I would go with a Double Blind study whenever possible. Utilizing a single blind study can lead to researcher’s bias. Researcher’s Bias is when the researcher looks for data that confirms a specific outcome that is beneficial to them. By removing this element, you add more validity to your study in my opinion.

Firstly, the video is hilarious!

Secondly, the video is a purposely over-the-top version of the comic strip. A lot of the time people may not realize how their requests can be on different spectrums. An interesting point is that “The Expert”, actually solved their problems as they came up, but extra stipulations continued to be added. The first…[Read more]

For that particular company, I would look at an LLC. Mainly due to the liability they have if something goes wrong. I don’t believe that they have enough revenue to cover a lawsuit and continue to function as a company proficiently afterwards. If over the next 5 years they project 80-100 % increases in revenue each year, I would look at…[Read more]

I wouldn’t turn down a job offer solely based on the type of company it is. Every job has it’s own experiences which cannot be taken away in case of the company going out of business. For example, say I accepted a supervisory position at a company that has sole proprietorship and 2 years later something causes the business to dissolve. I still…[Read more]

As aja38 & vcf3 have stated, a sole proprietorship cannot be passed on. If the father wants to give his business to his heirs then he would have to change the business to an LLP. From there the dad can “sell” his part of the company to his son in order to no longer have ties to the company.

To improve upon document control, you have to evaluate what you are currently doing. Is the reason because you are using paper files? You can switch to an electronic database using fancy software which also has the capability to print out the file when needed. Is the reason the workload? You would have to expand your quality department to…[Read more]

There isn’t much that can be done to overcome the bad relation, in my opinion. You could involve the Quality Department as early as you would like in the Project Life, but that wouldn’t change much (if anything). The people in the other departments may not agree with the regulations set forth which quality has no control of. There is bound to be…[Read more]

Quality is a huge part of any successful business operation.

From my experience working in a hospital, when there is a meeting and it is time for Quality to report there are always huge sighs. Maybe it is just because of the nature of the job, but it seems that most of the other departments do not like the Quality Department (or the regulatory…[Read more]

I don’t think the FDA is being too strict. With anything that is new, there has to be accountability. The regulations that are put in place, forces companies to be ethically sound when proposing new technology that can have negative impacts on the lives of people if corners are cut. No impact should be considered small enough to warrant a lack of…[Read more]

In the 1950s there was a pharmaceutical company (Chemie Grunenthal) created sleeping pills from thalidomide. It was advertised as safe for everyone to use, including pregnant and nursing mothers. The drug gained popularity fairly quickly and spread from West Germany into the UK.

The company also wanted to sell the drug in the US, but Dr. Frances…[Read more]

What kind of regulatory pathway would be required for an antibiotic-releasing hip stem?

The regulatory pathway that would be required for an antibiotic-releasing hip steam is first being reviewed by and approved by the Center for Devices and Radiological Health (CDRH). Since it is a class two device, a 510(k) application can be used. An IDE will…[Read more]

What kind of regulatory pathway would be required for an antibiotic-releasing hip stem?

The regulatory pathway that would be required for an antibiotic-releasing hip steam is first being reviewed by and approved by the Center for Devices and Radiological Health (CDRH). Since it is a class two device, a 510(k) application can be used. An IDE will…[Read more]

If I am working with a biomaterial that has never been used before, I shall do every single test that I can think of. Starting with all of the ISO 10993-1 standards. The reason being is the amount of liability that I will have if ANYTHING goes wrong that I had no idea would happen (but should have). When moving into uncharted territory, utilizing…[Read more]

Animal testing is not ethical … ever. Following that same thought process, however, neither is digging up the ground to place buildings there instead. Causing air pollution by driving a car is also unethical yet millions of people do it every day. The point I’m making is that with technological advancements, there will also unavoidably be…[Read more]

Having multiple project managers on a single project will cause some level of confusion. Everyone has their own preferences on the way tasks should be done even if they agree on the specific task. Because of individual thought processes, disagreements are inevitable. Another situation that can occur is the two managers having different levels of…[Read more]

I believe that the initiating phase is the most important phase. While every phase is important in its own way if you don’t progress through the initiating phase the project will never begin. A poorly executed initiating phase will also have a huge impact on the planning phase. The entire project can get delayed if you underestimate the budget or…[Read more]