Emerging technologies like IoT, AI, and machine learning are transforming how Quality Assurance is carried out by introducing automation, predictive analytics, and realtime monitoring. One effective w...

FDA approval does not always mean a device is truly safe. There have been high profile cases, such as metal-on-metal hip implants and implantable cardioverter defibrillators, where thousands of patien...

The FDA plays a critical role in safeguarding public health, but I don’t think FDA approval equates to an absolute guarantee of safety. Approval means that, based on current evidence, the benefits of ...

Many startups or academic teams can design and prototype a device that works in a lab or even in a small clinical pilot, but scaling production while meeting regulatory, reimbursement, and quality sys...

Animal variety can play a major role in the reproducibility of preclinical research, both positively and negatively. On one hand, relying on a single animal model (such as rodents) can make results di...

From my perspective, the biggest challenge in pre-clinical device development is navigating the organizational and approval process. Scientific questions are of course complex, but researchers are tra...

I believe animal testing in medical research is increasingly hard to justify, especially with the alternatives available today. While animal models have historically contributed to life saving devices...

I think one of the most important features of a project manager is the ability to adapt and really understand both the situation and the team. Every project will face unexpected changes, whether it is...

From my perspective, missing a milestone is not automatically a failure and depends on the context. In one of my biomedical projects, our team was developing a blood back detection system for an intra...

I think the best team dynamic for a medical device project is one where engineers and managers operate with mutual transparency and respect for each other’s expertise. Medical devices are heavily regu...

I can definitely relate to the idea of BME feeling like “a little of everything.” In my own experience, that has actually been one of the biggest strengths of the degree. Having exposure to mechanics,...

In my experience, many major companies and even smaller companies require a MS at minimum with additional experience. A BS in BME is a great foundation, but I have noticed it often serves as more of a...

I do not think AI is going to completely control the medical industry, but it is definitely going to become a major part of it. In my own experience working with biomedical projects, I have already se...