I think many companies initially treat design controls as a regulatory checkbox, especially smaller startups rushing toward 510(k) or PMA submission. However, the organizations that truly excel in pro...

I would argue that structured frameworks are the only reliable way to bridge user needs with design inputs. Translating a qualitative statement like “easy to use” or “comfortable to wear” into measura...

AI driven and adaptive algorithms in medical devices introduce a new layer of uncertainty. Unlike deterministic systems, machine learning models can behave unpredictably outside trained data sets. Ver...

This is definitely an issue that can occur. Validation should confirm that the final device meets documented user needs and intended use, not hypothetical scenarios. When teams start adding extra tes...

A recent (2024) example of insufficient design controls is Tandem Diabetes Care’s t:slim X2 insulin pump mobile app recall. The iOS version of the app had a software glitch that rapidly drained the ba...

Verification is the process of confirming that design outputs meet the specified design inputs. This typically involves documentation in the Design Verification Plan (DVP) and summarized in Design Ver...

I actually think double blind studies are essential in many cases because they minimize both participant bias and investigator bias, which can unintentionally influence the results. Even the most expe...

Personally, I would be more interested in the role of a Clinical Research Coordinator (CRC). The CRC is often the backbone of the trial and is responsible for handling data collection, maintaining doc...

I understand the concern about the risks involved in clinical studies, but I believe that human clinical trials are absolutely necessary and ultimately do far more good than harm. Without them, there ...

I think starting your career at a large, established company can provide an excellent foundation for long term growth. Big companies often have structured training programs, formal mentorship, and sta...

I believe an MBA or business related degree can be a major advantage for engineers who want to start a company or move into leadership roles. While technical expertise is essential, running a business...

I believe engineering students should be required to take an additional business course before graduating. While most engineering programs do a great job teaching technical problem solving, they often...

Personally, I would consider the type of company before accepting a position, especially when it comes to financial stability and long-term growth. For example, a corporation may offer more structure,...

You make a great point about AI being a double-edged sword; its potential for efficiency can clash with legitimate concerns about accuracy, bias, and even job security. I agree that implementation oft...

QA focuses on processes (about building systems and procedures to prevent defects before they happen). QC, on the other hand, focuses on products and is about identifying and correcting defects throug...