Avoiding Medical Device Project Scope Creep

​The world around us is ever-changing and constantly evolving, and for those of us who are leading teams, projects or companies this presents a daily challenge.  One area in the business world where we commonly run into change, or scope creep as many of us like to call, is in project work. It doesn’t matter if you are running an internal project, or if you are a consultant operating externally, change in work and projects alike seems constant.  If you are new to the term, scope creep is defined as “changes, continuous or uncontrolled growth, in a project’s requirements, at any point after the project begins.”  Simply put, it’s a change in plans that was unplanned for after the starting point of a body of work.

While complete prevention of scope creep might be unreasonable, employing strategies at the forefront of your project and throughout are vital to ensure you stay on track with as little change along the way.  Strategies like the ones listed below also allow the project to ebb and flow so that some change can be accommodated while other changes, which could derail a project, are held off at the proverbial gates.

Below you are some strategies to help you prevent scope creep on your next project:

1. Clearly Define the Scope Up Front
Have a detailed project scope statement that outlines the project's objectives, deliverables, boundaries, and limitations. Make sure all stakeholders agree on the scope before starting the project.  Special note – want to get approval quickly for your project?  Make sure the project and intended outcomes align with the company’s mission and primary objectives while clearly showing a good return on investment (ROI).

2. Engage Stakeholders From the Beginning
Involve key stakeholders in the scope definition and planning processes. Their input and feedback can help identify potential scope creep early on and ensure that their expectations align with the project's scope.

3. Set Realistic Goals
Establish achievable project goals and objectives. Unrealistic expectations can lead to scope creep as stakeholders try to add additional features or requirements.  If you can’t get agreement on the goals of the project this should cause you to pause before moving forward.  Remember, each person involved may have a different perspective of what is needed based on their own biases.

4. Create a Change Control Process
Develop a formalized process for requesting and approving changes to the project scope.  I like to use the engineering change order (ECO) process on our projects as it formalizes changes and requires approval from stakeholders before the changes are enacted. All changes should go through this process, involving the evaluation of their impact on time, cost, and resources before being accepted.
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Speaking of scope creep, in this episode of Medtech Snapshot Terry Vick, Sr. Director Program Management at Shockwave Medical out of Santa Clara, CA talks about some of the strategies in this list which we need to be aware of and consider upfront in the project planning phase into order to limit scope creep on the back end. Plus, the importance of having an internal project sponsor.

Back to our list of strategies to help you prevent scope creep…

5. Prioritize Requirements
Use techniques like MoSCoW (Must have, Should have, Could have, Won't have), Five Whys or the Analytic Hierarchy Process (AHP) to prioritize project requirements. This helps in focusing on what's essential and avoids unnecessary additions.

6. Track Progress Against Scope
Regularly track project progress against the defined scope. Tools like Microsoft Project which build out real-time Gannt charts are incredibly helpful to visualize tasks and progress.  This also helps identify any deviations early on and allows for timely corrective actions.

7. Communicate to Your Team Consistently & Clearly
Ensuring all team members and stakeholders understand the project's scope and the implications of scope changes is paramount to the success of the project. Effective communication can help prevent misunderstandings that might lead to scope creep.

8. Document Changes to the Project
Keep a detailed record of all changes to the project scope, including their rationale and impact. This documentation helps maintain transparency and accountability.

9. Manage Expectations by Providing Project Updates to Stakeholders
Continuously manage stakeholder expectations by providing regular updates on project status and any changes to the scope. This can help prevent unrealistic demands and last-minute additions.

10. Institute a Review and Approval Process for Scope Change
Institute a formal review and approval process for scope changes. All changes should be evaluated by relevant stakeholders and approved based on their impact.

11. Stay Firm but Flexible
While it's important to resist unnecessary scope changes, be open to valid suggestions or changes that genuinely enhance the project's value. Just ensure that these changes go through the proper evaluation and approval processes.  If you can’t readily identify the ROI of the change it probably isn’t a good change to consider.

12. Conduct Regular Project Reviews
Conduct regular reviews with stakeholders to ensure that the project is meeting their expectations and to address any concerns before they escalate.  When facilitating meetings, try to employ Jeff Bezos’ ‘Two Pizza’ rule when it comes to meeting attendees.

13. Manage Dependencies to Avoid Unintended Cross Functional Impact
Understand and manage dependencies between project tasks and deliverables. Changes in one area can often impact other parts of the project.
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Remember that while complete prevention of scope creep might be challenging, these strategies can significantly help to reduce its occurrence and impact on your project. Regular vigilance and proactive management are key to avoiding scope creep from taking over your project.

​The quickest way to overcome a business challenge is to get help from those who are experienced in besting your beast!  The team at Square-1 Engineering is comprised of a variety of technical and project management professionals who are subject matter experts in the areas of NPD, Quality, Compliance and Manufacturing Engineering.  Learn more about how we can solve your work and project problems today to get you back on track!