Something that I have learned working as an intern is an MSA, or more specifically a Gage R&R study, in which a measurement system, in which our case was a tool used for pull force testing our pro...

I work in a medical device company that manufactures surgical products and one of the main problems we have is when we scrap more material that we need to because the whole process that was fully opti...

The quality of the medical device needs to be ensured to protect the patient's health which is why there is a difficult regulatory landscape for this. And this is made harder because during an phase o...

We learned from this week that corporation can be considered as a moral entity so it receives the blame/praise instead of the people running the corporation. Should this be allowed? Currently, since ...

All of the profit margin depends on the type of product that a company is selling. If the device is something that is fairly conventional, these products are treated like commodities so their profit m...

I work at a medium-sized medical device manufacturing corporation company and I believe that you will definity gain more experience and learn more working at a smaller company than compared to a large...

Technology does not limit or inhibit the regulatory procedure but enhance and streamline it so that information/forms can be submitted digitally so that there is effective and expedited communication ...

@gdecarvalho22 You have brought up some good points that transparency of data would lead to a more thorough evaluation and benefit both companies seeking FDA approval and the public but there are pot...

We know that a large sum of the money(about 70%) for the FDA comes from the user fees paid by pharmaceutical and biotechnology companies. These fees are paid by companies when they submit applications...

With regards to entering a R&D into industry, these individuals usually need a Master's/phD to obtain a job in industry and there are many skills that is needed. First and foremost is knowledge or...

The cost of dental implants and other medical devices are especially high because the prices are set by the insurance companies that sell them. Sure there are its associated manufacturing, R&D, re...

Balancing both insight from research and the testing method ethics is a complex challenge that every researcher in both academia and industry has to maneuver to maintain both scientific rigor and get ...

It is definitely important to assess the diverse skillset of a team before initiating a project. Most of what project management is is getting work done by time and delivering it to the customer so a ...

Getting a job as a project manager is definitely not easy. It is a dynamic and challenging role that requires long work hours(about 50 hours a week), rich background skills/experience with engineering...

Most people in this discussion have mentioned many soft skills that a project manager should embody but I believe that the project managers that are set apart are ones with technical engineering skill...