There are a few key differences between an NDA and patent. An NDA is used to prevent a party or individual from revealing information talked, discovered or researched at one institution usually from a competitor. This is a way for…   Read more»

As others have mentioned, the biggest difference is the ability of a written contract being the “law” of the land that has little to no gray area to dispute. However, verbal contracts are often the first step when negotiating between…   Read more»

I would prefer working in a matrix organization. I feel taking some of the positives from the project based organization, such as being able to focus on a goal within a team while also limiting the negatives by promoting cross…   Read more»

A matrix organization appears to have to the most utility to allow a team to be successful. By having departmental resources and cross-progression of projects from one department to another, future work can be completed more smoothly and efficiently. One…   Read more»

A division between the whether or not a decision is the correct choice should ideally be brought up in a group setting to allow for the most back and forth with a new idea. However, if that is not possible…   Read more»

This is definitely a predicament with establishing standards for anything. If any standard is set it maybe seen as too strict or not strict enough down the line. “As far as possible” should mean within a reasonable expectation of due…   Read more»

It is the responsibility of the company to fully and accurately inform the end user of the risks associated with their product. Obviously, there are instances where not everything can be listed on a bottle or box but in that…   Read more»

Internal risk is risk associated with the development and standard testing of a product. Its simple to understand some products are inherently more risky than others such as a band aid vs. a hip implant. Additionally, standard testing may show…   Read more»

Validation is the process of ensuring the product you set out to make is correct. This means testing functionality and overall ‘benefits’ that the product may be advertised with. Verification is more involved with paperwork in the sense that it…   Read more»

Like those prior, I did not give much thought to meeting minutes prior to working in industry. They are extremely valuable for several reasons, namely keeping track of on going tasks but also apart of ‘good documentation practices’. Often after…   Read more»

Factors to consider when designing test methods usually pertain to the products application. Developing the test methods are a direct result of how your product will be used in the future as well as any scenario it might undergo. Take…   Read more»

I believe that the documentation part of the design control process is the most important. This is not to undermine the importance of any other portion of design control as they are all equally responsible to producing a safe and…   Read more»

I do not have first hand experience with this, but from previous classes I have learned just about what you have stated. Due to complex nature of testing on animal tissues, you’re study is susceptible to countless variables that can…   Read more»

I am not aware of any company that does this and if they did I’m sure it would be held close to the vest. While this strategy may work in the short term to avoid displaying the failures of a…   Read more»

Posted by: @smitshah I cant really think Why is it needed to use double blind study since I think single blind i.e. only patient blind must work.In double blind both Investigator and patient will not know about the drug and…   Read more»

Placebo-controlled trials are necessary for assessing the overall validity of a medical device or treatment. Without a blind control, experimental results will not be able to make an accurate comparison and which diminishes/exaggerates the study’s conclusions. Deciding whether placebo-controlled trials…   Read more»

Second to money, I think “need” is the greatest driving factor in participation of clinical studies. When a person is diagnosed with an incurable disease whether because of its stage or severity, they will try any possible treatment that may…   Read more»

Market research is necessary if you have serious intentions of selling a product. Think about a scenario where you reinvent the the toilet. It’s better in every way and only slightly more than the conventional cost. However, the conventional design…   Read more»

I think in favor of the company’s best interest salespeople should be given prior training on the general engineering behind their medical devices. It will not only help the salesperson recommend the correct product but also make selling easier considering…   Read more»

The internet has changed marketing by forcing companies to innovate. Think about the last time you were watching TV. What did you do immediately after your show went to commercial break? You picked up your phone and did nearly anything…   Read more»