Gonzalo

Forum Replies Created

RE: Can Product Claims Make Things More Complicated?

As other have mentioned before, I would most likely start with a smaller set of core claims first to secure a faster, lower risk path to market. Afterward, I would expand claims down the road as real ...

In forum Regulatory Basics for Medical Devices

2 months ago
RE: Should AI-Based Medical Devices Require the Same Regulatory Approach as Traditional Medical Devices ?

This is a very interesting discussion post, especially in the direction we are heading into with innovations in AI integrated in medical devices. I personally think that existing regulatory frameworks...

In forum Regulatory Basics for Medical Devices

2 months ago
RE: Are Regulations Helping Innovation or Slowing It Down?

Great points were made in previous responses to the original post about the balance between protecting patients and fostering new ideas. I agree with the original post and Areemoshe that the high cost...

In forum Regulatory Basics for Medical Devices

2 months ago
RE: From Pre-Clinical Research to Human Trials: When Is the Evidence Enough ?

Finances and industry pressure can certainly affect the timing of the clinical readiness of a project. When competitors are fighting within the same market, the pressure to fast-track a product is mas...

In forum Pre-clinical Device Development

2 months ago
RE: Pitching Research in Industry vs. Academia

After undergrad I aim to finish my masters degree while working in the industry. That being said, I expect that the research topic may not necessarily be up to me but rather my employer or manager. Ho...

In forum Pre-clinical Device Development

2 months ago
RE: This vs That

In the context of pre-clinical research, a great argument for research in academia is being able to explore what no one has explored before. Being able to dive into research areas that haven't been ex...

In forum Pre-clinical Device Development

2 months ago
RE: Pressure vs. Safety: A Project Manager’s Toughest Decision

Now that I am months away from joining the industry, I think of these situations since there is a possibility it can occur. Meeting a deadline is never sufficient justification for tolerating safety o...

In forum Intro to Project Management

2 months ago
RE: Manager Vs Engineering

A lot of great points have been made on this thread and I agree with the majority of them. It is always great for the entire project when a project manager has some experience in engineering or in med...

In forum Intro to Project Management

2 months ago
RE: Can a Strong Initiating Phase Prevent Most Project Problems Later?

All previous posts bring up a difficult issue: spending a lot of time in the initiating phase can cause the project to stagnate, and rushing through it may develop major roadblocks down the line. I de...

In forum Intro to Project Management

2 months ago
RE: Discussion Topic: Practical vs. Informational courses

I believe the amount of practical courses offered at NJIT needs to be reevaluated. I always hear from alumni or recruiters that college does not directly prepare you for the industry and I believe tha...

In forum Introduction to Medical Device Development

2 months ago
RE: Making a Difference in Academia vs Industry

Both academia and industry have distinct forms of impact, but I believe fulfillment comes down to not only the timescale in which you see your impact, but also the type of person you are. Not everyone...

In forum Introduction to Medical Device Development

2 months ago
RE: Thoughts on BME degree, "a little of everything"

When I started undergrad I wanted to pursue mechanical engineering, but I always had a passion for medicine and even thought about attending med school. I then discovered biomedical engineering and th...

In forum Introduction to Medical Device Development

2 months ago
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