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 definition to include anyone who experiences the…   Read more»

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 primarily dealing with technical deliverables and business milestones. With…   Read more»

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 deliberately building contingency into the broader project plan. The problem with padding…   Read more»

@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 build implantable devices, never develop…   Read more»

@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 a proper strategic leader….   Read more»

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 while degrees shape how someone thinks. Something like obtaining…   Read more»

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, without getting defensive or…   Read more»

@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 secondary parameter, due to its…   Read more»

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 on the situation to make changes)….   Read more»

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 device. In this situation, the PM has…   Read more»

The additional perspectives raised by Aby and Shreya highlight another important point within the product life cycle of medical devices that I overlooked, organizational alignment and operational execution by said organization. An emphasis on interdisciplinary collaboration needs to be strong…   Read more»

Product life cycle in medical devices is shaped far more than just technological innovation, but more by the stringent regulations behind it. Regulatory factors, post market performance and strategic planning all play a large role in determining longevity than novelty…   Read more»

A DHF that is assembled only at the end of a project creates significant risk, as FDA auditors are focused on whether or not design controls were followed throughout the development of the project, and not just reconstructed after the…   Read more»

The PM does indeed still have a role post-market, but it is important to be careful on where that role ends or blur on who actually owns the rights to the completed project. Once a device is created and approved…   Read more»

Vansh does bring up a good point with what roll a PM should take with FDA regulatory compliance, however as Jacob and mmk brought up, the PM should still have a great deal of involvement with a main regulatory body…   Read more»

As a project manager, the responsibility is to keep long development timelines and large budgets under control by proactively managing regulatory uncertainty, particularly for Class II and Class III medical devices. A PM should never assume a best-case scenario timeline…   Read more»

@vanshamin I actually disagree on the premise that interpersonal skills far exceed the need of technical skills for a PM. I haven’t personally been on the side of project management, however I have been part of the team that executes…   Read more»

The emphasis placed on shifting the focus away from personalities and back onto the project itself is really good point that was made. To seg28’s point, clarifying expectations and roles early is huge, many conflicts aren’t personal but instead are…   Read more»

Many of the points raised about regulatory, quality, and systems engineering skills being the strong foundation for a PM are essential. Yet, the regulatory or QA aspects shouldn’t always be the primary specialization in all cases. I agree that those…   Read more»