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ashleyfitzsimmons replied to the topic "Inadequate Testing" – 5 years, 11 months ago
Online reviews of this book explain how Lenzer compares and contrasts pharmaceuticals with medical devices. Lenzer makes the claim that pharmaceuticals go through more testing than medical devices. Does anyone have an opinion on this statement from their experience? Also,… Read more»
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ashleyfitzsimmons replied to the topic "Inadequate Testing" – 5 years, 11 months ago
From reviews online, it says Lenzer has written about several devices that have been proven problematic. Investigative journalism can sometimes bring notice to problems that may be overlooked. For example, Lenzer makes a point, “So the FDA has a database… Read more»
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ashleyfitzsimmons replied to the topic "Interpersonal skills vs technical knowledge" – 5 years, 11 months ago
Through getting my bachelors degree at NJIT, I felt that my interpersonal skills have improved tremendously. Different experiences that improved my interpersonal skills included getting involved with clubs and organizations, being an the executive board of clubs and organizations, learning… Read more»
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ashleyfitzsimmons replied to the topic "Project Manager Skills" – 5 years, 11 months ago
Of course emotional intelligence combined with technical knowledge are important qualities in a project manager, as well as all of the qualities people mentioned above. To me, one of the greatest skills in a project manager are the ability to… Read more»
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ashleyfitzsimmons replied to the topic "Validation and Verification" – 5 years, 11 months ago
Verification and validation are one of a project’s largest costs. Rework is the only cost larger than verification and validation in a project. If it is not adequately planned, not only will the schedule have to be extended but the… Read more»
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ashleyfitzsimmons replied to the topic "A advertising a sum of its parts?" – 5 years, 11 months ago
I think that all of this definitely should, and hopefully is, going through medical device reporting to the FDA. In my opinion, spending money and time to re-test this device is not the responsibility of the company. I think a… Read more»
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ashleyfitzsimmons replied to the topic "Fitbit Medical Device?" – 5 years, 11 months ago
In correction to my last post, fitbit does not currently monitor blood pressure. However, what I wrote about applies to the physiological factors it does monitor such as heart beat. On the other hand, there are a lot of different… Read more»
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ashleyfitzsimmons replied to the topic "Meat without Murder" – 5 years, 11 months ago
In response to AnmolKaur, MDR is very important. If a medical device is resulting in deaths or injuries, it needs to be investigated and potentially taken off the market. After pre-clinical and clinical testing, even if a device is proven… Read more»
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ashleyfitzsimmons replied to the topic "Fitbit Medical Device?" – 5 years, 11 months ago
Class 1 devices are intended for devices that require general controls by the FDA. At home blood pressure monitors are considered a class 1 device. Although they are not intended to diagnose, people rely on these monitors to make sure… Read more»
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ashleyfitzsimmons replied to the topic "Interpersonal Skills" – 5 years, 11 months ago
As stated in Dr. Simon’s lecture, leadership is 30% academic and intelligence based and 70% interpersonal skills based. While I do not have experience in industry, I spent this entire past fall interviewing with medical device and pharmaceutical companies. I… Read more»
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ashleyfitzsimmons replied to the topic "Significant or non-significant risk" – 5 years, 11 months ago
In response to my last post, I found sponsor responsibilities after the significant risk (SR) versus non-significant risk (NSR) determination. If the IRB decides a study is SR, the sponsor must: Submit IDE to FDA Not begin the study until… Read more»
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ashleyfitzsimmons replied to the topic "Significant or non-significant risk" – 5 years, 11 months ago
I think to add to the discussion of significant risk (SR) versus non-significant risk (NSR) it is useful to read about the considerations that the FDA suggests to the IRB for SR and NSR determination. I got the below information… Read more»
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ashleyfitzsimmons replied to the topic What’s Your Motivator? in the forum Project Management Application: Clinical Trial 6 years, 11 months ago
For me, goals are what keep me motivated. When what I am doing aligns with my short term and long term goals, it makes me passionate about the work I do because it is helping me get to the places I want to be. Throughout college, I had times when I was volunteering and working multiple jobs at once while participating in clubs while taking about…[Read more]
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ashleyfitzsimmons replied to the topic Overworked Americans vs. Motivation in the forum Project Management Application: Clinical Trial 6 years, 11 months ago
I think that an interesting thing to add to this thread is that while many people put in extra hours to increase productivity, research shows that it can actually make you less productive. There are a lot of different studies and sources that discuss this. I attached the link of one for an example. According to the article attached, research at…[Read more]
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ashleyfitzsimmons replied to the topic Different PM techniques based on size in the forum Project Management Application: Clinical Trial 6 years, 11 months ago
Every project and team is unique. For example, certain projects may be straight forward and predictable while other projects are more complex and risky. These two different types of projects would have to be managed differently because of this. Likewise, different sized companies have different types of projects and different risk levels and…[Read more]
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ashleyfitzsimmons replied to the topic Designing effective Communication management Plan in the forum Project Management Knowledge Areas 6 years, 12 months ago
While an outline of a communication management plan documented as a SOP can be beneficial to keeping the entire company on the same page, I think it is also important to give the project manager leeway. The project manager should know their team best and understand the best ways of communication and frequencies of communication that makes the team…[Read more]
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ashleyfitzsimmons replied to the topic WBS Pitfalls in the forum Project Management Knowledge Areas 6 years, 12 months ago
A WBS should be a break down of every project task and deliverable defined by the project scope. If the WBS is poorly constructed the following can occur: missed deadlines, going over budget, scope creep, confused project team members, project replanning and extensions. A WBS is a way to visualize and organize the scope of a whole project. If this…[Read more]
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ashleyfitzsimmons replied to the topic Things to look for in a contract while selecting a supplier in the forum Project Management Knowledge Areas 6 years, 12 months ago
I think another thing that is important to address in a supplier contract is to clearly define responsibilities. For example, if something goes wrong with the product, is it the company or supplier’s fault? According to the FDA, the device company is responsible for every component, even if those components are from other suppliers. However, I…[Read more]
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ashleyfitzsimmons replied to the topic Unexpected changes to the Project in the forum Project Management Process and Medical Device Development 7 years ago
I think it is important to have some buffers in the schedule to account for any unexpected delays for any reason. The time frame and budget is set when a project is approved. It is better to overestimate the time and money needed for the project when getting approved. If the time and money is underestimated, the company may not have the resources…[Read more]
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ashleyfitzsimmons replied to the topic Closing Phase in the forum Project Management Process and Medical Device Development 7 years ago
One important component of closing is creating a project closure report. This project closure report lists every activity that is required in order to close the project. This report enables the project manager and the team to make sure they are completing every single activity required to close the report smoothly and efficiently. The project…[Read more]
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