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»