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 design input and design specifications. As for…   Read more»

@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 making the device as accessible as…   Read more»

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 example that comes to my mind would be a heart rate monitor…   Read more»

@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 the device should be the…   Read more»

@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. Restating what @bryan-xavier said, I think it’s very likely the incident…   Read more»

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 industry, the OEM is responsible for adhering to regulatory…   Read more»

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 clinical trials, ensuring FDA guidelines are met. In regards…   Read more»

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 on to clinical trials, rigorous animal trials are completed to…   Read more»

@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 emphasize how useful everything disclosed in the…   Read more»

@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 should be compensated for providing feedback and evaluation of new products…   Read more»

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 discussion the…   Read more»

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 lectures, the sales team…   Read more»

@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 immediately may result in greater financial success, as patients…   Read more»

@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 doesn’t address the potential problem of working around…   Read more»

A possible method to improve communication between QA and QC is to have them in the same department, which is done relatively often in smaller companies. Even if there are still two separate divisions, having them in close proximity should…   Read more»

I believe quality assurance is a much more difficult task compared to quality control. Spotting a defect takes a lot less effort than reverse engineering the process and determining what caused that defect to occur. The conceptual nature of QA…   Read more»

@jfm23 I agree that QC/QA should be an independent body, specifically to ensure a QC/QA professional is always in the building. However, as @31623940 touched on, the responsibilities of QC/QA should not only fall on that body. I would consider…   Read more»

@raina I was under a very different impression about Regulatory Affairs! Before this week’s lecture, I thought that Regulatory Affairs was basically synonymous with Quality Assurance in a company. After looking into it more, I realized they do have similar…   Read more»

I don’t necessarily think the 501(k) process discourages innovation, but it does definitely make the approval process easier if a medical device is close enough to an existing product. Saving some time and effort getting the product approved is beneficial,…   Read more»