to have modifications during the project’s lifetime. We just need a way to stay ahead of these possible changes and challenges to execute the project effectively. That’s what we’ll discuss below.
The article includes:
The steps to scope and plan a new medical device project with ease.
- Scoping a new medical device project.
- Understanding Project scope
- Importance of project scope management
- Defining your project
- Anticipating the risks
- Planning a new medical device project
- Performing a GAP analysis
- Filling the gap(if any)
- Creating accurate estimates and timelines
- Allocating the right seats on the bus
- Having systems in place for feedback and reflection
Scoping a new medical device project.
A) Understanding Project scope
In the simplest of terms, project scope is the set of deliverables one needs to accomplish, features one has to include, and requirements one has to fulfill to call the project successfully executed. This also includes well-defined project goals, objectives, costs, timelines, and budgets.
B) Importance of project scope management
Whether it’s a change in the regulatory requirements, raw material availability, location, testing, or more, medical device projects have a lot of complex moving parts to manage and follow. If the project scope is unclear, it’s easy to lose track of all these parts and have the project go off the rails. Then there’s the constant scope creep that often goes hand in hand with medical device projects. Impacting the project costs, budget, project goals, and timelines.
“Scope creep is a huge concern for project managers, affecting 52% of the projects.”
Project management Institute
That’s why it’s important to have a project scope management plan and a project scope statement. They guide the project manager to make decisions in case of changes in the original plan. This brings us to the next point.
C) Defining your project – Waddell group style
The only way to manage scope creep is to understand what belongs in the project in the first place and then very clearly define:
- What you ARE going to do
- What you will NOT do – this is critical
But don’t do it alone. Ensure your team participates in this process. After all, they will be the ones who will work with you on it. This allows the Project Manager and the team to hold everyone accountable to the vision they all agreed upon.
At Waddell Group, we put a box around the product that is 25 words or less. The simple version is: what, by when, by whom, and for how much. This is our project definition statement.
The things you will NOT do get defined in the project plan right under the project definition statement. Useful categories for defining exclusions are:
- Features
- Geographies; where created, where sold
- Market
- Compatibility with other systems
- Regulatory requirements
- Technologies
- Suppliers …
The most important exclusions to list are those likely to get included sometime during the project.
D) Anticipating the risks
Other exclusions to consider: look at what risks you already know. Plan to include those risks or not. We generally see (at least) five different categories of risks, and several of them are not medically driven in nature. These risks are:
- Technology
- Cost
- Access to developers/human resources
- Competition
- Regulatory
As you look at the features of a new – or upgraded – product, meet with your team and assess the level of risk for each element and evaluate what is tolerable for the project and what is not. There are many tools for risk assessment. Choose one that you like, and use it.
Scoping a project correctly takes the skill and effort of a whole team. It also requires the right people at the table.
Waddell Group can help move you in the right direction.
Once you’ve created the project scope, it becomes a breeze to plan your project for execution. And this brings us to:
Planning a new medical device project
Before you plan for a new medical device project, you need to ensure you have the right people at the table to plan with you. In gathering your experts around a table, the Project Manager must put together the best team possible and establish the group’s culture that will drive the project forward. The right team working together on an agreed-upon vision can hold one another to the high-performance standard they want to be held to. Once you have the right team in place, you start by:
A) Performing a GAP analysis
To understand how you will reach where you need to go, you need to know where you are currently. With GAP analysis you can the gap between the two and determine what’s needed to bridge that gap. It involves analyzing data to see if your project requirements can be met with the company’s current resources. Often it also involves a cost-benefit analysis to determine how the necessary changes would impact your company margins, ongoing projects, vision, and mission in the long run.
B) Filling the gap (if any)
This involves gathering the information needed for various project phases, having the right personnel in place to execute the project and create internal project teams, and gathering the tools, techniques, and paperwork needed to execute the project successfully. This also includes planning for the risks assessed when determining the project scope. You do this while keeping track of associated costs, risks, and the company’s business needs.
C) Creating accurate estimates and timelines
For any project to be successful, you need to know when it needs to be completed, along with its budget and requirements. For that, you need to determine clear milestones that enable you to:
- Determine project phases
- Break down the project into smaller measurable activities
- Measure the progress of each activity
- Determine the order and time by which each activity needs to be completed
- Prioritize tasks and create a project schedule
- Define project costs
- Build in contingencies for possible risks and changes during project lifecycle.
D) Allocating the right seats on the bus
Jim Collins, in his book ‘Good to Great’ talks about the right seats on the bus. He says, “The executives who ignited the transformations from good to great did not first figure out where to drive the bus and then get people to take it there. No, they first got the right people on the bus (and the wrong people off the bus) and then figured out where to drive it.”
As a project manager, it’s your responsibility to make sure that the right seats are filled with the right people before driving the bus. That means getting the wrong people off the bus and looking for the right people when there is a gap.
E) Having systems in place for feedback and reflection
Determine in advance the feedback mechanism to use after project completion and during each stage of the process. This will help you gather data and analyze it to determine the efficiency and efficacy of the plan as well as the results generated. It will also enable you to make necessary changes if the results are not as anticipated.
Need help scoping and planning a project?
Our extensive experience and proven approach to medical device project planning allow us to quickly assemble the right team, develop accurate estimates, identify risk, and establish required contingencies. When we manage against the plan we build, we are confident we will deliver on time and on-budget.
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