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 drug sample. It yields more accurate data…   Read more»

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 preexisting condition(s) they have been selected for.   For…   Read more»

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 needs, statistical trends, and limitations. Thus, I’d likely…   Read more»

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 than it would take with…   Read more»

Patients should definitely have a say in the design of their products for companies. As they are the end users for the products intended to solve or at least mitigate their ailment(s), they can discuss what they enjoy most about…   Read more»

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 are willing to take on.  Ideally, I’d…   Read more»

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, and capital management. For a medical device company, one…   Read more»

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 circumstances that would allow prosecutors to point fingers at individuals,…   Read more»

Quality Assurance and Control are both crucial roles within the product development & manufacturing process. This is especially true for medical devices, where strict requirements need to be met and updated according to 21 CFR 820 or ISO13485, depending on…   Read more»

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 for an effective…   Read more»

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 for. For instance, smaller…   Read more»

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 this case, engineers must maintain a balance between…   Read more»

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 include categorized class designation for certain…   Read more»

Hey there, Atmeh, You bring up a point that I’ve learned at length about through courses and practical experience. I’ve learned that catching issues early in a process saves a lot of time and money. More importantly, it keeps risks…   Read more»

I unfortunately don’t have enough experience in academic research to provide a personal perspective, but I can share my experience in industry. During my time as a co-op at GAF, I saw a strong dedication to market research that helped…   Read more»

How important is the connection within a team to meet the project objectives in biotechnology?  This is one of the most fundamental aspects of a successful team, let alone a project. The connection between team members is critical in that…   Read more»