According to me, every milestone is important for any project. Therefore, any missed milestone will have an impact on a project. The only difference is whether the missed milestone falls under either of these two categories: major or minor. Minor…   Read more»

Design input document states what the product objective and its purpose. Besides the marketing team compiling the document, the whole team, sponsor, and customers also give their input, since the Design input document gives the necessary desires for the products…   Read more»

According to me, to help track the status of the project, one must establish goals and milestone and in order to keep track of this milestone, the manager must hold team minute meetings which provides detail on the project with…   Read more»

As you have mentioned already, combination products are combined drugs, devices, and/or biological products with one another, and are a growing and important category of therapeutic and diagnostic products. Similar to medical devices classification, combination products are also classified into…   Read more»

When it comes to an ideal project team, I believe the project manager must choose the project and its team members wisely. In order to have a successful project, it requires a sponsor, whose project the team is going to…   Read more»

In my opinion, I don’t think it is necessary to have a separate classification for the device as the function of the device is already known in the market or FDA database. If the FDA finds the devices with more…   Read more»

Design Reviews are designed to be checkpoints during medical device product development to ensure the product design is safe, effective, and progressing. In order to have a proper meeting for the design review and a project to move as swiftly…   Read more»

The core of the successful project manager revolved around the interactions of the team and their communications. As a project manager, one needs to communicate with everyone from a team member, to different departments, to physicians, to hospitals administration in…   Read more»

I believe in order to use an unapproved device, Physician’s must understand their role and responsibilities. And also understand when an emergency is to use an unapproved device. For a situation to be an emergency, there must be a life-threatening…   Read more»

Once a product is in the market for the public to use, any unpredictable problems can lead to a recall. However, recalls are always voluntary. Sometimes a company discovers a problem and recalls a product on its own without consulting…   Read more»

For every medical device, whether it involves risk or not, it needs to be regulated by FDA. And the center that regulates the medical devices is CDRH which is the Center for Devices and Radiological Health. They review and approves…   Read more»

A risk management plan is a crucial step in a project. It helps to identify risks and implement a plan to reduce them. It helps the members to foresee risks, identify actions to prevent them from occurring and reducing their…   Read more»

I think quality planning is a critical part of any project in the medical field. It allows an individual to agree on a set of quality targets with your customer. A quality plan helps you to schedule all of the…   Read more»

Certain companies ask an employee to sign an NDA (non-disclosure agreement) in order to protect their trade secrets. The reason being it allows their company to operate at a higher level and less risk. Things you should consider before signing…   Read more»

The difference between the verbal agreements and written agreements is that the written agreement is definitely easier to create, understand, and can be used as a proof to prove to someone or in court when there is a disagreement. While…   Read more»

certainly, I agree with most of the participants in this post regarding Dr. Simon’s class. This is my first time taking the class with Dr. Simon. I am glad I took this course. I found this course helpful, therefore I…   Read more»

We had our first meeting on Friday after the initial meeting where we formed a team. We meet every Friday at 7 pm on Google Hangouts through a conference call to share our perspective status of the project with every…   Read more»

I believe in my opinion, the best way to form a project team would be with people who are more knowledgeable in their department role rather than working with people who you have a better relationship with. The reason being,…   Read more»

I agree with many of the participants in here, matrix organization would be the best option to start my medical device company. There are many reasons, but one of the particular is that matrix organization is a combination of Project…   Read more»

There are several approaches used to manage risk in a project as mentioned by many in here. The fundamental steps for risk management are to establish the goals and context, identify risks, analyzing the identified risks, asses or evaluate the…   Read more»