QMSs Aren’t Just Red Tape—They Save Lives

I am a full-time auditor, and the most common complaint I hear from medical device teams is “Ugh, quality systems are so bureaucratic.” I get it. Paperwork feels tedious. Audits are stressful. But here’s the hard truth: skimping on quality isn’t just risky—it’s reckless.

I’ve seen what happens when companies treat quality as an afterthought. Patients get hurt. Careers implode. Brands become synonymous with “failure.” Let me share two stories that still keep me up at night—and why they should matter to you.

Story #1: The Machine That Killed Quietly (and Why No One Listened)

Picture this: It’s 1986. A 22-year-old woman named Cheryl enters a hospital for radiation therapy. Her tumor is treatable. But instead of healing her, the Therac-25 machine blasts her with a radiation overdose so severe it burns a hole through her chest. She dies weeks later.

What went wrong?
The Therac-25 had a software glitch. A typo in the code. Engineers knew about early complaints of “electric shocks” during treatment but brushed them off as user error. No one double-checked the code. No one tested worst-case scenarios. They’d removed physical safety mechanisms to save money, betting everything on untested software.

The kicker?
This wasn’t a one-off. Six patients died or were maimed before the machine was recalled. All because a company prioritized speed over safety checks.

The lesson screams at us:
Quality systems aren’t about pleasing regulators—they’re about catching the tiny errors that become tragedies. A simple design control process or post-market feedback loop could’ve saved lives.

Story #2: The Foam That Cost $1.3 Billion (and Counting)

Fast-forward to 2021. Millions of people rely on Philips CPAP machines to breathe at night. Then, the unthinkable: Philips admits the foam inside these devices can crumble into toxic dust. Patients inhale carcinogens. Panic erupts.

How’d this happen?
The foam wasn’t properly tested. Complaints about “black particles” in machines had piled up since 2015, but Philips’ quality team moved at glacial speed. By the time they acted, 15 million devices were in homes worldwide. The recall cost over a billion euros—and worse, patients felt betrayed.

The real tragedy?
This wasn’t a hidden flaw. It was a failure of vigilance. No one asked: “What if the foam degrades? What if patients inhale it?” A proactive quality system would’ve flagged this risk during design—or at least acted on complaints before disaster.

When “Good Enough” Isn’t Good Enough

Let’s be real: Building a bulletproof quality system isn’t glamorous. It’s audits. It’s documentation. It’s arguing with engineers about why “we’ve always done it this way” isn’t an excuse. But here’s what I tell my clients:

Quality isn’t a department—it’s a mindset.

Think of it like this:

• Design controls are your “What if?” playbook. (What if the software glitches? What if the foam cracks?)

• Risk management is your crystal ball. Use it.

• Post-market surveillance is your ears on the ground. Listen to complaints like they’re screams for help.

The Business Case for Caring

Yes, a strong QMS keeps regulators happy. But here’s what executives miss: Quality drives profit.

Take Stryker. After a 2015 FDA warning slapped their manufacturing practices, they overhauled their QMS. Trained every employee. Embedded quality into daily workflows. Result? Faster approvals, fewer recalls, and a reputation for reliability that boosted sales.

Meanwhile, Philips is still recovering. Lawyers circle. Families grieve. Stock prices tank.

Which future do you want?

A Challenge for You

Next time your team groans about a quality process, ask:

• “Would I let my child use this device?”

• “What’s the cost of being wrong?”

If your gut twists, you’ve got work to do.

Final Thought
In this industry, “good enough” is a gamble with lives. The Therac-25 and Philips stories aren’t ancient history—they’re warnings.

Your quality system isn’t red tape.
It’s the shield between your company and catastrophe.

Need help making it bulletproof? [Let’s talk]. No jargon. No judgment. Just real-world fixes that protect patients—and your bottom line.

Stories sourced from public records. Details simplified for clarity.

Arpit Bhugul
A Medical Device Whisperer | Consultant Who Fixes What’s Broken
P.S. Still think quality is boring? I’ll change your mind.