I think compensation should also consider the scenario that a participant cannot complete a trial. For example, a participant might experience severe side effects and decide to withdraw, or the doctor might conclude that it is not safe for a…   Read more»

I think an important factor in building trust is letting participants know that they can withdraw from the study without feeling guilty or worried that there will be consequences. Some people might feel pressured to continue a study even when…   Read more»

One thing to consider is if people will actually buy the placebo when there is the cost-free option of recovering. If people know its a placebo, they might not buy it because it will be a waste of money. Even…   Read more»

I think it depends on what the physician is being paid for. I think that physicians should be paid for their expertise when they are helping develop a device or are providing their facilities for testing. This is because they…   Read more»

One thing I have learned from capstone this semester is that creating customer needs is an important aspect in addressing the actual needs of physicians and patients. These are creating by interviewing surgeons and other involved healthcare professionals, observing procedures,…   Read more»

I think product has the greatest influence on whether a hospital adopts a new medical device because the product in general and the benefits it provides in improving patient care is very important. The reason someone would buy this depends…   Read more»

I think you brought up a good point of having a good balance between protecting people who start businesses and also holding leaders accountable when their decisions put patients at risk. I think that leaders should be held to a…   Read more»

Another factor to consider when debating whether to stay private or go public depends on how the company values their employees. A growing company can use its stock to give to employees as mentioned in the lecture as a reward…   Read more»

I think the best approach is to pick the structure that fits with the company’s needs. It is important to consider the funding and what type of investors will be involved. It is probably best for a small company to…   Read more»

I think QA can help ensure the safety of a Class III device by providing requirements on the components and materials that are used to create that device. QA can help provide requirements regarding supplier and supplier quality to make…   Read more»

Another aspect of having a unified quality system across all regions is that it would allow it provides a standard system on recording issues, conducting investigations, and other important details that is uniform across all sites. This allows it to…   Read more»

I think that the priorities and goals of QC/QA are different enough that they should be separated, but both teams should work with each other. Both teams can bring their knowledge and expertise to the table when designing a product….   Read more»

@justinwilliams On the topic of Johnson and Johnson during COVID-19, a conflict I remember arising during the pandemic was J7J’s vaccine for COVID. This vaccine did not go through the normal FDA process of approval and instead went through the…   Read more»

I think often, regulatory is often viewed in a negative light, because the engineers who are creating these medical devices probably don’t like hearing numerous rules that restrict their ideas. It might feel like regulatory just comes in to control…   Read more»

I think that regulatory professionals should be involved from the very beginning of the design process. By being involved early, engineers who are designing the medical device can get a clear understanding on what the regulations are and adjust their…   Read more»

A negative consequence that comes with animal studies for pre-clinical testing that hasn’t been discussed is the cost. As seen in the 2 animal study protocols posted on Canvas, getting animals for the study are very expensive. Additionally, many animals…   Read more»

From your discussion, I was able to learn about NAMSA, which I previously had no knowledge about before. According to their website, they help with “market research, preclinical studies, clinical trials, biological safety testing, regulatory submissions, and much more”. I…   Read more»

I agree with the points mentioned above about why it is financially safer, since using materials already in the market have a stable supply, reduces costs and times, and prevents financial downfall in the future. However, I think it is…   Read more»

I think it is very important to spend time planning details of a project before getting started. I don’t think a lot of time should be spend on it and not every detail can be planned out, but there should…   Read more»

I think one way to effectively strategize is mentioned in this week’s lecture about earned value (EV), planned value (PV), and actual cost (AC). Earned value is the value of the work that has been completed, planned value is the…   Read more»