Specimen strategy is one of the most common sources of avoidable delay in IVD development. Teams that defer specimen decisions until after the evidence plan is set tend to discover the mismatch at the worst possible time: during analytical validation, clinical performance work, or submission prep.

In this episode of Expert Insights, Mitzi Rettinger talks with Jim Boushell, Senior Vice President of Biospecimens at DCN Dx, about what experienced teams define early so their specimen sets and data packages hold up under regulatory scrutiny.
Jim has spent decades building biorepositories and supporting diagnostic developers. The conversation covers how to align a specimen plan to an evidence plan from the start, where programs get burned on matrix selection, prevalence, comparator methods, metadata, and pre-analytical handling, and what a high-integrity, audit-ready data package should contain.

Topics in this episode:

-What “specimen strategy” includes and why it is separate from procurement
-Early warning signs that a program is headed for specimen-related delays
-The most common failure modes in specimen planning
-The minimum inputs a developer needs to define before designing a collection
-When banked specimens make sense versus prospective collection
-How DCN Dx runs prospective collections: specimen types, special handling, site operations, and data packages
-What “audit-ready” documentation means for IVD submissions
-Where handoffs fail when collections, assay development, and clinical execution are split across multiple groups

Learn more about DCN Dx’s prospective biospecimen collections at dcndx.com/biospecimen-service