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...

Looking at the lecture, I can see that Quality Assurance builds the methods, rules, acceptance criteria, and systems that prevent errors in medical device development. On the other hand, Quality Contr...

In Dr. Simon’s lecture, he clearly linked the quality system hierarchy back to management. Quality starts at the top, where management defines the mission statement, leading to the quality policy. Thi...

I agree with everyone's response regarding the need for engineers to understand the regulatory basics in order to create products that don't need revision early on in the design process, since they ca...

EUDAMED is a big step towards transparency with medical devices. Even after a year from the last post in this forum, EUDAMED is still not fully operational or mandatory. It was originally set to becom...