-
nicoleb replied to the topic Team Development in the forum Project Management Process and Medical Device Development 5 years, 12 months ago
I think that the planning process should be done in a way where vacation and certain absences from employees will not derail the timeline. What I am saying is that there should be some cushion for employees to be absent, even unplanned absences. For example, for an employee with children it should be taken into consideration that kids get sick.…[Read more]
-
nicoleb replied to the topic Gantt chart in the forum Project Management Process and Medical Device Development 5 years, 12 months ago
Gantt charts are not done for processes like design verification where one task must be completed before moving on to the next. Instead, they are mainly utilized for scheduling parts of the project that can be going on simultaneously. Therefore, you can have tasks in different categories going on at the same time.
-
nicoleb started the topic Design Review Meetings in the forum Project Management Process and Medical Device Development 6 years 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 track with the timeline is crucial in project management. For those of you who work/have worked in industry. Have you ever had any instances…[Read more]
-
nicoleb replied to the topic Design verification vs design validation in the forum Project Management Process and Medical Device Development 6 years ago
I think a good way to really tell verification from validation apart is to think as verification as the theory and validation as the practice. Verification of a device begins with the idea of a project. While validation happens once the project is already produced and it is time to test if it really works.
-
nicoleb replied to the topic Overlapping activities in the forum Project Management Process and Medical Device Development 6 years ago
The planning phase of a project is very important, it details where the project is headed. Without a proper plan a project will not have adequate direction and may fail. However, the phases of a project in industry, are most likely not as defined as they are in our class. What I mean is that there is probably some blending together of the phases.…[Read more]
-
nicoleb replied to the topic Challenges PM face in the forum Project Management Process and Medical Device Development 6 years, 1 month ago
I think that a challenge a project manager would face, especially with longer term projects, would be how to keep a professional atmosphere. I bring this up because if you are going to be working with someone on a project for an extended period of time, it is difficult to just keep conversation to just work related stuff. Forming friendships, I…[Read more]
-
nicoleb replied to the topic Importance of Logging Work in the forum Project Management Process and Medical Device Development 6 years, 1 month ago
Working on my capstone project this year, logging in work has been crucial to our success. The project involves both hardware and software that need to work together in order to function. Therefore, the group members working on software must keep an accurate log of what they are doing in order for the group members working on hardware to be able…[Read more]
-
nicoleb replied to the topic Most Important Phase in the forum Project Management Process and Medical Device Development 6 years, 1 month ago
I believe that the most important phase of a project is at the end when it is truly tested whether or not the project is successful. What I mean is that if at the end of the day your project yields a product that does not sell, does not work, etc. Then all the steps in project management were essentially a waste.
-
nicoleb replied to the topic Are Missed Milestones really Bad? in the forum Project Management Process and Medical Device Development 6 years, 1 month ago
I think that answering your question is very dependent on the situation, and ones personal perspective.
For example, if a team misses a milestone due lack of preparation and negligence. What I mean to say is due to a lack of preparation. Then this is most definitely not a ” link to future success” . This is simply a failure, a misuse of company…[Read more] -
nicoleb replied to the topic Estimating Project Timeline in the forum Project Management Process and Medical Device Development 6 years, 1 month ago
Personally, I do not believe it should be too difficult to design a time line. Of course there will be challenges, but for the most part there should be some sort of precedent where a team can look and devise an accurate time line. Also, a good rule of time is to add time on a task that might be more difficult because it is always better to…[Read more]
-
nicoleb replied to the topic Unexpected changes to the Project in the forum Project Management Process and Medical Device Development 6 years, 1 month ago
I have not worked in industry but I am currently working on my senior capstone project where we are developing a device and mimicking how the process would occur in industry (having status meetings, design reviews, etc.) My group and I have done a really good job at being realistic with our customer and our advisor about the design expectations,…[Read more]
-
nicoleb replied to the topic Unexpected Time Delays – miniSim in the forum Project Management Process and Medical Device Development 6 years, 1 month ago
I think a cost-benefit analysis is important to answer your question. Will the risk cost the company more than it will benefit it? Or vise-versa? If the benefit is greater than the cost than the risk should be taken due to the higher expected benefit.
-
nicoleb replied to the topic Risk Management Team in the forum Project Management Process and Medical Device Development 6 years, 1 month ago
You bring up a really good point where you say that a project leader or risk leader develop a strong connection to the project, and therefore continue on with something that is too risky. I think that this a very valid scenario, and even though it might not occur often, when it does happen it might be detrimental to someones career or a company. I…[Read more]
-
nicoleb replied to the topic Inputs for Design Input Document in the forum Project Management Process and Medical Device Development 6 years, 1 month ago
I believe that design input should generally be managed by the marketing team, this is because these individuals have the knowledge to know what is in demand, and therefore will design a product that will sell and make money. However, although the marketing team has to set the design needs, it is the job of the engineering team to report back and…[Read more]
-
nicoleb replied to the topic Interpersonal Skills in the forum Introduction to Project Management 6 years, 1 month 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 lot of people might not realize, social media and the internet are very present in todays society. This…[Read more]
-
nicoleb replied to the topic Your Ideas about How to prepare/write a Successful Project Proposal in the forum Introduction to Project Management 6 years, 1 month 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, just because a device exists it does not mean that it fills an entire market, therefore, it is important to find…[Read more]
-
nicoleb replied to the topic Determining project priority in the forum Introduction to Project Management 6 years, 1 month 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 the priority. I believe that this indicates poor management in a company. From the initial “pitch” of a project, if…[Read more]
-
nicoleb replied to the topic Flaw in the design process in the forum Introduction to Project Management 6 years, 1 month 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 is to create a team with the necessary expertise to create this design process. This is where technical ability surpasses…[Read more]
-
nicoleb started the topic Possibility of Global Regulation of Medical Devices? in the forum Introduction to Project Management 6 years, 1 month 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 think that the medical community as a whole is moving towards globalization of regulatory procedures? If so, will this be beneficial or…[Read more]
-
nicoleb replied to the topic Unapproved Device in the forum Introduction to Project Management 6 years, 1 month 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 medicine can be seen as advanced, what I mean is that there are a plethora of different treatments available for…[Read more]
- Load More