The AdvaMed and DOJ oversight has become so strict since scandals have become large-scale and public. One example is the 2007 orthopedic device kickback scandal. In this scandal, major companies like ...

I think the real issue with defining what “modest” means is about how the gifts to the physicians are functioning on a psychological level. Something less expensive can still affect the physician’s mi...

I agree with what everyone has said so far. However, I think red flags can appear before you even look at the deliverables or compensation. The company’s internal behavior can be a telling sign of sus...

I think a key issue in integrating Design Controls and Project Management is the lack of continuous feedback loops between the two. The distinction between the two is blurred, and sometimes they are t...

I agree with the points raised by everyone so far. Addressing concerns to someone higher up is very daunting since relationships are at stake and you are in a lower position, possibly jeopardizing you...

  I agree with what everyone has said so far. Another way to make a matrix organization is to build predictability into the workflow, along with the predictability in communication. Dr. Simon’s l...

I think everyone here did a good job at breaking down the conceptual difference between hazards and hazardous situations. Something new I have to add is how time and device evolution should not blur t...

I like how everyone emphasized how important structure, preparation, and inclusion is in risk management meetings. I want to talk more about the format of a meeting itself that can influence risk visi...

Everyone has brought up excellent points about Poka-Yoke and how it reduces errors on the production floor. However, something that no one has touched on yet is how Poka-Yoke can bridge the gap betwee...

I agree that design controls are more than a regulatory requirement in the sense that they are frameworks for quality and long-term communication. To answer Krish’s question, I think that smaller star...

I think everyone made great points regarding documentation, calibration, and clear communication between the Original Equipment Manufacturers and the Contract Manufacturer. Something that hasn’t been ...

I agree that the Therac-25 incident changed how we think about design controls; however, I think that the next "Therac moment” might come from overconfidence in verification rather than poor verificat...

I am in agreement with what everyone has said so far, especially regarding the points about how collaboration and regulatory boundaries are imperative. I also like the emphasis on how pre-planning can...

I agree that verification and validation have distinct purposes that keep the design controls objective and therefore reliable. Verification makes sure the device gets the technical specifications dow...

I liked the point regarding maintaining consistent QC and QA in transferring design control. I also agree that there is great importance in maintaining traceability and documentation. Something that n...