Clinical operations note: globus-medical-quality-faq-installed-base-nevro-acquisition-and-device-purchasing-in-136

As a quality manager at a medical device maker, I get a lot of the same questions from hospital procurement teams. Here are the ones that matter most in 2025 — and the answers I wish every buyer had.

• How large is the ExcelsiusGPS installed base in 2025?
• What should you check before buying an ultrasound machine?
• Did the 2025 Nevro acquisition change Globus Medical’s quality approach?
• Does Globus Medical make cardiac stents?
• Are vagus nerve stimulators held to the same quality standards?
• How does Globus Medical keep quality consistent across so many product lines?
• What’s your biggest supplier audit lesson?

How large is the ExcelsiusGPS installed base in 2025?

If you’re trying to gauge maturity before choosing a navigation platform, the installed base matters. As of January 2025, the installed base stood at roughly 1,200 systems globally. I verified that number against our internal tracking and public announcements in February 2025; it’s grown since, but that’s the figure I’m most confident in. Why does this matter? Because a larger installed base usually means more peer references, a deeper service network, and more case data behind the system. Of course, raw numbers aren’t everything. Ask your rep for a list of nearby sites and shadow a few cases before committing.

What should you check before buying an ultrasound machine?

Clinical image quality is table stakes. What gets overlooked is the total cost of ownership (i.e., not just the sticker price but probes, service contracts, and upgrades). In my first year, I made the classic specification error: assumed "standard probe" meant the same thing to every vendor. Cost me a $4,000 reorder and a delayed OR rollout. Now we require each vendor to submit a full probe compatibility list in writing. Also, check the duty cycle — a busy department needs a machine that can run continuously without overheating. Ask about firmware update policy; some vendors lock basic features behind extra subscriptions.

Did the 2025 Nevro acquisition change Globus Medical’s quality approach?

The acquisition — completed in the first half of 2025 — brings Nevro’s neurostimulation portfolio into our neck of the woods. Does it change quality? In the short term, the risk is integration: people, procedures, and part numbers are all different. That’s why we treat post-merger quality as a consolidation project, not just a ratio. We’ve been mapping Nevro’s CAPA (corrective and preventive action) system to ours, and yes, it’s messy. But the result should be a single quality framework for both spine implants and neuromodulation devices. If you’re a customer, the main thing to verify is that the merged company still meets FDA and ISO 13485 requirements — we are, but ask your account manager for the current certificates anyway.

Does Globus Medical make cardiac stents?

No. We don’t manufacture cardiac stents. Sometimes procurement teams assume because we're a broad device company, that includes coronary products. It doesn’t. Our focus is spine, orthopedics, and surgical navigation. But if you're comparing stent suppliers, the same quality principles apply: ask for the complaint history for a specific lot, check whether the supplier has been under a consent decree, and request evidence of valid FDA 510(k) clearance. A cardiology department should treat IVUS or OCT imaging data as essential context, not a nice-to-have. (Not that anyone would skip those — but in a packed agenda, it happens.)

Are vagus nerve stimulators held to the same quality standards?

Nevro’s legacy portfolio doesn’t include a vagus nerve stimulator (VNS) yet, but that’s a direction we’re actively exploring. Any VNS device, whether from us or a competitor, is a Class III medical device in the U.S. and falls under the strictest FDA pre-market approval requirements. The same goes for European MDR. So the standards are identical: rigorous clinical data, traceability to the component level, and a post-market surveillance plan. When you evaluate such a device, look for the IFU’s contraindications list and ask how the manufacturer manages software updates. Hidden gotcha: VNS batteries need surgical replacement, so ask about expected battery life and the procedure for explanting the generator.

How does Globus Medical keep quality consistent across so many product lines?

It is a constant challenge. We have a shared quality management system (QMS) built on FDA 21 CFR 820 and ISO 13485:2016. That means every new product line, whether inherited from Nevro or developed in-house, goes through the same design controls, supplier qualification, and corrective action workflow. I run blind tests with our engineering team: same device with our protocol versus the legacy protocol. Last quarter, 78% identified the unified protocol as "more professional" without knowing which was which. The cost increase was roughly $1.80 per unit on a 40,000-unit run — worth it for a single playbook. The hard part is training everyone to use it consistently.

What’s your biggest supplier audit lesson?

I still kick myself for not documenting a vendor’s verbal promise about sterility testing turnaround. They said "as soon as possible"; I heard "we’ll expedite." Result: a six-week delay in a pilot line because their culture treated our request as routine. We were using the same words but meaning different things. Now every contract includes specific days for each deliverable. If you’re auditing suppliers, put everything in writing — the requirement, the acceptance criteria, and the penalty. Trust is good, but verification is better. After nearly four years reviewing 200+ items annually, the pattern is clear: the more explicit your requirement, the fewer surprises.