llefevre

Forum Replies Created

RE: Discussion Topic: Course conclusion and impressions

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 cl...

In forum Consultants and Legal Basics

4 years ago
RE: Restrictions for physician's gifts

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...

In forum Consultants and Legal Basics

4 years ago
RE: Malsow's law in organization

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, saf...

In forum Organizational Development in Device Companies

4 years ago
RE: Dealing with risk

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...

In forum Risk Analysis for Medical Devices

4 years ago
RE: Benefits of post-market surveillance

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 y...

In forum Risk Analysis for Medical Devices

4 years ago
RE: Risk Management Mistakes

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...

In forum Risk Analysis for Medical Devices

4 years ago
RE: When is validation is not required?

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 t...

In forum Introduction to Design Controls

4 years ago
RE: Minutes for meetings

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 meeting...

In forum Introduction to Design Controls

4 years ago
RE: Design Controls in the other countries

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...

In forum Introduction to Design Controls

4 years ago
RE: Placebo-controlled trials: Are they ethical? Are they necessary ?

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 alrea...

In forum Clinical Research Basics

4 years ago
Clinical trials for Alzheimer’s disease

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 ...

In forum Clinical Research Basics

4 years ago
RE: Informed consent: What if Henrietta Lacks checked No for research use?

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 i...

In forum Clinical Research Basics

4 years ago
Marketing Clinical trials And Recruitment

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 c...

In forum Marketing and Sales

4 years ago
RE: Manipulation or no?

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 ...

In forum Marketing and Sales

4 years ago
RE: Brand Coloring

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 oth...

In forum Marketing and Sales

4 years ago
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