One often overlooked part of global risk management is that even though the U.S., Canada, Australia, and Japan all endorse ISO 14971, they each interpret it a little differently The FDA focuses heavily on benefit-risk justification, while regions like the…   Read more»

It’s not idea when the project team also handles risk management in cases where the device introduces new technology or unfamiliar clinical use. When engineers are very close to the design, they tend to see the product through the same…   Read more»

I agree zero-risk devices aren’t realistic, but I think the bigger issue is that “acceptable risk” isn’t only an engineering decision, it’s also ethical and practical. Sometimes trying to drive risk to zero can actually create new risks, like adding…   Read more»

Design controls under 21 CFR Part 820.30 basically exist to make sure the device is intentionally designed, proven, and documented step-by-step instead of being developed randomly. Each part plays a different role. Design inputs define what the device needs to…   Read more»

Some examples of device changes that must be controlled include any change that can alter how the device performs, interacts with the user, or impacts safety. For example, changing a material inside a device (like switching to a different polymer,…   Read more»

I think the best way to balance user needs with business limits is to acknowledge that both sides are part of the design problem. In class, we have gone over how the design begins with user needs but that doesn’t…   Read more»

If I were a manager updating design controls, I’d start by improving communication and training before changing any documents or systems. Too often, people see design controls as roadblocks because they don’t fully understand how they fit into the bigger…   Read more»

I think verification and validation can sometimes happen at the same time, especially during prototype testing or early design iterations, but they shouldn’t completely merge. Doing both together can help teams spot issues early and make adjustments before things get…   Read more»

I agree that vague feedback can be hard to use, but I think teams can still learn a lot by watching how customers actually interact with a product instead of just relying on what they say. Observation and prototype testing…   Read more»

I think having a standardized process for handling adverse events is essential, but it should also include build-in flexibility. Each trial is different, and the severity or nature of an event might require a unique response. A clear chain of…   Read more»

I really agree with what a lot of people here have said about the gap between classroom learning and real-world clinical experience. I think spending time in a clinical setting would make a big difference for biomedical engineering students, not…   Read more»

I think another interesting angle that hasn’t been mentioned yet is how the placebo effect can actually reveal the power of patient-clinician interaction rather than just being seen as an obstacle in data collection. In some cases, the way a…   Read more»

To agree with many others, I think the product is overall the most essential part of the four P’s. You can have the best promotion, price, and placement, but at the end of the day it’s the product that goes…   Read more»

If I were to transition out of engineering, I’d probably lean toward marketing, especially since I’m pursuing a business minor. I think marketing would be a great way to blend the technical knowledge I’ve gained through engineering with the creative…   Read more»

I totally agree that the building trust is the biggest part of being a successful sales rep in the medical device industry. These relationships can last for years, and customers need to know they can rely on both the product…   Read more»

Going private can be a good thing for a company like EA that you mentioned because it gives them more freedom to focus on their long-term goals rather than worrying about the quarterly profits they have to post. Without that…   Read more»

I think most people choose an LLC over an LLP because of how much simpler and more flexible it is to manage. My brother actually started his own LLC creating websites for clients, and after talking to him and hearing…   Read more»

I was also shocked when the Professor dropped this fact in the lecture video, 80% seemed really high to me for a medical device. I was talking to a classmate the other day and they were mentioning that at the…   Read more»

From what I’ve read, one of the most common issues during QMS audits is weak traceability, especially when companies can’t clearly connect design changes or complaints back to something they documented. Studies point out frequent findings in supplier management, such…   Read more»

Quality assurance can also make sure Class III devices meet safety standards by focusing on strong documentation and traceability during design and development. Every change and decision should be recorded so that risks can be tracked and then addressed. I…   Read more»