@31623940 I think one of the main issues with this approach is that companies could play down the impact of a change, either intentionally or unintentionally. Also without a strict criteria on what is or isn’t considered a large change,…   Read more»

@at644 I like your point about how FMEA gets more effective based on how a company uses it. Using AI and incorporating customer feedback are great ways to add to the capabilities of FMEA. One of the bigger concerns with FMEA…   Read more»

@dcapera I agree that FMEA is best as a cross-functional effort, and your analysis of what teams can contribute in specific ways is very accurate. Engineers know most about design intent, but manufacturing can see failures that engineers would not…   Read more»

I support the idea that red is one of the most common colors in food marketing, and the evidence you provided proves that this is indeed true. Red color is linked to energy, urgency, and excitement, and because of this…   Read more»

I concur with the assertion that the leading medical device is not necessarily the most popular one, and I also believe you are right in your observation about marketing. Good technology is of no consequence if it goes unnoticed or…   Read more»

I am in favor of a business minor as long as it does not impede graduation. Biomedical engineering is an industry that relies on customers, and the ability to speak in terms of costs, risks, and customer needs in interviews…   Read more»

@aca In my opinion, having a tiered second review has merit and is consistent with how regulators view software in quality systems. The greater the impact of the AI tool output on patient safety or product quality, the more scrutiny…   Read more»

@ri62 I would disagree with quality controls being a barrier for innovation, as I believe that if there is no supervision, innovations are impacted even more negatively. In the absence of basic standards, accidents undermine clinician and society trust and…   Read more»

@james-olson I agree that QA is difficult because it is proactive but I would stress that in medical devices QC may not always be a back-up because some processes include barriers, seals, weldings, and sterilization that lead to outcomes that…   Read more»

@ej851996 In my opinion, while the process of getting the FDA’s approval implies that the product might have proven effective and safe, it does not always imply that the product is guaranteed to be safe and that there are no…   Read more»

@ri62 While I agree with the fact that regulations could at times serve as a barrier, I would also add that regulations can shape companies’ priorities regarding innovation. In a field where every device has implications for the safety of…   Read more»

@aca I agree with your point that AI-enabled medical systems don’t need to submit entirely new documentation each time there is an update. I think that the degree to which the system must be tested depends on how substantial the…   Read more»

@lmathis I agree that material selection could make or break a project. Corrosion/wear from the material could cause inflammation around an implant, which harms the patient and may need to be removed. Another factor is elastic modulus mismatch. If the device…   Read more»

@ajm73 I’ve worked in both academia and industry, and there’s been upsides and downsides to both. In academia, the ability to work on complex projects that are very innovative is unmatched. You’re able to work at your own pace, since you’re…   Read more»

@bjv9 I agree, animal models are crucial to the current pharmaceutical environment, and for good reason. With so much risk in evaluating new molecules/treatments, putting human lives in the balance for an idea seems unreasonable. However, there is a lot…   Read more»

@andrewg I agree heavily. While the initiating phase is extremely important, and can build a strong base for a project, investing too much time can derail the realization of the project. Thinking too much about how to do something can…   Read more»

@mmd55 We had a very similar strategy to your teams, where we tried to minimize costs wherever possible to ensure that later oversights would not surpass the allotted budget. However, there were times that we did not go with the…   Read more»

@thuytienlecao I have worked on projects with multiple project managers, and while it seems like having more leadership might be helpful, there have often been miscommunications and complications associated with too much leadership. There were some instances when communication to…   Read more»