I agree with the idea that having a clear and legally documented plan is crucial for any company’s stability. A lot of you emphasized how important it is, not just for the sake of organization, but to prevent confusion, disputes,…   Read more»

This thread really highlights how broad and serious federal fraud laws are within healthcare. I especially appreciate how several of you broke down the differences between the Anti-Kickback Statue and Stark Law. As many of you mentioned, they often get…   Read more»

Nick, you brought up an important point about NDAs serving a dual purpose, not just protecting the company’s IP, but also creating a clear basis for action if the agreement is breached. I agree that in fields driven by innovation,…   Read more»

I agree with the point others made about communication and authority, but I think the impact of organizational structure goes even deeper, it actually shapes how a project team thinks and behaves. In a functional structure, teams tend to focus…   Read more»

After working in our groups for a couple of weeks, I think a matrix organization makes the most sense for our device development. Even though we were assigned by functional areas, none of our deliverables can be completed completely alone….   Read more»

Working in a matrix organization in the medical device world can feel like The Office: Medical Device Edition, where two managers are giving directions, multiple deadlines that need attention, and meetings about which meeting should have priority. But the structure…   Read more»

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»