The pressure on medtech quality leaders has never been higher. From tighter regulatory oversight to global market expansion, the expectations placed on quality and regulatory (QA/RA) teams are expanding, but headcount rarely is. For many medical device manufacturers, the model that once worked no longer does.

Today, scaling compliance with more people simply isn’t sustainable. The real path forward requires rethinking how quality is structured, supported, and delivered.

This article kicks off a three-part series exploring how medtech organizations can evolve their quality functions to meet modern demands, without increasing overhead. The focus for this portion is to determine why medtech’s quality model is breaking, and what comes next. 

The Legacy Quality Model Is Cracking

For decades, the operational quality model in medtech has remained largely unchanged: assign experienced professionals to maintain documentation, chase CAPAs (corrective and preventive action), manage audits, and prepare regulatory submissions. These teams have been stretched thin across sprawling supplier networks, evolving global standards, and growing product portfolios.

But the cracks are now showing.

• EU MDR implementation revealed how underprepared many organizations were for the rigor and depth of new requirements.
• MDSAP and global inspection programs have raised the bar on documentation, traceability, and oversight.
• Notified Body capacity constraints are delaying approvals, often because QMS readiness wasn’t assessed early or thoroughly enough. 

Teams are working harder, but outcomes aren’t improving proportionally. Compliance costs are up, approval timelines are long, and burnout is real.

The Hidden Cost of Quality

When manufacturers think about cost of quality, they often focus on failures: non-conformances, complaints, or recalls. But the hidden costs of inefficiency, redundant reviews, inconsistent audit prep, or unscalable document control are just as significant.

In orthopedic manufacturing in particular, where product variety is high and margins are tight, these inefficiencies can quietly erode profitability.

Quality should be a driver of value, not a drag on speed or margin. Yet many companies are stuck in reactive cycles, responding to findings, fixing documentation, or scrambling to prepare for the next inspection.

Why Traditional QA/RA Teams Can’t Scale

The instinct to “just hire more people” isn’t solving the problem. Why? Because the challenge isn’t headcount, it’s structure and strategy.

Hiring without addressing systemic gaps in processes, tools, and data integration is like adding more rowers to a leaky boat. You’ll stay afloat for a while, but you’ll still be bailing water.

We’ve seen this time and again at MB&A. Whether it’s a multi-billion-dollar orthopedic device OEM or a fast-moving contract manufacturer, the issue is the same: current quality systems are too people-dependent and not process- or technology-enabled enough.

The New Mandate: Smarter, Leaner, Tech-Augmented

It’s time to reframe how we think about scaling compliance. Modern medtech companies need a model that’s:

• Smarter—Built on strategic delegation, clear roles, and high-value work
• Leaner—Minimizing manual tasks and focusing expertise where it matters most
• Tech-Augmented—Using digital tools to boost speed, insight, and consistency

This isn’t about replacing people. It’s about empowering them. When quality professionals are freed from chasing signatures and formatting reports, they can actually focus on risk, improvement, and innovation.

Case in Point

Let’s consider a recent client example.

A mid-sized orthopedic manufacturer approached MB&A after failing back-to-back supplier audits. Their quality team was skilled, but overwhelmed. Supplier issues were only discovered after escalation, and audit reports varied wildly depending on who conducted them.

We helped them build a unified audit model, implement a streamlined document review process, and train suppliers on shared expectations. Within six months, they reduced repeat findings by 67% and regained client trust. Further, they did it without hiring a single new team member.

The Real Shift Is Mindset

What’s required now isn’t just operational change, it’s a mindset shift.

Quality can no longer be seen as a gatekeeper or a checklist exercise to survive audits. It must become a strategic function that enables scale, drives decision-making, and signals maturity to investors and acquirers.

To do that, QA/RA teams need to:

• Challenge legacy workflows
• Invest in their digital literacy
• Build systems designed for today, not 1995

In the next two installments of this series, we’ll explore the tactical changes and team evolution needed to build this modern quality model. But first, it starts with one question: “Is your current quality system built to scale, without adding more people?” If the answer is no, you’re not alone. But you don’t have to stay there.

In Part 2 of this series, we’ll explore what a lean, modern, and audit-ready quality system actually looks like in practice, from role clarity and smarter internal audits to scalable supplier oversight. We’ll also examine how small shifts in process and mindset can reduce burnout, improve consistency, and lay the groundwork for AI-powered efficiency, without adding more headcount.

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Monica Burt is the founder and CEO of Monica Burt & Associates (MB&A), a trusted partner to private equity firms, investors, and medical device innovators worldwide. MB&A provides deep expertise in quality, regulatory, and operational excellence across all stages of investment and product development. Before founding MB&A, Burt spent 17 years in corporate leadership roles at Smith+Nephew, Medtronic, and Wright Medical, where she led global quality and operations teams through complex transformations, integrations, and compliance initiatives. This firsthand experience gives her an unmatched understanding of how strategy, systems, and people intersect in high-stakes manufacturing environments. Under her leadership, MB&A has become an industry authority in auditing—from readiness and execution to remediation and response—and is now at the forefront of AI-enabled quality system management, helping clients modernize compliance, reduce risk, and accelerate innovation.