The debate over certification validity often comes down to what specific skills and frameworks you need in your career. Google PMP, is a relatively new credential that emphasizes practical, agile, and digital project management skills designed for modern, fast-paced environments….   Read more»

A WBS not only breaks down the total scope of work into manageable tasks but also offers flexibility and adaptability in project planning. By decomposing the project into work packages, it becomes easier to identify dependencies and potential risks at…   Read more»

Scope management, time, and cost management are deeply interconnected, especially in complex projects like medical device development. When scope changes, it forces a reevaluation of the timeline and budget. One effective approach is using tools like Earned Value Management (EVM)…   Read more»

In the initiation phase of medical device project management, key inputs such as the Project Charter, feasibility studies, regulatory landscape assessments, and stakeholder analyses are critical. The Project Charter formally defines the project’s purpose, high-level objectives, and authorizes the commitment…   Read more»

During verification testing, it is quite common to encounter unanticipated issues (like adhesive failure in water) that drive budget increases for additional experiments. One way to mitigate this is to incorporate contingency funds into the initial project budget. For example,…   Read more»

I believe the differences between project managers and program managers extend into both technical focus and soft skills. Project managers concentrate on the detailed execution of individual projects (managing schedules, budgets, risks, and quality control through hands-on use of tools…   Read more»

When determining the correct product code and regulation number, I think it’s important to develop a detailed comparison. This tool helps align your device’s key attributes (such as intended use, material composition, and technological features) with those of potential predicate…   Read more»

The Design and Development Plan is a foundational blueprint that guides the medical device engineering process. By first setting clear objectives, the plan ensures alignment across each phase of development. As outlined, Design Inputs are the specifications that the device…   Read more»

Design verification and design validation, though both integral parts of the PDCA cycle, serve distinct roles in medical device development. Verification confirms that the product has been built according to the design inputs and specifications. For instance, if a suture…   Read more»

Transitioning into project management in the medical device industry blends technical acumen with strong organizational skills. A typical day involves monitoring timelines with Gantt charts, coordinating cross-functional teams, and managing stakeholder communications. Along with navigating a rigorous regulatory landscape, a…   Read more»

A project manager’s ability to adapt goals while preventing scope creep also hinges on understanding the personal challenges team members may face. Imagine a scenario where a key contributor stops attending meetings or providing updates because of a sudden life…   Read more»

Balancing value between stakeholders and customers often hinges on project context, timelines, and long-term strategic goals. On one hand, prioritizing customers can foster loyalty and market expansion, especially if you’re addressing unmet needs or aligning with consumer trends. This approach…   Read more»

Regulatory risk is indeed a significant challenge in medical device project management. Even when the team has meticulously planned for FDA approvals, shifts in regulatory standards can occur unexpectedly, prompting additional testing or documentation. These sudden changes can strain budgets,…   Read more»

Project managers can cope with external risks, such as supplier delays or supply chain disruptions, by implementing proactive strategies and maintaining flexibility within the project plan. Tools like Gantt charts are invaluable for visualizing the project timeline and identifying critical…   Read more»

Incorporating new technologies into a project depends significantly on the stage of the project and requires careful evaluation to balance potential benefits with risks. Early in the project, adopting new technologies can be more feasible, as there is typically greater…   Read more»

When verification tests fail, the first step would be to distinguish between a test design issue and a device design issue. For example, a medical device might be designed to operate within specific temperature ranges, but if it overheats during…   Read more»

I’ve never experienced being a ring-fenced employee after a company was sold off, but it sounds like a bad situation. From what I understand, an advantage for the company that buys the business is that it helps ensure continuity. By…   Read more»

Consulting and legal services are critical to the success of medical device companies, especially when navigating regulatory submissions. Regulatory compliance is a complex and ever-evolving landscape, and these services help ensure that a company’s products meet the required legal standards….   Read more»

International contract law plays a critical role for medical device companies seeking to expand into foreign markets. These companies must navigate a complex landscape of varying regulations, standards, and legal requirements in different countries. Without a standardized framework, medical device…   Read more»

The sudden move to remote work during the COVID-19 pandemic introduced unique challenges and benefits that affected each organizational structure differently. Functional organizations faced hurdles in maintaining clear communication across established hierarchies, which is typically facilitated by physical proximity. This…   Read more»