Medical Device Courses | Gonzalo | Activity

Gonzalo replied to the topic "Why Packaging and Labeling Matter in Medical Devices" -

Mon, 09 Nov 2026 02:18:02 -0500

As previous posts have stated, packaging and labeling are just as important as the medical device itself. One aspect I would add is that packaging should also be considered throughout the entire lifecycle of a device and not just during… Read more»

Gonzalo replied to the topic "When meeting the Spec is not Enough: Verification vs. Validation" -

Mon, 09 Nov 2026 02:02:42 -0500

I think one of the biggest challenges is that engineers can sometimes focus too much on meeting the technical requirements that they overlook how the device will actually be used in a real-world environment. From speaking to engineers in the… Read more»

Gonzalo replied to the topic "When Should Engineers Stop Improving a Medical Device ?" -

Mon, 09 Nov 2026 01:42:05 -0500

I agree with both responses that safety and reliability should remain the priority, especially because even minor design changes can introduce risks that were not present in the original device. I also think that another important factor to consider is… Read more»

Gonzalo replied to the topic "Incentives for Clinical Trial Participants" -

Mon, 26 Oct 2026 01:18:58 -0400

One of the best ways to attract participants besides money is to make the study more convenient and provide them with benefits. For example, offering transportation reimbursement, flexible appointment times, or even virtual follow-up visits could encourage more people to… Read more»

Gonzalo replied to the topic "Can AI Replace Human Participants in Clinical Trials ?" -

Mon, 26 Oct 2026 01:02:55 -0400

AI assisted virtual trials could be useful during the early stages of medical device development but I would not feel comfortable using a device in a hospital if it has only been tested virtually. One thing I think AI could… Read more»

Gonzalo replied to the topic "Double Blind Vs Single blind Study" -

Mon, 26 Oct 2026 00:48:49 -0400

I understand the argument that a single blind study should be enough, especially if the investigator has no intention of influencing the results. However, I think double blind studies are important because bias can happen unintentionally. For example, in an… Read more»

Gonzalo replied to the topic "Understanding Customer Needs in Medical Device Marketing" -

Mon, 19 Oct 2026 03:59:15 -0400

I think medical device companies can make sure they are meeting actual needs by focusing on three things. First, they should communicate directly with physicians and patients to understand the challenges they face and what improvements they would like to… Read more»

Gonzalo replied to the topic "The Four Ps of Marketing for Medical Devices" -

Mon, 19 Oct 2026 03:55:16 -0400

I think price has the greatest influence on whether a hospital adopts a new medical device because hospitals have to consider their budgets and whether the benefits justify the cost. Even if a device is more effective than existing options,… Read more»

Gonzalo replied to the topic "Advertising" -

Mon, 19 Oct 2026 03:41:36 -0400

Advertising is a crucial component of marketing, however memorable ads are subjective and highly depends on each persons interests. The most memorable ads are those that increase the value of a company or brand. Nike’s “Just Do It” ad campaign… Read more»

Gonzalo replied to the topic "80% margin" -

Mon, 12 Oct 2026 01:50:16 -0400

I was also surprised after hearing the 80% statistic in this weeks lecture. There are a lot of great points in this discussion thread regarding the ethics behind shelving a medical device just cause it won’t generate the necessary profit…. Read more»

Gonzalo replied to the topic "Ethics of Corporation considered as an entity" -

Mon, 12 Oct 2026 01:14:24 -0400

The aspect of limited liability is something that has always bothered me about corporations, especially those whose leaders and/or decision makers get no punishment after harming the public. Corporations with limited liability set a dangerous ethical environment for the company’s… Read more»

Gonzalo replied to the topic "Switching Between Types of Business" -

Mon, 12 Oct 2026 00:44:31 -0400

I was intrigued by this discussion thread because I know very little about the business side of medical device companies and this weeks lecture helped me better understand it. From what I learned, it comes down to saving money on… Read more»

Gonzalo replied to the topic "AI vs Human Judgment in QA : Who Makes the Final Decision ?" -

Mon, 05 Oct 2026 03:52:21 -0400

Like most other posts, I believe that the final decision should be made by the QA professional. From what I have learned, AI tools are increasingly being used in medical device companies, specifically in quality related activities but mostly as… Read more»

Gonzalo replied to the topic "Who Should Be Responsible for Quality: Engineers or Dedicated QA/QC Teams?" -

Mon, 05 Oct 2026 03:31:34 -0400

I think the original post is phrased in a way where we have to pick which option is better and dcapera does a great job of breaking down the differences between each role and their contribution to the medical device… Read more»

Gonzalo replied to the topic "Quality Assurance vs. Quality Control" -

Mon, 05 Oct 2026 03:06:37 -0400

I agree that companies may be more likely to focus on QC because catching defective parts gives an immediate measurable result while the benefits of QA are harder to see since they involve problems that never happen in the first… Read more»

Gonzalo replied to the topic "Can Product Claims Make Things More Complicated?" -

Mon, 28 Sep 2026 02:30:41 -0400

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 world data accumulates…. Read more»

Gonzalo replied to the topic "Should AI-Based Medical Devices Require the Same Regulatory Approach as Traditional Medical Devices ?" -

Mon, 28 Sep 2026 02:10:58 -0400

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 are not sufficient for the regulation of AI powered medical… Read more»

Gonzalo replied to the topic "Are Regulations Helping Innovation or Slowing It Down?" -

Mon, 28 Sep 2026 01:49:33 -0400

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 costs and long timelines can feel like a… Read more»

Gonzalo replied to the topic "From Pre-Clinical Research to Human Trials: When Is the Evidence Enough ?" -

Mon, 21 Sep 2026 03:59:40 -0400

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 massive. A previous post mentioned how we can never… Read more»

Gonzalo replied to the topic "Pitching Research in Industry vs. Academia" -

Mon, 21 Sep 2026 03:34:30 -0400

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. However, I would like… Read more»

Gonzalo replied to the topic "This vs That" -

Mon, 21 Sep 2026 03:08:15 -0400

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 explored does not only take great… Read more»

Gonzalo replied to the topic "Pressure vs. Safety: A Project Manager’s Toughest Decision" -

Mon, 14 Sep 2026 03:42:40 -0400

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 or regulatory risks. Harming customers or patients… Read more»

Gonzalo replied to the topic "Manager Vs Engineering" -

Mon, 14 Sep 2026 03:18:10 -0400

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 medicine, and… Read more»

Gonzalo replied to the topic "Can a Strong Initiating Phase Prevent Most Project Problems Later?" -

Mon, 14 Sep 2026 02:14:16 -0400

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 definitely agree that companies sometimes… Read more»

Gonzalo replied to the topic "Discussion Topic: Practical vs. Informational courses" -

Sat, 05 Sep 2026 22:31:02 -0400

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 that’s something NJIT can and should… Read more»

Gonzalo replied to the topic "Making a Difference in Academia vs Industry" -

Sat, 05 Sep 2026 20:08:15 -0400

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 is meant to work… Read more»

Gonzalo replied to the topic "Thoughts on BME degree, "a little of everything"" -

Sat, 05 Sep 2026 18:43:35 -0400

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 thought it was a great way to merge both…. Read more»