Jacob, your argument about status review meetings as one of the most important tools for effective product execution brings up really strong points. W...

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 p...

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 u...

The distinction you are drawing between surface-level deviations and foundational assumption failures is an extremely important judgement call a PM an...

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 varia...

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...

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

Slack should definitely account for uncertainty, but that doesn't mean padding every individual task estimate. There's a real difference between quiet...

@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 devi...

@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...

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

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 ...

@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...

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 c...

For a Class III bioabsorbable stent, dissolution timing is the value proposition. It dissolving too quickly then it does not meet the customer needs o...