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»

Hi @atmeh-njit! Excellent post and question. I totally agree that marketing is essential, but also very risky in the medical device field. Marketing is so that the buyers want the product and understand why they should want it. This is…   Read more»

Thanks for the scenario! I agree with Krish, I would do a Limited Liability Company (LLC) that would likely be taxed as an S-Corp instead of a sole proprietorship or general partnership. In Dr. Simon’s lecture, he talked about how…   Read more»