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 Zimmer, DePuy, and Biomet were investigated for paying surgeons…   Read more»

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 mindset, leading to obligation or influence depending on…   Read more»

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 suspicious consulting agreements. For example,…   Read more»

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 treated as two separate processes. However, without…   Read more»

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 yourself. However, the stakes in medical device…   Read more»

  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 lecture emphasizes how matrix structures are beneficial since…   Read more»

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 the line between the two as…   Read more»

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 visibility. Dr. Simon talked about how risk management…   Read more»

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 between manufacturing and compliance. Dr. Simon talks…   Read more»

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 startups can gain a strategic advantage if they integrate…   Read more»

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 discussed yet, however, is ownership of data and traceability in validation. Modern validation is about…   Read more»

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 verification. ISO 13485 and IEC 62304 have made verification extremely…   Read more»

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 help avoid most conflicts before projects even begin….   Read more»

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 down, and validation makes sure that those specifications are actually solving the user’s…   Read more»

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 no one else has mentioned, however, is how the intent of…   Read more»

I think biomedical engineers play a role in the entire feedback system that determines whether a clinical trial can evolve efficiently. In Dr. Simon’s materials, we can see how each subsystem of a process is reliant on controlled inputs and…   Read more»

I love this topic regarding the psychological aspects of clinical research. Dr. Simon and the provided protocol template discuss the importance of reducing bias in study development and how that is done with blinding, randomization, and standardization. Usually, these effects…   Read more»

I agree with both of you that the complexity of clinical research makes everything more time-consuming and stems from the ethical and regulatory layers. After reading the clinical trial protocol that Dr. Simon provided, I can see how much coordination…   Read more»

If I were to create a company, it would be a physician-led medical technology company. I would be the physician, and this company would design and create evidence-based devices directly from clinical experience. I would close the gap between engineering…   Read more»