I think Placebo-controlled trials is ethical and necessary because Using placebos in clinical research helps scientists more clearly understand whether a new medical treatment is safer and more effective than no treatment at all. This is not always easy because some patients get better in a clinical trial even when they don’t receive any active m…[Read more]

I think having a clinical background is very useful specially when you are dealing with the patient in clinical trials as a Bio-medical Engineer, I worked as a patient sitter in the hospital for 2 years and I also currently work as an EMT and from that I can say that It requires a lot of Patience and not every person is same you have to deal with…[Read more]

One example of grand Strategy is Market growth. Market growth is a low-risk strategy compared to other, more encompassing, strategies. Instead of investing in research and development to create new product offerings, the market-growth strategy focuses on growing the market for a current product. An example of this is an electronics company that…[Read more]

I think the best example for this is Coca-Cola, In the United States, the average person drinks one can of Soda a day, so a company like Coca-Cola, which has already acquired most of the people in the United States, naturally shifts their marketing focus away from immediate sales transactions, and towards a more long-term emotional connection with…[Read more]

Emotional Intelligence is something which is within us that helps us to sense how we feel and enables us to truly connect with others and form a bond. It gives us the ability to be present and listen to someone when they most need it. And emotional intelligence is that sense of internal balance within us that enables us to keep our composure, make…[Read more]

The principal difference between public and privately held companies is that public companies have shares that can be publicly traded on a stock market. A privately held company might become a publicly held company by conducting an initial public offering, which is the offering of shares of the company to the public.
The main advantage public…[Read more]

I did Research on Colgate Palmolive:-
Net income and Diluted earnings per share in second quarter 2017 were $524 million.Gross profit margin was 60.1% in second quarter 2017. Operating profit decreased to $853 million in second quarter 2017 compared to $944 million in second quarter 2016. Excluding charges resulting from the 2012 Restructuring…[Read more]

I would prefer a S Corporation for my business S corporation has some appealing tax benefits and still provides business owners with the liability protection of a corporation. With an S corporation, income and losses are passed through to shareholders and included on their individual tax returns. As a result, there’s just one level of federal tax…[Read more]

I totally understand when people will complain about the quality, but hey I rather spend some money right now and higher some quality people instead I might have to lose my business. If I am running a business I would never every take a risk of not having a quality department even if I am best at it because the second and third opinion is always…[Read more]

From a quality perspective, I will say that I have follow all the rules to make this product and I have all the documents in details from the start to end of the project with good GMPs. The quality person will only be afraid of hopefully he did not miss anything and they don’t get bad audit report or a 483 because it is embarrassing for the…[Read more]

I think the main issue is the ego the R&D department thinks they know every thing and what ever they do is 100% right, so in a situation when the quality people comes and tell them according to rules you have perform this test 3000 times not 300 times to test the device then at that point they R&D start explaining theories to quality people and at…[Read more]

Antimicrobial wound dressings is consider a combination product, it is mainly used to cover partial and full-thickness wounds the wounds and it also help to reduce the risk of infection. I think it will be consider as CDRH and it does required RFD because it delivers a drug and 510(k)only because it is consider as class 1. And Bio-compatibility…[Read more]

For sure cigarettes kills people and based on FDA agenda they should regulates cigarettes but I guess they are not regulating normal cigarettes because it contain pure processed tobacco but it will be regulated by FDA in near future[1]. On the other hand the e-cig is been regulated by FDA because it consider a device which delivers nicotine so can…[Read more]

Antibiotic-releasing hip stem would be consider a combination device, it will follow in to CDRH based on the primary function of the device which is to replacing the bone. This device will be consider a class 3 because we will implant this in to a human body so definitely we PMA for this device. I said class 3 instead of class 2 because I am…[Read more]

Personally I would do research in the industry, because it will help people right away. I think it is more appreciable and I can see it’s been used in the market and it’s really beneficial to people while I am alive. I think it is more satisfactory because it feels like you have put in something for the change or to advance in the healthcare…[Read more]

At university professor more care about their research what I mean by that is they would like to perform studies on as much as different animals they can because they would perform some other studies on that for their research for which your company will pay the money which ultimately result into more budget for your project. They really care…[Read more]

The first thing I want to point out is, I would never do such a study whee I know a lot of people and specially university because that relation of knowing people can definitely delay the our project purpose and we are here to do business not making friends and the only think I care is my experiment data on time, I don’t care if you will not…[Read more]

To Study the Bio-compatibility of a brand new bio-material of which our device or product has been made, I will use ISO 10993-1 Test Matrix to determine what kind of test I should perform. And the decision of the test’s I should perform on my product is completely based on the use of my product, for example where in the body my product will be…[Read more]

Six Sigma is another management style, and study shows that firms who successfully implement this style is typically deliver better return on investment, return on sales, employment growth, stock growth and value growth.
Pros:
1)Six Sigma strategy places a clear focus on achieving measurable and quantifiable financial returns to the bottom-line…[Read more]

A bunch of related or non-related projects of an organization is known as Portfolio. It can consist of multiple programs or multiple projects without having a single program. A portfolio can have multiple non-similar projects without having a program, because two or more non-related projects will be managed under portfolio management. And…[Read more]