The communication between Quality Assurance and Quality Control is really important because even though they have different responsibilities, they are still working toward the same goal. I think one way to improve communication is by having both departments communicate regularly…   Read more»

I think AI medical devices make regulation more complicated because the technology can change over time. With a regular device, the company can test the product and know what the device is supposed to do. With AI, an update or…   Read more»

The 510(k) pathway can make the process easier for devices that are similar to something that is already on the market. It makes sense that a company should not have to start from scratch if there is already a similar…   Read more»

I agree that Regulatory Affairs is much more involved than just handling paperwork. I also thought they mostly dealt with the paperwork and approval part, but it makes more sense that they are involved from the beginning because decisions made…   Read more»

Medical device development has a lot of steps and requirements, and I think each phase is important for making sure the final device is safe to use. I didn’t realize how many different parts of the process have to be…   Read more»

I agree that biocompatibility is really important because even if a device works well, it still needs to be safe for the body. Personally, I think starting with materials that are already well known would be safer, especially when the…   Read more»

I agree that funding is a key part of research. I also think passion is what makes people want to keep working on a problem, but without the money and resources, it can be very hard to turn an idea…   Read more»

I agree with you that quality and risk management need to be considered throughout the project, not just at the end. It would be difficult to wait until the final stage to find out that something does not meet the…   Read more»

I agree with you that communication and staying calm are really important qualities for a project manager. I think both organization and motivation matter, but if I had to choose, I would probably say motivation is a little more important….   Read more»

I agree with you that planning is important, but I don’t think a project needs to have every single detail figured out before the team starts. Sometimes you can plan something really well and still run into problems that you…   Read more»

I think both academia and industry have good opportunities, but they are different depending on what someone wants from their career. One advantage of working in academia is that you can spend more time learning, doing research, and focusing on…   Read more»

I think using digital healthcare has made healthcare more accessible in a lot of ways, especially after COVID-19. Being able to have an appointment through a phone or computer can be very helpful for people who have a hard time…   Read more»

I prefer working on-site because I have been working in on-site positions for more than six years, and honestly, I don’t see myself working remotely. I like being able to communicate with people in person, keep my work and personal…   Read more»