Personally, I know a little bit about sales through my father who has spent a lot of time working as a sales rep for, first Quest Diagnostics, and now LabCorp. For his work he is specifically focused on selling various…   Read more»

I do not have any background in branding, and I do not know if I would be a great fit with my current qualifications. I feel like branding is more along the lines of what a marketing or communications major…   Read more»

I would say that the best medical device is not always the bestselling product. I feel like the quality of the medical device is incredibly important, but that the marketing strategies of the company actually matter more when it comes…   Read more»

S-Corps and C-Corps are two types of corporations that share a number of key benefits: limited liability, stability in the case of shareholder death, ability to sell shares to raise money, and ability to get loans more easily. The biggest…   Read more»

I agree with the idea that a profit margin of 70-80%, at the minimum, for medical device sales is unethical. There must be so many medical devices that have sufficient safety and efficacy but will never see the market because…   Read more»

I feel as though an additional business-only course would be very beneficial to all engineering students. Prior to taking IE492 I had little exposure to project management or business concepts outside of the macroeconomics and microeconomics courses I took in…   Read more»

One way to prevent manufacturing risks is to closely follow the standards set by the ISO and FDA.  If all companies are kept up-to-date on quality assurance requirements, they are more prepared to ensure the safety and efficacy of their…   Read more»

I believe that one of the key challenges in guaranteeing the safety and efficacy of medical devices is ensuring that quality control and assurance processes are advancing at the rate of technology. New technology and innovation introduce problems and risks…   Read more»

A unified quality management system (QMS) seems like it would be ideal for medical device companies, especially those based in different regions. If all the different parts of the company are following different procedures nothing will be standardized and simple…   Read more»

I believe that the main reason that the 510K process exists is to make it easier and faster to gain approval for medical devices. If a product already has a relevant predecessor, it can gain market approval without as much…   Read more»

This topic is something that caught my attention as well when watching this week’s lecture videos. I hadn’t realized that the claims a company makes about their device would hold so much weight and that the claims have to be…   Read more»

I would say that the FDA ultimately slows innovation, but for good reason. All medical devices, drugs, and treatments must meet the FDAs requirements prior to being utilized on/for humans. The existence of the FDA ensures that medical devices perform…   Read more»

The smarter approach really depends on the overall goal of the company. If the company has made a product that is reliable and successful they should continue using the same materials and production process. As the saying goes, there is…   Read more»

The end of this prompt brings up one of the most important current questions in preclinical testing. Do we continue using animal models or do we start focusing more on incorporating alternative models? At this time animal models are still…   Read more»

The discussion surrounding animal use in animal testing is incredibly relevant today, with more and more people fighting against the use of animal models. I personally understand the necessity of animal models; however, I still feel bad whenever I hear…   Read more»

I would say that the majority of the project management strategies discussed in the lecture are not used often in research. In industry, professionals are placed on a strict schedule that only deviates when a change request is made, thoroughly…   Read more»

Project planning is incredibly important, but the amount of time and detail spent planning really depends on the project and the capabilities/past experience of the team. I would think that a team that has never worked together before should definitely…   Read more»

Personally, I find one of the biggest challenges in teamwork to be communication. Through my own research experience, I have realized that communication makes everyone’s life easier. For example, when I first started working in my lab I wasn’t really…   Read more»

Biomedical engineering is one of the most diverse degrees out there. We end up learning concepts rooted in biology, chemistry, mechanical engineering, electrical engineering, data science, medical devices etc. We are certainly exposed to many different skills and knowledge sources,…   Read more»

I think that this discussion is a great one and that a person’s personality and overall goals play a huge role in whether they would be more fulfilled as a researcher/professor in academia or a worker at a job in…   Read more»