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 of the project proposal and during clinical trials. A negative result during these clinical trials will…[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 the problem and fix it by understanding the reason causing the problem and identifying based on this problem how many other tasks…[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 changes/modifications that would impact the other areas of the project. But this would also lead to a pressure…[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 the project can go ahead after the elimination of the possible risks. However, if the risks involved are severe and cannot be avoided…[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 in having an effective communication, having a good support to the team from the organization depending on the progress made.…[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 positive working environment. In my view communication, cooperation and the ability to understand…[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 well enough time to review the necessary details and have an overview of the changes needed to be made and know what would be the topic…[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, cost and time estimates and management. Speaking of which the term project manager…[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 the project. You may not exactly know what the project is going to do but one should have sufficiently enough idea 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 checks if the output conforms with the input and verification is conducted…[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, any changes made by any of the other departments would affect the work of the…[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 if the physician knows that the device is capable of curing a life-threatening disease then it should be used with…[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 that do not have any associated risks with it and hence and are exempt from premarket notification 510(k) while class 2…[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 your team when working as a team project would have a bad impact on the outcomes of the project. On the other hand lacking the necessary…[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 a good amount of understanding about each others ideas is what is needed. Having a team leader and coming to…[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 are not able to gain the confidence of the market which will come with considerable amount of your interpersonal skills…[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 working with a project group and help me learn new things which I may not be so good at. Having worked in groups for…[Read more]