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Expert Insights

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by DCN Dx

5.0(2 reviews)

18 episodes

Updated Daily

Accepts GuestsHas SponsorsLocation 🇺🇸

Podcast Authority

Beta

PoorBased on show quality, social media presence, reviews, charts, and more

Quality12

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YouTube0

Engagement32

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Podcast Overview

Expert Insights offers an inside look at the diagnostics industry, with practical advice and real-world examples from experienced professionals. Hosted by Mitzi Rettinger, Chief Revenue Officer at DCN Dx, this podcast focuses on the key decisions and challenges involved in developing and commercializing diagnostic technologies. Each episode features conversations with industry experts who share their experiences in assay development, clinical research, manufacturing, and regulatory processes. From overcoming technical hurdles to ensuring a smooth path to market, Expert Insights provides clear, actionable guidance for diagnostics developers, R&D managers, and innovators. Subscribe to Expert Insights on Spotify, Apple Podcasts, or your preferred platform, and visit dcndx.com for additional tools and resources.

Language

🇺🇲

Publishing Since

1/29/2025

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🇺🇸 Charts #3

Outreach generated

Apple 142

Spotify 827

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Podcast Authority

Beta

PoorBased on show quality, social media presence, reviews, charts, and more

Quality12

Social0

YouTube0

Engagement32

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Excellent Areas

Good Performance

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excellent

Episode Length

29 minutes

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good

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3.0/5

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Every 27 days

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Recent Episodes

June 10, 2026

Stuck in a Holding Pattern: The IVDR Revision and Planning for Two Markets at Once

The 2026 IVDR transition deadlines are here, and a lot of IVD companies are sitting still. After the European Commission proposed a revision to the regulation in December 2025, many manufacturers are waiting to see what survives before they file. By late May, notified bodies reported that submissions had slowed so much that some have cut staff and a few may close. The old IVDD deadlines keep running out, the dates for higher-risk classes have already passed, and the Commission's message has been consistent: no more extensions. Dan Simpson, Director of Regulatory Affairs at DCN Dx, and Sarah Barchard, Senior Clinical Trials Manager at DCN Dx, talk through what the waiting costs a company that has to sell in both the EU and the US, and why it pays to plan for both markets at the same time instead of one after the other. Dan takes the regulatory side: where the two systems differ, and how those differences shape design and development long before anyone files. Sarah takes the clinical side: where EU and US requirements pull in different directions during analytical and clinical work, and what it takes to run studies that hold up in both places. This conversation leads into their RAPS sponsored webcast, The IVDR Transition in 2026: Parallel Regulatory Planning for EU and US Market Entry, on June 17 at 12pm ET. It's free, and you can register through RAPS. Dan and Sarah will walk through the case studies behind what they discuss here. Register: ⁠https://www.raps.org/learn-develop/events/sponsored-webcast-the-ivdr-transition-in-2026-parallel-regulatory-planning-for-eu-and-us-market-entry.html⁠ Talk through your own program: ⁠dcndx.com/contact

May 8, 2026

QMSR Is in Effect: What IVD Manufacturers Still Need to Do

In this episode, Emily Friedland, VP of Clinical Research at DCN Dx, talks with two guests who come at QMSR from different directions: the regulatory strategy side and the quality systems implementation side. Dan Simpson, RAC, Director of Regulatory Affairs at DCN Dx, covers the regulatory framing: what changed with the QMSR transition, how to map an ISO 13485-based QMS against QMSR’s U.S.-specific requirements, and what FDA’s updated inspection approach under CP 7382.850 means for how teams document and maintain QMS records. Kevin Gunning, Principal Consultant at Gunning Quality Systems LLC, brings the quality systems implementation perspective: what it takes to build and maintain a QMS that holds up under QMSR, how organizations should think about the practical work of a gap assessment and remediation, and what teams with established ISO 13485 systems often overlook when they assume the transition is “mostly handled.” Kevin has spent more than 25 years implementing and managing quality systems at IVD and medical device companies, and has extensive firsthand experience on both sides of FDA and ISO audits and inspections. Together, Dan and Kevin cover the four gap areas that matter most for IVD manufacturers, what FDA can now request during an inspection that was previously off-limits, and how to scope a proportional remediation effort. Read the companion article here: https://dcndx.com/insights/qmsr-ivd-manufacturers-gaps-iso-13485/

April 3, 2026

Specimen Strategy Is Development Strategy (And Why "We'll Source It Later" Fails)

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

18 total episodes available

Recent guests on Expert Insights

Guests from recent episodes — sign up to see every guest that has ever appeared on this show.

Rob Rich

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Claude Noguès

Guest

Cyril Gilbert

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Kellie LaRochelle

Guest

Klaus Hochleitner

Guest

Sarah Barchard

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Jeremy Elser

Guest

Helen Hsieh

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Frequently asked questions

Have a different question and can't find the answer you're looking for? Reach out to our support team by sending us an email and we'll get back to you as soon as we can.

What is Expert Insights?: Expert Insights offers an inside look at the diagnostics industry, with practical advice and real-world examples from experienced professionals. Hosted by Mitzi Rettinger, Chief Revenue Officer at DCN Dx, this podcast focuses on the key decisions and challenges involved in developing and commercializing diagnostic technologies.

Each episode features conversations with industry experts who share their experiences in assay development, clinical research, manufacturing, and regulatory processes. From overcoming technical hurdles to ensuring a smooth path to market, Expert Insights provides clear, actionable guidance for diagnostics developers, R&D managers, and innovators.

Subscribe to Expert Insights on Spotify, Apple Podcasts, or your preferred platform, and visit dcndx.com for additional tools and resources.
How often does this podcast release new episodes?: This podcast updates daily.
Where can I listen to this podcast?: This podcast is available on 4 platforms including Apple Podcasts, Spotify, and more. You can also use the RSS feed directly.
Does this podcast accept guests?: Information about guest appearances is not available.

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