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llefevre replied to the topic "Discussion Topic: Course conclusion and impressions" – 3 years, 10 months ago
My personal reflection is that this course really took the time to break down the many different aspects of medical device development and I appreciated the information that we received during this class. There were some things that I knew… Read more»
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llefevre replied to the topic "Restrictions for physician's gifts" – 3 years, 10 months ago
There was a time where pharmaceutical companies and medical device developers used to have lavish accounts and spending on physicians to be able to prescribe or use their products. Incentives included concert tickets, sporting events, lavish dinners, gift baskets, expensive… Read more»
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llefevre replied to the topic "Malsow's law in organization" – 3 years, 10 months ago
This is an interesting topic because like Maslow’s hierarchy of needs, organizations have a hierarchy of needs as well. Maslow’s theory is based on the motivation of people based on psychological, safety, belonging and love, social or esteem and self-actualization…. Read more»
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llefevre replied to the topic "Dealing with risk" – 3 years, 10 months ago
Similar to pharmaceutical drugs that are being implemented for human consumption there is inherent risks associated with medical device development but there is also this idea of scaling risk, scaling for the level of severity or harm or the probability… Read more»
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llefevre replied to the topic "Benefits of post-market surveillance" – 3 years, 10 months ago
The point of post market surveillance is to maintain a product quality as well as its performance. Despite the fact that in the United States it is a regulatory requirement, it allows you to improve your device for a future… Read more»
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llefevre replied to the topic "Risk Management Mistakes" – 3 years, 10 months ago
Some of the biggest mistakes and medical device companies make include but are not limited to designing the wrong product. Sometimes the market isn’t big enough and in some cases there is no market to begin with. This happens when… Read more»
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llefevre replied to the topic "When is validation is not required?" – 3 years, 10 months ago
According to the FDA, Human factors/usability engineering focuses on the interactions between people and devices. this includes understanding the user-device system, it’s importance to understanding the ways people perceive information from the device, the way they interpret the information and… Read more»
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llefevre replied to the topic "Minutes for meetings" – 3 years, 10 months ago
Thank you @rgb29 for bringing this conversation to the forefront. As a secretary to a nonprofit organization, I can attest to how important it is to take accurate minutes of the proceedings of meetings and the importance of minutes. I… Read more»
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llefevre replied to the topic "Design Controls in the other countries" – 3 years, 10 months ago
In the People’s Republic of China, the manufacturing, marketing, distribution, and sale of medical devices, are mainly regulated by the Regulations on Supervision and Administration of Medical Devices. These laws were developed by the State Council and are governed by the… Read more»
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llefevre replied to the topic "Placebo-controlled trials: Are they ethical? Are they necessary ?" – 3 years, 10 months ago
The placebo is usually a saline solution. Something that is harmless to inject (and is often used to dilute actual vaccines), but has no medical benefits. Although in some cases an unrelated and already approved vaccine is used as placebo…. Read more»
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llefevre posted a new topic "Clinical trials for Alzheimer’s disease" – 3 years, 10 months ago
According to the National Institute of Health web site on clinical trials, there are over 225,506 studies currently being conducted throughout the United States and 192 countries. Less than 1% of the total number of studies being conducted addresses the… Read more»
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llefevre replied to the topic "Informed consent: What if Henrietta Lacks checked No for research use?" – 3 years, 10 months ago
Posted by: @alexandrabuga Background: Henrietta Lacks was a woman whose cancer cells were the source of the HeLa cell line, the first immortalized cell line and one of the most important cell lines in medical research. Lacks was the unknowing… Read more»
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llefevre posted a new topic "Marketing Clinical trials And Recruitment" – 3 years, 11 months ago
It is estimated that globally, the market for Clinical Trials is in upwards of $44 Billion as of 2020 and is expected to grow by approx 6% over the next 7 years, mostly fueled by the need to address chronic… Read more»
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llefevre replied to the topic "Manipulation or no?" – 3 years, 11 months ago
Emotional intelligence also known as the emotional quotient is the ability to understand someone’s feelings and someone else’s thoughts it is probably responsible for more than half of the success in professional marketing. According to the world economic forum emotional… Read more»
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llefevre replied to the topic "Brand Coloring" – 3 years, 11 months ago
Brand coloring is as essential as the product that the organization is advertising. Some of the most iconic companies in the healthcare industry also utilize this technique in their branding which others can readily identify from generic products. Johnson &… Read more»
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llefevre replied to the topic "The people we shall encounter in the field" – 3 years, 11 months ago
Diversity is the bedrock of all successful enterprises. The more diverse your workforce the more honorable people a company will amass for their leadership and employee pool. An honorable person is selfless, forthcoming, and honest. Honor requires you to have faith,… Read more»
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llefevre replied to the topic "A VICIOUS GAME PLAYED BY PHYSICIANS AND DRUG DESIGNERS MUST BE STOPPED." – 3 years, 11 months ago
I totally understand how jaded you feel about the state of medicine and the treatment vs cure conversation. I get it. Just thinking about diseases like pancreatic cancer and how much of a death sentence it has become in our society,… Read more»
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llefevre replied to the topic "Drugs banned in US but not in other countries" – 3 years, 11 months ago
I can think of a few drugs that are banned in the US including angiotensin receptor blocker / heartburn medication Ranitidine (Zantac) was recalled in 2020 due to the presence of low levels of a contaminant NDMA and are no… Read more»
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llefevre replied to the topic "Talking about animal research" – 3 years, 11 months ago
Animal research is unique in a sense that you can’t ask the animal if he or she would like to participate in an experiment because we are not at the level of communication where an animal can consent, at least… Read more»
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llefevre replied to the topic "Research for the Fututre or Now?" – 3 years, 11 months ago
Posted by: @hm243 In industry, research is done to make discoveries for products that can help people right away, while in academia, research create results for the long run. I feel that both types of research are important and necessary…. Read more»
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