I Reject 11% of First Passes, and That’s a Good Thing
I’m a quality and brand compliance manager at NuVasive, now part of Globus Medical. I review clinical services materials, surgical technique guides, and labeling before they reach customers. That works out to roughly 200+ unique items per year.
In our Q1 2025 quality audit, we rejected 11% of first-pass deliverables because of specification mismatches. I don’t say that to alarm you. In my role, rejection isn’t failure. It’s the guardrail that keeps a product claim honest.
I believe the most credible medical device companies are the ones willing to say, “We don’t do that.” The companies that never say it are the ones that worry me.
The Broader Catalog Trap
When I first started in medtech quality, I assumed the safer company was the one with the broadest catalog. If one vendor could supply a spinal implant, an IV catheter, and a prosthetic limb, they must have deep expertise everywhere, right? I was wrong. Actually, I was confusing familiarity with mastery.
Take the IV catheter example. It is a relatively small device, but it involves insertion force, blood compatibility, kink resistance, sterility, and packaging integrity. A spine company could manufacture a catheter, but its quality staff would need to learn an entirely new set of failure modes. This isn’t a knock. It’s the point: you can’t outsource expertise by adding a SKU.
Prosthetic limbs are even further outside that lane. A prosthetic socket has to manage residual-limb pressure, dynamic loads, alignment, and gait. The testing protocols are different, the regulatory history is different, and the users are different. The day a surgeon trusts my spinal implant decision because I also signed off on a socket liner is the day I should retire.
What the NuVasive Globus Medical Merger Really Did
When NuVasive and Globus Medical combined forces, the conversation quickly turned to scale. I don’t think scale was the real goal. The strategic value was sharing a lane.
The NuVasive Globus Medical portfolio brought together two companies that know spine and musculoskeletal surgery deeply. It was not a move to become a one-stop shop for every medical disposable. It was about having more resources to build better surgical systems, train surgeons, and support clinical evidence for procedures like ALIF, TLIF, XLIF, and ACDF.
In my view, that type of merger is rare. It is tempting to use scale to launch unrelated products. It is harder to say: “We will use this scale to go deeper, not wider.”
“How Does Mammography Work?”
I occasionally ask this question during onboarding: “Explain, from memory, how mammography works.” The answers are usually vague: low-dose X-rays, compression, detector. That’s okay. What I want is not an imaging lesson. I want people to notice where their competence ends.
If NuVasive were suddenly asked to develop a mammography accessory, we could hire imaging experts. But building a quality system around a new discipline doesn’t happen by magic. It requires validation plans, risk management, and a team that knows what normal versus artifact looks like. In the same way, I can explain the basics of an IV catheter, but I should not be the person who writes its sterilization validation. And I definitely shouldn’t pretend to know how a prosthetic limb feels to a patient walking downhill.
Knowing your limits is a competence.
Quality Systems Are Not Generic
This is also a regulatory matter. Medical device manufacturers operate under quality management systems such as ISO 13485 and FDA 21 CFR Part 820. Those standards ask us to verify design inputs, control risk, trace processes, and monitor post-market performance. They don’t require a company to be everything. They require us to be precise about what we make and how we know it works.
During supplier audits, I ask vendors what they refuse to make. The best vendors usually have a clear answer. They say, “We don’t do single-use sterile packaging,” or “We avoid active implantable devices we haven’t studied.” At first, I saw that as weakness. Now I see it as evidence that their current product lines have been tested under real scrutiny.
Isn’t Refusing Work Bad Business?
I know what some procurement managers will say: “Hospitals want fewer vendors, not more.” There is some truth to that. But quality issues cost far more than contract simplicity saves.
Several years ago, I audited a supplier that expanded into a product family next to their core line. On paper, it looked like a good fit. In storage-stability testing, 8,000 units were ruined because they didn’t know the material had a temperature limit they had never tested. The expansion cost them a complete batch, a launch delay, and a customer relationship. I don’t remember the name of their sales deck. I remember the quality failure.
The same logic applies to medical device companies. A spine company that says “yes” to an IV catheter line without rebuilding its team might ship thousands of units before an issue emerges—units placed in veins, with consequences far worse than a product recall.
Boundaries Build Trust
I am not arguing that companies should never expand. NuVasive and Globus Medical did expand, but they did it around a surgical specialty: spine care. That is intelligent growth. Expansion that happens simply because “it’s a bigger market” is the beginning of a quality problem.
So here is my position: A medical device brand should be judged not only by what it makes, but by what it refuses to make. If a company is comfortable telling you that a prosthetic limb, a mammography system, or an IV catheter is outside its lane, trust that. It probably has a much better grip on what lies inside.
I’ll take a specialist who knows their limits over a generalist who overpromises any day.
