Copy to clipboard 
Quality culture is no longer just a buzzword reserved for C-suite conversations and conference education programs. FDA frequently focuses on organizational culture when working with companies that undergo remediation for regulatory violations.
“Addressing quality issues isn’t an easy fix, but a strong, well-rooted culture led by committed leadership can prevent many problems before they arise,” said Amra Racic, Vice President of Global Government Strategy, MedTech at Veeva Systems.
Racic cautioned that organizations that may not have prioritized culture in the past have the greatest opportunity for growth. When organizations commit to building a strong quality culture, the reward is profound organizational excellence.
“If leadership doesn’t model it correctly, it’s an uphill battle,” she said. “Instilling quality throughout an organization requires constant attention. Leaders need to talk about it, embody it and set an example. That’s how the mindset seeps into cross-functional teams and becomes part of the organization’s fabric.”
Racic is co-authoring an upcoming position paper that will offer practical ways to build a quality culture. “It’ll contain some compelling reflections from leaders on what they’ve done to strengthen their organizations’ cultures, and how they’ve successfully embedded quality at every level,” she said.
Here are a few of the main takeaways that she learned from the leaders.
Start with the Patient. Patient safety is the foundation of compliance in medtech. Regulators evaluate every decision through the lens of surgical outcomes, making patient-centered thinking the clearest ethical and operational north star for the industry.
Every medtech organization plays a role in making patient care the ultimate priority. Embedding that mindset across all company functions ensures that decisions are not only compliant, but purposeful.
“Everyone who is part of the medtech ecosystem has a responsibility to keep the patient in view,” Racic said. “That’s what connects all of us.”
Make the Business Case. Conversations in medtech that focus on quality and regulatory compliance often walk a fine line between technical precision and business strategy. After more than 18 years working in regulatory affairs, Racic fully understands that dynamic.
“Quality and regulatory professionals have a specific way with words,” she said. “We need to know how to bridge business and quality talk by translating what we do into terms that company executives understand.”
That translation is crucial when discussing the hidden costs that poor quality has on time to market, the strategic lever that influences an organization’s overall success.
“It is vital for business leaders to recognize that proactively addressing quality issues immediately is a fundamental business strategy,” Racic said. “That upfront investment is crucial because it successfully mitigates the exponential cost of corrective action down the line.”
Despite quality’s critical role in product development, Racic acknowledged that it’s sometimes viewed as a perceived cost to overcome rather than a strategic asset. “Quality assurance professionals should exhibit some level of empathy to demonstrate that they understand the operational complexities,” she said. “But they also need to show how quality can accelerate the business rather than slow it down.”
According to Racic, discussing quality is often an accessible entry point for broader conversations about a company’s culture. “It’s a topic that everyone should understand and see value in,” she said. “The challenge is translating that into tangible actions that strengthen a company’s culture and performance.”
Motivate and Empower. A strong quality culture depends not only on systems and processes but also on trust. Leaders must create an environment in which employees feel safe speaking up to alert their teams to manufacturing issues before they escalate into major concerns.
“Psychological safety is really important,” Racic said. “All employees must be given the opportunity to voice their concerns, even if they’re not completely certain about the issue they’re seeing.”
Maintaining that level of support prevents potential product recalls or quality failures and builds engagement and accountability throughout the company.
Many companies celebrate “quality champions” across functions by highlighting individuals who exemplify a culture of vigilance and integrity. “It’s about praising them in a way that makes them feel good and sets an example for their colleagues. They think, ‘If I do this, then my teammate can be the next person in line to do the same,’” Racic said.
Building a team full of empowered employees ultimately comes down to trust built by present leaders who set an example for their teams to follow. “The successful leaders I’ve seen spend time with employees at all levels of the company,” Racic said. “They open their office door, listen and make it clear that quality is everyone’s responsibility. That’s so important.”
So are the small gestures that let team members know they’re thought of as more than just a cog in the manufacturing wheel. Remembering the details about someone’s life, asking how a child’s baseball game went or taking a moment to listen about something other than work carry a deep message of connection.
When employees feel seen and valued, they’re far more likely to speak up, take ownership to solve problems and act with integrity.
Future-proofing the Process. Racic believes technology must take a leading role in modern quality management, specifically with predictive analytics that ensure medtech companies remain ahead of device-related issues instead of reacting to FDA’s adverse event reports.
Managing quality data has so far been a fragmented process handled by a single employee who tracks individual product complaints on a spreadsheet. “Companies now need to be proactive, and for that to happen, technology is the only way forward,” Racic said. “And that technology already exists”
Advances in AI and integrated quality systems consolidate information into a single source of truth. With tools that can analyze complaint data and highlight emerging trends, companies can make faster and more informed decisions.
“Being able to automatically extract that data, assess it quickly and act on it can make an organization more efficient and ultimately improve patient care,” Racic said. “In the end, that’s what matters most.”
This article is part of the ongoing Orthopaedic Surgical Manufacturers Association (OSMA) series.
