Given the choice, I’d begin as a hands-on engineer and pivot into management after three to five years. Starting on the technical front line builds hard-won credibility: when you’ve debugged a flaky s...

Like you, I feed off a spark—but for me that spark is impact clarity. I’m at my best when I can see a direct line between the task in front of me and the people it will help. Once that link clicks int...

Had the team spent even 30 minutes on a micro-FMEA, “residual solvent odor” would have arisen instantly (common with heat-sealed pouches). The stage-gate would then have required (i) a 10-unit pilot l...

Defining “enough” planning generally hinges on clear alignment of project goals, stakeholder buy-in, and well-documented assumptions, even if all future risks are not fully predictable. Employing iter...

Implementing robust and continuous QA strategies requires comprehensive testing and validation at every stage, from early design to post-market surveillance. This involves integrating iterative risk a...

Collaborations become valuable when a company recognizes it lacks internal resources or expertise needed to rapidly and effectively bring a product to market. In situations like the BoneFix and FactoS...

When deciding which factor is more important—time or money—it ultimately depends on the specific context and objectives of the project. If the product under development requires extensive testing, inn...

Task scheduling is indeed a critical aspect of project management, as it lays the foundation for successful project execution by clearly defining timelines, priorities, and dependencies. By developing...

Efficient inbox management is critical for project managers looking to stay on top of their responsibilities and avoid getting overwhelmed by constant communication. One effective approach is to creat...

The Google PMP (Project Management Professional) certification, while gaining popularity, differs significantly from established certifications like the CAPM (Certified Associate in Project Management...

Striking the right balance between cost control and maintaining quality standards in medical device projects requires a strategic approach that incorporates thorough planning, risk management, and con...

Gantt charts are a valuable tool in medical device project planning, offering a clear visual representation of tasks, dependencies, and milestones. They help teams coordinate efforts, track progress, ...

A structured, continuous approach to risk assessment, as outlined in ISO 14971, is key to preventing overlooked hazards. Narrowing the planning process into specific steps allows teams to focus on eac...

Project managers often factor in potential delays, and missing a milestone sometimes yields benefits—like uncovering technical flaws that improve the final product. However, if the delay results from ...

Balancing rigorous design controls with innovation is a crucial element in medical device development, ensuring compliance and the continuous evolution of technologies. Implementing robust documentati...