@anthonynjit I agree that cutting corners in research or clinical trials is never a good idea or compliant with standard GLP. When testing the efficacy and safety of any medical device safety should be paramount. I do know that there…   Read more»

@anthonynjit to answer your response on this topic I do believe that in the era we live in now of pre pandemic and post pandemic of Covid-19, virtual access to meetings and project management on zoom calls are more critical…   Read more»

@anthonynjit I think Covid has forced organizations to communicate better because of the pandemic’s longevity. For companies to maintain a sense of normal functions employers and leaders throughout different industries had to adapt to still convey the same messages they…   Read more»

@anthonynjit  I can agree with Anthony, on how using Linked in gave opportunity to be added onto a project for “additional resources”. I think this method helped a lot as an undergraduate since it gave a lot of opportunity to…   Read more»

I agree with @anthonynjit . Although the analogous approach is quicker and less costly, its downfalls include being less accurate, considering little detail and understanding in preparing estimates, and caps on overall project costs. On the other hand, the bottom-up…   Read more»

I agree with @anthonynjit above – sometimes budget is not there for smaller projects therefore there is less QA/QC support on that end. A company needs to prioritize at the end of the day. I think in this case where…   Read more»

In my opinion, both verification protocols and reports are incredibly important however if I had to choose, I think that verification reports are more important than verification protocols. As @anthonynjit described above, a verification protocol lists what is going to…   Read more»

@anthonynjit I agree the logic of small teams is that the fewer people working together, the less confusion. For example, fewer moving pieces equals more efficiency. Following are several benefits of smaller teams. Individual efforts are perceived as less valuable…   Read more»

I agree with @anthonynjit its impossible to design a design verification test that is guaranteed not to fail. The purpose of design verification is to make sure that your inputs = outputs. It’s an important part of the design control…   Read more»

@anthonynjit I agree with you Anthony, I was on a team in my undergrad and a student was bossy, I can not remember her personality letters however we both were power hitters and it was not a matter of how…   Read more»

I agree with @anthonynjit in that both are very important with the project manager edging out the stakeholder for importance. @anthonynjit raises a really great point about “No amount of funding can override the decisions of poor management.” Since the…   Read more»

I believe individuals should work on separate parts and that smaller groups should gradually form within the team before the product is finalized as an entire team. I agree with @anthonynjit in that every successful group understands the importance of…   Read more»

To clarify from my original post, I would think as per the conditions listed by the FDA for what devices qualify as a Class 2 device and what prohibits devices from filing a 510(k) as per the post from @anthonynjit,…   Read more»

@anthonynjit This is true. Developing protocols based on tensile strength of a device after repeated use is a commonly overlooked factor. I would have to believe its because big corporations might sign a contract with the buyer and cover the…   Read more»

@anthonynjit Medical devices involved in surgery have one primary customer: surgeons. Surgeons are skill based professionals that develop procedural techniques based on the device they are using, therefore if the new medical device requires a different surgical technique, though it…   Read more»

@anthonynjit Biomaterial/biomechanic/bioinstrumentation content of the training depends on the product, but in general I believe that a training course on a medical device product should include the following: – what medical device regulations govern the product they are selling and…   Read more»

Posted by: @anthonynjit While this class is not very centralized around history, you raise an interesting dilemma within the United States that there should be a line drawn between the rights of a corporation and an individual. Do you believe…   Read more»

@anthonynjit I think that statistics are not a sure way to determine safety as it is completely dependent on how the study is set up that the data is being extracted from. If the study is not robust, the data…   Read more»