As mentioned by multiple people above, close to 100% transparency is required. However, I do not necessarily agree that transparency is requried in the pre-clinical phases of product development; only the trials of the released prototype should be made public….   Read more»

What is most important to address is that most physicians, while possessing an exceeding amount of knowledge in clinical practice, which may inspire their development of a medical device, they often lack the technical expertise necessary to create a medical…   Read more»

As a student, I believe that the two approaches to research, academia and industry, each have their own merits and drawbacks. In academia, research tends to be more fundamental and exploratory, focused on advancing knowledge and fostering collaboration across institutions…   Read more»

I agree with the previous commentor: MSA is critical to making sure that you are providing exactly what you said you would. Without MSA, there would be no consistent or reproducible data to show that your device should be on…   Read more»

I agree with most of the commentors here saying that a company needs to be 100% transparent with the FDA. It’s for the safety and efficacy of the device coming to the market and it is 100% necessary to avoid…   Read more»

Although not entirely ideal, I believe the FDA handled the vaccine rollout in the best way they could. A big component of getting people vaccinated was fighting against misinformation, which is always an uphill battle. Misinformation can spread easily and…   Read more»

As a student, I’ve learned that whether missing a project milestone is seen as a failure or a success in terms of improving the overall project depends on several critical factors. First and foremost, the reason behind missing the milestone…   Read more»

As a student, it’s evident that project management serves as the cornerstone for achieving successful outcomes. To bolster my prospects as a future project manager, I’ve learned about several valuable project management certificates. These certifications, including the Project Management Professional…   Read more»

As a student, I’ve come to understand that the stakeholder who would be most affected by the abundant success of a project is unquestionably the project sponsor. This person or organization provides the crucial financial and resource support that drives…   Read more»

Academically speaking, I would prefer to be overqualified for my job. In the short term, this would likely lead to a smoother and more confident start in the position, as I would possess the necessary skills and knowledge to excel…   Read more»

The challenges that a physician would face in trying to create a medical device is that they may not have experience with design controls, such as understanding how to develop design inputs, outputs, verification, and validation. Additionally, the physician may…   Read more»

As a student, I can definitely attest to the immense impact of having a positive and supportive relationship with a teacher. When I feel that my teacher genuinely cares about my progress and well-being, it fosters a sense of trust…   Read more»

An example of a combination product is an auto-injector. An auto-injector contains a pre-filled syringe and the device releases a plunger that contains a spring when activated to inject the drug product into the patient. Auto-injectors can be used to…   Read more»

Over the course of the last year, the FDA recalled Smiths Medical’s Computerized Ambulatory Delivery Device pump, which is a combination product which delivers a drug at a programmed time and dose. This device was recalled due to issues with…   Read more»

I personally believe that the transition to digital healthcare has significantly increased healthcare accessibility, especially in response to the COVID-19 pandemic. Before the pandemic, many individuals were hesitant about utilizing digital healthcare services. However, the pandemic compelled numerous people to…   Read more»

I used to think that FDA-approved drugs were completely safe, but after seeing the endless lists of side effects in drug commercials and hearing about FDA-approved drugs that were later recalled, I’m not so sure. This raises the question: Does…   Read more»

Yes, the FDA does currently regulate e-cigarettes as tobacco products. This means that e-cigarette manufacturers must adhere to specific regulations, including restrictions on sales to minors, and the FDA has authority over various aspects of e-cigarette production and marketing. When…   Read more»

In no way are FDA rules too strict. Although many manufacturers and pharmaceutical suppliers may face difficulty in bring thir products to market, this ensures that the medical products released to the market cannot cause undue harm to members of…   Read more»

I come from an engineering background, and the idea of transitioning to a regulatory role did cross my mind. What attracted me to this possibility were the broader perspectives it could offer. As an engineer, I was primarily immersed in…   Read more»

I think it is dependent on a case by case basis. In my experience, I have met professors that are inclined to research, or a combination of both. There may be a professor who is content with simply presenting lecture…   Read more»