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 (DDP) should be continuously updated only for significant design changes, while minor updates…   Read more»

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 user’s intent behind the qualitative statement—for example, “easy to…   Read more»

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—they are not yet fully equipped to handle the complexities of…   Read more»

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 translation. First, the design team should clarify the intent behind…   Read more»

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 user requirements—those that affect safety, performance, or regulatory compliance—because compromising these can cause product…   Read more»

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 outputs meet the design inputs — it’s about technical accuracy, consistency, and compliance with specifications…   Read more»

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, formal reviews, and verification steps that…   Read more»

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 because it helps researchers determine how much of a treatment’s success can be…   Read more»

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 technical support to clinicians—designing devices, processing data, or developing software tools. However, the modern…   Read more»

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 shareholders, which can accelerate expansion and attract top talent, but they also…   Read more»

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, limiting experimentation, or discouraging startups from scaling. This is especially…   Read more»

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 mission statement and cascading through the quality policy, manual,…   Read more»