This prompt brings up a really good point about how diverse user needs can be. We already know that user needs are the driving factor behind design controls and the development of a new medical device. What may not be…   Read more»

The requirements of device design are incredibly important to ensure the device performs successfully and prevents any harm to the patient, but packaging and labeling are just as important in both of these roles. Packaging helps protect the device’s intended…   Read more»

Design verification and design validation are two incredibly important processes that work in tandem to ensure successful device design and future manufacturing. Device verification focuses on the technical aspect of the design and how well it meets previously set requirements…   Read more»

One of the major processes that a team must take in order to define their success criteria is learning and understanding their customer needs. There is little value in creating a device that does not solve an active problem. Talking…   Read more»

It is difficult to say how many design reviews are “enough” because the amount of reviews really depends on the product, its intended use, and any associated risks. I think that all teams should have two reviews at the minimum….   Read more»

Both documents are necessary to communicate key aspects of the device design. The DID design input document is primarily used for addressing high-level, broader design inputs such as the specific user needs that the device will address, the regulatory requirements…   Read more»

I agree that diversity and inclusion in clinical trials is very important. As mentioned in the prompt, white males used to dominate the clinical research field, which is problematic because researchers made conclusions about a single group and assumed that…   Read more»

I do believe that patients taking part in clinical trials should be paid for their contribution. People may have to take time off from work, spend money on gas or public transport, pay for childcare, and will definitely end up…   Read more»

I don’t think that AI will ever be able to fully replace human participants in clinical trials. The human body contains too many complex processes and interactions to be captured by a computational model. There are still parts of the…   Read more»

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»