I have experienced a solution to this quality and r&d integration problem. A separate department called "Advanced Operations" assists the R&D team to formulate manufacturing & testing plan...

Technology such as AI can be helpful in developing semi or fully automated quality inspections processes. I think it's important to note that these new technologies also have to get validated themselv...

Quality Assurance is the methods used to ensure a product is suitable for the market. The methods include all of the systems, structures, reviews and evaluations used to meet product requirements. Qua...

I agree that many new medical devices have no business being compared to 40-year-old devices. One of the primary benefits of a 510k is to bypass long and expensive clinical trials. So truly "new" deve...

A physician would likely have a hard time developing their own medical device. The design, development, verification, and validation phases can prove to be very expensive. Depending on the completixit...

The FDA's strict regulations are often based on incidents where the lax of regulations caused harm to the public. The 1902 Biologic Act was instituted after a diphtheria antitoxin caused a Tetanus out...

My first consideration would be how the device interfaces with the human body. A prolong-use device like an implant would have to satisfy far more regulations than the surgical instruments used to the...

Industry research often has the benefit of short term results. With the goal of bringing a product or device to market, research is sought to be completed quickly. Long-term research can also be seen ...

Research in Industry is generally completed faster due to strict deadlines. The time management risks of an industry research project should be accounted for in the planning phase. In Industry, the wh...

From my own experience and from most of the replies on this thread, Microsoft Project seems to be the most popular software. During my undergrad, and even working in the industry, I have found the sof...

Multiple project managers could be a good idea depending on the scope and hierarchy of the project. In a large scale project, large or complicated tasks could be delegated to other managers. It is imp...

Missing a milestone for a project should definitely be considered a failure. Failure to complete tasks on-time stems from poor estimation during the planning phase. Inexperienced project managers migh...

Perhaps I can share my thoughts as a Mechanical Engineering student. When starting my degree, I always had intentions of working in the medical device industry. The fact that BME is a "broad degree" i...

My experience working in the industry is that the projects are goal-oriented. The project team works together to complete these goals and meet the desired specifications. I think the most rewarding be...

Speeding up the approval of medical devices certainly has its benefits. The COVID-19 pandemic has created a dire need for devices such as vaccines and respirators. The dilemma of COVID-19 devices taki...