The ideal frequency of project update meetings depends on the project's size, complexity, and pace. For most projects, weekly or bi-weekly meetings strike a good balance, allowing teams to stay aligne...

Capturing and applying lessons learned during the project closing phase is a vital practice in project management, particularly in medical device development, as it drives continuous improvement and e...

During the execution phase, maintaining accurate and up-to-date documentation is essential for effective project management and decision-making. Using version control software (e.g., SharePoint, Confl...

Altering or omitting the sequence of activities in a project can have significant consequences on its scope, timeline, and overall success. The sequence of activities defines the logical order in whic...

The frequency of project update meetings largely depends on the project's size, complexity, and pace. For most projects, weekly meetings strike a good balance, allowing teams to stay aligned on progre...

Project Integration Management (PIM) is essential for ensuring that all project processes work cohesively throughout the project lifecycle. According to the PMBOK guide, PIM consists of several interc...

Response to Forum: Success Rate of Projects I believe project success can be classified into multiple dimensions beyond simply meeting the original scope, budget, and timeline. A project is traditiona...

When customers request changes to the project scope after execution has started, it is essential to follow a structured process to prevent scope creep and maintain project control. First, I would thor...

Planning is undoubtedly a crucial phase in project management, as it lays the foundation for successful execution. I appreciate the emphasis on structured techniques like work breakdown structures (WB...

Patient-reported outcome measures (PROMs) can significantly enhance QA by providing real-world insights into device performance and usability. Digital platforms, such as EHR integrations and mobile ap...

Collaborations like the one between BoneFix and FactoSet offer strategic advantages when companies lack the in-house expertise, technology, or resources needed to develop a competitive product. In thi...

Collaborations like the one between BoneFix and FactoSet can provide significant advantages when companies lack specific expertise or resources. By leveraging FactoSet’s specialized growth factor, Bon...

Ensuring effective scope verification in medical device development is crucial to maintaining compliance and preventing costly rework. One major challenge is managing evolving requirements while ensur...

The initiation phase of a medical device project is foundational, as it defines the project's direction and feasibility. Several key inputs—such as the Project Charter, feasibility data, regulatory la...

The ranking of change difficulty in medical device development makes sense, as changes to SOPs are generally easier to implement compared to modifications in the Bill of Materials (BOM), design contro...