This is a really interesting question! In order to successfully complete a project on time, project team must collaborate at a defined frequency and must work collectively to achieve the project goal. In choosing the right people for the team, one must have the required knowledge and the skills to be able to perform well in the project. In…[Read more]

I believe my organization is consider to be Matrix Organization, but also overlaps with the functional organization. We have a CEO, followed by Group President, who oversees multiple medical divisions including Orthopedic, Trauma & Extremities, and Spine. Each individual medical division has a functional head, president. We have multiple…[Read more]

My company also uses the FMEA (Failure Modes Effects Analysis) technique to evaluate the risk associated with the medical device or production process for risk assessment. It is a process to identify all possible failures during all stages of design controls. Failure is any defect of the device or any error that may potentially harm the patient…[Read more]

This is an interesting topic for discussion! I agree with Dr. Simon that labeling or putting a warning on the package is not a direct way of mitigating risk. There are Instructions for use, also known as IFUs, which surgeons use as a guide for the surgery. In the real world, I don’t think this happens as the surgeon must be already trained to t…[Read more]

I agree with most of the participants on the above post. ISO 14971, major regulation detailing the Risk Management Requirements for Medical Devices. Medical device manufacturers must have a good understanding of Risk Management Process including the Risk Management Plan should be part of the Quality Management System to obtain the ISO…[Read more]

This is an interesting discussion topic! In the medical device industry, it is very critical to have the most up to date DHF as the project moves forward with different phases. Many medical device companies have internal audit program, part of the quality system that can help the company identify any gaps and remediate immediately. If the…[Read more]

I agree with most of the participants in the above posts. During my senior design class at NJIT, I learned more about the requirement and the test method documents and its importance. My professor constantly stressed every class that the requirement and the test plan document must be “idiot proof” and easy to understand. Requirement doc…[Read more]

I do not have an experience with design review meetings in the industry, but I will share my experience participating in the design review meeting for my senior design project. A couple of weeks before the design review, each of us had to read the other team’s requirements document for their project and comment on how to make it better. During t…[Read more]

This is an interesting question. I agree with most of the participants that depending on the device classification, EU regulatory looks at the device development in the Tech File. While, in the US, Design Controls such as DHF and DMR are required by the notified bodies such as FDA. It is beneficial for the medical device companies in the US…[Read more]

This is an interesting question! I agree with most of the participants that depending on the device classification, EU regulatory looks at the device development in the Tech File. While, in the US, Design Controls such as DHF and DMR are required by the notified bodies such as FDA. It is beneficial for the medical device companies in the US…[Read more]

This is an interesting question! I agree with most of the participants that having clinical background is a plus, but again it depends on the type of role within the CRA profession. For example, Statistician might not need as much medical background as Principal Investigator because they are mostly working with the data and analysis. Principal…[Read more]

I agree with most of the participants in the forum that clinical studies/trial comes with a risk and a side effects. However, it is crucial for the researchers and doctors to perform these clinical trials to determine the effectiveness of the new drug or medical device. As we learned from this week lecture, that prior to signing up for the…[Read more]

This is an interesting question. In my opinion, when recent graduates apply for the positions in the related field, they do not necessarily look whether the company is Limited Liability Company vs Corporation. In today’s world, it’s very challenging to land a job without having internship or co-op experience. Furthermore, for recent college gra…[Read more]

If given the choice to open my own business, I would file my business as Limited Liability Company (LLC) over a Corporation. There are many reasons in terms of Taxes, Business Ownership, and Business Operation. In an LLC, one has the flexibility on how to file taxes. Unlike, corporation, LLC’s is treated as single taxation. On the other hand, in a…[Read more]

Privately owned companies are privately held. This means that the company is owned by small group of people, or private investor. On the other hand, in public company, there are shareholders that claim to be a part of the company’s assets. One of the biggest difference between public company and private company is that public company is required t…[Read more]

Privately owned companies are privately held. This means that the company is owned by small group of people, or private investor. On the other hand, in public company, there are shareholders that claim to be a part of the company’s assets. One of the biggest difference between public company and private company is that public company is r…[Read more]

This is an interesting question. In my opinion, when recent graduates apply for the positions in the related field, they do not necessarily look whether the company is Limited Liability Company vs Corporation. In today’s world, it’s very challenging to land a job without having internship or co-op experience. Furthermore, for recent college gra…[Read more]