Quality & yield
Manufacturing & supply chain
550 episodes across 34 shows cover quality & yield. The shows that cover it most are Global Medical Device Podcast, Let's Combinate and Being an Engineer. The most recent, from 12 Oct 2026, is “R&D RADIO: Oil Analytics, Seed Oils and Adulterated Avocado Oil with Dr. Selina Wang of UC Davis” from The Startup CPG Podcast.
Quality control and assurance, inspection, yield, defects, returns and recalls.
550 episodes from 34 shows, most relevant and most recent first.
550 episodes
R&D RADIO: Building a Reliable Formula Brand with Casey Bauer, COO, Bobbie
Casey Bauer, COO of Bobbie, explains how the company maintains food safety as one of only four U.S. infant formula manufacturers by conducting over 2,000 safety and quality checks at multiple stages, from raw materials to finished cans. He…
248 - What Is a Quality Unit? QA vs. QC Explained
Subhi Saadeh, a quality consultant specializing in drug-device combination products, explains the regulatory and practical distinctions between the Quality Unit, Quality Assurance (QA), and Quality Control (QC). He defines the Quality Unit…
#462: Implementing an eQMS: The Ultimate Move-In Guide for MedTech Leaders
Michaela Kivett, a medical device consultant at Greenlight Guru, explains the strategic implementation of an electronic Quality Management System (eQMS) using a 'moving house' analogy to warn against simply migrating messy legacy data. She…
238 - 6 Audit Strategies Every Auditor Should Know
Subhi Saadeh, founder of Let’s Combinate and a veteran auditor with experience at Pfizer, Gilead, and Baxter, explains six major auditing strategies for quality systems in drug-device combination products. He details the tracing method…
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255 - Audit Interview Techniques: How Good Auditors Get Better Evidence
Subhi Saadeh, founder of Let's Combinate, explains audit interviewing techniques developed with partner Andy Robertson, emphasizing that interviews are the bridge to verifying quality systems beyond desktop reviews. He details how to build…
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#474: Behind the QMSR Audits: The Top 5 FDA Citations & Risk Management Pitfalls
Nikhil Mangale, Vice President of Quality at Kapstone Medical, discusses the real-world impact of the FDA's Quality Management System Regulation (QMSR) based on seven months of inspection data. He identifies the top five FDA citations as…
#420: MedTech Synergy: The Project Manager and Quality Professional Relationship
Beth Waring, a medical device consultant at Greenlight Guru, discusses the critical relationship between project managers and quality professionals, advocating for a shift from a 'police force' mentality to a collaborative partnership. She…
How Quality and Innovation Roles are Changing in Data-Rich Manufacturing Environments w/ Daniel First
Daniel First, founder and CEO of Axion, explains how AI is transforming quality and innovation roles in manufacturing by turning overwhelming streams of customer, device, and service data into actionable insights. He argues that quality…
Your Machines Have a Heartbeat: Here's What It's Telling You | Ep #48
Lauren Dunford, co-founder and CEO of Guidewheel, explains how their platform uses current transformers on power cords to monitor machine electrical heartbeats, providing non-invasive visibility into run, idle, and down states without PLC…
DeepDive 1-on-1 Series: EXECUTION READINESS - Verifying the Factory Before the Climb (30m42s)
Rob Carl, Founder & CEO of Global NPI Solvers, explains how to verify factory execution readiness before mass production, warning against the 'golden road' tours that hide cultural and process gaps. He details the risks of 'perfect…
How Safety Drives Your Bottom Line and Why It Starts With You w/ Brian Fielkow
Brian Fielkow, former CEO of JetCo Delivery and author of 'Making Safety Happen', argues that safety must be a core value rather than a priority or compliance function. He explains that safety failures cost five times more than insurance…
254 - Saying No Is the Easy Part of Quality
Subhi Saadeh, founder of Let’s Combinate, outlines four scenarios where quality professionals must firmly say no, including real patient risk, insufficient evidence, requirement violations, and schedule pressure. He contrasts these with…
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#417: Evaluating EQMS: A Crucial Step for Medtech Success
Andy Rogantino, an account executive at Greenlight Guru, joins host Etienne Nichols to discuss the strategic evaluation and implementation of Electronic Quality Management Systems (EQMS) for medical device companies. They argue that teams…
252 - Acceptance Sampling Fundamentals: AQL, Attributes vs Variables, and Risk (OC Curves)
Subhi Saadeh, founder of Let's Combinate, explains the fundamentals of acceptance sampling, clarifying that it is a probability-based tool rather than a guarantee of quality. He distinguishes between attribute sampling (counting defects)…
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249 - The Best Audit Advice Nobody Told Me
Subhi Saadeh, a quality professional and certified lead auditor specializing in drug-device combination products, shares five key lessons learned from transitioning from the auditee to the auditor side. He emphasizes that audits should…
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#410: Is the MAUDE Database Broken? An Insider’s Take on Adverse Event Reporting Failures
Regulatory expert Mike Drues joins host Etienne Nichols to critique the FDA’s MAUDE database, arguing that widespread late reporting and poor data hygiene undermine its safety mission. Drues highlights that nearly 30% of reports are late…
#400: The State of the Medical Device Industry
Greenlight Guru’s Sara Adams joins host Etienne Nichols to discuss the 2025 Medical Device Industry Benchmark Report, highlighting that global sales are projected to reach $800 billion by 2030. They analyze key industry shifts, including…
Inside Component Testing: Fighting Fakes in the Electronics Industry
Elijah Miller, VP of Operations at The Lab Worldwide (TLW), explains the sophisticated methods counterfeiters use to infiltrate the electronics supply chain, including remarking, harvesting, and cloning. He details how even franchise…
ValuJet 592 crashed in 1996 with 110 people aboard. We reconstruct the layered failure and what Perrow's normal accident theory says about why it happened.
Hosts John Brunner and Alex Howe reconstruct the 1996 ValuJet Flight 592 crash, attributing the disaster to a layered failure involving expired chemical oxygen generators lacking safety caps, which ignited in the cargo hold. They analyze…
DeepDive 1-on-1 Series: MAPPING THE ROUTE - Path to the Summit (20m32s)
Rob Carl, Founder & CEO of Global NPI Solvers, explains the 'Pre-Ascent Protocol' for New Product Introduction, arguing that a working prototype is merely a sketch, not a map to mass production. He details how 'architecture freeze' on…
Quality Management in a Changing Manufacturing Environment w/ Naveen Poonian
Naveen Poonian, President and CEO of iBase-T, discusses the critical state of quality management in aerospace and defense manufacturing, citing Boeing and Starliner delays as examples of risks when speed compromises quality. He argues that…
246 - The 3 Ways to Structure a Quality Management System (Centralized vs. Federated vs. Decentralized)
Subhi Saadeh, a quality consultant specializing in drug-device combination products, explains the three primary structures for Quality Management Systems: centralized, decentralized, and federated. He details how document hierarchies…
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#443: Generative AI in MedTech: Quality, Risks, and the Autonomy Scale with Ashkon Rasooli
Ashkon Rasooli, founder of Ingenious Solutions and a specialist in Software as a Medical Device (SaMD), discusses the unique quality assurance challenges of generative AI in the medical device industry. He explains that unlike traditional…
236: ICH Q9: Quality Risk Management (QRM) + ISO 14971 Differences
Subhi Saadeh, Founder of Let’s Combinate, explains the ICH Q9 Quality Risk Management (QRM) framework, defining risk as the combination of probability and severity. He details the five-step QRM process—initiation, assessment, control…
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231 - Audit Findings Explained: Nonconformity vs Observation (CQA)
Subhi Saadeh, host of Let's Combinate and a certified ISO 13485 Lead Auditor, explains how to classify and write audit findings for the ASQ CQA certification, drawing on his experience with companies like Baxter and Pfizer. He…
#460: FDA AI Regulations: Master the QA/RA Skills to Stay Ahead
Etsy Nichols discusses the evolving FDA regulatory landscape for AI-enabled medical devices, highlighting the establishment of the Digital Health Center of Excellence and the shift toward rigorous documentation over algorithmic…
#390: Building a Non-BS QMS: 4 Core Principles for MedTech Success with Ashkon Rasooli
Ashkon Rasooli, a quality and regulatory expert, joins host Etienne Nichols to outline four core principles for building an effective, non-burdensome Quality Management System (QMS) for medical device companies. Rasooli argues for 'Quality…
PCB Metrology Gap: How SCAN Labs Is Automating Microsectioning
Geoffrey Leeds, founder of SCAN Labs, explains the 'metrology gap' between semiconductor and PCB industries, detailing how his company automates microsectioning to provide high-fidelity data for high-reliability sectors. He describes a…
S7E6 Bob Hankins | Medical Device Engineering Leadership & Working With the FDA
Bob Hankins, Director of Engineered Component Development at TE Connectivity, discusses leading global engineering teams in the regulated medical device space, focusing on complex components like catheters and structural heart devices. He…
Crossover with Embedded AI Podcast
Jeff Gable, Luca, and Ryan Torvik discuss integrating Large Language Models (LLMs) into embedded systems engineering workflows, emphasizing that AI must augment rather than replace rigorous engineering discipline. They identify 'vibe…
S5E29 Steve Gompertz | Medical Device Quality Control & Regulatory Requirements
Steve Gompertz, a partner at QRx Partners with prior leadership roles at Medtronic, Boston Scientific, St. Jude Medical, and Pelican Biothermal, explains how to build scalable quality management systems for medical device companies. He…
227 - When Should You Open a CAPA? Triggers, Human Error, and Investigation Basics
Georg Digel, founder of Elevate CAPA, explains to host Subhi Saadeh how to determine when to open a Corrective and Preventive Action (CAPA) and how to conduct effective investigations. Digel argues that 'human error' is rarely an…
#388: Elements of an Effective CAPA Program
Georg Digel, a CAPA expert with over a decade of experience in medtech, explains how to build an effective Corrective and Preventive Action (CAPA) program that drives real improvement rather than just compliance. He details the critical…
243 - Why Kitting A Finished Medical Device with a Drug Create So Much Work
Subhi Saadeh, Founder of Let’s Combinate, explains why selecting commercially available finished medical devices for combination product kits creates significant regulatory and quality challenges. He argues that an 'already approved'…
217 - 5 Fixable Problems Holding Back Drug–Device Programs
Subhi Saadeh, founder of Let’s Combinate BioWorks, outlines five critical quality issues in drug-device combination products, drawing on his experience at Pfizer, Gilead, and Baxter. He addresses documentation misalignment in design…
#449: 7 Pitfalls of International MedTech Expansion
Mike Drues, President of Vascular Sciences, joins host Etienne Nichols to discuss the regulatory pitfalls international medical device companies face when expanding into the U.S. market. Drues challenges the assumption that a CE Mark…
#418: Biocompatibility Brief - What Medical Device Companies Need to Know
Marina Daineko, a MedTech expert and chemist specializing in biological evaluations, explains the critical importance of integrating biocompatibility into a company's Quality Management System (QMS) rather than treating it as an isolated…
R&D RADIO: Oil Analytics, Seed Oils and Adulterated Avocado Oil with Dr. Selina Wang of UC Davis
Dr. Selina Wang, Faculty Director of the UC Davis Olive Center, explains how her lab’s studies revealed that many commercial avocado oils and finished products like chips and mayonnaise are adulterated with cheaper oils like soybean or…
Paradromics CEO Matt Angle on building the highest data rate brain-computer interface, hermetic sealing vs. Neuralink, and what makes BCIs last a decade in the body.
Matt Angle, CEO of Paradromics, explains the engineering behind the Connexus brain-computer interface, which achieves over 200 bits per second and is designed to last more than a decade in the body. He contrasts Paradromics' hermetic…
S2 E8: Quality Engineering and Strategy for Hardware with Matt Lipsitz
Matt Lipsitz, Head of Quality at Formlabs, explains that quality is a culture of managing risk to meet customer expectations, starting with Failure Modes and Effects Analysis (FMEA) in the design phase. He details how startups can build a…
Ep. 11 - Quality Control
Stephen Hawes and Lucian Chepa of Opulo discuss their quality control philosophy, emphasizing that testing is a critical second product. They detail the implementation of the 'QC Buddy' system to combat human error and the use of 'Gundam'…
253 - FDA Is Making Big Changes to Its Inspection Approach
Eric Pittman, former Bioresearch Monitoring West Division Director at the FDA and now VP at Project Farma, explains the FDA's transition from a specialized program-aligned inspection model back to a broader, medical-product-specific…
#379: Meet the Guru - Building Quality Management in Early-Stage Medical Device Companies and other Insights from a Veteran Engineer
Vernon Baker, a veteran medical device engineer and quality expert, explains how early-stage MedTech companies can build effective Quality Management Systems (QMS) without massive resources. He emphasizes that early quality hires must be…
209 - ALCOA++ EXPLAINED | What Everyone Gets Wrong About Data Integrity with Monika Andraos
Monika Andraos, Principal at Dunamis Compliance, explains that data integrity is a broad governance goal, not just a Computerized System Validation (CSV) activity, and must be designed into processes from the start. She details the ALCOA++…
205 - Why Less Than 20% of Companies Have Started Quality 4.0
Larry Mager, Founder of MGMT-CTRL, explains why fewer than 20% of companies have started Quality 4.0 despite 63% believing it will transform operations. He introduces his Quantum Quality Management (QQM) framework, a five-phase roadmap…
#447: Solving the Pediatric MedTech Gap with Edwin Lindsay
Edwin Lindsay, a MedTech operator and QARA leader who co-founded SureMakers and runs Compliant Solutions, discusses the systemic barriers to pediatric medical device development, noting that these devices face adult-level regulatory risks…
#438: QMSR Mythbusters Episode
Host Etia Nichols from Greenlight Guru explains the FDA's new Quality Management System Regulation (QMSR), which replaces 21 CFR Part 820 and incorporates ISO 13485:2016 by reference, with a mandatory enforcement date of February 2, 2026…
BONUS: Predictive Maintenance: The Key to Replacing Unplanned Downtime with Personal Downtime (Sponsored by AssetWatch)
Patrick Carmitchel, VP of Product Management, and Dustin Moore, Condition Monitoring Engineer Manager at AssetWatch, discuss the practical application of condition monitoring and predictive maintenance in manufacturing. They explain how…
The EMS (Eric Miscoll Show) - Is Inspection Leading the AI Revolution in Manufacturing?
Oshri Cohen, CEO of Cybord, and Joel Scutchfield, General Manager of SMT and Semicon Business Operations for Koh Young America, discuss how AI is transforming inspection in electronics manufacturing. They explain that while traditional…
#248 - How to Work with a Formulator with Rebecca Urciuolo from BevSource (FB Solutions Group)
Rebecca Urciuolo, a formulator with 23 years of experience at BevSource (FB Solutions Group), explains the critical importance of writing a detailed project brief and using reference products to guide beverage development. She details the…