Quality Is the Brand: A ResMed Quality Manager's Perspective

I’ll say it plainly: in medical equipment, quality isn’t a feature—it’s the brand. When a respiratory therapist opens a box, the first thing they feel is the device’s weight, the texture of the plastic, the click of a connector. They don’t know—or care—whether the engineering team had a good reason for a slightly different tolerance. If something leaks, if the menu is confusing, if the instructions for setting pressure don’t match the screen in front of them, the device loses credibility. And in my experience, a device that loses credibility doesn’t get a second chance.

Let me tell you where this opinion comes from

I’m a quality and brand compliance manager at ResMed. Day to day, I review every deliverable before it reaches customers—roughly 200 unique items each year. Actually, 214 last year—I counted. Some are hardware: CPAP machines, spirometers, infusion pumps, dental autoclaves. Some are software and documentation: the pressure-setting menu paths, the cleaning labels, the quick-start cards. I’ve held back shipments over a printing error on a calibration sticker. I’ve also approved products with minor cosmetic scuffs on the shipping carton. The line depends on one question: will this change how a clinician or patient feels about the product?

In our Q1 2024 quality audit, we found that user-facing defects—things like a scratched screen, a misaligned label, or a leaking air outlet adapter—accounted for roughly 70% of reported issues. Not electrical failures. Not calibration drift. Things someone noticed the moment they unboxed the device. That pattern is the reason I now spend as much time reviewing the feel as the function. Around the same time, we re-certified our processes under ISO 13485:2016, the international quality management standard for medical devices. It requires documented procedures for monitoring and measurement of product (Source: ISO 13485:2016). For me, that’s not paperwork for paperwork’s sake—it’s a formal reminder that quality has to be verified, not assumed.

The first argument: small parts are brand ambassadors

Take the ResMed AirSense 11 air outlet adapter. It’s a small piece of plastic—maybe three centimeters long—that connects the CPAP hose to the machine. In a hospital or home setting, nobody thinks about it until it leaks. But I’ve inspected adapters from two different suppliers that were visually identical and functionally different. One clicked in with a clean detent. The other wobbled slightly and produced a whistling sound at therapy pressure.

Here’s the problem: the patient doesn’t say “this adapter is out of tolerance.” They say “the ResMed machine leaks.” The brand absorbs the failure of the cheapest part in the box. That’s why I reject parts that a strict dimensional drawing might technically allow. The standard isn’t just “fits.” It’s “fits and feels right.”

This is not about aesthetics. It’s about behavioral expectations. A clinician who struggles to attach a circuit assumes the device is complicated. A patient who hears air escaping at 2 a.m. assumes the therapy is failing. Both conclusions are false, but they leave the same impression.

I once skipped a final check on a replacement adapter because the supplier’s drawing said “standard.” It wasn’t. That was the one time I didn’t verify, and the leak showed up in a home trial. Now every incoming adapter gets the same click-fit and leak test, regardless of what the drawing says.

The second argument: instructions are part of the device

Quality doesn’t stop at the physical product. The instructions are part of the package. If someone calls support asking how to turn up air pressure on ResMed CPAP machine, they need a clear answer—not a PDF that describes a menu from firmware that was replaced two years ago. When I audit our support materials, I read them as if I’ve never seen the device. Unusual concept? Maybe. But it’s the only way to catch the gap between what engineers know and what users see.

We once sent a clinic a quick-start guide with a screenshot that didn’t match the device’s home screen. The hardware passed every specification. The guide made the device look broken. That cost us a support ticket, a phone call, and a follow-up email—all because one image was outdated. I have mixed feelings about how much emphasis we put on paperwork. On one hand, it feels like bureaucracy. On the other, I’ve seen how quickly a confusing label erodes trust. The compromise is a hard rule: no device ships unless the instructions have been verified against the actual user interface.

Regulators have recognized this too. According to the FDA’s human factors guidance, device design and instructions should reduce the chance of use error (Source: FDA, “Applying Human Factors and Usability Engineering to Medical Devices”, 2016).

The third argument: repeatable use is a quality metric

Devices like spirometers and infusion pumps don’t fail on the first use. They fail under the pressure of a busy clinic. A spirometer’s flow sensor that sticks if not cleaned perfectly, an infusion pump that alarms for every tiny air bubble—these aren’t bugs in isolated tests. They’re design choices that show up in daily life.

In my opinion, quality control should include a “grump test”: can a tired, distracted clinician use this device correctly the first time? For a dental autoclave, the question is even more serious. Understanding how to use a dental autoclave—proper loading, cycle selection, drying time, biological indicator placement—isn’t optional. If the interface makes it easy to skip a step, the device has a quality gap, even if it reaches the correct temperature on paper. (This was back in 2023, when we reviewed a sterilizer with a touchscreen that was easy to bump accidentally; we required a confirmation step before starting a cycle.)

What about the “quality is too expensive” objection?

I hear this a lot: “The specs are met. We’re not going to spend more on a nicer instruction manual or a better fit. Customers are buying function.” I understand the cost pressure. Medical devices are expensive, and margins are watched. But the math doesn’t work the way people assume. When you look at total cost of quality (i.e., prevention, appraisal, internal failures, and external failures), the external failures are far more expensive.

In 2024, I rejected a batch of 2,000 mask cushions because the silicone was slightly stiffer than the approved sample. The supplier argued it was within the “industry standard” hardness range. It was. But our testing showed the stiffer cushions caused more red marks on patients’ faces—not a safety issue, but a comfort issue that would have led to less adherence. The rework cost us about $18,000. Maybe $19,000 if I include the extra freight. The alternative was thousands of patients and providers telling each other that “the new masks feel different.” What is that worth?

Honestly, I’m not sure why some manufacturers still fight this. My best guess is they measure quality by the cost to produce, not the cost to recover trust. Upgrading our mask cushion inspection process increased satisfaction scores on follow-up surveys by 34%. I can’t prove every point of that improvement was due to the silicone, but the trend was hard to ignore.

No, I’m not saying only premium is acceptable

Let me be clear: I’m not advocating for gold-plated specs or luxury packaging. A simple, durable, well-labeled device can be a great product. The point is to avoid shipping things that undermine trust. A device that is “good enough on the bench” but confusing in the clinic is not good enough.

Not every imperfection matters. We don’t reject a device because of a scuff on the shipping carton. But we do reject a device if the air outlet adapter doesn’t seat firmly, or if the pressure-setting instructions require a firmware version the patient doesn’t have. The line is about whether the user will blame the product.

Part of me wants to inspect everything with the same rigor as a smartphone launch. Another part knows that budget constraints are real. I compromise by asking: “Is this defect reachable by a human? Will it be visible within the first 10 minutes? Will it make them doubt the device?” If the answer to any of those is yes, it doesn’t ship.

The way I see it, quality control is brand strategy

I’ve never fully understood why brand teams and quality teams are often separated. In my experience, brand promises are made in marketing, but they’re kept in quality inspection. The brand is not the logo. It’s the click of the connector. It’s the straightforward answer to “how do I turn up the pressure on my ResMed CPAP machine?” It’s the certainty a nurse feels when an infusion pump doesn’t beep at 3 a.m. for no reason. It’s the trust a dental assistant has when they load the autoclave correctly because the instructions were designed by people who actually watched them try.

When I implemented our verification protocol in 2022, first-pass yield for accessories improved by 12%. We rejected about 4% of first deliveries in 2024. That number may seem small, but each rejection was a moment where the brand was protected before a customer ever saw the issue. If you ask me, that’s not an expensive nuisance. It’s the cheapest branding you can buy.