Organizations can balance the need for up-to-date documentation with efficiency by adopting a structured, tiered approach to document management. Core documents like the Design and Development Plan (D...

The best way to translate a qualitative user need into a quantitative and testable design input is through iterative analysis and measurable criteria definition. The design team should first study the...

While modern design control systems like ISO 13485, IEC 62304, and FDA 21 CFR 820 are far stronger than those in the Therac-25 era—mandating rigorous verification, risk management, and traceability—th...

The best way to translate a qualitative user need into a quantitative and testable design input is to follow an iterative process of user analysis, measurable criteria definition, and engineering tran...

In practice, successful design teams balance user needs and business realities through structured trade-offs rather than choosing one side completely. Engineers should advocate strongly for essential ...

Having both design verification and validation as separate processes is necessary because they address fundamentally different questions in product development. Verification ensures that the design ou...

While design controls under regulations like ISO 13485 and FDA 21 CFR 820 can feel restrictive, they actually play a dual role in innovation. On one hand, they slow things down by adding documentation...

Clinical research is the systematic process of testing medical devices or treatments on humans to ensure safety, efficacy, and ethical integrity, extending beyond what pre-clinical animal or laborator...

Both the placebo and nocebo effects provide valuable insight into how psychological factors influence physiological outcomes in clinical research. I find the placebo effect more beneficial overall bec...

Biomedical engineers play an increasingly central role in clinical research as the boundary between medicine and technology continues to narrow. Traditionally, engineers were seen as providing technic...

Choosing between going public or staying private depends on the kind of strength a company seeks—public companies benefit from access to large-scale capital, increased visibility, and liquidity for sh...

You’ve raised a thoughtful point about the importance of top-down quality system design and the challenges that arise when companies grow, merge, or restructure. I agree that starting with a clear mis...

Regulations can both hinder and drive innovation, depending on how they're structured and applied. On one hand, overly rigid or outdated rules can slow progress by imposing high compliance costs, limi...