-
Karen Immanuel replied to the topic Written Agreement v/s Verbal Agreement in the forum Consultants and Legal Basics 6 years, 4 months ago
I think we need to first understand that both verbal and written agreements are recorded in some manner or the other. So both can be used and defended with. The difference is that verbal agreement usually isn’t as detailed as written agreements. But having a written agreement for everything is time consuming and can be a waste of resources when it…[Read more]
-
Karen Immanuel replied to the topic Forming a Project Team in the forum Organizational Development in Device Companies 6 years, 4 months ago
Building a strong team is crucial to working better. I believe that a strong team is made of people with a mixture of skills. For example, they must have certain knowledge in their field, must be motivated to be on board and to do the project, work well with others, and most importantly keep in communication! I think being comfortable in…[Read more]
-
Karen Immanuel replied to the topic Collaboration projects in the forum Organizational Development in Device Companies 6 years, 4 months ago
For collaboration process, I think matrix type organization is the best option. A matrix type organization allows people to move around based on projects and their talents. I think this is a good option because a project manager can pick and choose the best employees of the company for each project. They can pick and choose who they think…[Read more]
-
Karen Immanuel replied to the topic Discussion Topic: Your organizational type in the forum Organizational Development in Device Companies 6 years, 4 months ago
I work in a functional based organization. I work for a specific department and my manager is the department supervisor. I haven’t been a part of a project, but I work on tasks that is required within my department. If I had a choice I would like to work for a matrix type organization where I would be moved around based on projects. I like this…[Read more]
-
Karen Immanuel replied to the topic Risk management and Labels in the forum Risk Analysis for Medical Devices 6 years, 4 months ago
When it comes to Off-The-Shelf (OTS) products, I think the quality department knows that consumers don’t really read the labels and instructions that warn them about risks, and try their best to make them as safe as possible. OTS products can’t be prescribed to a specific group of consumers, it can be used by young and old, readers and…[Read more]
-
Karen Immanuel replied to the topic Manage Risk in the forum Risk Analysis for Medical Devices 6 years, 4 months ago
This is a great question! For high level risks, I would try my best to go with avoidance, I do not want to put the patient and the company at risk, given that we know the failure occurs frequently and its effects are severe. It’s not worth it to put a product out there, that could and most probably will fails and will affect the patient’s health,…[Read more]
-
Karen Immanuel replied to the topic Factors Contributing to Risk Values in the forum Risk Analysis for Medical Devices 6 years, 4 months ago
Although severity and number of occurrence are the main large categories that must be looked at for risk management, there should be more evaluation and discussion of other categories such as user’s age, quality of life after product failure, cost of replacement, cost of losing or damaging brand name, number of users, shares affected, patterning…[Read more]
-
Karen Immanuel replied to the topic Consequences Of Insufficient Design Controls in the forum Introduction to Design Controls 6 years, 5 months ago
In the company that I work for, we interchange the term “Design Control” and “Document Control” because everything in design control is detained in documents called Standard Operating Procedures (SOPs). So when design control fails, it means we have taken a detour for the procedure. This introduces variability or failure in production. This could…[Read more]
-
Karen Immanuel replied to the topic Design input sources in the forum Introduction to Design Controls 6 years, 5 months ago
As many of the students stated, design inputs so usually come from research and other investigational ideas. I would like to add that some also come from doctors and other medical companies. Hospitals and companies contract other companies to provide certain parts and products. In these cases, they provide the design inputs to the contracted…[Read more]
-
Karen Immanuel replied to the topic Customer Needs and Design Input in the forum Introduction to Design Controls 6 years, 5 months ago
I think the need or the advantage of the DID and DSD is that they serve two different audience. DID, which contains the broad specifications, is great for the customers, the ones who are actually interested in buying the product. It is also good for project managers, to review the market needs and the importance of such a product. This audience…[Read more]
-
Karen Immanuel replied to the topic Design Documents in Academia in the forum Introduction to Design Controls 6 years, 5 months ago
From my experience in research, we did also document a lot and were very specific. But we didn’t have anyone inspecting us or our documents, we did it for the sake of honest data that was needed for publication. When publishing, we need unbiased and true data, so we recorded anything and everything we can. We also needed to show that we knew what…[Read more]
-
Karen Immanuel replied to the topic Minutes for meetings in the forum Introduction to Design Controls 6 years, 5 months ago
When I used to work at a research lab on campus, I didn’t really pay much attention to the meeting minutes sent to me. This is because it had the information (tasks and decisions) for all the members in that meeting. I already took notes on my tasks for my project and so I didn’t worry about what was in the minutes. But now at my internship, I do…[Read more]
-
Karen Immanuel replied to the topic Informed consent: What if Henrietta Lacks checked No for research use? in the forum Clinical Research Basics 6 years, 5 months ago
Informed consent in very very important and I’m happy to say that now a days, it is taken very seriously. Back in Henrietta’s case, I don’t even think she was given a consent form, she just went for cancer treatment but they took her cells for research and other discoveries that neither she or her family knew about until a generation or two later.…[Read more]
-
Karen Immanuel replied to the topic Discussion Topic: Having a "clinical background" in the forum Clinical Research Basics 6 years, 5 months ago
As many students above stated, having a clinical background depends on the role. There are some roles like the PI that require clinical background, this is because the role is usually critical and can’t allow much mistakes. Having clinical background means that the person has experience and practical knowledge of the situations. There are other…[Read more]
-
Karen Immanuel replied to the topic Double Blind Vs Single blind Study in the forum Clinical Research Basics 6 years, 5 months ago
Double blind studies much better than a single blind study, mainly to avoid mental bias. Thinking that drug will make someone better alters the mind to feel like it has actually worked. This is true for both the patient and the clinician. If the clinician is not blind to which drug does what, they may foster bias questions and approaches to the…[Read more]
-
Karen Immanuel replied to the topic Discussion Topic: Emotional Intelligence and its affect on sales in the forum Marketing and Sales 6 years, 5 months ago
Emotional Intelligence (EI) is the ability to recognize one’s own emotions and feelings and of those around them. One will know if they have EI based on how they are able to cope with their own emotions and control their behavior accordingly. They will also be able to understand the behavior and thinking of others based on their emotions and act…[Read more]
-
Karen Immanuel replied to the topic Medical Device SWOT Analysis in the forum Marketing and Sales 6 years, 5 months ago
-
SWOT analysis for Becton Dickenson (BD)
Strengths:
– Strong Free Cash Flow
– Highly successful at Go To Market strategies for its products.
– Good Returns on Capital Expenditure
– Highly skilled workforce through successful training and learning programs.
– Successful track record of developing new products – product innovation.
– Reliable s…[Read more] -
Karen Immanuel replied to the topic WHAT IS MARKETING TO YOU? in the forum Marketing and Sales 6 years, 5 months ago
Marketing has changed over time. Gone are times when advertising was honest and to the point, now more tactics such as emotional intelligence and manipulation is used to lure people to buy the products. I think that the main reason these tactics are used is because of competition. Similar products with similar functions in the market poses a huge…[Read more]
-
Karen Immanuel replied to the topic Partnership characteristics in the forum Business 101 6 years, 6 months ago
If I was an entrepreneur, I would definitely do a partnership. Choosing the right person/persons is very very important. I prefer partnership over sole proprietorship mainly because it’s better to have more people to discuss, decide, and execute a plan rather than one person. The difference in opinion and methods would be helpful. People of…[Read more]
-
Karen Immanuel replied to the topic Accepting job based on company. in the forum Business 101 6 years, 6 months ago
Being eager to get an internship, I really didn’t look into the company’s financial and economic history. But my dad was the one who sat with me and went through the company’s financial history, revenue, efficiency , stock price, competitors, employee reviews, etc. Although for an internship this doesn’t really matter, this matter for me when I…[Read more]
- Load More