Medical Device Courses | ed273 | Activity

ed273 replied to the topic "Customer Needs and Design Input" -

Mon, 09 Nov 2026 03:12:12 -0500

I think both the DID and DSD are important since they provide different information needed for the medical device. The DID gives the general idea of what the device needs to accomplish, while the DSD are the requirements the engineers… Read more»

ed273 replied to the topic "What are Design Controls?" -

Sun, 08 Nov 2026 22:30:25 -0500

I agree that design controls do make things more complicated in the development process, as there is more documentation and testing that is needed. Documentation, at the end of the day, saves time and resources in the long run. At… Read more»

ed273 replied to the topic "The importance of design changes and documentation" -

Sun, 08 Nov 2026 21:56:57 -0500

I think any design change has to be documented. An example I can think of is when even changing the angle of one component can impact how many of that component can be accepted when it is manufactured. If the… Read more»

ed273 replied to the topic "The Role of Different Users in Device Development" -

Mon, 02 Nov 2026 01:47:12 -0500

I agree that the term “user” is a wide range of people; many of us first think it pertains to the patient only, but it applies to healthcare professionals who will be using the device. I think one way a… Read more»

ed273 replied to the topic "Why user needs should come before designing a medical device" -

Mon, 02 Nov 2026 01:06:15 -0500

User needs are one of the major and important steps before developing a medical device. The device has to consider what the customer needs, as that is how they can sell their device. If there is no market, then the… Read more»

ed273 replied to the topic "How Many Design Reviews Are Enough?" -

Mon, 02 Nov 2026 00:10:20 -0500

I believe having multiple design reviews is more important throughout the development of a medical device than just having one. One factor in how many design reviews a device should have is based on the class I-III, complexity of the… Read more»

ed273 replied to the topic "Double Blind Vs Single blind Study" -

Mon, 26 Oct 2026 02:40:40 -0400

Based on what we have learned and even reading other posts, double-blind studies are deemed more beneficial than single-blind studies because they help reduce bias. The double-blind studies reduce bias from the patient and investigators therefore there are no chances… Read more»

ed273 replied to the topic "Benefits for Patients in Clinical Research" -

Mon, 26 Oct 2026 01:16:38 -0400

Patients who participate in the clinical trials should receive some form of compensation. The patients are taking time out of their day and taking risks. As mentioned previously in other discussion posts, is that particpanting in these clincal trials can… Read more»

ed273 replied to the topic "Can AI Replace Human Participants in Clinical Trials ?" -

Mon, 26 Oct 2026 00:28:48 -0400

AI can be useful in the clinical research field, but it can never replace human participants. The human body is so complex that we truly do not understand every single thing that happens plus every human body is so different… Read more»

ed273 replied to the topic "Is the Best Medical Device Always the Best Selling Product ?" -

Wed, 21 Oct 2026 14:17:28 -0400

No, I don’t think the best medical device is always the best-selling product. It depends on the promotion of the product, customer needs, and how often it is really being used. A medical professional might still use a different product… Read more»

ed273 replied to the topic "Brand Coloring" -

Wed, 21 Oct 2026 13:12:19 -0400

Brand coloring is important and I have noticed many medical brands use blue and white or red and white. On the top of my head we have Medtronic, Abbott, Pfizer, Amgen, and Roche and for red we have Johnson &… Read more»

ed273 replied to the topic "Brand Coloring" -

Wed, 21 Oct 2026 13:06:34 -0400

ed273 replied to the topic "Importance of building TRUST as a Sales Rep" -

Wed, 21 Oct 2026 12:40:23 -0400

I agree building trust is so important as a sales rep for a medical device or medication. Since these medical devices affect patients health and lives. Sales rep help inform medical professionals with new studies done with the medication, intended… Read more»

ed273 replied to the topic "Public vs. Private" -

Mon, 12 Oct 2026 03:29:18 -0400

I believe there is a difference between public and private but it does not stop innovation. At the end of the day, it is a company that needs to make profit. Therefore, any company whether it is private or public… Read more»

ed273 replied to the topic "Accepting job based on company." -

Mon, 12 Oct 2026 03:20:45 -0400

I would not turn down a company based on their type of business structure they run. As someone who is graduating in a few weeks, getting experience is important but it is in someones best interest in researching about the… Read more»

ed273 replied to the topic "First Job: What type of company to choose?" -

Mon, 12 Oct 2026 03:08:57 -0400

Based on my experince so far in the industry as an intern and co-op, I have preferred in being in a mid-larger size company. In a larger company, there is more often resources that allow to grow and learn new… Read more»

ed273 replied to the topic "Emerging technologies and QA" -

Tue, 06 Oct 2026 00:33:38 -0400

To be able to keep up with the changes in technology, is by being knowledgeable about them. QC should be aware of technologies that could help them, and higher-ups are in charge of doing all the training or creating training… Read more»

ed273 replied to the topic "Relation of Quality with other department." -

Mon, 05 Oct 2026 13:26:16 -0400

In my prior experience, quality and R&D would often work with one another. One way my company worked with one another was by having meetings set up to touch base every week on the progress of the device and documentation…. Read more»

ed273 replied to the topic "Can Too Much Quality Control Slow Down Innovation?" -

Mon, 05 Oct 2026 13:18:50 -0400

Innovation would be slowed down by QC but it is necessary. I would also not say it slows down by so much since QC helps question the innovation itself. One could ask the innovator why use this material if you… Read more»

ed273 replied to the topic "FDA biased?" -

Sun, 04 Oct 2026 18:44:30 -0400

I do not think the FDA is biased but it does raise concerns since money is involved. The money that the FDA gets from applications is there to help review the applications. However, I think it is difficult to discredit… Read more»

ed273 replied to the topic "Predicate Devices and the 510(k) Process" -

Sun, 27 Sep 2026 23:58:21 -0400

I believe the 510(k) pathway helps create devices without going through the Class III medical device process. Many companies try to avoid Class III because it takes time and money to be able to do all the testing and paperwork…. Read more»

ed273 replied to the topic "Should AI-Based Medical Devices Require the Same Regulatory Approach as Traditional Medical Devices ?" -

Sun, 27 Sep 2026 23:49:45 -0400

I believe like others have mentioned that AI based medical devices do not need to re-submit paperwork for every update. The company is liable for the updates and how it can effect their device. Companies should be required to maintain… Read more»

ed273 replied to the topic "Pressure vs. Safety: A Project Manager’s Toughest Decision" -

Mon, 14 Sep 2026 22:29:13 -0400

A project manager is to balance the project timeline based on the projects needs and issues. The patients safety is always the first concern as there are many blocks if the problem is not solved. The main one is the… Read more»

ed273 replied to the topic "Exceeding the budget" -

Mon, 14 Sep 2026 22:11:21 -0400

While, I have never been in a budget meeting before. I assume the higher ups decide what is the worth of this project to their portfolio and how much shareholder will this project give them. An example is if a… Read more»

ed273 replied to the topic "Multiple Project Managers for one project" -

Mon, 14 Sep 2026 22:05:23 -0400

I have worked on a project that had only one project manager. The projects in my internship had always one project manager but also a project lead. As a our project manager could be managing mulitple projects therefore the project… Read more»

ed273 replied to the topic "Co-Op / Internship Experience" -

Tue, 08 Sep 2026 00:11:12 -0400

I believe having the experience of a co-op or internship really helps the applicant check out in the application pool. In my experience there was a difference between my resume having the co-op+ internship vs not having it done prior…. Read more»

ed273 replied to the topic "Thoughts on BME degree, "a little of everything"" -

Tue, 08 Sep 2026 00:11:11 -0400

I agree to an extent how Biomedical Engineering is a little bit of everything. As our first two years at NJIT, we had to take courses on each speciality to understand how each one works within the field. But, we… Read more»

ed273 replied to the topic "Is AI going to control the medical Industry ?" -

Tue, 08 Sep 2026 00:11:10 -0400

As many mentioned prior, AI will not “control” the medical industry but it will play a role in how jobs will be done. In my past internship, the managers wanted employees to use AI to help speed up researching, data… Read more»