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hzy2 replied to the topic "Medical Device SWOT Analysis" – 5 years, 10 months ago
I am choosing J&J to do a SWOT analysis. Strengths They provide to three different segments: consumer products, pharmaceuticals and medical devices. This helps them have a higher presence in the market compared to some other companies that provide only… Read more»
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hzy2 replied to the topic "Partnership characteristics" – 5 years, 10 months ago
Yes, I would definitely consider doing a partnership in the future. Partnerships are a great way to do business when you have family members or friends that you want to work with. It comes with many benefits including not having… Read more»
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hzy2 replied to the topic "Public vs. Private Companies" – 5 years, 10 months ago
One major difference between publicly and privately held companies is the way they deal with public disclosure. A public company has to reveal everything quarterly and annually to the SEC who reviews this information. The company has to hire accountants… Read more»
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hzy2 replied to the topic "Types of Corporations" – 5 years, 10 months ago
If I was to have ownership of a business, I would most likely choose to go with the limited liability company option. This form of business allows the owners or partners to minimize their personal liabilities while giving them all… Read more»
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hzy2 replied to the topic "Relation of Quality with other department." – 5 years, 10 months ago
I think every department needs to understand the importance of their individual roles. R&D shouldn’t blindly rely on the quality department to make sure the products they developed are safe. Quality control department seems to be the one to get… Read more»
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hzy2 replied to the topic "Discussion Topic: The cost of Quality" – 5 years, 10 months ago
In my opinion quality control is an integral part of any company and is worth every single dollar spent on it. Companies serve to customers who have specific needs and it is the quality engineers’ responsibility to make sure that… Read more»
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hzy2 replied to the topic "FDA rules too strict?" – 5 years, 10 months ago
It might be a lot of work on the companies’ end because of all the regulatory steps they need to follow to bring a product to the market. It seems to be tedious work but these products are used on… Read more»
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hzy2 replied to the topic "Discussion Topic: Antibiotic-Releasing Hip Stem" – 5 years, 10 months ago
An antibiotic-releasing hip stem is a combination product. If I was the regulatory person working with this product, the first thing I do would be to submit a request for designation to the office of combination products. They will determine… Read more»
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hzy2 replied to the topic "Discussion Topic: Brand new biomaterial" – 5 years, 10 months ago
If a new product is getting ready to be put into the market, there are a lot of testing that needs to be done in order to prove to FDA that it is biocompatible. The ISO10933 table provides a series… Read more»
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hzy2 replied to the topic "Approaches to Research" – 5 years, 10 months ago
In academia, a project is born out of a desire or a passion you have towards a certain topic. It is done with the intention of discovering things no one has discovered before to help out humans in some way…. Read more»
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hzy2 replied to the topic "Ethics of Animal Testing" – 5 years, 10 months ago
It’s sad that animals have to be sacrificed in order to try and test the safety and efficacy of drugs and biomedical devices but it seems that it’s the only option at the moment. Animal studies provide valuable information to… Read more»
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hzy2 replied to the topic "Obstacles while working on a project" – 5 years, 10 months ago
When working on our senior design project, my teammates and I ran into a couple of unexpected obstacles. We were trying to procure the materials we needed to start developing our product and found out that the company we ordered… Read more»
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hzy2 replied to the topic "Project Life Cycle" – 5 years, 10 months ago
I think that the most crucial phases for the success of a project are the initiating and the planning phases. Initiating phase is where the project manager identifies the project objectives and determines whether the project meets a need in… Read more»
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hzy2 replied to the topic "Project Management Softwares" – 5 years, 10 months ago
I never worked in the industry but for my senior design project, my teammates and I created a Gantt chart using Microsoft Project. This chart helped us organize our tasks all throughout the project time frame. We divided our tasks… Read more»
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hzy2 replied to the topic "Thoughts on BME degree, "a little of everything"" – 5 years, 10 months ago
Yes, it’s true that Biomedical Engineering curriculum exposes you to a variety of fields. You are required in your sophomore year of college to take some courses that introduce you to the different tracks that exist within the biomedical field… Read more»
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hzy2 replied to the topic "Advice for Biomedical Engineering Students" – 5 years, 10 months ago
I’m not currently working in the industry but based on what I’ve seen so far and heard from the people around me it is very difficult to get a job without some sort of relevant experience. I think that the… Read more»
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hzy2 replied to the topic "Discussion Topic: Practical vs. Informational courses" – 5 years, 10 months ago
I don’t think that that is a good ratio at all. I think that the students should be able to receive an education that consists of an even number of academic courses and practical courses rather than an education where… Read more»
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hzy2 posted a new topic "Form 483" – 5 years, 10 months ago
Dr. Simon mentioned in this week’s lecture that FDA can issue Form 483 to a company if its practices are not in compliance with the rules and regulations set by them. He gave the analogy that having Form 483 issued… Read more»
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hzy2 posted a new topic "RECALLS" – 5 years, 10 months ago
Has anyone seen the documentary called The Bleeding Edge on Netflix? The documentary talks about a medical device (Essure) that was cleared by FDA and implanted into women for sterilization purposes. Following implantation, these women started to experience adverse effects… Read more»
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hzy2 replied to the topic Restrictions for physician's gifts in the forum Consultants and Legal Basics 6 years, 4 months ago
I think it makes perfect sense that there are rules and laws that prevent these things from continuing to happen. As Dr. Simon mentioned in this week’s lecture, there are products out there that could give better results for patients and morally the doctors should choose to work with whatever product they think will provide the best treatment for…[Read more]
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