Going based on of the question proposed in the title of this post, Risk assessments are absolutely necessary for medical devices. Risk analysis or assessments are required not only in the US by the FD...

As was already said before me, I think it is virtually impossible to completely eliminate risk. Even using a medical device in perfect conditions and following intended use protocols to a tee, there i...

I believe that in most scenarios it is ideal for the risk management team to be made up with members of the project team and those that belong to the risk management department. The individuals that a...

To answer your question, I do not believe it possible to entirely predict all real world failures of medical devices. The core problem of design controls is that they are created with what the designe...

In reference to the title of the question, I do not think that there should necessarily a winner in regards to whether user needs or engineering viability are more important. The teams should instead ...

I believe that you make a great point that the constant updating of the documents contents can become very confusing or lead to an overload of information as you say. The most important thing to do in...

User needs are often qualitative, for example the customer may want the device to be a specific dimension, or may want the device to be easy to clean. Regulatory compliance however demands that Design...

Teams can establish when they have done enough reviews by following the framework they initially created at the beginning of their design process. To ensure success, teams should plan to have a design...

I think that design controls ultimately help innovation because they make the design process more sustainable and efficient in the long run. Checkpoints such as design reviews allows the creator to en...

Clinical research is a a complex multidisciplinary process that takes collaboration amongst clinicians, researchers, regulatory experts, and engineers. As biomedical engineers, we apply design princip...

I think one the most obvious reasons for participants to volunteer or willing join a clinical study is the financial compensation (or equivalent) they may receive for their time in the study. Not all ...

I think whether or not you need a clinical background in this specific field is highly dependent on the role you are taking. For example principle investigators certainly should have clinical experien...

As mentioned by others before me, there is certainly a psychological element when companies design their branding whether that be their logos, colors, or websites. This is no different in the medical ...

Marketing and design are different disciplines within industry, but have commonality in the sense that they both strive to understand the people using their product. Design has to take into account hu...

In present times, device innovation no longer guarantees product success, and more often than not, it is the marketing or pitching of products that determines whether or not the device makes it to mar...