I'm somewhat of a step slightly above an entry-level engineer in the medical device industry. For context, I graduated in 2016 with a BS in Biomedical...

I would start by getting some clarification on the statistics of the clinical trial market and minority participation rates in the United States. The ...

This is an important point to make. inclusion of a sales rep from the beginning of a product's planning phase allows the rep to grow with the product....

I would look into the supplier quality agreement structure and inspect that for differences. I would identify differences between the no change clause...

I would definitely go with having a backup vendor for the coating material of the catheter. This would increase the time and the cost of the project, ...

This may be why cross training employees on all tasks toward the beginning of a project is so important. Having someone that can temporarily pick up t...

I think good communication between interacting departments is a critical point when it comes to maintaining the cost of a project. At the company I wo...

What are the threats of being under budget to a project? If you had a planned value for your project would this have reduced the value of the project?

When would a fully functional prototype be a good idea to have before the formal project is even initiated? In the limited number of product developme...

Thank you for clarifying the difference between this and a quantitative variance report used in design controls. In your experience how are the varian...

Great post! I would love to see a sample report you have worked on in the past. This seems like a great way to document the closure of the project. Do...

I work for a hydrophilic coating company for medical devices. It's an early-mid size functional organization. In my department, the projects are mainl...

Hi, I'm a biomedical engineer with about 4+ years of medical device development experience. It's not a lot, but it's enough to have experienced som...