@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...

@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 ...

@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 manufact...

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, a...

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 cons...

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 custo...

@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 pr...

@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 standa...

@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, an...

@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 sa...

@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 dev...

@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 de...

@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....

@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 ab...

@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 fo...