Whether or not a company utilizes design controls as a tool or a checkbox ultimately comes down to their internal culture and the overall attitude within. Companies, whether big or small, that value a...

I think balance really can come down to defining the purpose for each document tier. Perhaps removing informal working logs or notebooks that are not officially updated changes in the DDP (such as des...

Similarly, as everyone has mentioned, I also believe that this incident (Therac-25) caused a fundamental rethinking and reshaping of how the industry approaches both software safety and design. With t...

Yes, I, along with a lot of others I am hoping, do feel safer knowing medical devices go through the verification and validation process not just now, but for the future as well. Off the top of my hea...

To me, balancing the user needs alongside business goals seems like a hard challenge to accomplish, although also an important part of the development process. From any viewpoint, the ideal position i...

While I don't currently work in the medical device industry, the understanding and learning of the difference between verification and validation are essential and closely related cogs in the design c...

The placebo effect is a great example of how phycological and physiological systems in our bodies are so deeply intertwined with each other. This makes it both a challenge and a learning opportunity i...

Biomedical engineers I believe play a significant role in clinical research and can be the bridge to piece a lot of aspects together. The background in the field has big focuses on design controls, sy...

While clinical research can feel like it's being weighed down by the scope of the idea or complexity, every process and layer within it from approval and documentation to analysis is there for good re...

I know I am not unique in saying this, but I feel a little invested in answering this because I had to go through the process of getting a dental implant that took a long while. Also the way I did it ...

There is such a wide variety of medical devices out there and variations that innovation on its own would rarely help in its own success, or at least propel it forward to the spotlight. Strategic and ...

Marketing plays such a critical role in the diffusion of medical devices and technology, but in regards to healthcare, persuasive communication and the responsibility to be ethical can be pretty thin....

For the first question, I think we have to be careful only slightly when describing courses to prep for industry. While I personally want to go into industry, I think having courses that prepare a stu...

I feel it is a cop out again to say it depends on the business, but if I am going to think about from the biomedical perspective, I feel perhaps going through the public domain is better? In my head, ...

I have contemplated trying to acquire an MBA previously before I decided to focus on just what I am going for at the moment. I do believe that a business can be created without needing one; especially...