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In this episode of the Global Medical Device Podcast, host Etienne Nichols continues his conversation with regulatory consultant Michael Drues, Ph.D., to examine the FDA's Center for Devices and Radiological Health (CDRH) guidance document priorities for fiscal year 2027. The discussion kicks off with a critical evaluation of the A-list, B-list, and under construction categories, analyzing the agency's timeline commitments and the practical realities behind how regulatory priorities are established and executed.The conversation explores specific topics featured on the lists, ranging from AI-enabled device software functions and predetermined change control plans (PCCPs) to more traditional products like respirators and menstrual devices. Dr. Drues shares his perspective on the distinction between wellness devices and those intended for medical purposes, emphasizing the importance of reading between the lines of regulatory text.Finally, the dialogue delves into broader structural questions surrounding FDA transparency, resource allocation, and how medical device professionals can effectively engage with the agency during the public comment period. Listeners are provided with practical insights on navigating evolving regulatory expectations and submitting comments before the November 30 deadline.TakeawaysMonitor the Guidance Lists: Review the CDRH A-list and B-list priorities early to align your R&D and regulatory submission timelines with upcoming FDA expectations.Understand Regulatory Intent: Recognize that placement on the A-list reflects CDRH's stated intent rather than a hard guarantee, meaning manufacturers must build flexibility into their regulatory strategies.Distinguish Medical Purpose from Wellness: When reviewing product codes and guidance, carefully evaluate how the FDA defines medical intended use versus general wellness to avoid unexpected classification hurdles.Participate in Public Comments: Take advantage of the public comment window open until November 30 to provide actionable data and feedback on guidance priorities that impact your specific device portfolio.ReferencesCDRH Guidance Document Database: The primary repository for published FDA draft and final guidance documents.Etienne Nichols on LinkedIn: Connect with host Etienne Nichols for ongoing medical device discussions and industry updates atEtienne Nichols' LinkedIn.SponsorsThis episode is brought to you by Greenlight Guru. Navigating complex regulatory landscapes like the FDA's fiscal year priorities requires a robust quality management system and efficient data management. Greenlight Guru's industry-leading Quality Management System (QMS) and Electronic Data Capture (EDC) solutions are built specifically for the medical device industry, helping you bring life-changing products to market faster and with total compliance confidence. Visit Greenlight Guru to streamline your design controls, risk management, and clinical data workflows today.Feedback Call-to-ActionWe want to hear from you! Your feedback helps shape future episodes and ensures we bring you the most relevant regulatory and engineering insights in the MedTech industry. Please leave a review, share your thoughts, or suggest future episode topics by reaching out directly to our team at [email protected]. We personally read and respond to every message we receive.

In this episode of the Global Medical Device Podcast, host Etienne Nichols and regulatory consultant Mike Drues dive deep into the world of FDA guidance documents. They unpack what these documents truly represent—the agency's current thinking rather than binding law—and explore how manufacturers can navigate them effectively. The discussion covers the distinction between regulations in the Code of Federal Regulations and agency guidance, highlighting why a rigid, literal interpretation can be dangerous for product development.The conversation examines the practical realities of using guidance documents as tactical tools and highlights the importance of proactive engagement with the agency. Mike shares valuable insights on challenging assumptions, understanding the shades of gray in regulatory compliance, and the strategic advantages of addressing deviations early through the pre-submission process. They also touch upon the limitations of the FDA guidance database and why revision history matters.As part one of a two-part series, this episode lays the critical foundation for understanding how guidance shapes medical device development. Listeners will gain a fresh perspective on interacting with the FDA, moving beyond compliance checkboxes to build robust, defensible regulatory strategies. Stay tuned for part two, where the discussion shifts specifically to the fiscal year 2027 guidance list.TakeawaysUnderstand the distinction: Recognize that regulations in the CFR carry legal weight originating from Congress, whereas guidance documents represent FDA's current administrative or technical thinking and are technically non-binding.Avoid absolutism: Do not treat guidance documents as immutable laws; manufacturers can propose alternative approaches if they satisfy statutory and regulatory requirements.Leverage the pre-sub process: If your device strategy diverges from a published guidance document, address the deviation proactively during a pre-submission meeting rather than waiting for a rejection on your final submission.Look beyond the database: Use multiple search avenues—including broader web searches and direct inquiries through OICE/Dice—to track updates, historical revisions, and guidance documents currently in development.References21 CFR Part 10.115 - FDA’s Good Guidance Practices regulation outlining how guidance documents are developed and utilized.CDRH Guidance Document Database - The primary repository for current FDA medical device guidance documents.Etienne Nichols' LinkedIn - Connect with Etienne Nichols for more MedTech discussions and insights.SponsorsGreenlight Guru provides an industry-leading MedTech quality management solution that integrates both powerful QMS and EDC software onto a single platform.Feedback Call-to-ActionWe want to hear from you! What topics would you like us to cover in future episodes, or how are you navigating FDA guidance updates in your current projects? Send your thoughts, feedback, and topic suggestions directly to [email protected], and our team will provide a personalized response. Don't forget to leave us a review!

Lisa Voronkova, co-founder of OVA Solutions and a designer of 200+ medical devices, reveals what medtech development really costs. She breaks down the four engineering phases, realistic hour and budget ranges, and why premature manufacturing can trigger massive rework. Hear case studies spanning a rehabilitation chair and an $1.5 million CGM program, plus lessons on DFM, patents, and market fit.

Jordi Martorell, biomedical engineer, researcher, and Aortyx co-founder, shares the leap from academic vascular science to entrepreneurship. He discusses developing a bioresorbable device for aortic dissection, surviving years of fundraising in Barcelona, using crowdfunding and grants before Series A, navigating Class III regulation and soaring costs, and turning first-in-human data into investor momentum.

Michael Sprauve, President of Speck Design, brings nearly 30 years of experience turning hardware concepts into manufacturable, FDA-cleared products. He explores the hidden users who shape MedTech design, from nurses and technicians to disposal teams. The conversation covers alarm fatigue, AI-generated visuals, physical prototyping, regulatory constraints, and why manufacturability must begin long before tooling.

Nikhil Mangale, a medical device quality leader and Kapstone Medical’s VP of Quality, unpacks early FDA QMSR inspection findings. They explore the five leading citation areas: risk management, supplier controls, complaints, UDI, and corrective actions. The conversation also examines legacy products, layered gap assessments, inspection-ready audit records, and practical QMSR priorities for startups.

Chris Gates, founder and CEO of arsMedSecurity and a medical device cybersecurity specialist, makes security practical for manufacturers of any size. He explores why software triggers FDA cybersecurity expectations, how late fixes can derail budgets and submissions, and why a 180-day delay matters to burn rate. The conversation also covers LLM-driven threats, threat modeling, eSTAR readiness, standards, and affordable support for startups.

Shai Policker, Managing Partner at Edge Medical Ventures and a seasoned medtech entrepreneur and investor, explains why market strategy should precede prototyping. They explore validating clinical needs, reimbursement, regulation, and hospital economics; uncovering opportunities through strategic partnerships; designing familiar devices with dramatic outcome improvements; and helping international companies navigate the U.S. healthcare system.

Most discussions around medical device quality stop at commercial launch. Once a product ships, teams tend to celebrate and move on to the next development cycle. However, the real engineering work often begins the moment a device leaves the manufacturing floor. In this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Shawnnah Monterrey, founder of Beanstalk Ventures and an FDA-accredited third-party reviewer with 25 years of medical device software experience, to explore what happens after product deployment.Monterrey shares rare insights gained from evaluating FDA submissions and troubleshooting high-impact field issues across platforms ranging from glaucoma imaging at ZEISS to CTDNA cancer assays at Illumina. The conversation covers the often-overlooked requirements of manufacturing transfer, deployability, and software upgrade mechanisms. Monterrey explains how inadequate upstream characterization—such as neglecting physical shipping stresses or omitting subsystem-level DFMEAs—directly manifests as costly "dead on arrival" (DOA) failures and field complaints.The discussion also dives deep into the mechanics of defect detection, comparing hardware tolerance stack-ups with complex software root cause analysis. Monterrey illustrates how robust unit testing, clear design documentation, and structural post-market surveillance prevent catastrophic field recalls. Finally, the episode highlights the critical need for open communication channels between R&D, manufacturing, and post-market complaint handling teams to feed field intelligence back into future product iterations.Key Timestamps00:00 - Introduction to Etienne Nichols and guest Shawnnah Monterrey, CEO of Beanstalk Ventures.01:15 - Crucial pre-shipping checks that first-time medical device founders routinely miss.02:05 - Software transfer to manufacturing, deployability, eStar submissions, and cybersecurity requirements.03:10 - Root causes of "Dead on Arrival" (DOA) product deliveries and shipping reliability testing.04:20 - The concept of injection detection: Why detecting bugs earlier in R&D saves exponential costs.05:45 - Unanticipated failure modes, software-hardware interaction, and the necessity of bottom-up DFMEAs.07:30 - Software defect isolation, unit testing vs. system-level troubleshooting, and simulating user environments.08:15 - Case study: Class 1 ventilator recall, software algorithm flaws, and root cause analysis across 80,000 units.10:40 - Field upgradeability, patchability in legacy firmware devices, and managing regulatory trade-offs.12:15 - Transforming customer complaints from isolated fires into upstream process and product design improvements.14:00 - Usability issues, off-label user behavior, and manufacturer liability regarding indications for use.16:30 - Closing feedback loops: Structuring open communication between R&D, post-market teams, and field service.Quotes"The sooner a defect is injected into the product and the later you find it, the more expensive it is going to be to correct. You want to tighten that gap up as close as possible." - Shawnnah Monterrey"A lot of defects manifest themselves in software, but they are actually electromechanical issues that the software didn't intend to catch." - Shawnnah MonterreyTakeawaysPrioritize Software Deployability Upstream: Under current FDA eStar submission standards and cybersecurity guidance, software deployment, upgrade mechanisms, and maintenance processes must be documented and tested well before shipping.Execute Bottom-Up DFMEAs: While FDA risk management emphasizes top-down system hazard analysis (ISO 14971), robust subsystem-level DFMEAs are essential to capture unexpected interaction defects between electromechanical hardware and software.Unit Testing Accelerates Root Cause Analysis: Simulating inputs via automated software unit tests allows engineering teams to reproduce obscure field defects instantly without needing to replicate complex human-patient variables.Design for Field Upgradeability: Building patchable, field-upgradeable firmware and software architectures protects device manufacturers from catastrophic physical recalls across large installed bases.Bridge R&D and Complaint Management: Companies must establish formal feedback channels between post-market complaint handling teams and R&D engineers to ensure real-world failure trends drive future design controls.ReferencesEtienne Nichols LinkedIn Profile: https://www.linkedin.com/in/etiennenichols/FDA eStar Program: The FDA's electronic submission template used to streamline medical device 510(k) and De Novo review processes.ISO 14971: The international standard for the application of risk management to medical devices.Cardiac Arrest: Five Years as a CEO on the Fed's Hit List by Howard Root: Recommended book detailing off-label use, regulatory enforcement, and legal liability in MedTech.MedTech 101 SectionInjection Detection Think of building a medical device like baking a cake from a recipe. If you accidentally add salt instead of sugar at the start (injecting a defect), it is easy and cheap to toss out the flour and start over. But if you don't taste the cake until after it is baked, frosted, packaged, and delivered to a customer's party, fixing that mistake requires shipping a whole new cake, apologizing to the buyer, and paying for delivery. In MedTech software and hardware, "injection detection" means testing early and often so you catch design "bugs" while they are still in the mixing bowl rather than after thousands of devices are in patients' hands.Design Failure Mode and Effects Analysis (DFMEA) Imagine examining every individual part of a car engine—from the biggest piston down to the smallest rubber seal—and asking: "How could this specific part break, and what happens to the driver if it does?" A DFMEA is a systematic, bottom-up engineering blueprint where teams evaluate each component or software line to predict failures before the device is ever built.Feedback Call-To-ActionWhat post-market challenges has your medical device team encountered after product launch? We want to hear your thoughts, topic requests, and guest suggestions. Send your feedback directly to [email protected]. Every message is reviewed personally by our team to help shape future episodes.SponsorsThis episode is brought to you by Greenlight Guru.Navigating medical device quality from early-stage R&D through post-market surveillance requires tools built specifically for the MedTech industry. Greenlight Guru offers an all-in-one Medical Device Success Platform combining modern Quality Management System (QMS) and Electronic Data Capture (EDC) solutions. Whether you are preparing software documentation for an eStar submission or connecting customer complaint signals back to upstream design controls, Greenlight Guru helps you scale compliance, streamline clinical data, and bring safe devices to market faster. Learn more by visiting www.greenlight.guru.

Navigating the regulatory landscape for combination products requires understanding how primary modes of action (PMOA) dictate oversight pathways. In this episode, host Etienne Nichols sits down with Jim Fentress, Director of Regulatory Affairs at Galero (a Santa Group company), to unpack the structural differences and hidden pitfalls when medical device and pharmaceutical worlds collide. They discuss how the FDA handles lead agency designation across CDRH and CDER using interagency agreements and official Requests for Designation (RFD).A central theme of the discussion is managing quality management systems under 21 CFR Part 4. The pair explore the friction that occurs when pharmaceutical companies act as lead applicants for drug-led combination products, requiring them to incorporate device design controls (ISO 13485 / QMSR) and CAPA systems into their existing CGMP framework. Jim explains the practical realities of integrating Part 210/211 elements—such as calculation of yield and stability testing—into a single, operational QMS without overcomplicating procedures.Finally, the conversation delves into critical execution details: risk management under AAMI TIR105 (ISO 14971 vs. ICH Q9), labeling classifications (single entity, co-packaged, and cross-labeled), and strict change control protocols. Jim highlights how post-market design changes to a device constituent part can impact the pharmaceutical partner's NDA or baseline regulatory filings, underscoring the necessity of transparent cross-industry communication from initial development through full commercial release.Key Timestamps00:00 – Introduction to combination products and guest Jim Fentress.00:48 – Understanding Primary Mode of Action (PMOA) and regulatory pathways (FDA vs. European authorities).01:57 – FDA interagency agreements (CDRH and CDER) and Requests for Designation (RFD).03:00 – 21 CFR Part 4 quality system integration (CGMP Part 210/211 and QMSR/Part 820).05:22 – Navigating the communication gap between pharma companies and device manufacturers.07:44 – Calculation of yield in drug manufacturing vs. medical device production.09:05 – Risk management for combination products (AAMI TIR105: evaluating device-on-drug and drug-on-device risks).12:15 – Bridging ISO 14971 and ICH Q9 framework structures in registration files.13:16 – Design controls, user needs, and human factors validation (Module 5 / Section 3.2.R ECTD filings).15:06 – Labeling pathways: Single Entity (Integral), Co-Packaged, and Cross-Labeled products.18:18 – Change control risks: How minor device modifications affect drug application filings (NDAs, CBER/CDER supplements).20:41 – Advice for device manufacturers partnering with pharma: Alignment on risk, documentation depth, and cleanroom requirements.Standout Quotes"There's four aspects of risk that you need to take into account: what is the risk of the drug alone, the risk of the delivery system alone, the risk of the drug on the device, and the risk of the device on the drug." — Jim Fentress"Before you even think about making a change, you need to talk to your pharmaceutical partners because now what's represented as the co-packaged device constituent element is changing, and they need to inform the FDA." — Jim FentressActionable TakeawaysEstablish Cross-Disciplinary Risk Management Early: Adopt frameworks like AAMI TIR105 to integrate traditional device risk protocols (ISO 14971) with pharmaceutical risk management (ICH Q9). Ensure assessment of cross-interaction hazards (e.g., drug interactions with delivery plastics, viscous drug effects on ejection times).Define Clear Part 4 QMS Interfaces: If operating primarily under device rules (QMSR/ISO 13485), build project-specific addenda to account for drug CGMP requirements such as stability testing, container-closure assessments, and calculation of yield limits.Align Post-Market Change Control Protocols: Establish explicit notification procedures between the device supplier and the NDA holder. Simple component material updates or geometry changes to a constituent part may require formal NDA supplements or changes-being-effected (CBE) filings with CDER.Scope Document Deliverables Upfront: Clarify whether the pharmaceutical partner requires high-level summary reports or the complete device master record (DMR) and design history file (DHF) to populate Section 3.2.R of their eCTD submission.Validate Cleanroom and Sterility Assumptions: Discuss cleanroom requirements early to avoid unnecessary cost structures; verify if an ISO 8 or ISO 7 environment is scientifically required for the assembly of non-sterile device constituents before adopting conservative pharma-grade aseptic norms (ISO 5).Essential References21 CFR Part 4: Regulation governing current good manufacturing practice (CGMP) requirements for combination products.AAMI TIR105: Technical Information Report providing guidance on the application of risk management to combination products.ICH Q9: International Council for Harmonisation guidelines for Quality Risk Management in pharmaceutical manufacturing.eCTD Section 3.2.R: Regional information section of the Electronic Common Technical Document where medical device constituent data is filed.Host Contact: Connect with Etienne Nichols on LinkedIn.MedTech 101Primary Mode of Action (PMOA)The primary mode of action is the single mechanism that provides the primary therapeutic effect of a combination product.Think of a drug-eluting stent:The main goal is to physically prop open a blocked artery (a mechanical action performed by the stent device).The drug baked into the metal coating slowly releases to prevent scar tissue from re-blocking the artery (an ancillary chemical action).Because the physical propping open is the primary therapeutic mechanism, the FDA classifies the product as a device-led combination product under CDRH. Conversely, an epinephrine auto-injector's main therapeutic outcome comes from the epinephrine drug working in the bloodstream; the plastic casing and needle are auxiliary delivery mechanisms, making it a drug-led combination product overseen by CDER.Feedback & CommunityWe want to hear from you! Have questions about combination product regulatory strategies, or want to suggest a topic for a future episode?Email us directly at [email protected]. Every message is reviewed personally by our team to help shape upcoming content.Sponsor IntegrationThis episode is sponsored by Greenlight Guru.Navigating the blurred lines of 21 CFR Part 4 between drug CGMPs and device design controls requires dynamic, interconnected quality tools. Greenlight Guru provides purpose-built Quality Management Software (QMS) and Electronic Data Capture (EDC) solutions designed specifically for MedTech teams. Whether you are managing complex design controls, tracking supplier changes, or managing clinical trial data for combination products, Greenlight Guru helps you bring safe, compliant devices to market faster.Discover how to streamline your regulatory files and risk matrix at www.greenlight.guru.