I think user training can also help manufacturers identify weaknesses in their product before it reaches the market. Manufacturers can see how users during training struggle with a device, one of its steps, misunderstand instructions, or not understand certain features…   Read more»

I think manufacturers should decide after conducting a thorough risk assessment and determining whether future design changes would work or introduce other risks. For example, adding a safety feature to a medical device might make it more complicated to operate,…   Read more»

I believe that medical devices should be able to implement certain software updates and improvements  without obtaining FDA approval if they provide minimal risk. Requiring FDA approval for each update can slow down advancement and prevent patients from benefiting from…   Read more»

I think packaging is very important because different medical devices are stored and transported differently, so packaging is important in making sure everything is still safe. For example, certain medications or medical products need to be refrigerated or kept without…   Read more»

I think it is also important to consider whether a medical device will be used outside of a hospital or clinical setting. If a product is intended for both hospital and home use, the design needs to be accommodate patients…   Read more»

I think one challenge companies face is designing for the average user while overlooking patients who have different needs or limitations. For example, a medical device might be designed around the typical patient, but there are differences in age, mobility,…   Read more»

A factor that should be considered is how design controls should consider the entire lifespan of an implanted device, not just focus on how it performs when it is first implanted. Hip implants are expected to last for many years,…   Read more»

I think foreseeable misuse should be considered part of a device’s design inputs. A big medical device with experience such as Philips should have anticipated that some users would purchase cleaning products, especially since people using it at home might…   Read more»

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»