An interesting perspective that can be overlooked is how individuals who never interact with the project can still be a stakeholder since they are integral to being affected as a general byproduct of the project. For instance, when it comes…   Read more»

As mentioned, estimation failures can be detrimental in the planning phase of a medical device since they can disrupt budgets and timelines but also the confidence of stakeholders. Compared to general engineering projects, medical devices have to meet strict verification,…   Read more»

A PM has the responsibility to balance FDA expectations, shareholder pressures, and consumer needs. The way they may tackle these objectives is by prioritizing regulatory compliance and patient safety above all while managing cost, risk planning, timelines, and communication. The…   Read more»

An essential difference when it comes to constructing a WBS for medical devices is that it should be built around regulatory readiness as an ongoing process instead of a final step. In a general engineering project, compliance and testing usually…   Read more»

I agree, a certification can be complementary to a degree, especially for a PM. However, I would argue that it is also a representation of how much resilience a PM can have through the changes and fast developing technologies that…   Read more»

I agree with Krish, a DHF is evidence that the developed device meets regulatory requirements. I would like to add a different perspective as well. It is also worthwhile to question if a DHF is actually the PM’s major deliverable…   Read more»

As others have mentioned, a methodology for design review can be crucial when assessing changes from a completed project. A perspective that can also be considered is the importance of decision structures. This structure can relate to distinguishing between a…   Read more»

Another impact to organizational structure that can be considered, it how accountability and making decisions can speed up a project, especially when there are technical risks and challenges that arise. In some instances, there can be weak functional decisions where…   Read more»

A new concept that can be discussed is design controls and regulatory documentation and traceability when animal data affects the product’s timeline. In a Class III medical device like the bio-absorbable stent, since the dissolution rate can be directly caused…   Read more»

In development lifecycle of a medical device, one aspect that hasn’t been discussed is how the development life cycle affects verification and validation. As mentioned, development lifecycles can be predictive however, there can be unpredictable setbacks that can lead to…   Read more»

I agree with the standpoint on how a DHF should be an evolving document. It is also crucial to take into consideration that a DHF is not only an evolving document for regulatory record keeping, but it is also a…   Read more»

From the responses, I see that many focus on the significance of the Check and Act phases of the PDCA cycle, which is valid. However, I would like to emphasize that the plan phase is just as valuable since it…   Read more»

Regulatory and post market efforts are essential to a medical device’s product life cycle. I would like to add onto what Ehab mentioned; another point of view to consider is how collaboration of interdisciplinary roles impacts product life cycle. Devices…   Read more»

Building off of what Ehab mentioned as to how PM should have an understanding of FDA requirements and maintain involvement in project development. It is also essential to include another strategy such as implementing a system that is able to…   Read more»

One perspective that can contribute to meeting deadlines is utilizing a decision based milestone plan tied to FDA risk thresholds with a range in timeline rather than having designated dates. In terms of Class II and Class III medical devices,…   Read more»

Once a product is in the post-market phase, a project manager’s role changes from developing to ensuring that the product maintains continuity, which involves coordination and an organized approach to learning, therefore preserving the development phase. Instead of focusing on…   Read more»

Interpersonal skills are essential to PM than technical skills as a Vansh Amin points out and are required for facilitating collaboration. However, for these efforts to be established it is vital for a PM to have the trait of prioritizing…   Read more»

I’ve encountered situations where there was friction between problem-solving initiatives. An effective approach that can be considered is utilizing a more structured and stakeholder aware problem solving approach to address interpersonal conflict. Especially in medical devices when the individuals that…   Read more»

Although it can be agreed upon that most project managers are not required to have a deep level of understanding in technical projects and their expertise can be shown in regulatory disciplines, it is essential to acknowledge that medical device…   Read more»