@bryan-xavier @james-olson I agree the user need comes first, but I’m not sure “consensus” works as a threshold. A room agreeing the device works is still an opinion. I think the threshold should be something you can check on paper,…   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»

@bryan-xavier I one hundred percent agree that peer mentorship and knowledge sharing is beneficial to fostering a successful project. Apart from our advisor on our capstone project, we also collectively shared a peer mentor who guided us through certain aspects…   Read more»

@bryan-xavier Hi Bryan! I certainly agree. Utilizing a traceability matrix is a fantastic method to keep organization in the Design History File (DHF), I found it quite useful when organizing one for a previous semester project. It guarantees a systematic…   Read more»

@bryan-xavier Your information about the Breakthrough Devices Program definitely changed my own view about this topic I created. When I found out about this certain predicament from Dr. Simons lecture, my thoughts were pretty set on that medical device innovation…   Read more»