An advantage of Cooperations lies in the fact the company’s debts can’t be transferred to individual owners. However, this advantage comes with the requirement that personal assets be separated from those of the company. For instance, using a company credit…   Read more»

As the name indicates, sole proprietorship implies that a company with the single owner which will dissolve if the owner dies. Passing the company on to the two sons will require to create a new company. As Dr. Simon suggested…   Read more»

I would prefer filing my company under a Limited Liability Company (LLC). First of all, an LLC limits personal liabilities because an LLC is legally separate from its owners. LLCs are responsible for their own debts and obligations, and although…   Read more»

I used to ponder about the relationship between physician and drugs designer as well, so I completely understand where you are coming from. However, I believe eradicating or improve this relationship which is truly toxic to the patient will never…   Read more»

From other departments point of view, I understand why they can sometimes regard Quality as a burden. Ultimate, Quality gets to determine if their project gets to move to the next phase or get complete rejected. Imagine spending time and…   Read more»

This is an interesting question. I think inspections are always stressful for the quality department. Even if Regulatory has put forth current procedures and regulations of certain products, it is ultimate upon Quality ‘s responsibility to ensure that adherence to…   Read more»

It is an absolute necessity to improve the relationship of QC with other company departments. It is in fact in those other departments best interest to ensure a healthy relationship with their QC. The quality department usually runs deep within…   Read more»

I don’t believe companies intentionally want to fail to adhere to the rules. With the analogy of the speed ticket, for instance, let say you are rushing to get somewhere and unfortunately get pulled over and get a ticket. I…   Read more»

When the De Novo process was first initiated, sponsors needed to submit the premarket notification (510(k)), to which the FDA would issue final 510(k) decision of “not substantially equivalent” due to no predicate. The sponsor would then need to submit…   Read more»

An example of FDA approved wireless medical devices is the wireless electrocardiogram. It consists of the ECG monitoring circuit, microcontroller circuit, and an Android mobile phone. The phone has a function that detects if the wearer has fallen down and…   Read more»

Combination product: metered dose inhalers, MDIs An MDI is made up of a pressurized canister containing a drug substance and possibly excipients formulated with a propellant. The formulation is aerosolized through a valve fitted with an actuator (mouthpiece). Per FDA…   Read more»

While I find it interesting that the standard for labeling is inverted between Sweeden and the US, I am not a bit surprised that the US opted to have the genetically modified goods be ” standard”. I think it works…   Read more»

Although I believe animal testing is clearly unethical, I do find the efficacy of their results extremely valuable. Animal testing has been the most accurate and reliable strategy for checking new drugs, with few limitations or side effects due to…   Read more»

As others students stated, referencing the Toxicity Table from ISO 10993 should give a general idea of tests needed prior to clinical trial phase. Ultimately the test needed will depend on the expected functionality of the medical devices. For instance,…   Read more»

Research is always important no matter if it is in Industry or Academia. As Dr. Simon mentioned research in Industry is usually to create a solution to a problem while Academia researches tend to focus on understanding the problem, study…   Read more»

Before considering if Industry research is ” successful” , we need to define what ” success” actually is. What parameters are we using to measure success? is it in term of achieving an end result within the expected timeframe, or…   Read more»

I think all these three features of a project are all intertwined. Although the achievable seems to stand as the most important one, in reality, it will be greatly undermined if the other two characteristics are not fully met. For…   Read more»

Besides having a solid technical background that most people are suggesting, I believe a manager should have excellent communication and people skills. We can’t really coordinate a project if you don’t relate or assimilate with the people actually doing the…   Read more»

I think no single phase is more important the others because the end project results in the efficiency of all the phase combined. However, I think the initiation phase should be given ample consideration as it set the tone for…   Read more»

One project in which I encountered crucial setbacks was my capstone project assigned to a group of five. We had a year to submit and present our findings. Although we did have an elaborate planning, almost nobody followed through. Communication…   Read more»