I feel as though many companies are guilty of this to some extent. Maybe they need the product out now for revenue and they feel they can fix what they missed in an update or they feel as though the…   Read more»

Posted by: @rgp29 Hello everyone, I have noticed how Dr. Simon keeps pointing out to importance of taking minutes in all the meeting of the team. I never really thought of how important they are. Before this, when I was…   Read more»

As you said, both have many similarities however there are some differences. Drug trials are testing for safety and tolerability along with pharmacokinetics; medical device trials are mainly checking for the safety and the performance of the device so therefore…   Read more»

Without proper design controls the whole project is in high jeopardy of failing. The product/device can be missing requirements or be built improperly or may even be harmful to the patient its supposed to help. Many injuries, deaths, and lawsuits…   Read more»

@ayomide-o Hi Ayomide! I do agree that there is importance in each of the 9 steps of the design process. I do think that while each part has its own value, what would be one that without it, a device…   Read more»

Posted by: @kbentleymsm-edu Consider the Design Controls lecture that Dr. Simon has made available.   Yes, we know that all parts work together to support the goal of medical device development. What aspect of Design Controls do YOU feel is most…   Read more»

I believe that the project manager would have the most say in the timeline of the project. There is the potential that the project manager’s boss or a higher up executive may have an input, but I believe it ultimately…   Read more»

There are some key differences between Medical Device and Drug Clinical Trials. In most drug trials, therapies are tested on a small group of healthy individuals first, then administered to incrementally larger populations. Medical device trials typically only involve subjects…   Read more»

Animal models to predict human conditions in biomedical research relies on the notion that basic processes are sufficiently similar across species to allow extrapolation. Animal model validity has similarities between the model and the human condition it is intended to…   Read more»

The verification aspect is the most important part of the design control process. This process is a crucial part of the design control process because without the verification process you cannot ensure this is safe for the person using it….   Read more»

Companies may take the wrong approach to metrics if they measure only results obtained over a long period of time (retroactive). An alternative approach is to supplement the standard performance metrics with predictive metrics. This type of metric measures is a driver…   Read more»

All nine parts of design controls are necessary and play an important role in designing an effective product. I believe the most important part is the design input. Input is the first key part of a successful product because it…   Read more»

Minutes are considered an official record of actions on the board or committee took at a meeting. They serve as a historical purpose, also as a legal purpose, documenting the group’s adherence to the proper procedures. When first hearing about…   Read more»

I think that the design verification is the most important aspect of design control. Design verification checks that the inputs match the outputs. It consists of coming up with a verification protocol that includes test for each output. I think…   Read more»

Verification can be defined as the process of establishing the truth, accuracy, or validity of something. Verification can be crucial when it comes to medical devices or any other medical process for the health of a human’s well-being. Verification ensures…   Read more»

Meeting minutes are extremely important and a necessity for effective communication. They serve as a guide for what happened at a meeting and, in the case of a project, can serve as a document that will keep in order who…   Read more»

Great questions @hodafattel! Communication is very important to making sure a project stays on track and also to allow cross collaboration between other groups and teams. At my previous job, we used Microsoft Teams to communicate with each other. Whether…   Read more»

Design controls are used in many other countries, while at the same time there are countries that have little to no regulation on devices at all. Two countries that I would highlight are China and the Central African Republic. I…   Read more»

Usually, project managers prefer the face-to-face communication method, as they have a better opportunity to explain the project status with charts and analysis and get instant feedback, which will help them alter project plans according to the inputs given by…   Read more»