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...

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 pro...

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 do...

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 ...

This week’s lecture discusses the mission statement for a company and how the marketing in medical devices must align with this statement across departments. What stood out to me was how marketing is ...

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 ...

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 understa...

Understanding how to measure success is extremely important to run a successful business, especially with medical device development. Return on Investment and Net Present Value are tangible measuremen...

I know many people who want to become physicians and eventually open their own practice in whatever specialty they choose, since it gives them more freedom than a hospital job. It also allows them to ...

Dr. Simon discusses the corporate veil in his lectures. The corporate veil is the legal protection that the owners of a company get. In a sole proprietorship, someone’s personal assets are in danger i...

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’...

Dr. Simon’s whiteboard explanation this week showed how every subsystem (design controls, purchasing, risk management, training) is a process that is a part of a larger process. Each has inputs, outpu...