Human resource management is extremely important. I recently started working for a new company and HR is in charge of finding the best fit for open positions. It seems that some of the operators/technicians that were hired were not a good fit which really impacted our production in a negative way. The operators who do not deliver either quit or…[Read more]

I would say that a company should have a communication management plan and document it as an SOP. It should be a broad plan though and include what every communication plan would have. So with different projects, the team should make sure they follow this SOP and add on anything specific to their project. I think a controlled document like an SOP…[Read more]

Adding on to what as934 said above, a good contract should also include quality criteria, clarification of ownership, defined deliverables and review period, and any changes (as as934 listed above). From previous experience, usually a supplier will have one thing even if it small that will distinguish it from another supplier when choosing between two.

I currently work at an orthopedic company. We recently had to make an update to insert a class III PMA logo for all level III medical device. Since I had to go through several devices, I did not want to ask my manager about each one and tried to figure them out myself. I actually found the FDA website to be useful, it has a section on how to…[Read more]

These factors each contribute to the success of a project. For example, if a team is unable to effectively communicate than the project will not be done at a mannerly time and it would be difficult to coordinate roles and jobs. I recently finished a project, that involved working with another department. There was no effective communication…[Read more]

Adding on to what bnb6 said above, I looked up some metrics that would be beneficial for project management. The first one is productivity, this compares the total effort to the budgeted effort. The second one is cost. The third is quality and satisfaction. Next is gross margin which is the difference between total income achieved and total costs…[Read more]

To start off, the monitoring and control phase of “…the project management process consist of the activities involved to observe the process after project implementation, identify problems and risks, and deploy a mitigation strategy to control new processes”. Planned value and actual cost matter in both phases because it allows the team to…[Read more]

I was recently part of a small project at work which involved me figuring out a solution for an audit finding they recently had. I spent a while working on the solution, looking for and putting codes together until it worked. I also had to contact a lot of people, change a part, and work on validations. In the end my team decided to go with a…[Read more]

The most important thing that must be done between team member’s is communication. Changes to the timeline can be avoided if team members are constantly communicating whether via text, calls, emails, or in person. I agree with ial4 that if Patty spoke with Dr. Derek Malekai before coming up with the timeline than this whole issue could have been a…[Read more]

During the process of developing a team, absence and vacation time should be discussed with each employee. If they are unable to be present enough to get the project done by the deadline, the team member should be replaced accordingly. If a member has a family emergency that is out of their control, the work should be distributed or a temporary…[Read more]

It is important that inputs are equal to user needs or intended needs. “Successful design validation can only occur if the user needs and intended use have been well defined at the very beginning of the design and development phase. One of the major reasons for product failures over the years has been the inability of devices to meet the user a…[Read more]

Expanding on what Aasutosh said above, the primary mode of action (PMOA) is a significant process because it determines the regulatory and product development framework. A PMOA is determined by asking these 2 questions, “what is the device’s MOA?” and “what is the drug’s MOA?”. So if it is determined from the PMOA that a drug is involved th…[Read more]

As a project manager of this project, the first thing that must be done is to layout each possible method. The next step is to do extensive, in-depth research of each method. This is an extremely important step because it can help avoid wasting time doing experiments that will end up failing. This was an issue our group had as well since midway…[Read more]

Communication is extremely important for a successful outcome. Each member of a team should know that they must communicate if they have any issues where they cannot make the deadline. If you have a unresponsive member, the first thing you must do is to reach out to them through e-mail or by phone. If that method fails, the PA should personally…[Read more]

So for a basic understanding of Garntt Chart, it illustrates project schedules such start/end dates of activities, important activities, and more. It is useful in the medical device field because this chart can constantly be updated, it provides a simplistic view of phases in the planning process. It can also indicate critical points in the plan.…[Read more]

I agree with Parth that planning ahead is important to avoid this type of pitfall. During these weekly meetings, they should set a goal for what should be done and make sure they meet it. So if a person mentions they will be going on vacation or if there is a holiday, during the weekly meeting they can discuss what work they need to get done…[Read more]

User’s needs is indeed an important topic to be discussed in the planning phase of a medical device project. A question that should be answered is: what questions should be considered when talking about user’s needs? I will list three main questions. The first one is who will use the medical device? The next one is how will users/patients int…[Read more]

The stages of the Engineering Change Order are 1) Issue Identification and Scoping, 2) An engineer change request is created, 3) the engineer change request is reviewed, 4) The engineer change order is created and reviewed, 5) the change order circulates to each department, 6)if approved the change is implemented. The benefits of the ECO is that…[Read more]

If I was a PM running a Risk Management meeting, I would, as most mentioned above, get everyone attending the meeting to be familiar with ISO 14971. I would start by getting everyone to identify the possible risks. The next step would be to evaluate and address these risk. We would speak about the risk that may be possibly present throughout the…[Read more]

At my company, the engineers also must redline the change they are making to the document. This is done online using microsoft’s track change. The newly edited document is than printed as a hard copy. If the newly edited document is checked as PMA, it is sent to someone from the headquarters of the company to approve. After it is approved, a p…[Read more]