I agree with srg36 only if the selection of a new supplier would hinder the progress of a project or manufacturing of devices. But I also agree with ks629 that sticking with the same supplier does not solve the issue. I believe this comes down to the amount of risk the team leader is willing to endure this decision because this does not meet the…[Read more]

I had not gone thru the experience yet however I would imagine that if the team is not adequately prepared as Hiren stated, then that could be difficult to overcome. The timeline will get pushed back if there is a reasonable justification as to why the schedule needs to be pushed back. If the deadline is critical to the business then the deadline…[Read more]

The rate of return is similar to Return on investment (ROI) in the sense that there exists an amount or percentage of money coming back to the investor(s). Factors that influence the rate of return include the current climate in the market, inflation rates, bank’s interest rates (as Agnieszka stated above), the speculation around which can shift…[Read more]

I agree with the above posts that Metrics are essential to showing progress on any project, action, task, etc. Metrics not only show the status but can reveal critical information about how for example, Quality Systems or KPIs are performing in the company. Management usually holds meetings called monthly metric meetings to discuss said metrics…[Read more]

From my experience, the project schedule is a pretty solid way to track progress and determine potential end date of the project. However I agree with Aasutosh’s list and as934 addition to that list. These components all make up the project status and directly impact the direction of the project. It is in the team’s best interest to show and…[Read more]

From my experience and as msc52njit-edu and srg36 have mentioned, missing project members due to other commitments may affect the schedule variance. This is because without one person or two, etc. each action item that the team members are in charge of will get delayed. The next time the action items will get worked on is when the person gets…[Read more]

I agree with everyone stated above that the project team should be open to communicating on a consistent basis. Communication is key because any issues that arise or may arise can be solved or addressed during meeting times instead of having it come up later towards the due date. I also agree with my colleagues that the project schedule should be…[Read more]

I agree with srg36 that the mentioned parts are very important in the project but are not the most important. I do however understand where rjs84 is coming from because if enough resources are not allocated to, for example, suppliers, then the materials used may be rejected heavily and create a slew of issues down the road. Also, if the vendors…[Read more]

Design Validation is a pivotal stage in the product development cycle. I have experience regarding process validation but not design validation. However, user needs need to be met because that is directly coming from the customer who is providing the insight and need for such a device with x functionalities. If a user need is not met then the…[Read more]

Communication is key to any project team. Therefore, it is part of the project manager to facilitate an open environment for expressions of any concerns. One should first schedule a meeting with the PM to discuss the issue and then plan accordingly. I believe from personal experience setting up a meeting or having face to face meeting is best.…[Read more]

Typically the Project Manager would be notified ahead of time if it’s for a personal leave. If its an unexpected leave, then the PM would need to accommodate and move dates and action items around to the remaining members of the team to meet deadlines. Now what this does is create more work for everyone. Good communication is essential in all…[Read more]

The planning phase is very crucial and dictates the direction into which the team will take to accomplish the project goals. Overlapping tasks and projects is a common thing that sometimes inescapable. Communication between teams and project leads is essential to meeting deadlines and not leaving any lingering action items. Planning for a project…[Read more]

In my company, one of the projects I am on closely resembles the second option. The second option is more relatable to a typical medical device product development cycle. One of the main problems is time. Assigned tasks or action items may get pushed back when members are bombarded with multiple priority tasks. This is also an issue of limited…[Read more]

Currently, I work with the Process Validation aspect of our Cardio Surgery devices where I validate test methods. Deviations from protocol do occur every now and then but it is best to avoid them at all cost. One deviation I am facing right now is the incorrect revision of the test method instruction in protocol. This occurred because a change was…[Read more]

Scheduling time for each person to complete assignments is definitely a bottleneck or can become one. One way to get around this is to schedule around the persons personal time off and have them approve of it. Another potential setback is shared resources. So on my team, several of us are on different teams so the project manager and leads have to…[Read more]

When I attended my first design review meeting, I did not participate much because my project lead and supervisor led most of the discussion. However, I had my validations and other documents prepared in case I was questioned on process or design related v&vs. One thing that did bother me was the lack of interaction from others who needed to…[Read more]

On a daily basis, I almost always refer to the project plan (gaant chart) to give me guidance regarding the project deadlines and other assignments. This is particularly useful because I see what my action items are and what steps I need to take in order to complete the assignment. Gaant charts also help organize due dates so assignments can get…[Read more]

Design review meetings at our company are very big in the sense that various members of several departments are invited. There, the project lead discusses the progress and changes in the device and asks for recommendations or is given feedback from other personnel. Meeting minutes are noted with actions established shortly after the meeting. It is…[Read more]

At Getinge, the engineers redline the latest version of the document depending on what changes need to be incorporated which can be given by various inputs of managers, personnel etc. From there, the engineer creates a change notice which contains the necessary approvers, attachments, and documents affected. The approvers attached to the change…[Read more]

Engineering change orders allow engineers and others to make changes to documents, parts, etc. Typically one or more potential changes are discussed in a meeting or in a brief conversation. Then the person who becomes responsible for making the changes needs to discuss the changes with the applicable departments to speed up the Change Request…[Read more]