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 just like written agreements. The only problem is that they are difficult to enforce in a legal dispute, so I am in full…[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 with skills, review and prioritization of work respectively. In collaborative…[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. More often than not, silos come about because of a conflicted leadership team. The…[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 an organization operates in. It is important to note that poorly designed organizational structures will often lead to inefficient and…[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 to identify risks is through past experience, and this includes both negative and positive feedback.…[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 a point that has been brought forth by Katlin and jnm22. The companies that develop these regulations spend…[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 discuss about a risk, its characteristics, actions that they think can help and those they think…[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, risks to the users, and the costs of meeting the regulatory requirements. To…[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 members to review their progress and discuss a way forward. When evaluating a d…[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 ought to do to meet the requirements. While manufacturers are required to come up…[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 even the most confusing debates. Although most meetings have a minute maker, an individual can decide to take his…[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 are not followed in creating Gantt Charts, then they may not be effective. From experience, I’ve l…[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 to be prepared for the audits conducted by regulatory agencies such as FDA, and this means that they should…[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 sign the form. They should ensure that the people they are obtaining consent from understand the aim of the study and are…[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, and risks of drugs in an effort to ensure that they are safe and can go on the market. Basically, I will be involved in all the…[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 the nature of the tasks carried out. This is an individual charged with the responsibility 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 intends to accomplish. Without vision and mission statements, a company would be d…[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 diseases, diabetes, vascular diseases, and so forth. The three strategic…[Read more]

I agree that social media is the most commonly used marketing platform today. Participation marketing can happen online and offline through social media, in grocery store lines, on blogs, and at events. At the heart of participation marketing, lies engagement, which aims to get the audiences engage and participate in conversations about brands.
A…[Read more]

A major merit difference I have noted in public and private Limited Liability companies is the prestige that comes along with bearing a “PLC” at the end of their name Whether deserved or not, having ‘plc’ at the end of a company name can add standing and prestige. There is a sense of status about a public limited company that its private com…[Read more]