When Culture Outpaces Compliance: A Wake-Up Call for US Medical Device Manufacturers

Consider the real-life example of a mid-tier manufacturer that faced a seemingly routine CAPA investigation following a recurring production defect. The process was executed flawlessly—design updates, SOP revisions, employee retraining. On paper, they were golden. But in practice, the defect persisted. Why? Because operators quietly reverted to old methods during crunch time. Not out of defiance, but because the organizational culture subtly rewarded speed and productivity over precision. This disconnect between prescribed process and lived behavior is the Achilles’ heel of compliance.

Quality Management System Regulations such as 21 CFR Part 820 are not suggestions—they’re mandates. They span design controls, production protocols, complaint handling, and risk management. They require that companies will build systems not just to follow rules, but to design and produce products that meet specifications with the ultimate purpose of protecting patients. Yet, no regulation can safeguard against a culture that doesn’t believe in its purpose.

Audit findings rarely cite "poor culture" as a direct cause—but they often trace back to it. The FDA doesn't regulate culture—but its consequences show up on every production line, every investigation report, and every customer complaint. One of the most prominent inspectional observations appearing on Form FDA 483s is the failure to establish and maintain processes and procedures. Though FDA can cite a company for a procedure that does not address all of the requirements from the regulation, in most instances, the observation focuses not on the procedure itself, but on deviations from complying with them. When operators take short-cuts or falsify documents to meet production demands, when CAPAs focus on containment rather than root cause, when silence becomes the default response to quality concerns, the process becomes meaningless.

Medical device regulations demand precision adherence. Design controls ensure products meet specifications and meet user needs. Risk management tracks hazards, from concept to patient use. CAPA systems compel organizations to identify, investigate, and eliminate failures both in the short and long term. These systems work brilliantly—on paper. Yet they collapse when the people executing them aren’t empowered, engaged, or aligned with the principles behind them, or otherwise do not recognize the implications associated with deviating from them.

A culture misaligned with quality reveals itself in subtle but dangerous ways:

• Silence in the face of uncertainty: Employees hesitate to raise concerns for fear of being reprimanded, blamed or ignored.
• Box-ticking mentality: Procedures are followed for appearances, not understanding.
• Hero culture: Employees feel rewarded for fixing problems urgently instead of preventing them systematically.
• Compliance fatigue: Quality becomes an abstract burden instead of a shared commitment to patient safety.

Leadership sets the tone. If senior management pressures teams to meet quotas while glossing over deviations, culture deteriorates. If quality personnel are seen as "obstructive gatekeepers" or the “compliance police” instead of collaborative partners, resentment builds. If training focuses solely on SOPs without context or purpose, teams disengage.

The antidote is cultural integration—where quality is not a department, but a shared ethic. To repair this disconnect, organizations must treat culture as the foundation—not the fringe—of quality. Here’s how:

• Model quality-driven behavior from the top: Executives and managers must visibly prioritize patient safety and quality compliance over production speed. Every decision should reflect a commitment to do the right thing, even when it takes more time, it’s inconvenient or costly.
• Embed quality values into daily routines: Recognition programs, peer shout-outs, and meeting agendas should all celebrate vigilance, integrity, and teamwork.
• Train beyond procedures: Ensure employees understand how their actions affect the end user. Real stories from clinicians or patients can be powerful reminders of why their work matters. The adage of “imagine your loved one as the patient” should permeate throughout the organization. Training must focus on the why, not just the how—to ensure understanding, not memorization.
• Create psychological safety: Psychological safety must be engineered into the workplace, so that speaking up is encouraged, not feared. Encourage employees to speak openly about process weaknesses or observed deviations. Use postmortems and audits to learn—not punish.
• Facilitate cross-functional accountability: The Quality Department shouldn’t be the sole owner of a quality culture. Production, design, and supply chain teams must all see themselves as co-owners of compliance. Although different teams and functional areas have unique talents and expertise that they bring to the table, each team should recognize their important role in quality as a whole and work together to ensure the products are safe, meet specifications and that when issues arise, they are identified and addressed.
• Foster deliberate cross-functional dialogue—especially where roles overlap: Encourage regular, structured conversations between groups with intersecting responsibilities, such as R&D and Design/Quality, or Regulatory and Quality during design changes and recalls. Break down silos by ensuring these teams jointly review risks, decisions, and process changes, so that no group operates in isolation or in competition. When teams share ownership of outcomes and communicate openly about overlapping duties, the organization moves from competing silos to a unified, patient-focused culture.
• Monitor culture metrics alongside quality metrics: Internal surveys, feedback loops, and behavioral audits should be part of the QMS itself.
• Recognize and celebrate the courageous: Recognition must flow to those who uphold compliance, not just those who meet quotas.

In the end, process is necessary. But without culture, it’s hollow. In medical device manufacturing, culture determines whether compliance is sustainable—or superficial. It's the invisible force behind every validated process, every inspection pass, every life saved.

In a field where actual lives depend on unseen decisions, the real regulator isn’t always the FDA—it’s the collective conscience of the organization. And that begins not with documentation, but with belief.

Culture doesn’t just eat process for lunch. It dictates whether lunch is safe to eat.

Authored by Jodi Scott and Mike Heyl