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…   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…   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…   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…   Read more»

There is no project that is completed without going through any risk (as a part the process), thus, it is necessary to deal with those associated risks in a well-managed way, and avoid mistakes that others did previously in similar…   Read more»

As for Design Verification, I believe that a necessary practice is to let experts from a different discipline test the product under unusual circumstances. I think that there are circumstances that the product might be used under. While Verification is…   Read more»

As mentioned in other discussions, ensuring an adequate design control would lower the risk of a product failure at any point. Design Controls, in general, were explained a lot in this discussion, thus I wanted to discuss in particular the…   Read more»

As my classmates mentioned above, insufficient design control would lead to a production failure at one point. And as FDA stated on their website: “Design control does not end with the transfer of a design to production. Design control applies…   Read more»

I must agree with most of the discussion points mentioned above, but I would like to point out that for an engineer, the DSD would be a must-read document, as we don’t rely on broad descriptions. For example, an engineer…   Read more»

As Dr. Simon mentioned in the lecture, meeting minutes are very important for any meeting at any project, as it will be a clear and direct proof for any case of project misleading or a role misunderstanding later. In many…   Read more»

I totally agree with you. I saw some Gantt Charts that made the project more complicated rather than breaking down the process and mapping it in the right and simple way. However, Gantt Charts may not be an ideal option…   Read more»

I would like to think of a CRO as a local credit union, and a Big Pharma as Bank of America. One would be more intended to resolve a certain community’s financial needs and the other’s focus is to take…   Read more»

I have conflicting opinions about the Right to Try Law. Clearly, if someone is seriously ill and all medical treatment options have been exhausted, and the doctors say that there is no FDA-approved medication that would help me, however, there’s…   Read more»

I believe that it is in fact an attack on our freedom of choice when a government entity decides what clinical trials are permitted and what are not. By doing so, governments tend to create a bureaucratic delay in advancing…   Read more»

Bristol-Myers Squibb Co (BMS) which is a global biopharmaceutical company that discovers, develops, license, manufacture, sell and distribute medicines to patients. Its main focus is on cancer, cardiovascular, immunology, and virology therapeutic projects. (Ref. BMS website) SWOT Analysis: 1. Strengths:…   Read more»

There are different schools of thoughts when it comes to defining marketing. Northwestern University professor Philip Kotler defines marketing as “managing profitable customer relationships”. He believes that marketing is an essential part of the business and sees the influence not…   Read more»

The brand coloring is one of the interesting topics for me, as psychologist proved that colors are one of the most powerful ways to for companies to grab attention, and highlight a specific target/product. Most companies use colors as a…   Read more»

Private businesses are usually owned by a family, or subgroup of a larger company. It can be either partnerships or sole proprietorships. While a public company is a firm that offers a part of itself for share to the public…   Read more»

That was my question to myself last summer when I was offered two different internships. One was in J&J and the other one was in a small start-up company. I was convinced by friends and family that training in a…   Read more»

I agree with msc52, my decision would change depending on the corporation type, goals, and the aimed features. For me, I would prefer to have an ownership of the Limited Liability Company (LLC) type due to its advantages in the…   Read more»