I was also very interested in the difference between validation and verification! I never really put too much thought into it, as before last week's lecture I was unaware of the difference between des...

@31623940 I agree that the intended setting and user for the product greatly affects how the design should accommodate the user. I would like to bring up that decisions are often made to prioritize ma...

The fundamental difference between the definitions of design inputs and design specifications leave plenty of opportunity for an instance where verification is passed but validation is failed. An exam...

@bryan-xavier I would say the most important threshold to meet for a design review is the consensus around whether or not the device addresses its user need. Though this is very broad, the function of...

@shreya I would say that requiring diversity-based simulations would increase safety to some degree. However, I don't believe the lack of simulations solely caused the DePuy incident to occur. Restati...

One limitation/complication that may not come to mind at first would be the presence of national regulations in the case that the contract manufacturing company is international. In the medical device...

When I searched up Good Clinical Practices, one of the first jobs listed is a Clinical Quality Assurance Program Lead. The role consists of providing quality oversight of the company's various clinica...

Researchers should always prioritize the safety of the patient first and foremost. Specific parameters for initial trials should be based on sound results from animal testing. Before a project moves o...

@aysegultinas I agree that being upfront about the informed consent can greatly help build trust between the investigators and the subjects in the case of a blind study. I would like to further emphas...

@andrewg I disagree, and feel that physicians should not be compensated for recommending products due to ethical concerns and the potential for financial conflicts of interest. I think physicians shou...

I agree with the general consensus, that product is the most important factor in whether a hospital adopts a new device, as well as long term sales of the device. However, I would like to add to the d...

I believe that one of the most important things a medical device company can do when developing a new product is to get significant input from the sales team. As we learned about through this week's l...

Upon further researching this topic, I discovered it is legally possible for one type of corporation to convert to a different type of corporation outside of the C-Corp S-Corp conversion we learned ab...

@imarah-ar   Physicians must make a risk vs reward decision when deciding when to pursue innovation. When a new technology or treatment is authorized for medical use, choosing to adopt it immedi...

@andrewg I believe those first two tradeoffs you mentioned can be remediated by hiring supervisors to ensure your company standards are being met by the company you are outsourcing to. While this does...