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 field and projects. As my classmates mentioned many possible mistakes that would hinder the project successful…[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 meant to ensure a product meets the operational needs of the user, it can also be widened to…[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 Design validation section.
Each medical device would go through a validation process (examination tests) to…[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 to all changes to the device or manufacturing process design, including those occurring long after a…[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 will not only tell a certain device works with a 110-volts or 220-volts, but rather would tell you the polarity and amperage. S…[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 cases, when any mistake happens or any decision taken in a project process, every member may blame someone else to get rid of…[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 for some complex projects that includes many details associated with a big number of tasks. Another case that Gantt chart won’t…[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 advantage of anyone’s financial struggles. But when it comes to choosing between the two to work for, I would probably choose Big Pharma. I think…[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 a drug company that developed a treatment that might work, even with a 1% chance, it is reasonable t…[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 medical research that might result in discovering or inventing new treatments. I think that an easy argument can be made for…[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:
– Innovation
– Strong focus on Research…[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 only by price but also by advertisement, sales promotions, etc.…[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 communication tool with their customers, through their designs and advertisements. For example, Apple, the brand…[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 through Initial Public Offering (IPO) to raise investment assets, which means investors owned a part of the company’s profits…[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 start-up company and gaining experience may be more useful than a large corp. As in a start-up, I would have more roles to play, more…[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 limited risk potential over the other types. The most important advantage of this type is that my personal holdings are…[Read more]

Complaining about the quality assurance and management in any company and considering it as a burden that can be waived, means complaining about being globally competitive and a customer long-term satisfaction.
Within these days where medical devices companies are growing very fast, it may be very risky to abandon the important role of Quality…[Read more]

Totally agree with other replies, having a bad relationship between R&D and Quality Department could lead to work deficiency and further delays as well as many other barriers that would hinder the workflow in its right and proper way.
One way to overcome disagreements between these two departments is to limit the direct contact between R&D’s and…[Read more]

As a part of the Quality Unit, Document control main procedure depends on ensuring medical devices or product safety and quality. This includes ensuring the production processes security and determining restrictions needed to: accept, inspect, update, distinguish differences, know update status and provide access to the most recent document…[Read more]

Accuracy refers to how a measurement is close to the right or acquired absolute value while precision how a measurement matches the same exact value being estimated. Both fields are independent. Which means a measurement may be highly precise but inaccurate, and vice versa.
Both accuracy and precision are essential to be insured in medical device…[Read more]