Hello Roberto, While I understand where Dr. Simon and many of these posts are coming from, I would like to play devil’s advocate and also recount a more negative aspect of meeting minutes. I have found in the past that…   Read more»

In the world of medical devices, I would imagine that companies take corporate responsibilities pretty seriously because patient safety and following FDA regulations are highly crucial. How companies actually commit however, depends on the company itself. Some factors are the…   Read more»

My capstone project focuses on creating a chitosan based sulfated polysaccharide hydrogel for wound healing, specifically aimed at larger cutaneous wounds, including the potential for diabetic foot ulcers. There is a gap in the market regarding diabetic wound care, as…   Read more»

I agree with you that design controls are very important for ensuring the safety and efficacy in medical device development. They help in maintaining the structural approach that aligns with FDA requirements, especially for class II and III devices which…   Read more»

As I worked in research with a Veterans Affairs Hospital, one major incentive outside monetary compensation that was used was access to free medical care or treatments. The offer of free medical evaluations, diagnostic tests, and healthcare services during the…   Read more»

@atk27njit-edu I would disagree that the placebo effect is “all in the mind.” While the placebo effect does rely on expectation, it’s not simply a mental trick played by the mind. This is rather a real phenomenon that is exploited…   Read more»

Coordination during unexpected adverse events in clinical trials is absolutely essential for patient safety and maintaining the integrity of the trial. A standardized, predefined process for assigning responsibility is ideal because it really ensures clarity and rapid response. Each key…   Read more»

@an83 I would have to disagree on your perspective because a business minor can offer valuable skills that actually benefit a student beyond an MBA or entry level role. An undergraduate education does often focus on immediate next steps, but…   Read more»

Some common aspects touched upon for recruiting underrepresented communities for clinical trials were building trust, making the process more accessible, and ensuring the message has some form of relatability and clarity. However, one aspect that is often overlooked is the…   Read more»

The original poster brings up a good point about the marketing engineer role, especially in the medical device industry, as this career path blends technical expertise with the need of strong interpersonal skills and the ability to sell complex ideas….   Read more»

@tamanna While I agree with you that working in a smaller company can offer valuable exposure to multiple areas, I would also like to make note of the downside that being spread too thin across multiple departments can limit the…   Read more»

Having volunteered at a tissue bank before, I see that non profit tissue banks are playing a critical role in public health by focusing on service rather than profit. My favorite aspect about non profits is that generally, their goal…   Read more»

After working with a couple medical device companies, I believe my top requirements do not depend on the notion of public or private, but rather the entirety of benefits offered to me. First, I personally flourish in a place of…   Read more»

I appreciate that the original topic starter had mentioned thinking from the patient’s point of view. I believe this is a highly important notion for the medical device industry. There are standards such as ISO 14971 that allow for risks…   Read more»

@fh28 I agree with your perspective on the importance of diversity as well as varied expertise on an FDA expert panel! This is crucial as each member brings a different background to the evaluation, as every side of a product’s…   Read more»

The most common problem I face as a quality engineer intern are challenges due to document control. In other words, updating procedures, specifications, and records among different teams and ensuring that the correct standards are being followed. This issue also…   Read more»

@dmf2 I respectfully disagree with the notion that the primary responsibility for addressing a damaged label should fall on the store. In my point of view, I believe that the manufacturer is 100% responsible for ensuring their product is properly…   Read more»

Although it is tempting for me to say that post-market management is where the issues arise, I would argue that product development is the single most critical phase in determining a project’s success or failure, as this is where the…   Read more»

@sn64 In addition to these categories, an important comment I would like to make is that  “Voluntary Action Indicated” (VAI) should be taken seriously. They may not lead to recalls but rather they reflect areas where compliance could worsen if…   Read more»

I believe the extent of a professor’s passions in academia and research depends on the individual professor, but often professors have a mix of these motivations. I have had professors who have been deeply passionate about the subject they teach,…   Read more»