In medical device development, we talk a lot about “risk mitigation,” but rarely about whether total risk elimination is even possible. For example, implantable devices like pacemakers or insulin pump...

Failure Mode and Effects Analysis (FMEA) is the go-to tool for risk analysis in most medical device companies, but does it make us too mechanical in our approach? Real-world failures — like software b...

The Therac-25 radiation therapy machine (1985–1987) caused multiple fatal overdoses due to software design flaws and inadequate verification. Engineers reused old code and skipped redundancy testing —...

The DePuy ASR XL hip implant recall (2010) shows how gaps in design controls can lead to massive patient harm. Despite passing early testing, design verification, and post-market surveillance failed t...

The lecture emphasized that documents like the DDP are “living documents.” This continuous update process helps ensure design alignment as the project evolves. However, constant updates can also creat...

Sometimes it feels like design controls exist mainly to satisfy regulators rather than to improve design efficiency. Yet, when applied properly, they create structure, traceability, and accountability...

Design verification checks if we built the product right, while validation checks if we built the right product for the user. Both are required, but they often overlap in testing and documentation. Is...

The lecture made it clear that design starts with user needs, what the device should do, for whom, and in what environment. But in real companies, business goals like cost, timeline, and market size a...

After learning about how strict design controls can be — from defining user needs to managing risk and verifying every output — I started wondering if they sometimes slow down innovation. Regulations ...

Good Clinical Practice (GCP) rules are there to protect patients and make sure studies are ethical and accurate — but sometimes it feels like there’s more focus on paperwork than patients. While the s...

We talk a lot about design, data, and regulation in clinical research — but none of it works without trust. Patients need to believe researchers will protect them, and researchers need honest data fro...

I’ve noticed that clinical research involves so many moving parts — from ethical approvals to data collection and analysis. Every step seems designed to minimize risk and bias. I get why this is impor...

Sometimes I feel like marketing in the medical device world is a mix of serious science and a little bit of stand-up comedy. On one hand, we’re dealing with cutting-edge technology that saves lives. O...

AI is starting to shape how medical devices are marketed. It can analyze large datasets, predict which hospitals are most likely to adopt a device, and even personalize messaging for specific audience...

One thing that’s becoming increasingly clear in healthcare is that patients today are more informed, more active, and more involved in their treatment decisions than ever before. Traditionally, medica...