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hzy2 replied to the topic Partnership characteristics in the forum Business 101 6 years, 5 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 to carry all the financial risks associated with businesses by yourself. The risk is shared among the partners in a…[Read more]
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hzy2 replied to the topic Public vs. Private Companies in the forum Business 101 6 years, 5 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 who can prepare these reports to submit to the SEC, which means paying more workers. Public…[Read more]
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hzy2 replied to the topic Types of Corporations in the forum Business 101 6 years, 5 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 the tax benefits that people owning sole proprietorship or partnership businesses get. Limited liability company and…[Read more]
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hzy2 started the topic Form 483 in the forum Quality Control and Quality Assurance 6 years, 6 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 is like receiving a speed ticket that gets posted online and everyone finds out about it. This hurts the company’s reputation with…[Read more]
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hzy2 replied to the topic Relation of Quality with other department. in the forum Quality Control and Quality Assurance 6 years, 6 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 all the blame if something goes wrong however, R&D is just as responsible for anything that can go…[Read more]
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hzy2 replied to the topic Discussion Topic: The cost of Quality in the forum Quality Control and Quality Assurance 6 years, 6 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 the products developed by that company meet those needs. They go through a list of specifications and evaluate the…[Read more]
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hzy2 replied to the topic FDA rules too strict? in the forum Regulatory Basics for Medical Devices 6 years, 6 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 or implanted into humans and in order to protect their safety, FDA has to be strict about its rules and regulations. It does slow down the process of…[Read more]
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hzy2 started the topic RECALLS in the forum Regulatory Basics for Medical Devices 6 years, 6 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 and most of them had to have multiple procedures to have the implant…[Read more]
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hzy2 replied to the topic Discussion Topic: Antibiotic-Releasing Hip Stem in the forum Regulatory Basics for Medical Devices 6 years, 6 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 which center has lead responsibility based on the mode of action and the device will then follow that…[Read more]
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hzy2 replied to the topic Discussion Topic: Brand new biomaterial in the forum Pre-clinical Device Development 6 years, 6 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 of tests that can be used to test devices based on which category they fall under. For example, if you developed a patch that will only come in contact…[Read more]
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hzy2 replied to the topic Approaches to Research in the forum Pre-clinical Device Development 6 years, 6 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. In industry, however, the driving force behind research is money. The management of a company comes up with a project idea that will fill a…[Read more]
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hzy2 replied to the topic Ethics of Animal Testing in the forum Pre-clinical Device Development 6 years, 6 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 research scientists as to whether a product can make it to clinical trials or not i.e. if an adverse effect is observed on…[Read more]
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hzy2 replied to the topic Obstacles while working on a project in the forum Intro to Project Management 6 years, 6 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 from wouldn’t be sending them out on time. This resulted in delays in every single step that followed the procurement…[Read more]
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hzy2 replied to the topic Project Life Cycle in the forum Intro to Project Management 6 years, 6 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 the market. If you don’t pay much attention to this step of project management and end up working on a…[Read more]
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hzy2 replied to the topic Project Management Softwares in the forum Intro to Project Management 6 years, 6 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 into four main categories: idea testing, product design, product development and product testing. Each one of these…[Read more]
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hzy2 replied to the topic Thoughts on BME degree, "a little of everything" in the forum Introduction to Medical Device Development 6 years, 6 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 such as biomechanics, bioinstrumentation and biomaterials. This helps you determine which one of these…[Read more]
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hzy2 replied to the topic Advice for Biomedical Engineering Students in the forum Introduction to Medical Device Development 6 years, 6 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 students should make it a priority for themselves to look for internship and coop opportunities as early as possible. This will save them tons…[Read more]
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hzy2 replied to the topic Discussion Topic: Practical vs. Informational courses in the forum Introduction to Medical Device Development 6 years, 7 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 one outweighs the other. While academic courses provide you with the background information that you need, it won’t be useful when…[Read more]