Smith+Nephew Modernizes Quality Ecosystem to Scale Operations

To scale its complex medical technology portfolio while maintaining a commitment to clinical innovation, Smith+Nephew needed a modern global quality ecosystem that supports its corporate growth strategy.

Rather than treating quality as an isolated cost center, the team built a strategic business case focused on cross-functional efficiency, IT consolidation, and maintaining a flat cost of quality as a percentage of revenue.

Michelle Blevins, vice president of global quality systems and regulatory compliance, shared how Smith+Nephew’s quality organization built a blueprint for quality transformation focused on cross-functional alignment, user-centric technology, and future-ready data.

Rigid legacy systems stalling operational agility

Smith+Nephew’s continued growth strained their existing quality system, creating operational bottlenecks. While the legacy systems maintained compliance, they relied on rigid, non-user-centric interfaces, and highly manual workflows that failed to deliver the agility needed to support a modern workforce.

“We evaluated our QMS broadly and realized our existing platforms did not position us well to support our various business units,” shared Blevins. “We needed to automate manual workflows and integrate our ecosystem, rather than execute another costly upgrade that wouldn’t deliver true feature and business value.”

Aligning quality strategy with corporate growth

“One of the most important things you can do when you’re building your case for quality is being able to align your quality strategy to the overall corporate strategy, demonstrating that your investment is aligned with the company’s vision.”

-Michelle Blevins, VP Global Quality Systems & Regulatory Compliance

The quality team forecasted the impact of business growth on their resource requirements to build a compelling business case for executive leadership. Without a built-for-purpose digital platform, scaling operations would require a significant increase in quality personnel.

The quality team proved the value of moving to Veeva Quality Cloud by mapping the investment directly to Smith+Nephew’s corporate “RISE” strategy (Reach, Innovate, Scale, and Execute). They demonstrated that smart automation and supplier collaboration would absorb rapid enterprise growth while keeping the total cost of quality neutral.

“One of the most important things you can do when you’re building your case for quality is being able to align your quality strategy to the overall corporate strategy, demonstrating that your investment is aligned with the company’s vision,” shared Blevins.

To secure organizational buy-in, the team engaged over 30 stakeholders across IT, procurement, training, and supplier quality to evaluate potential solutions against a simple, three-question rubric: Does it maintain current ways of working, enhance the process, and provide tangible benefit?

“It’s one thing to have a central team telling you that you need a new system,” Blevins noted. “It’s a lot different, and that message resounds much higher up, if you’ve got cross-functional teams all in lockstep, advocating for organizational change.”

Building the business case: ROI, cost avoidance, and M&A playbooks

Quantifying the return on a quality system upgrade is a major hurdle. Smith+Nephew overcame this by shifting the dialogue away from maintaining compliance to automating and scaling quality. “We didn’t have a case where someone was knocking on our door,” said Blevins. “So we really had to make the case about the future, growth, and supporting the business.”

Smith+Nephew evaluated the cost of maintaining their status quo against the long-term value of a connected platform. They realized that continuing on their current path and sinking resources into aging infrastructure carried a massive hidden cost.

“Return on investment is hard to quantify,” Blevins explained. “A lot of times we were equating this to, ‘What’s your ROI on Microsoft Word?’ It’s just how business works today. So we did a lot of forecasting around what it would cost us over the next five years if we didn’t do this, if we had to go out and buy four or five different systems, and if we stayed in an upgrade cycle with our legacy on-prem systems.”

Adopting a single platform approach did more than just solve operational headaches; it created a scalable foundation that directly supported their growth strategy. A critical pillar of their business case was streamlining merger and acquisition (M&A) integrations. As a historically acquisitive company, Smith+Nephew needed a repeatable digital playbook to onboard new entities rapidly.

“We are routinely bringing new products and technology into our mix, and with that comes a new quality system and technology stack,” Blevins noted. “What we’ve been trying to transition to is having a common system for acquisitions to land in. It gives us a real sense of risk reduction because we know they can quickly align to our harmonized processes.”

By transitioning to Veeva Quality Cloud, Smith+Nephew expects to unlock immediate operational value across key business functions. The platform is positioned to boost enterprise-wide training efficiency, optimize complaint intake, and enable direct supplier collaboration. In addition, streamlining their IT infrastructure is projected to simplify M&A integrations and scale operations while maintaining global compliance.

A phased roadmap for future-proofed quality operations

Smith+Nephew structured this enterprise transformation as a deliberate, phased rollout. By targeting high-volume, high-friction processes like training and complaint management first, the team set out to demonstrate value early and maintain stakeholder engagement.

Smith+Nephew’s collaborative partnership with Veeva MedTech, paired with an internal culture of agile execution, helped maintain strong transformation momentum. Consolidating quality processes onto a unified cloud platform provides the clean, structured data engine required to fuel future innovations and pave the way for emerging capabilities like AI.

By establishing this fit-for-purpose quality ecosystem, Smith+Nephew successfully prepared the enterprise to scale quality operations, support strategic business growth, and maintain global compliance.

To build a business case for your own organization, read how medtech leaders are making a compelling case to invest in quality transformation.