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 — clear failures of design controls we take for granted today. This case shaped…   Read more»

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 to catch issues like metal debris generation and tissue necrosis…   Read more»

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 create confusion and documentation fatigue. How can organizations balance maintaining up-to-date documentation…   Read more»

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 that benefit the entire team. Do you think companies truly use design controls…   Read more»