When discussing the placebo effect in a blind/double blind study and how it provides a neutral control for researchers to determine how well their drug performs, we focus on the assumptions that patie...

Unlike a good portion of the responses here, I believe the placebo effect is a reliable way to keep patients and researchers from having implicit expectations relating to the response to the given dru...

Patients participating in a study should generally be compensated in some form, including financially. This is dependent on several factors, namely the phase of the study and the severity of the preex...

As I’ve worked closely with designers, manufacturers, and everyone in between during my short time in the industry, I’ve gained much understanding of how a product should be developed based on market ...

The ethical value of AI can be twofold. On one hand, it’s a powerful resource that will help researchers & even designers compile a large chunk of pertinent information in a shorter period of time...

Patients should definitely have a say in the design of their products for companies. As they are the end users for the devices intended to solve or at least mitigate their ailment(s), they can discuss...

When it comes to starting either a sole proprietorship or a partnership, it depends on the circumstances and type of business. It also depends on the amount of taxes, liability, and responsibility you...

For a small business, it would be most beneficial to start as simply as possible, aligning with your market aim. This includes aspects such as liability protection, taxation, flexibility in ownership,...

The corporate veil is indeed a powerful tool utilized to protect individuals of interest within a larger organization. As you’ve correctly identified, this is not foolproof, as there are extreme circu...

Quality Assurance and Control are both crucial roles within the product development & manufacturing process. This is especially true for medical devices, where strict requirements must be met and ...

In my bit of industrial experience, I have worked in various companies ranging from medium to large corporations. Their level of performance and quality was proportional to their size (or, better stat...

This is a harrowing example that reveals not just a risk in the product itself, but also a potential breach of trust in those who are supposed to solve a patient’s problem. Those who neglect the need ...

This is a great question that relates to a reply I gave in another thread.   As you’ve noted, engineers may have more or less responsibility depending on the size of the company they are working...

Balance and reality are key to success, indeed. A combination of both would work. When developing a device, you have two things to worry about: the customer’s requirements and federal regulations. In...

When it comes to newer technology that does not only involve physical devices (such as software), reform would be necessary as the FDA would need to define how it assigns these solutions. This can inc...