It’s a novel and fascinating experience to take on the project manager position at a medical device firm. It isn’t easy, but if you’ve chosen to take on this responsibility, you’re probably more than capable of handling it. Any project manager starting a new career in a medical device business will go through three stages. Continue reading to learn more.

What is a medical device project work breakdown structure?

Each project manager can benefit significantly from a work breakdown structure, yet many are unaware. This article outlines the creation process for a medical device’s work breakdown. The WBS (work breakdown structure) is a hierarchical breakdown of the entire scope of work that the project team must carry out to achieve the project’s goals and produce the deliverables. What it should include in the project is organized and defined by the task breakdown structure. The job breakdown structure is frequently graphically represented and organized into many levels. Project deliverables and project tasks are broken down into smaller, more manageable components to establish a work breakdown framework. This process’s main advantage is that it gives an organised picture of what must be provided.

When to create a work breakdown structure?

An early stage of a medical device project’s planning involves the creation of a work breakdown structure. The work breakdown structure should represent the work outlined in the project scope statement.

How to create a work breakdown structure?

Decomposition divides the project into more manageable chunks to produce the medical device work breakdown structure. Most work breakdown structures are built by indenting tasks in project management software to deliver summary tasks and work packages. Hence, a basic project management structure will be created. Unless there are exceptional reasons to add extra levels, the most profound component of a work breakdown structure should only have four or five layers. Using the work breakdown structure successfully for its intended purpose will be challenging if there are too many levels.

Why should you have a work breakdown structure?

Tasks are organized into work packages and summary tasks using a work breakdown framework. It is impossible to manage hundreds of tasks in a list, get an overview of the situation, assign responsibilities, or report costs to the project’s proper level. A Gantt chart is a long list of tasks that must be finished without a work breakdown framework.

3 Stages of Project Management in the Medical Device Industry.

Stage One: Planning and building relationships: Consider this first phase as building the foundation for your future project management triumphs. You’ll prepare for your first project and start cultivating relationships with important stakeholders here. Throughout this phase, you will produce three documents, each of which will position you for future success

  • The Project Charter: Every project has a sponsor, who is most motivated to see it through. You must collaborate with the project’s sponsor to develop the project charter
  • The Communication Plan: Many project managers will struggle with the communication plan. Although it’s a crucial document, project managers frequently want to move directly from defining the vision to determining how to make it happen. That makes sense, but your project will quickly fail if you don’t have a solid communication strategy in place
  • The Project Plan: Your project plan will be influenced by your choice of methodology. Most business employe agile methadology but many also apply waterfall. As a result, it will be based on a waterfall-based project. It would be best if you created your milestones before you can create a project plan

Stage Two: Managing timelines and fighting scope creep: You’ll spend more time managing the project throughout the second phase of your new employment. While you carry out design controls, you’ll be closely examining your project plan, checking that your milestones and work breakdown structure are accurate, and ensuring that your design history file (DHF) is being fully developed

  • Fighting scope creeps: In this second step, you’ll unavoidably face some scope creep. You once believed that this device only required A, B, and C, but you have since learned that it also requires D and F. The easiest approach to prevent this is to implement a change management procedure. Your design controls for change orders also include change control.

Stage Three: Reestablishing your baseline and lessons learned: At this point, everything should go in a smooth manner if you’ve managed scope creep and kept as close to your project plan as possible. You’ve established the connections necessary to comprehend problems quickly and find solutions, and you probably feel more at ease in your new position. It indicates that now is a perfect moment to create a new baseline for your project, document your learnings, and spread them out. It’s important to bring everyone up to speed and reset expectations while creating a new project baseline. It’s not a guarantee that you’re falling behind. The project might be completed on schedule. Yet not all of the tasks that must be completed throughout the design and development of a medical device will proceed at the same rate.

An example of a medical device work breakdown structure:

The “Pre-Heart” product is a hypothetical gadget. It is a mechanism for moving donated hearts from a hospital that serves as the donor to a hospital that performs the transplant. On the left is a transit box, and on the right is a disposable organ container.

  1. Life-cycle work breakdown structure: Design, design verification, design transfer, design validation, and close out make up the first level of the breakdown. Even though some of these phases would occur concurrently, they still serve as life-cycle phases instead of deliverables. The life-cycle breakdown structure is thus present, and this is one method of developing a work breakdown structure
  2. Traditional deliverable-oriented work breakdown structure: If one looks at the following level, one can see the disposable, labeling, and transport box. The transport box’s mechanics, electronics, and software are categorized. It is a more conventional work breakdown structure that is hierarchical in the sense that the transport box is divided into two tiers and deliverable-oriented
  3. A combination of work breakdown structures: The verification has been divided into system testing, software unit testing, and system testing, which are further divided into several types of testing in the design verification branch of this tree. This work breakdown structure integrates different breakdown structure kinds in order to help the project grow to the maximum level!

Work breakdown structure and scheduling:

Before it can be finalized, the job breakdown structure is typically repeated numerous times. Significant portions of the schedule are typically not developed until this structure is finished.

Which software should you use for a work breakdown structure?

You can use mind-mapping software to illustrate the task breakdown structure graphically. One highly recommended tool is MindManager, which can easily export a mind map job breakdown structure to Microsoft Project. You would generally indent the text to establish a hierarchical breakdown structure in this case. Excel, Word, or Microsoft Project are all suitable substitutes for a text-based WBS.

Work breakdown structure template:

Your work breakdown structure can get off to a head start if you can obtain a template from someone managing a similar project within your organization. You must make the work breakdown structure yourself if you don’t already have one. The advantage of this is that you may design a framework that suits your needs and your projects.

Phases in a project process:

Project Management Institute (PMI) created five stages of project management. Below mentioned are the stages:

  • Conception and Initiation
  • Project Planning
  • Project Execution
  • Performance/Monitoring
  • Project Close


Successful new medical device product introductions depend on sound project management procedures and rules. The project scope is typically quite broad for medical devices, necessitating several communication links across various functional areas. Additionally, a business needs to set up an internal quality system that guarantees adherence to design controls and employs risk management guidelines. Corporate administrators, directors, and other department and group leaders are among the personnel involved in the project’s implementation and management.


Level 0: Final deliverable or project title
Level 1: Important outputs
Level 2: Deliverables that can still be divided
Level 3: The team may be responsible for completing the third-level deliverables

Analysis of the opportunity and risk at the beginning
Concept and feasibility examination during formulation
Design and development, along with validation and verification, to make sure the design output matches the required design input
Final approval and planning for the launch of the product

Firstly, you need to specify the project’s objectives, goals, and scope
Define Project Phases & Account Control
List the outputs of your project
Establish WBS Levels
Produce Work Packages
Choose task owners

Phase 1: Device discovery and risk analysis
Phase 2: Conceptualization, Feasibility, and Formulation
Phase 3: Design, Development, Verification, and Validation
Phase 4: Final validation and planning for the launch of the product

The phrase “8-80” means that the minimum work should be between 8 and 80 hours.

The rule is the same for all levels of the hierarchy: the total amount of work represented by each “child” level must equal 100% of the total amount of work represented by each “parent” level. The WBS should not include any work outside the project’s scope, which means it cannot have more than 100% of the work.

The entire project’s work is contained entirely in the WBS. The project’s ultimate aim is at the top level, followed by the project results on the second level, the project outputs on the third level, and the project activities on the fourth level.

The things that make a successful work breakdown structure are as follows:

Those who perform the work produce group project components according to deliverables
Covers 100% of the work specified by the scope or contract and includes project management. It also includes all deliverables (internal, external, interim)

The fundamental parts of a medical device are mechanics, motors, and motion control, which must be continuously developed and improved for increased effectiveness.

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