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 product quality recognize that design controls are not barriers but rather they…   Read more»

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 measurable engineering terms requires more than experience or assumption;…   Read more»

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. Verification methods for such systems are still evolving, and traditional validation approaches may…   Read more»

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 testing or features outside the original user requirements, they risk…   Read more»

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 battery for the pump, which caused it…   Read more»

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 Verification Reports. These might include mechanical testing data, electrical safety testing, software…   Read more»

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 experienced researchers may subconsciously affect outcomes when they know which patients…   Read more»

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 documentation, scheduling participants, and ensuring compliance with both…   Read more»

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 would be no safe or effective medical devices,…   Read more»

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 standardized processes that help new engineers transition smoothly from school to…   Read more»

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 involves an entirely different skill set…   Read more»

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 overlook how those solutions fit into a company’s financial and strategic…   Read more»

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, benefits, and opportunities for advancement, while a smaller LLC or…   Read more»

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 often depends on company size and available resources. Larger…   Read more»

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 through inspection and testing. QA professionals usually need a strong…   Read more»

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 way to keep up is by integrating these tools into the QA workflow rather…   Read more»

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 patients were harmed before recalls were issued. In many of these…   Read more»

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 a product outweigh its risks for the…   Read more»

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 system requirements is another challenge entirely. Producing only…   Read more»

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 difficult to translate to humans because of species…   Read more»