I have always believed that the overwhelming outcome of shared resources and collaborations would lead to a positive outcome. One of the main benefits of global regulation of medical devices is that scientists and research groups in one country would arrive at conclusions that others might not see. this will result in a common good output that…[Read more]

In this week simulation, the experiment forced the team to follow a specific resolving its failure as the project deliverables were stated and the protocol followed in the lab was clarified. In my opinion, it was good to think first about the possible reason behind the experiment’s failure and study all those reasons, in order to be able to handle…[Read more]

Interpersonal skills are the most important qualification an employee can have in my opinion. We all came from an academic background and have certainly encountered many individuals whos interpersonal skills have inspired us. For example, I remember as a freshman in my undergrad, a professor’s response to my question about losing some points in an…[Read more]

Although FDA approval is very useful to protect public health thru controlling medical devices and pharmaceutical drugs and ensure safety and effectiveness. Some of the most important points to be followed by the design process team in order to ensure production efficiency is to meet the pre-set development goals in a well-studied time frame (the…[Read more]

“While physicians may prescribe medical devices for unapproved uses, a manufacturer may not distribute medical devices in interstate commerce with the intent that those devices be used for unapproved purposes”
This sentence in an article on whistleblowerfirm website grabbed my attention. So it is possible for doctors to prescribe an FDA approved…[Read more]

A risk is an event or condition that, if it occurs, could have a positive or negative effect on a project’s objectives.
Risk Management is defined as the process of recognizing, classifying, evaluating, responding to and managing risks that could appear in any project. This plan is usually created by the project manager. The team members i…[Read more]

Quality plans are essential in any project, although in many cases the project manager won’t give it the priority. QP can be defined in project management as “a set of planned, systematic actions to ensure that products and services comply with specified requirements. It not only involves checking the final quality of products to avoid defects,…[Read more]

As a biomedical engineering graduate student, I would say one in this field would need both skills (interpersonal skills and technical skills) in a ratio of 50:50. Although I agreed in an earlier reply that “interpersonal skills are more essential to the work environment especially to teamwork oriented place than technical skills”. I still…[Read more]

I would agree with the reviews above which thinks that a product with a peeled off label or similar defects should still be recalled as they may lead to a severe dangerous consequence in some cases. For example, a pain relief medicine that is unsafe to be used by a pregnant woman (such as Aspirin, Ibuprofen, Herbs, minerals, etc.) and the content…[Read more]

I believe that interpersonal skills are more essential to the work environment especially to teamwork oriented place than technical skills. For example, an engineer could be top-notch in his/her technical skills, but if he/she fails in communicating and explaining their thoughts clearly, the implementation of their technical knowledge would be…[Read more]

Having the right people in the right place in the project would absolutely make the project manager life easier and would make the project flow smoother and would ensure the project success.
Choosing the proper team member doesn’t necessary means having people with great resumes only, it also focuses on having all the skills a project manager…[Read more]

A project manager should have multiple skills including:
“- Leadership
– provide direction
– provide vision
– coach/mentor team members
– sound judgment
– issue & conflict resolution
– effective decision making
– Negotiation
– Communication
– Team building” [Ref. PMI . org]
However, according to many articles I was…[Read more]

I think these restrictions are essentials and would help physicians and employers to avoid many problems at work. I think without any gifts restrictions, some people would go crazy thinking that the more expensive the gift we give is the more we will get back from the physician, and that would cause a lot of embarrassment and issues for people…[Read more]

I agree with most replies here, which finds a written business agreement the better option in a project, compared to the verbal agreement, as it and can be easily defended in court and would provide more certainty by stating the details clearly. Depending on someones words and honesty would not always work and could cause some later issues which…[Read more]

This was my first online course in my Master degree, and I enjoyed it a lot, and never regret taking it. I like how we learned about different aspects every week, and how this course taught me a lot about the pharmaceutical industry as I don’t have any experience yet. I think this course should be a core BME course, and all students should take it…[Read more]

I personally find my talents, skills, and qualifications are more suited for upper management. I believe that what makes a good upper management individual is someone whose leadership skills are strong in the sense that he or she can lead a team of employees to achieve certain outputs and goals. This leadership is complemented by a well managing…[Read more]

Choosing the right members to form a project team is very critical in the workflow and project outputs, thus it is essential to carefully choose the team members. For me, I would focus first on the skills and abilities of each depending on my project, so that I can give each member the right task which I see him/her well-qualified for it. I would…[Read more]

If I were to start up my own medical devices company, I would choose the Matrix Org Structure as I think it would have enough flexibility to work under different bosses, fast to grow, and would have the space for decision making. Since the Matrix Org would have group members from different disciplinary and functional units, it would be more…[Read more]

I think planning is the key to reach the goal of a successful project. The first thing in the process is identifying risks in the project, and understanding each risk and its cause and effect later on the project. Then I would simplify the needed process depending on the output from step one, in which I would be able to assign tasks to each member…[Read more]

I don’t have the industry experience yet, but from what I was reading on the PMI website, I understand that the risk identification is always followed by the risk management planning step. Risks can always be identified through a detailed studying and analyzing of the Risk Management Plan. This could be done by understanding the project…[Read more]