To minimise the risk of delay, we need to know the finish date and work in the backward direction as studied in the lecture this week. The PM should know how much time each task requires in the process, taking…   Read more»

Risk/benefit ratio for a medical device manufacturers will be all the possible benefits of the device which would come along with a number of possible associated risks. These risks and benefits have to be reviewed and discussed at the starting…   Read more»

Since a milestone was missed it may have an impact on the entire project team and the various departments involved mainly the R&D. The PM will have to consider the more amount of time that will be needed to identify…   Read more»

Having the project team and risk management team would provide the ability to assess the risks associated with the project better and having a good overall sense of the project would allow the team to predict the outcomes/risks of certain…   Read more»

In my opinion, if the probability of risk is analyzed to be high then an analysis needs to be done about the costs involved in getting those risks eliminated. If the risks can be avoided within a small budget then…   Read more»

According to me the factors that can help detect the status of the project and allow us to have a rough estimate of the time frame about the project would be having timely progress and status reports which would result…   Read more»

Interpersonal skills is an extremely important aspect in order to be successful apart from having an equally balanced technical knowledge. Having an effective interpersonal skills can result in making you a good team player at work and help promote a…   Read more»

In my view the best way to have a design review approval faster is by sending in the documents well ahead in time to the review meeting attendees well in advance as Dr. Simon mentioned so that the attendees have…   Read more»

Project managers are found in almost all sort of organizations. The project manager is responsible for the tasks involved from the beginning phase of the project to the closure of a project which includes the planning, designing, execution and checking/controlling,…   Read more»

Initiating a project is definitely a crucial task as it in general clarifies the objectives of the project and what is needed to achieve those object and does not necessarily involve starting work on creating any of the products of…   Read more»

Verification and validation have an association but with some important differences.It is important to look into Verification and Validation in the early stages of design which is when developing required specifications for the product. Design Verification is a process that…   Read more»

As explained in the lecture videos of this week there are 3 types of organizational structures. First, the Functional Organization which has a dedicated team with members having shared skills and knowledge and this helps individuals for increased specialization. However,…   Read more»

Using an unapproved medical devices is allowed in a case where clinical trials are supposed to be submitted as claims for a pre-market approval (PMA) but with only a small group of people and with their approval. Apart from this…   Read more»

The FDA’s CDRH (Center for Devices and Radiological Health) follows a set of protocols to classify medical devices as class 1, class 2 or class 3 device depending on the risks involved with the device. Class 1 device are devices…   Read more»

I do agree that interpersonal and technical skills do go and in hand or as a ratio of 50:50. Lacking in one of these can have drawbacks. Having really good technical skills and not being able to get it to…   Read more»

Picking a good project management team is a crucial decision for a lot of reasons. The main is having the project completed on time successfully, having different ideas and working on them together with a clear goal. A team having…   Read more»

I feel that both interpersonal skills and technical skills are important at the same time to be successful this is because as an example as a BME engineer if you develop a device with your reasonably good technical skills and…   Read more»

I am currently not employed in industry nor do I have any industry experience, but I believe working in a project-based industry in the initial phase of my working career would give me a better understanding of various aspects of…   Read more»