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Every diagnostics start-up lives with risk.
A reagent batch fails QC.
A new ISO interpretation changes your documentation burden.
An investor delays signing, and cashflow tightens.

Boards can’t eliminate these risks but they can make sure the business is ready to absorb and adapt without losing momentum.

1. Map Risk Early and Update Often
Risks shift as you move from concept to scale-up.
In R&D, assay performance may be the top concern.
In commercialisation, it could be reimbursement delays or tender losses.
Boards should require a rolling risk register that evolves with the company’s stage, funding status, and market changes.

2. Funding Risk is a Strategic Risk
Many boards treat finance as a separate track to product and market.
But in diagnostics, a cash crunch can cause regulatory slippage, missed sales cycles, and loss of key staff all of which destroy valuation.
Boards must track runway as closely as product KPIs, and know the trigger points for raising capital before an emergency.

3. Build Redundancy into Critical Systems
Single-supplier dependency is a silent killer in diagnostics.
A disruption in reagent supply or instrument calibration services can shut down operations for weeks.
Boards should press management to qualify multiple suppliers, diversify lab capacity, and document contingency protocols.

4. Make Risk a Cultural Habit
Risk management works best when it’s embedded in daily decisions not as a quarterly board agenda item.
That means everyone, from lab techs to sales teams, understands both the tolerance for risk and the escalation pathways when something feels off.

5. Plan for Regulatory Shocks
Changes in IVDR guidance, FDA classification shifts, or heightened CAP/CLIA scrutiny can land without warning.
Boards should ensure regulatory intelligence is baked into the company’s horizon scanning ideally with proactive lobbying or industry group participation.

Final Thought:
Resilience isn’t about surviving a single crisis, it’s about making sure no single risk can take you out.
In diagnostics, that means treating funding, compliance, supply, and culture as interconnected parts of the same survival system.

References
ISO (2023) ISO 22301: Security and Resilience — Business Continuity Management Systems. [Online] Available at: https://www.iso.org (Accessed: 9 August 2025).
European Commission (2022) In Vitro Diagnostic Medical Devices Regulation (IVDR). [Online] Available at: https://health.ec.europa.eu (Accessed: 9 August 2025).