Jim Boushell, Senior Vice President of Biospecimens at DCN Dx, joins Mitzi Rettinger to talk about what experienced IVD teams define early in their specimen plans and what goes wrong when they don’t.
Expert Insights | Season 3, Episode 5
Biospecimen strategy is the set of decisions that determine which specimens an IVD program needs, how they will be collected, what clinical and demographic metadata must accompany them, and how the resulting data package will hold up under regulatory review. It is distinct from specimen procurement, which is the operational act of acquiring material. When teams conflate the two, or defer strategy decisions until late in the program, they risk discovering the mismatch at the worst possible time: during analytical validation, clinical performance work, or submission prep.
In this episode of Expert Insights, Mitzi Rettinger, Chief Revenue Officer at DCN Dx, talks with Jim Boushell, Senior Vice President of Biospecimens at DCN Dx, about how to prevent those delays. Jim has spent decades on both sides of the equation, building and operating biorepositories and supporting diagnostic developers who need traceable, well-characterized specimens for submission-quality evidence packages.
The conversation covers how to align a specimen plan to an evidence plan from the start; where programs get burned on matrix selection, prevalence requirements, comparator methods, metadata completeness, and pre-analytical handling; and what a high-integrity, audit-ready data package should contain. Jim also describes DCN Dx’s prospective biospecimen collections service, which provides IRB/IEC-approved, protocol-aligned collections with end-to-end operational ownership for IVD evidence generation.
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What you’ll hear in this episode
Defining specimen strategy versus procurement: Jim explains what the term “specimen strategy” should cover, why it is a development decision rather than a sourcing task, and the early warning signs that a program is deferring these decisions too long.
Common failure modes: The conversation identifies how specimen plans go wrong in practice: matrix mismatches between the intended use and the specimens on hand, insufficient positivity rates for the statistical analysis plan, missing or incomplete metadata, comparator method misalignment, and pre-analytical handling errors that compromise specimen integrity. Jim discusses whether these problems cluster around specific modalities and indications or cut across all IVD programs.
The inputs developers need to determine in early: What are the minimum inputs Jim needs from a development team before he can design a collection mapped to claims and an evidence plan? The episode covers this checklist and Jim’s perspective on when “representative” specimens serve a program better than “perfect” ones.
Prospective collections versus banked specimens: When banked specimens are appropriate, when prospective collection is the better path, and what distinguishes a prospective collection designed for IVD evidence from one that was not designed with regulatory submissions in mind.
How DCN Dx runs prospective collections: Jim describes the specimen types DCN Dx routinely supports (including saliva, capillary blood, nasal swabs, stool, urine, and plasma/serum), the special handling scenarios the team manages, and where handoffs tend to fail when collections, assay development, and clinical execution are split across multiple organizations. He also discusses when integrating specimen collection with clinical research operations reduces risk versus when a standalone collection is sufficient.
Quality, compliance, and the data package: What should an IVD developer expect from a high-integrity data package? Jim explains what “privacy controls and quality systems appropriate to the program” means operationally, including ICH-GCP alignment, chain-of-custody documentation, audit trails, and PHI protections. He also identifies the most common false sense of security he encounters around specimens.
About Jim Boushell
Jim Boushell is Senior Vice President of Biospecimens at DCN Dx, where he leads the company’s prospective biospecimen collections offering. His career spans decades in biorepository operations and diagnostic development support, working with IVD teams that need traceable, well-characterized specimens for analytical validation, clinical performance studies, CLIA-waiver intended-user comparison studies, reproducibility, bridging, and lot release. At DCN Dx, Jim’s team designs and operationalizes IRB/IEC-approved prospective collections mapped to each client’s claims and evidence plan, with end-to-end operational ownership from protocol development through data package delivery.
About Expert Insights
Expert Insights is the podcast from DCN Dx, a Carlsbad, California-based immunoassay CDMO and IVD CRO. Each episode features conversations with diagnostics professionals on the technical, regulatory, and operational decisions that shape IVD development programs.
Browse all Expert Insights episodes →
Frequently Asked Questions
What is biospecimen strategy in IVD development?
Biospecimen strategy refers to the decisions that should be made before a single specimen is collected: which matrices the program needs, what prevalence rates the statistical plan requires, how specimens will be handled and transported, what metadata needs to travel with each specimen, and what the documentation package needs to look like for the intended regulatory pathway. It is separate from procurement. Procurement is buying or collecting the material. Strategy is defining what “the right material” means for your specific claims and evidence plan. The reason this distinction matters is that procurement decisions made without a strategy behind them tend to produce specimens that look fine on paper but fall apart under regulatory scrutiny.
When should an IVD developer use banked specimens versus prospective collection?
It depends on what the specimens need to do. Banked specimens can work for some analytical validation activities, particularly when you need well-characterized material and the storage conditions and metadata are documented. Prospective collection makes more sense when pre-analytical handling needs to be controlled to your protocol, when prevalence is low enough that you need enrichment or targeted recruitment, or when a clinical performance study or intended-user comparison study needs to reflect how the test will be used outside a lab. The decision should be made early. Prospective collections have lead time, and discovering that banked specimens do not fit your intended use after enrollment planning is already underway is an expensive mistake.
What does DCN Dx’s prospective biospecimen collection service include?
DCN Dx’s collections service is structured around designing a collection protocol mapped to your claims and evidence plan, then running it. That includes central IRB/IEC management, site qualification and training, specimen kitting with temperature controls, and comparator or reference testing when the study design calls for it. Data capture runs through eCRFs and a LIMS, with chain-of-custody documentation and audit trails. The team handles specimen types including saliva, capillary blood, nasal swabs, stool, urine, and plasma/serum, and supports collections for analytical validation, clinical performance, positivity enrichment, rare matrices, intended-user comparison studies, reproducibility, and bridging or lot release work. Quality operations are aligned to ICH-GCP with HIPAA/GDPR privacy controls. The Biospecimen Collection Services page has more detail on what the deliverables look like.
What should an IVD data package include for regulatory submissions?
The short answer: everything a reviewer or auditor would need to trace each specimen from collection to test result without gaps. That means chain-of-custody records, IRB/IEC approval and informed consent documentation, the collection protocol (including pre-analytical handling and transport), clinical and demographic metadata per specimen, temperature monitoring records, comparator or reference test results with reconciliation, and deviation documentation. The specific requirements vary by pathway (510(k), de novo, PMA, IVDR), which is why defining the documentation standards before collection starts is important. Retrofitting a data package to meet submission requirements after the fact is where most of the rework happens. If your clinical research team and your specimen team are not aligned on this from the beginning, the gaps tend to show up late.
How does poor specimen planning affect IVD regulatory timelines?
It adds months, and the delays are hard to compress once they start. The problems are usually noticed during analytical validation or clinical performance studies: the specimen matrix does not match the intended use, prevalence is too low for the statistical analysis plan to work, metadata is missing or inconsistent, or the chain-of-custody documentation has holes. Any of these can force re-collection. Depending on the specimen type and site access, re-collection timelines can stretch well beyond what the original program plan accounted for. This is why experienced teams treat specimen planning as part of the development conversation, not something they hand off to procurement after the evidence plan is set.
