In contract law, a non-compete clause (often NCC), or covenant not to compete (CNC), is a clause under which one party (usually an employee) agrees not to enter into or start a similar profession or trade in competition against another…   Read more»

The difference is that a patent is a federal document proving ownership of an idea, and an NDA is simply a contract between two people. NDA is a contract and not a law. Contracts are interpreted in different manners depending…   Read more»

I agree with the previous posts mentioning that a written contract is more useful and reliable than a verbal agreement. Verbal contracts are extremely difficult to defend in court as it is difficult to show all the aspects of a…   Read more»

In the real world scenario, we usually do not pick who we end up working with and it always best to work with those who have the right skill set to do the job and project needed. This is also…   Read more»

I agree that a composite organization will be best suited since it allows a company to blend the functional, matrix, and project-based types of organizations to help suit the company requirements. This can also be done in various combinations as…   Read more»

I think that the matrix organization structure would be the best for most companies. It provides a well-balanced structure as the employees have to report to at least two bosses – their functional manager and product manager. It offers more…   Read more»

Proper risk management implies control of possible future events and is proactive rather than reactive. For low severity risks, acceptance or mitigation needs to be done. If the benefit is worth the severity of risk then one can accept the…   Read more»

This is an interesting discussion, thank you for sharing it! I think a major mistake is to assume that one is only looking for extreme and catastrophic risks and therefore overlooking smaller less out there and harmful risks which are…   Read more»

I think PMS is very important for newer devices or those of Class II or higher because these devices tend to be of newer technology where all of the risks can not be covered during the design phase. In order…   Read more»

A successful validation program brings together engineering, manufacturing, regulatory compliance, and quality assurance to develop test solutions that are unique to each application. Developers of medical devices must validate the product design to ensure that it meets the user’s requirements….   Read more»

Verification is the process of ensuring that objective evidence is present and that the specific requirements are met. Any unforeseen side effects that it may have can also be recognized. This early detection reduces potential failure in the field, which…   Read more»

Although I am somebody who has the habit of making notes proactively during a meeting, I think meeting minutes are important just so I can cross-check in case there’s something I have missed out on. They capture the essential information…   Read more»

The benefits of outsourcing the design transfer into the manufacturing process are leveraging multidisciplinary expertise to have breakthrough ideas from other industries and technologies and be able to expand without needing to maintain the technology in-house.  I agree that small…   Read more»

A design specification document (DSD)is a detailed document that provides information about a designed product or process. The design specification must include all necessary drawings, dimensions, environmental factors, ergonomic factors, aesthetic factors, required maintenance, details on performing the work, etc….   Read more»

The different areas of the Design Controls allow for each section of the project to be organized and ensure the product released is of the highest quality. Without design controls, the company is running the risk of their product not…   Read more»

The need for having a clinical background is definitely dependant on the type of role and responsibility. For example, as stated in the question, a statistician for example does not require a clinical background in analyzing or developing code. Saying…   Read more»

Clinical trials are definitely important but there should be no reason to expose a person to such a risky trial. But in most scenarios,  subjects agree to go through these trials willingly because they are suffering from a disease and…   Read more»

Clinical research is of great importance for emerging technological diagnosis and treatment. But like everything else, this comes with its pros and cons.   Pros being that the individual may get promising new treatment methods that are not currently available outside…   Read more»

Companies that offer value propositions to customers and convince them to buy a better product are engaging in persuasion, while companies hiding the weaknesses of a flawed product are engaging in manipulation. I also feel that Emotional intelligence should be…   Read more»

To me, marketing is knowing your customers and targeting your sales pitch to get them to want to buy your product. This includes things like getting advertisements sent by mail or online, commercials/infomercials, or phone calls. But of course with…   Read more»