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 sensor bus at 2 a.m. or watched a…   Read more»

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…   Read more»

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 lot, (ii) a simple head-space GC/MS sniff test, and…   Read more»

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 iterative techniques like rolling-wave planning—where details become more defined as the project progresses—and regularly…   Read more»

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 assessments, real-time data collection systems, and rapid feedback loops to detect potential device failures more…   Read more»

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 FactoSet partnership, where specialized technology or research is required, external collaboration…   Read more»

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, innovation, or regulatory compliance, taking more time may be essential to ensure…   Read more»

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 a carefully structured schedule, project managers can visually map out every task…   Read more»

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 create filters and labels that automatically categorize and prioritize emails based on…   Read more»

The Google PMP (Project Management Professional) certification, while gaining popularity, differs significantly from established certifications like the CAPM (Certified Associate in Project Management) from PMI and CompTIA’s Project+. Each certification serves a different purpose, so their validity depends on the…   Read more»

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 continuous evaluation. One key strategy is to ensure that cost estimation occurs after a…   Read more»

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, and meet important deadlines by outlining the order of tasks and highlighting…   Read more»

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 each task and identify potential pitfalls early, rather than waiting…   Read more»

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 poor planning or communication, it can harm the company’s reputation. Ultimately, it’s…   Read more»

Balancing rigorous design controls with innovation is a crucial element in medical device development, ensuring compliance and the continuous evolution of technologies. Implementing robust documentation systems helps organizations systematically capture key decisions and track risk mitigation efforts without stifling creativity….   Read more»

I think having a basic understanding of project management is valuable, even if someone isn’t planning to pursue it as a career. In industries like medical devices, where projects are highly regulated and involve multiple teams, knowing how project management…   Read more»

When dealing with verification failures in a project, I always find that a structured problem-solving approach is the best way forward. In the case of label adhesion failure during water submersion testing, the first step should be a thorough root…   Read more»

f we’re running verification tests to check the specs, inputs, and outputs from the DSD, the probability of needing a budget change depends largely on how well the initial planning and risk assessment were conducted. Thorough upfront validation can reduce…   Read more»

When transitioning to new technologies during an ongoing project, one thing to ensure is to stay compliant with regulations. Sometimes just merely changing the temperature of a certain stage of the product’s production by one degree is considered a Design…   Read more»

Sizes of project teams must directly reflect the amount of responsibility that is needed in the completion of it. I do prefer smaller teams since I feel like actions and decisions are taken with much more agility, and they are…   Read more»