Jacob, your argument about status review meetings as one of the most important tools for effective product execution brings up really strong points. While systems and procedures are necessary, they ar...

Dev, I think you made a really good point about connecting each team member's task to a measurable output and to the next stage of development. When people understand how their work fits into the bigg...

Although I do not have direct industry experience, I have found both from my senior capstone experience and the examples shared here are helpful for understanding how project plan execution would actu...

The distinction you are drawing between surface-level deviations and foundational assumption failures is an extremely important judgement call a PM and project team have to make, and often does not ge...

The point about Design of Experiments is one of the more underutilized tools in this kind of situation. The advantage of a DOE approach over one variable at a time testing is exactly what was describe...

The tendency in most PM frameworks is to define stakeholders in fairly transactional terms: the people who fund the project, the people who approve it, and the people who use it. Expanding that defini...

The WBS is arguably the backbone of any project plan, but in medical device development it carries greater weight than a typical engineering project. In a regular engineering project, you are primaril...

Slack should definitely account for uncertainty, but that doesn't mean padding every individual task estimate. There's a real difference between quietly inflating each task "just in case" and delibera...

@dev-doshi You make great points in avoidance, as it is not always the dominant or most appropriate strategy to use in the development of medical devices. If we truly avoided all risk, we would never ...

@aca your challenging of the idea that the DHF is the PM's ultimate deliverable. If a PM's mindset becomes to produce a perfect DHF, they risk placing too much focus on compliance instead of acting as...

Krish and Shreya both bring up good points on something that goes deeper than surface level degree or certification. Krish, you make a good distinction that certifications signal good tool competency ...

Dev's point about humility is a really substantiative topic that I think needs to be addressed more in actual practice. A PM who has the humility and confidence to say a phase needs to be reopened, wi...

@aca You raise an interesting issue here, as this is not just a technical setback but a design control and traceability event. With a high risk device like the stent, dissolution rate is not a seconda...

Changing the DSD is not just a technical adjustment, it is primarily a strategic decision that must be taken carefully (As it can be costly and time consuming, and often times is unnecessary depending...

For a Class III bioabsorbable stent, dissolution timing is the value proposition. It dissolving too quickly then it does not meet the customer needs or design input that was actually intended for the ...