The obvious benefits of a Gantt chart and their utility as a project management tool to map out who is doing what and when will they be doing it have already been explained quite will in the posts above. One thing that I wanted to add was the usefullness of the Gantt Chart to the project team members, not only the project manager. I reference the…[Read more]

I am curious about what is meant by “death by prioritizing and analysis”. The way that I understand this is that it is the issue of over-analyzing and giving to much priority (high risk level) to every risk, instead of just the major risks, resulting in delays for the risk analysis. While risk management is an ongoing process and is crucial to any…[Read more]

Scope Management is also important because of the delays that can be caused by scope creep. Scope creep is the continuous and uncontrolled growth of the project after the project has already been initiated. As a project manager, it is important to watch out for this because it can cause delays to your project. It is the project manager’s job to…[Read more]

Another source to use to identify risks is with complaint analysis. When your product reaches a customer and the product that they receive is not satisfactory, they will file a complaint. For example, it is possible that the product was damaged during transport. When the product is returned to the company, it can be examined and the ways in which…[Read more]

The concerns that have been brought up in this thread make a good argument for the importance of test method validation. It is important to make sure that the testing that is done is in fact adequate for verifying the test criteria. While Lenzer brings up concerns with having sufficient clinical evidence, there is a lot of bench-top testing that…[Read more]

The FDA has a program called the Humanitarian Device Exemption (HDE) Program which allows for medical devices intended to benefit patients in treatment or diagnosis of a disease or condition that affects fewer than 8,000 individuals per year. Since conditions like this are hard to gather enough clinical evidence to meet FDA standards, this…[Read more]

The difference between verification and validation is well explained by considering the question that each is trying to answer. Verification answers the question, “Did we make the device right?” while validation answers the question, “Did we make the right device?” Both are very important in the process of device development. The challenges that…[Read more]

In addition to the project team, stakeholders within the company also include people who are not working directly on the project but who will be affected by the outcome of the project. For example, rather than being tasked with coming up with a new device, a project team could be tasked with finding a way to improve an existing device in order to…[Read more]

Currently I am working at a company that has traditionally been structured as a functional organization. Employees work on a project within a department, and report to the manager of that department. However, there is a very open environment and good communication between departments. In other words, if one department needs something from another…[Read more]

In response to krp67: Is there “generic form” that you proposed a suggestion that the regulating body for medical devices should be a global organization? Or is your suggestion that a company’s documentation should be formatted in such a way that it is compliant for all major regulating bodies throughout the world?

I do not think that a global…[Read more]

As has already been stated in the posts above, Regulatory Compliance is a tedious, expensive, and lengthy task which can prove to make the engineers’ job full of obstacles and headaches in order to make sure that a new product is compliant with FDA standards, and that products already on the market remain compliant. With this task it is the…[Read more]

As rjs84 said in their response, the company’s highest priority needs to be maximizing profit. If you cannot sell a product, then you will not be able to fund development. With this in mind, a major determinate of project priority can come from audits. Whether done internally, by a consulting group, or by a regulating body, audits will point out…[Read more]

The company that I currently work at is quite proficient with project management. It has a dedicated project management office with several project managers. Projects are ranked in priority, and the status of the highest priority projects are regularly reported to the executive board.

For things like timelines, the software that is primarily…[Read more]

Parth brings up a very good point. Interpersonal skills are not just people skills, they are crucial communication skills that allow you to convey effective ideas to the people that you work with. In an office setting, this can be done face to face. However, if you work at a larger company or a worldwide corporation, then you may not get the…[Read more]