The most valuable asset that every business has is its secrets. In this era where your competitor can get your secrets and outsmart you in performance, NDAs come in handy. They provide protection in the event that prospective relationship with…   Read more»

This is a good question for discussion, Roberto. I agree with zmh4 that if two people are out to discuss business, then it should only be about business. However, some issues can come up, and an uninvited or invited party…   Read more»

I agree with cef3 that verbal contracts are difficult to defend in courts in case a dispute comes up between the two parties to an agreement. This, however, does not mean that verbal contracts are not binding. They are binding…   Read more»

I agree with smk45 that matrix organizational structure is the most ideal for collaboration projects. Staffers in a matrix organizational structure report to a product line manager and a functional manager who determines the direction on product offerings and help…   Read more»

Silo mentality refers to a mindset present when sectors or departments are not willing to freely share information with other members in the same organization. It is not a coincidence that most organizations are constantly faced with interdepartmental turf wars….   Read more»

I agree with Anthony Monaco that the choice of an organization structures depends on the size of the company. I must also add that the type of structure chosen also depends on the aims and the type of industry that…   Read more»

I agree with ds654 that the full project team should be actively involved in the process of risk identification and that every contribution of each member should be well-documented whether other members consider it significant or not. The best way…   Read more»

This is a pretty good topic for discussion, sdl3. You see, these regulations are developed by other companies to help others be compliant. They are basically doing a service to others companies by ensuring that they remain compliant. This is…   Read more»

I agree with markabdelshahed that a risk management meeting starts with the project manager sending a meeting invitation to all the attendees ahead of time so that they prepare themselves adequately for the meeting. Usually, the attendees would want to…   Read more»

Verification is the process of ensuring that objective evidence are present and that the specific requirements are met. This process is usually done by inspections, tests, and in some instances analysis. I agree with merzkrashed that verification reduces commercial risks,…   Read more»

I agree with you that design meetings facilitate communication between the parties involved such as management, design team, and the customer. Although I don’t have experience with design review meetings, I understand, from research, that they are critical for the…   Read more»

One of the most problems common with design controls is that medical devices companies put emphasis on following the regulation rather than understanding the intent. For instance, some of the regulations are vague and contain scant details about what manufacturers…   Read more»

I agree that meetings are important, but often many people do not see their importance. Taking minutes in a meeting requires skill, especially since the minute taker has to follow what the people in the meeting are saying and document…   Read more»

Gantt Charts are useful in this industry, particularly since they describe and monitor all types of projects being carried out. I agree with your bullet points about the factors to put into consideration when preparing Gantt Charts. If those points…   Read more»

A Design History File (DHF) is part of a regulation that established new standards for medical devices. In the event of an audit by a regulatory body, you will need to provide information from the DHF. Medical design companies need…   Read more»

While obtaining a signature on an informed consent form is crucial, it is just but a step in the process of obtaining informed consent. As such, researchers should not put a lot of focus and emphasis on making the people…   Read more»

I would opt for the role of a Clinical Research Associate (CRA) if I were to take part in a clinical research. With this role, I would be responsible for running clinical trials so as to test the effectiveness, benefits,…   Read more»

I agree with amandaally1029 that the necessity of a clinical background depends on the role that one decides to follow. I would say that roles such as Principal Investigator in clinical research, for instance, requires a clinical background because of…   Read more»

A mission statement defines a company, its business culture, brand identity, and what the company currently achieves. A vision statement, on the other hand, is a blueprint for success. This statement should clearly indicate the company’s aspirations and what it…   Read more»

The company that I focused on is Medtronic, Inc., a medical technology company. This company specializes in manufacturing, development, and marketing of medical devices as well as services and therapies for use in treating chronic ailments like spinal conditions, heart…   Read more»