Incorporating slack into a project timeline/schedule is critically important. I’ve learned in school and at work that in any project, anything that can go wrong will go wrong (A little something called Murphy’s Law). Slack is something to help prevent…   Read more»

I completely agree with @ridmehta , I would also argue that time is more valuable. @ridmehta raises a great point by discussing how cutting corners and getting a project done quickly can ultimately become more costly in the long term…   Read more»

In my experiences working in projects, I have found Gantt charts to be very useful in helping to visualize timelines and tasks, and for identifying critical path items that need to be completed. I’ve worked on several projects where the…   Read more»

I agree with pv223, transference is not a feasible risk management strategy in the medical device/pharmaceutical field. Like pv223 mentioned, avoidance and mitigation are the two primarily used strategies with mitigation being preferred. In Dr. Simon’s medical device development course,…   Read more»

In my career so far, I’ve only ever worked at a large company. Since the company is very big, there are teams dedicated to very specific things (Exactly like you and Dr. Simon mentioned). To me, this question boils down…   Read more»

I don’t have too much experience working or knowledge in medical device companies to say which organization approach is most common. However, from my experiences I have noticed Matrix-based organizations to appear more frequently in major medical device companies. I…   Read more»

I prefer to work for bosses/project managers that take a more hands-off approach. Personally, I think this allows project team members more autonomy in their work and reduces pressure. As long as the project team members are able to accomplish…   Read more»

I don’t think there is one “essential” design control. Design control is an essential process that guidelines how to create a safe and effective medical device, so each step in the process is essential in achieving that. Each of the…   Read more»

Personally, I enjoy working in a larger project team. As you’ve said, “people can have different backgrounds and areas of expertise” and I think that really adds value when working in a project-setting. The biggest advantage is that these different…   Read more»

I think the most important management skill to grasp is understanding conflict. There are 2 types of conflict: Relationship-based and Task-based. Relationship-based conflict is when a person is disagreeing with another person, for example personal attacks, “People vs. People”. Task-based…   Read more»

Posted by: @ajy6 Product development and post-market management are the two major functions of the regulatory department. Out of the two, which one would you want to work for and why? Also, which one seems to be the most important. …   Read more»

Some major advantages of grouping projects under a program include sharing/leveraging resources, personnel, and project capital, as others have mentioned. Another major advantage that I have noticed from the programs where I work is that similar projects can allow a…   Read more»

One particular skill that helps me keep projects on track is strict time management. Not only is it important to have the timeline set and agreed upon early in the project initiation & planning phases, but it is also critical…   Read more»

I agree with @cassiem , I think that the projects that interest me the most are difficult and complex projects. Difficult projects allow you to push outside your comfort zone and achieve things you may have thought you were not…   Read more»

I, personally, have never worked with consultants in the Medical Device industry. However, I do think consultants can be a very useful tool. One area I think that consultants can be of use, in particular, is the supply chain. Specifically,…   Read more»