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djr32 started the topic In the Shoes of a Project Manager in the forum Project Management Process and Medical Device Development 8 years, 7 months ago
In last week’s lecture, we learned about the term Work Breakdown Structure (WBS), which a hierarchical breakdown of tasks performed for the project and we learned about the importance of a Gantt Chart.
Suppose you are the project manager in charge of this week’s simulation. As a project manager, how would you break down the tasks performed for…[Read more]
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djr32 started the topic Revising a Gantt Chart in the forum Project Management Process and Medical Device Development 8 years, 7 months ago
In 2015, the FDA approved the ReShape Integrated Dual Balloon System. This is a device that is a weight-loss system of a gastric balloon that occupies in the stomach. The system consists of two attached balloons that are filled and sealed separately. The device works by taking up space in the stomach, which makes the patient fill full and thereby…[Read more]
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djr32 started the topic Missing a Milestone Experience in the forum Project Management Process and Medical Device Development 8 years, 7 months ago
This week we learned about the importance of a Gantt chart and how it allows project managers to highlight the critical path of a project.
Think of a project that followed a specific Gantt chart. Share a time when you missed a milestone and how did your team explain this missed milestone to the project manager or professor. What did you and your…[Read more]
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djr32 started the topic Experience Breaking Down A Project in the forum Project Management Process and Medical Device Development 8 years, 7 months ago
In this week’s lecture, we learned about the term Work Breakdown Structure (WBS), which a hierarchical breakdown of tasks performed for the project.
I have not yet had the opportunity to work in industry, but I did take part in many projects at NJIT. One of the projects was my capstone project, AudiQ. Unknowingly, we applied the broke down the p…[Read more]
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djr32 replied to the topic Risk Management in the forum Project Management Process and Medical Device Development 8 years, 7 months ago
A medical device is my capstone project, AudIQ, which is a mobile application that trains people with hearing aid’s auditory cues. One possibility of risk of the product is the application does not control the level of sound it outputs when training. This risk can be detrimental to the user because an app that is meant to help someone’s hea…[Read more]
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djr32 replied to the topic Discussion Topic: The critical path in the forum Project Management Process and Medical Device Development 8 years, 7 months ago
A time when an extraneous task suddenly wound up on the critical path for the project is the discovery of Scotchgard stain repellent. Patsy Sherman, a researcher, who worked at 3M company as a chemist was assigned to work on fluorochemicals to develop a new kind of rubber for jet aircraft fuel lines. An assistant had accidently spilled a bottle of…[Read more]
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djr32 replied to the topic Discussion Topic: Design and Process Verification in the forum Project Management Process and Medical Device Development 8 years, 7 months ago
Verification means to check if the inputs and outputs are equal to each other and to verify each output with a verification protocol. To an extent, it is a rigid rule that Verification takes place during the execution phase of the project. The reason is that it would become costly if verification occurred at other processes because design control…[Read more]
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djr32 started the topic LifeVest Wearable Cardioverter Defibrillator in the forum Introduction to Project Management 8 years, 8 months ago
Zoll LifeVest is a wearable cardioverter defibrillator to monitor and treat dangerous abnormally fast heart rhythms. These abnormal rhythms can lead to a complete absence of heartbeat and death if not treated. Thus the LifeVest treats abnormal rhythms by applying a high energy shock similar to that of a traditional defibrillator.
What FDA class…[Read more]
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djr32 started the topic General Wellness Product in the forum Introduction to Project Management 8 years, 8 months ago
According to the FDA, general wellness products are “(1) intended for maintaining or encouraging a general state of health or a healthy activity or (2) an intended use that related the role of a healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions.” The Center of Device and Radiology Health def…[Read more]
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djr32 started the topic Fitbit: A Medical-Grade Device? in the forum Introduction to Project Management 8 years, 8 months ago
Fitbit is a consumer product that has the intention of tracking one’s daily fitness, heart rate, and blood pressure. However, there are people who filed a lawsuit against this company. The plaintiff David Urban bought a Fitbit PurePulse Tracker to monitor his heart rate while training for the marathon. Since Urban had a family history of heart d…[Read more]
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djr32 started the topic Toxic Medicine in the forum Introduction to Project Management 8 years, 8 months ago
In the article, FDA: Toxic Belladonna In Homeopathic Teething Product, the FDA found that Hyland’s homeopathic teething products had belladonna, which is a toxic chemical, a level far exceeding the amount claimed on the label and asked the Standard Homeopathic Company in Los Angeles to recall its product.
What design controls would this company h…[Read more]
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djr32 started the topic Experience with Design Control in the forum Introduction to Project Management 8 years, 8 months ago
From this week’s lecture, there are multiple steps in a project cycle. Describe a time when you took part in a project in industry or in school. What design controls did you take part in the project? Was your experience with a specific design control you worked in similar to what is described in the lecture? Do you think these 9 design controls a…[Read more]
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djr32 started the topic Initiating a Project Idea in the forum Introduction to Project Management 8 years, 8 months ago
From the lecture, there are 9 parts to design controls. Why is initiating a project idea the hardest part of project development? How does business and market research play an important role when initiating a project idea? What are some ways people with a project idea that they think are worth wild can convince their company or others to fund the project?
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djr32 replied to the topic Combination Products in the forum Introduction to Project Management 8 years, 8 months ago
The necessary regulation to get FDA approval of a combination product is first the company has to request for designation (RFD), in which companies have to outline the rationale of the product. Then, the company has to submit the “pre”pre-investigational device exemption(“Pre”pre-IDE) and the pre-IDE are regulatory meeting. The pre”pre…[Read more]
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djr32 started the topic Meat without Murder in the forum Introduction to Project Management 8 years, 8 months ago
A Brooklyn startup company, Modern Meadows, has a technique to develop meat without killing any animals. The process they use to make this meat is by incorporating fetal bovine serum, which is the blood drawn from the fetus of a pregnant cow, usually collected by puncturing the heart. Moreover, if the in vitro meat were on sell today, a pound of…[Read more]
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djr32 started the topic Mobile Medical Applications in the forum Introduction to Project Management 8 years, 8 months ago
When you open your Google play store or Apple Store, you can find an app for everything, even things related for medical purposes, such as an app that measures blood pressure.
Moreover, the FDA has regulation for apps that are considered “mobile medical apps”. The FDA says that “mobile medical apps” is a mobile app that is intended “to be used as…[Read more] -
djr32 started the topic Mobile Medical Applications in the forum Introduction to Project Management 8 years, 8 months ago
When you open your Google play store or Apple Store, you can find an app for everything, even things related for medical purposes, such as an app that measures blood pressure.
Moreover, the FDA has regulation for apps that are considered “mobile medical apps”. The FDA says that “mobile medical apps” is a mobile app that is intended “to be used as…[Read more] -
djr32 replied to the topic Discussion Topic: The 510k Process in the forum Introduction to Project Management 8 years, 8 months ago
One of the critiques the IOM said about the 510 (K) process was that it lacked the legal basis to be reliable of the safety and effectiveness of moderate -risk class II devices. The reason why the 510(K) lack safety and effectiveness is because of its reliance on “substantial equivalence”. The IOM believes that relying on the substantial equ…[Read more]
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djr32 replied to the topic Discussion Topic: State of your Organization in the forum Introduction to Project Management 8 years, 8 months ago
The kind of organization I feel that I would be most suited for is project-based one, which an organizational structure when a company’s department and personnel are organized around a particular project. One of the main reason is that I enjoy working on a project from scratch and build up because it involves coming up with a solution to a g…[Read more]
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djr32 replied to the topic Discussion Topic: Projects of all types in the forum Introduction to Project Management 8 years, 8 months ago
I think project management differs in different industries is in terms of regulations involved on a project. For instance, projects in the biomedical industries need to take into consideration the FDA regulations, such as 510(K) clearance. While construction site has to fulfill safety and health regulation established by Occupational Safety and…[Read more]