When Standard Labs Reach Their Limit
A MedTech innovator developing a specialized neurological device had exhausted what a commodity laboratory could offer. After one IDE submission with subsequent amendments, the FDA cited major deficiencies: uncharacterized chemicals the original laboratory had been unable to identify. The chemistry reviewer did not accept the chemical analysis due to the volume of unknowns remaining in the report. With a six-month delay looming and investor confidence eroding, the path to clinical trials was seemingly blocked.
This case study shows how Jordi Labs, an RQM+ Company, applied expert-led chemical characterization to resolve the deficiencies that standard medical device testing services could not. It also shows how Jordi’s analytical precision turned a stalled program into an approved IDE and active clinical trial.
What This Case Study Covers
- Why using a “checkbox” commodity laboratory approach to chemical characterization created compounding FDA deficiencies that threatened the clinical timeline
- The value of Jordi Labs applied expert identification to fully characterize unknown substances with a zero-tolerance policy for unresolved compounds
- How eliminating unknowns from the chemical analysis gave the chemistry reviewer a complete and defensible profile, enabling IDE approval
- Results of the shift from a commodity lab to an expert analytical partner avoided more than six months of projected delays
Who This Is For
Regulatory affairs leaders, biocompatibility specialists, and development teams at MedTech companies who work on IDE submissions, chemical characterization deficiencies, or programs where prior laboratory work has left unresolved unknowns.
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