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James Saleh
@james-saleh
Active Member
Joined: Sep 5, 2025
Last seen: Sep 28, 2025
Topics: 0 / Replies: 12
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RE: FDA on Recalled Items

FDA approval does not always mean a device is truly safe. There have been high profile cases, such as metal-on-metal hip implants and implantable card...

6 days ago
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RE: Does the FDA guarantee safety?

The FDA plays a critical role in safeguarding public health, but I don’t think FDA approval equates to an absolute guarantee of safety. Approval means...

6 days ago
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RE: Discussion Topic: Make a few, sell a few

Many startups or academic teams can design and prototype a device that works in a lab or even in a small clinical pilot, but scaling production while ...

6 days ago
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RE: Animal Diversity in Pre-clinical Research

Animal variety can play a major role in the reproducibility of preclinical research, both positively and negatively. On one hand, relying on a single ...

2 weeks ago
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RE: What Is the Biggest Challenge in Pre-clinical Device Development?

From my perspective, the biggest challenge in pre-clinical device development is navigating the organizational and approval process. Scientific questi...

2 weeks ago
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RE: Ethics of Animal Testing

I believe animal testing in medical research is increasingly hard to justify, especially with the alternatives available today. While animal models ha...

2 weeks ago
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RE: Which feature is the most important for a project manager?

I think one of the most important features of a project manager is the ability to adapt and really understand both the situation and the team. Every p...

3 weeks ago
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RE: Milestones Missed: Failure or Success?

From my perspective, missing a milestone is not automatically a failure and depends on the context. In one of my biomedical projects, our team was dev...

3 weeks ago
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RE: Manager Vs Engineering

I think the best team dynamic for a medical device project is one where engineers and managers operate with mutual transparency and respect for each o...

3 weeks ago
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RE: Thoughts on BME degree, "a little of everything"

I can definitely relate to the idea of BME feeling like “a little of everything.” In my own experience, that has actually been one of the biggest stre...

4 weeks ago
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RE: Thoughts on BS, MS, and PhD in BME

In my experience, many major companies and even smaller companies require a MS at minimum with additional experience. A BS in BME is a great foundatio...

4 weeks ago
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RE: Is AI going to control the medical Industry ?

I do not think AI is going to completely control the medical industry, but it is definitely going to become a major part of it. In my own experience w...

4 weeks ago