Last December, I was standing in a hospital sterile processing department when the manager pointed at the Fujifilm logo on our endoscope. “I grew up with a Fujifilm 35mm camera in the house,” she said. “But this isn’t film.”

I didn’t argue. She was right. A brand heritage gets you through the door; it doesn’t survive contact with reprocessing chemicals. By the time I left two hours later, she had changed the way I review product lines I used to treat as low priority.

I’m a quality and compliance manager at Fujifilm Medical Systems. I review every endoscope reprocessing manual, MRI coil test record, and packaging label before it reaches customers—roughly 140 unique item releases a year. In 2024, I rejected 8% of first submissions because the validation protocol didn’t match the actual product configuration. That 8% usually isn’t about big systems. It’s about the small details: a sterilization lot number that doesn’t match, an IFU revision listed on the label but not in the box, a test report with the wrong MRI coil type.

When the SPD manager asked what I actually did all day, I opened my laptop and showed her a validation matrix for an MRI coil. She asked, “What are the different types of MRI coils?” It’s a fair question, and the answer matters more than most people assume. Broadly, we classify them by receive mode and geometry: birdcage, phased array, and some transmit/receive volume designs. A birdcage coil and a phased-array coil do not share the same test fixture.

The MRI Coil That Failed the Label Test

Last year, one of our contract manufacturers made two types of MRI coils for us: a birdcage head coil and a phased-array body coil. I said “validate the coil.” They heard “run the same test we already have.” Result: the phased-array coils were shipped with a birdcage test template.

I caught it during a second routine review. The surprise wasn’t that the vendor had cut a corner—questionable shortcuts are the background noise of quality work. The surprise was that their engineer genuinely believed the two tests were equivalent. “They’re both coils,” he told me. I said, “And a cardiac stent and a camera are both manufactured products. That doesn’t mean they get inspected the same way.”

The batch was 80 units. We quarantined all of them. The vendor saved maybe $8,000 by reusing the test template. The redo cost them $41,000 and delayed the product by six weeks. A textbook penny-wise mistake.

I used that example in the SPD staff room later that day. A reprocessing tech was trying to photograph a damaged connector on a flexible endoscope with her phone. The light was bad, and the phone couldn’t hold focus. I offered her my Fujifilm X-T5 mirrorless camera, which I carry on audits. She looked at it like I’d handed her a spacecraft. It sounds a little pretentious, but the extra resolution lets me see label wear and surface defects that a phone camera misses. Same discipline as my old Fujifilm 35mm camera—know the tool, focus, expose it correctly, and keep the proof.

The $500 Part That Bought Us a Conversation

Back in the conference room, the manager stopped asking about cameras and started asking about documentation. Then she asked a completely different question: “Can you send us a replacement pressure gauge for our old reprocessor? It’s a tiny part. Do you even bother with parts that small?”

I said yes, because small orders deserve the same process. But honestly? The $500 part didn’t get the same attention as a new endoscope. It fell into the “as soon as possible” pile, which in real life means “whenever the normal cycle takes” (ugh, I hate that phrase). When she called the next Friday, it hadn’t shipped.

That was my fault, not hers. I’d called the part “tiny,” and my own team heard “low priority.” We shipped it in two days after a few urgent phone calls. There’s something satisfying about a small part leaving the building on time—not because it’s revenue, but because it’s trust.

Small doesn’t mean unimportant. It means potential. I’ve been on the other side of a delayed small order, and I remember how dismissive it felt. That hospital is now evaluating one of our portable digital radiography systems. The $500 part didn’t win that deal, but it bought us the conversation.

What the Label Tells You

People sometimes tell me quality is overthinking. Under ISO 13485:2016, though, verification is a living record, not a formality. The FDA’s Unique Device Identification rule (21 CFR Part 830), which started phasing in for class III devices in 2015 and reached most classes by 2022, makes traceability a legal expectation. As of January 2025, I treat a UDI label as a promise, not a sticker.

What do a 35mm camera, an MRI coil, and a cardiac stent have in common? In our quality system, the answer is traceability. A stent arrives with a sterile barrier that carries a lot number. A coil arrives with a test record that matches its geometry. A camera arrives with a calibration certificate that says the focus is accurate. If the label doesn’t match the product, nothing else matters.

Three things: traceability, reproducibility, and honest labels. In that order. I didn’t change the SPD manager’s mind with a brand story. I changed it with the same thing I use every day—a product history file that tells the truth. If that’s not worth doing for a $500 part, it’s not worth doing for anything.