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 accountability, learning, and growth will naturally treat…   Read more»

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 design changes that affect verification, validation or…   Read more»

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 that said, it isn’t only just verification that is changing, but…   Read more»

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 head, I…   Read more»

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 is that the device proposed not only is specified…   Read more»

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 control process. Verification is the involvement of checking that the…   Read more»

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 in clinical research and study. Viewing it…   Read more»

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, systems thinking and even data analytics;…   Read more»

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 reason. The challenge I think lies…   Read more»

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…   Read more»

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 targeted positioning in marketing…   Read more»

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. Medical devices are unique in that they directly impact…   Read more»

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 student for industry automatically assumes…   Read more»

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,…   Read more»

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 considering if the…   Read more»

Audits are something I do have experience with when I was managing a lot of communication equipment. I understand how PAINFUL they can really be, especially if poorly mismanaged from previous personnel, but really, if one is properly managing their…   Read more»

In the strict sense for the last sentence and technically, I don’t think I’ve ever been in the position to have a negative experience with QC and QA. I agree that the PDCA cycle highlights the dependency of each other…   Read more»

In terms of the hierarchy of quality, in my own way, I do think that a unified quality system sounds ideal. I naturally gravitate towards that given the experience I have with similar leadership so in a way, I do…   Read more»

To me, regulation can seem like a double edge sword, but I’d like to say outright that I think safety is paramount. With this in mind, the FDA’s intense and rigorous observations should build trust for all. Everyone would promotes…   Read more»

While one would hope that the FDA does guarantee safety, I don’t believe that to be the case. I think instead, the FDA, with as much scientific evidence and proof that is both gathered and tested, weighs a benefit to…   Read more»