Activity | nicoleb | Medical Device Courses

nicoleb replied to the topic "Interpersonal Skills" – 5 years, 10 months ago

I am a firm believer that interpersonal skills are crucial in order to succeed in a professional setting. I think that one of the easiest ways to develop these interpersonal skills is by using social media, specifically, linkedin. While a… Read more»
nicoleb replied to the topic "Your Ideas about How to prepare/write a Successful Project Proposal" – 5 years, 10 months ago

I believe that a good project proposal should include the market gap which you are trying to target with your product. Today’s technology develops incredibly fast, and because of this, there is a device to meet almost any need. However,… Read more»
nicoleb replied to the topic "Determining project priority" – 5 years, 10 months ago

This is a very interesting topic, as I personally had never imagined projects being outright cancelled due to low priority. In all honesty, I do not see any reason why there should be a cancellation of projects, no matter what… Read more»
nicoleb replied to the topic "Flaw in the design process" – 5 years, 10 months ago

The FDA has regulations in place in order to protect the general public. Therefore, the design process of a product is crucial to its success. I believe that in order to ensure a flawless design process the most important step… Read more»
nicoleb replied to the topic "Unapproved Device" – 5 years, 10 months ago

Using an unapproved medical device seems to me like an ethical issue. If the device fails the patients health could be put at greater risk. If the device is not given a chance the subjects health might also deteriorate. Modern… Read more»
nicoleb replied to the topic "Funding in Medical Devices Industry" – 5 years, 10 months ago

This is a very interesting question that most likely has no correct answer. My personal opinion lies within the nature of the product. I think that often times the use of the project is overlooked when considering going through with… Read more»
nicoleb replied to the topic "Project management team" – 5 years, 10 months ago

I believe that picking the project team is a crucial step towards the success of a project. As people have stated above, there has to be cohesiveness from a technical and interpersonal standpoint in order for the project team to… Read more»
nicoleb replied to the topic "Update to Classification System" – 5 years, 10 months ago

I believe the system is fine as is. During this weeks mini-sim i chose the bluetooth connected glucose meter and pump. Although there has not been a device like this on the market, you can think of this as a… Read more»
nicoleb replied to the topic "Should Interpersonal skills be more valuable than technical skills?" – 5 years, 10 months ago

I think that overall interpersonal skills are just as valuable as technical skills. I do not think that anyone is capable of doing everything on their own. By default this means that everyone needs help at one point or the… Read more»
nicoleb replied to the topic "Safety Recalls" – 5 years, 10 months ago

I think that a recall on a product with a faulty label depends on the product itself. For example, makeup products have ingredients that have to be approved by the FDA, if a makeup product has a faulty label I… Read more»
nicoleb replied to the topic "Discussion Topic: State of your Organization" – 5 years, 10 months ago

I do not currently work in industry, and unfortunately during my undergrad I did not get any internship opportunities. I did however shadow an orthopedic surgeon during my time as an undergrad which provided me some direct insight into how… Read more»
nicoleb posted a new topic "Design Review Meetings" – 5 years, 10 months ago

In this weeks lecture Dr. Simon mentions design review meetings which happen at the end of every design stage in order to be able to move to the next stage. In this class we have also learned that staying on… Read more»
nicoleb posted a new topic "Possibility of Global Regulation of Medical Devices?" – 5 years, 10 months ago

When we met with Dr. Simon in person for the introductory class a portion of the time we spoke about Europe’s new regulatory system, and how it has dethroned the FDA as the “big dog.” My question is, do you… Read more»
nicoleb replied to the topic Sponsorship for companies in the forum Project Management Application: Clinical Trial 5 years, 11 months ago

Business sponsors are a very valuable resource that companies have. Therefore, the relationship between business and sponsor must be a strong one. The relationship mainly revolves around the first stages of project development since a sponsor is deciding on how much money to give, aka the budget of the project. Once this is done the sponsor works…[Read more]
nicoleb replied to the topic How was this class helpful in the forum Project Management Application: Clinical Trial 5 years, 11 months ago

I am at a point in my life where I am about to graduate and seek job opportunities. So i feel like currently this class gave me the knowledge i need to find a project manager i would enjoy working under. In other words i now know how to find a good project manager. In the future i feel like this class will have given me the tools to become a good…[Read more]
nicoleb replied to the topic Why do people leave work? in the forum Project Management Application: Clinical Trial 5 years, 11 months ago

I agree with the overall consensus of the class that says that at first it is easy to receive praise because you are new and upper level management will be impressed by you. Once you set a standard of work for yourself this praise will decrease as your superiors will be used to the work you do. I feel like this is something that will happen…[Read more]
nicoleb replied to the topic Engineer vs. Manager in the forum Project Management Application: Clinical Trial 5 years, 11 months ago

I would personally decide to stay as an engineer. Being a manager requires a lot of organizational, leadership, and people skills. I am not sure that I would enjoy having to deal with those things. I would much rather stay an engineer and not have to deal with the heavy consequences a manager deals with if a project goes awry.
nicoleb replied to the topic Why do people work? in the forum Project Management Application: Clinical Trial 5 years, 11 months ago

My personal motivators for why I want to pursue my career is that I want challenging work that makes a difference. I also want stability, both financially and in my career. I believe that what motivates one to work is very personal to each person and can not be encompassed in a multiple choice question study. Which explains these results. I do not…[Read more]
nicoleb replied to the topic Let's Be Motivated!!! in the forum Project Management Application: Clinical Trial 5 years, 11 months ago

I think that the main way that a project manager can motivate their team is by being passionate about the project they are working on. I think that this can be achieved by only managing projects that one is truly excited about. By leading a project that one is excited and passionate about you can one find individuals to work on your team that…[Read more]
nicoleb replied to the topic Sucess Factors in the forum Project Management Process and Medical Device Development 5 years, 11 months ago

I agree that all these factors are important for project success. Primarily, everyone in the project should be able to agree on the project goals. This is important because that way there is no discrepancies of some project members saying more or less could have been done. Communication is crucial in all aspects. From being able to build…[Read more]
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