@aca I don’t particularly think there should be an emphasis on patient diversity as clinical trials are meant to be done for the potential population who will utilize the medical device. If patient diversity is emphasized, companies could lose the…   Read more»

@ahmed-elmonier I feel like sometimes one can get away with not involving manufacturing until the later stages of medical device development, but I also feel like they can offer firsthand experience in medical device production. They could help identify practical…   Read more»

I would like to discuss Botswana’s regulatory system as this has not been mentioned yet. Botswana has historically had minimal medical device regulations but is increasingly adding a more comprehensive framework for regulatory. Its regulatory authority is the Botswana Medicines…   Read more»

One example of a medical test that was used in clinical research is the at-home pregnancy test which is a medical device thats regulated by the FDA. These tests detect human chorionic gonadotropin (hCG) which is a hormone that’s produced…   Read more»

I would like to focus on patient monitoring and risks during clinical trials as the other answer focuses on animal testing. Researchers need to regularly monitor patients throughout clinical trials to determine if things are going well or if any…   Read more»

As the other responses defined much of the information regarding good clinical practices, GDP, and also gave a few examples, I wanted to discuss 21 CFR Part 11 which is electronic records and electronic signatures. This part gives the requirements…   Read more»

Yes. I think this is fairly important as developing markets view many medical devices in a much different lens than in the USA. This can be simply access. Marketing as having easy access to the device may be enough in…   Read more»

I feel like a certification would be highly beneficial to an aspiring engineer as this provides proof of knowledge in the business side of things. This can lead a candidate to a potential engineering role to be looked at in…   Read more»

This one is not even direct advertising as I would classify it as indirect advertising. Creality makes some awesome 3D printers, and I love 3D printing. When one gets a product from creality, the product comes with some super awesome…   Read more»

I may be a bit biased, but even if I didn’t help out in my family’s LLC, I would still choose an LLC. They don’t run that much risk compared to a sole proprietorship especially in a lawsuit, and I…   Read more»

In my first internship, I worked at a relatively small private company that was in the middle of restructuring to go public. There was high demand for productivity and output. It was a bit surprising for me, and I felt…   Read more»

As I was pondering the question, I couldn’t help but think that it honestly wouldn’t matter for the average engineer. Engineers, from my understanding, generally have a project to work out and are at the mercy of decisions made by…   Read more»

I have come across many of these experiences in the past, but I want to discuss one instance which I feel fits the prompt quite well. This is referring to my prototyping class as an undergraduate in which we were…   Read more»

Some of these processes include change control. Corrective and preventive actions (CAPA), and post market complaints. In change control, embedded software might need updates once medical devices have been released. These changes need to be controlled and reviewed so that…   Read more»

I’m going to discuss the role of the complaint specialist. Their main responsibility is to receive and document complaints that involve products that are out on the market and review the complaints to see what happened and if there is…   Read more»

I just want to focus on one thing here and that is long-term use. Some products are hard to evaluate after extensive use. Off the top of my head I’m thinking of a grill brush that was recalled after atleast…   Read more»

One thing that I think could fit under this category are certain diagnostic tests that are currently listed as Class III. I think over time, some of these tests should be reconsidered to join Class II. This is because testing…   Read more»

This is genuinely what has made me dislike the FDA. When I interned at a small pharmaceutical company, there were what I felt were obvious biases against the company that I worked for. They didn’t have a lot of money…   Read more»

I think many professors are genuinely interested in teaching. Having a love for research and ones field probably means that they want to leave a lasting legacy for their students and introducing people to an area that they love. This…   Read more»

Overall, I think it would be great to go into academia. I enjoyed academic research far more than industry research. However, the pay difference is too big to ignore. Getting a PhD means relatively low pay for many years, and…   Read more»