When it comes to medical device testing, more isn’t always better.
One of the biggest mistakes we see? Teams defaulting to comprehensive test panels — even when the risk doesn’t call for it. I recently helped a client avoid six months of rework after the FDA flagged several redundant biocompatibility tests. Why? Their Biological Evaluation Plan (BEP) included everything, instead of focusing on what was actually required.
The Problem with the “Test Everything” Approach
Too often, medical device teams fall into the trap of running the full ISO 10993 suite:
- Cytotoxicity ✔
- Sensitization ✔
- Irritation ✔
- Systemic Toxicity ✔
- Genotoxicity ✔
Even when their device’s risk profile doesn’t justify it.
What does that lead to?
Wasted time. Wasted budget. Wasted samples.
The Smarter Way: Strategic Test Selection
Instead of testing everything, align your strategy with the factors that matter:
- Contact Type – Is it surface, implant, or blood-contacting?
- Contact Duration – Limited (<24h), prolonged, or permanent?
- Material Characteristics – Is the material novel or well-established?
- Patient Population – Pediatric? Immunocompromised? Reproductive age?
What Strategic Testing Looks Like
✅ Surface contact <24h: Cytotoxicity + irritation/sensitization
✅ Implants >30 days: Add systemic tox, genotox, chronic tox — possibly carcinogenicity
✅ Blood-contacting devices: Include hemolysis, thrombogenicity, complement activation
✅ Drug-device combos: Add extractables/leachables & chemical characterization (ISO 10993-17/18)
Real-World Win
A client recently submitted a 12-test panel for a mucosal contact device with just a 2-hour exposure time.
After reviewing exposure risk and leveraging predicate data, we trimmed it down to just 4 targeted tests.
Results? They saved tens of thousands in testing fees and slashed their BEP review time in half.
The Bottom Line
Strategic test selection is about justifying what you test — and why.
If you’re testing everything “just to be safe,” you’re doing it wrong.
Need Help with Your Test Strategy?
Drop a comment with your device type and I’ll point you to the right ISO 10993 endpoints.
Or get in touch directly:
📧 info@kandih.com
📞 240.565.8933
🌐 kandih.com
Regulatory Toxicologist | Helping device teams build focused, defensible biological evaluation plans that pass the first time.
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