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The diagnostics world is built on trust, trust that results are accurate, that patient data is protected, and that the company acts with integrity.
Regulators check for compliance. Investors check for growth. But it’s culture that holds everything together when no one is watching.

Here’s how boards can actively shape both culture and compliance to protect value and speed success.

1. Compliance is Minimum Viable Governance
ISO 13485, IVDR, CAP accreditation, these are the tickets to play in diagnostics.
Boards must make sure compliance isn’t just a “tick box” exercise but a living, breathing part of daily operations. That means looking beyond pass/fail audit results to the behaviours and incentives behind them.

2. Culture Multiplies or Erodes Compliance
If the unwritten rule in the lab is “get results at all costs,” corners will be cut.
If leadership values transparency over blame, issues get surfaced early before they become headlines or investor liabilities.
Boards need to actively test the cultural pulse, not just read management reports.

3. Financial Pressure is a Cultural Stress Test
Funding squeezes expose culture faster than any HR survey.
A company that can maintain quality control, data integrity, and staff morale while cash is tight is far more likely to survive scale-up.
Boards should be alert to whether financial strain is driving risk-taking that could backfire with regulators or customers.

4. Role-Model the Balance
When boards demand aggressive growth but under-resource compliance, they send the wrong signal.
Equally, when every minor risk is treated as a red flag, innovation dies.
The right tone from the top is: Move fast but never at the cost of accuracy, ethics, or safety.

5. Use Culture as a Value Proposition
In diagnostics, a strong culture is a competitive advantage.
Investors, acquirers, and large health system partners increasingly want to know how you work, not just what you’ve built. A visible, values-driven culture can attract better talent, better deals, and better valuations.

Final Thought:
In diagnostics, compliance gets you through the door, but culture decides whether you stay in the room.
Boards that nurture both protect more than regulatory status; they protect the trust that underpins long-term commercial success.

References
International Organization for Standardization (2023) ISO 13485: Medical Devices — Quality Management Systems. [Online] Available at: https://www.iso.org (Accessed: 8 August 2025).
European Commission (2022) In Vitro Diagnostic Medical Devices Regulation (IVDR). [Online] Available at: https://health.ec.europa.eu (Accessed: 8 August 2025).