In this episode of the Global Medical Device Podcast, host Etienne Nichols continues his conversation with regulatory expert Mike Drues in part two of their series on home use medical devices. The discussion centers on critical topics such as labeling, usability challenges, and the future of medical devices in home settings. They explore how these devices, increasingly used by non-healthcare professionals, face unique hurdles such as user training, environmental factors, and technological concerns like cybersecurity and data security. Together, Etienne and Mike also delve into how regulatory frameworks need to adapt for home use, and they highlight potential future issues with devices as AI and robotic assistance grow in prominence.Key Timestamps:[02:20] - Recap of Part 1 & Introduction to Home Use DevicesMike revisits key topics from part 1, focusing on why home use devices matter.[10:45] - Defining the Intended User and EnvironmentDiscussion about how labeling must account for who will use the device and where.[15:30] - Technological and Environmental Challenges for Home Use DevicesExploring temperature, humidity, and power inconsistencies affecting performance.[30:05] - Reprocessing and Cleaning Devices at HomeThe challenges and risks associated with reusing and cleaning devices like CPAPs.[40:15] - Usability Testing & Human FactorsImportance of considering non-healthcare users when designing home devices.[55:12] - Cybersecurity Risks in Home DevicesThe growing significance of data security and strategies for protecting devices in non-clinical settings.[1:05:30] - Post-Market Surveillance and Reporting for Home DevicesThe complexities of tracking device performance and recalls when used in home environments.Memorable Quotes:"When we talk about intended users, we must shift our thinking from healthcare professionals to patients. Designing for non-clinicians is crucial because usability directly impacts safety." – Mike Drues"If your device has to be recalibrated, why not have a mechanism that disables it when calibration is overdue? That’s a much stronger safeguard than relying on users to remember." – Mike Drues"Cybersecurity is a growing challenge in home devices. It’s not just about protecting personal data—imagine if a critical medical device was hacked." – Etienne NicholsKey Takeaways:Latest MedTech Trends:Increasing Use of Home Medical Devices: Patients are increasingly managing their own health at home, necessitating devices that are user-friendly and adaptable to various home environments.AI & Robotics in Home Devices: With the rise of AI and robotic assistance, the definition of an "intended user" is evolving, requiring future-proof regulatory considerations.Data Security: As more devices become connected, cybersecurity is becoming a top priority, particularly for critical, life-sustaining technologies.Practical Tips for MedTech Professionals:Understand the End-User: When designing devices, consider that patients, not healthcare professionals, will be the primary users. Usability is key.Incorporate Environmental Testing: Take environmental factors like humidity, power outages, and storage conditions into account during the device development phase.Push Updates Automatically: For connected devices, push software updates automatically to mitigate cybersecurity risks, rather than relying on users to pull them.References:FDA Guidance on Home Use Devices: Relevant guidelines shaping the regulatory landscape for home use devices.Philips Respironics CPAP Recall: A case study highlighting the importance of post-market surveillance and recalls.Etienne Nichols’ LinkedIn Profile: Connect with EtienneMedTech 101: Home Use Medical DevicesFor new listeners, home use medical devices are designed for patient self-administration and management outside of a clinical setting. Examples include CPAP machines, blood glucose monitors, and wearable heart monitors. These devices must meet stringent usability and safety standards, as patients using them often lack formal medical training. Key considerations in the design and regulation of these devices include labeling (clear instructions), user environment (temperature, lighting), and cybersecurity risks.Discussion Question:What technological advancements do you think will have the most significant impact on the future of home healthcare?Let us know by emailing us at podcast@greenlight.guru!We'd love feedback:Enjoyed the episode? Leave us a review on iTunes—it helps others find us and lets us know how we're doing! Have thoughts or suggestions for future episodes? Reach out to us at podcast@greenlight.guru or connect with Etienne on LinkedIn.Sponsor Message:This episode is brought to you by Greenlight Guru, the only quality management system (QMS) built specifically for medical device companies. Streamline your quality processes and get to market faster with Greenlight Guru’s easy-to-use platform. Visit www.greenlight.guru for a free demo today!This episode is also sponsored by Rook Quality Systems. Documentation is key to a successful quality management system, and Rook Quality Systems helps you create and maintain clear, compliant Standard Operating Procedures (SOPs) and other essential documents. Their team of experts ensures your documentation aligns with regulatory standards, making audits easier and your processes more efficient. Start optimizing your quality management system today at rookqs.com.

In this episode, Etienne Nichols hosts regulatory expert Mike Drues to discuss the evolving landscape of home use medical devices. The conversation covers critical topics such as regulatory definitions, safety challenges, and compliance hurdles for devices intended for use outside traditional clinical settings. They explore how home use devices, such as CPAP machines and infusion pumps, can differ significantly from hospital-based devices in terms of design, post-market surveillance, and user interaction. The discussion is grounded in real-world examples, most notably the Philips Respironics recall, which became the largest medical device recall in history due to design oversights and failure in post-market surveillance. This episode sets the stage for a deeper dive into technical, regulatory, and user-related challenges in the next installment.Key Timestamps:[00:01] – Introduction: Etienne introduces the episode and topic of home use medical devices, along with a quick sponsor message.[02:30] – Defining Home Use Devices: Mike Drues explains what qualifies as a home use medical device from a regulatory standpoint.[07:50] – Why Home Use Devices Matter: Discussion on why home use medical devices are a strategic priority for CDRH in 2025 and the safety issues identified by the Emergency Care Research Institute (ECRI).[12:15] – Case Study: Philips Respironics Recall: Mike discusses the technical and regulatory issues behind the Philips Respironics recall and its implications for manufacturers.[25:45] – Post-Market Surveillance and Complaint Handling: The challenges of post-market surveillance and complaint handling for home use devices, and the role of regulatory compliance.[35:30] – The Importance of Intended Use Environment: Exploring how intended use environment should influence design and usability considerations.[45:20] – Teaser for Part 2: Mike and Etienne preview topics for the next episode, including labeling challenges, human factors, and usability testing for home use medical devices.Key Quotes:“A home use device isn’t just a device that could be used at home; it’s one that’s intended and labeled for use outside traditional clinical settings.” — Mike Drues“When post-market surveillance fails, it’s not just a compliance issue—it’s a safety issue that can put lives at risk.” — Mike Drues“Regulatory logic goes beyond the written rules—it’s about understanding the intent behind them to ensure devices are safe wherever they’re used.” — Mike DruesKey Takeaways:Latest MedTech Trends:Home Use Device Surge: There is a growing trend toward designing devices for non-clinical environments, driven by technological advancements and patient demand for convenience.Regulatory Focus on Safety: Regulatory bodies like the FDA are increasingly prioritizing the safety of home use devices, as seen in CDRH’s 2025 strategic priorities.Impact of High-Profile Recalls: Large-scale recalls, like the Philips Respironics case, highlight the need for robust design controls and post-market surveillance practices for home use devices.Practical Tips:Design for Real-World Use: When designing home use devices, consider environmental factors like temperature, humidity, and patient handling to prevent unintended failures.Emphasize Post-Market Surveillance: Develop strong post-market surveillance and complaint handling processes to catch and address issues early.Communicate Clearly with Users: Create user-friendly labeling and instructions that cater to non-professional users to minimize the risk of misuse.Future Predictions:Regulatory Changes for Home Use Devices: Expect more detailed guidance from the FDA on defining and managing home use devices.Enhanced Usability Testing: Usability and human factors testing will become even more critical as devices move into less controlled environments.Increased Liability Focus: Manufacturers will need to pay closer attention to liability issues as more devices transition to home settings.References:FDA Guidance on Home Use Devices: Design Considerations for Devices Intended for Home Use – This guidance provides detailed recommendations on how to design and label home use medical devices.ECRI’s Top 10 Health Technology Hazards for 2023 and 2024: An annual report highlighting the safety concerns for home use medical devices.Philips Respironics Recall Case Study: The recall case, which affected over 5.5 million devices, serves as a key example of post-market surveillance failure and design oversight.Connect with Etienne Nichols on LinkedIn.MedTech 101: Home Use Medical DevicesFor new listeners, home use medical devices are defined as devices intended for use in environments outside of traditional clinical settings, such as homes, schools, and offices. These devices must be designed to accommodate non-professional users, accounting for factors like usability, environmental conditions, and ease of maintenance. Understanding these nuances is essential for developing safe and effective devices for a growing market.Audience Poll:What do you think is the biggest challenge for home use medical devices?A) User error and trainingB) Environmental factorsC) Post-market surveillance and complaint handlingD) Device design limitationsShare your thoughts with us at podcast@greenlight.guru!Discussion Question:With the rise of home use medical devices, how do you think the role of post-market surveillance will change over the next five years? Let us know your predictions at podcast@greenlight.guru.Feedback:We'd love to hear your thoughts on this episode and suggestions for future topics! Leave a review on iTunes, and feel free to reach out to us at podcast@greenlight.guru with any feedback. Your insights help us bring you the content that matters most!Sponsor Mentions:Greenlight Guru: Is your QMS holding you back? Greenlight Guru is THE eQMS built for medical device companies to accelerate success and ensure compliance with FDA, ISO, and EU MDR requirements. Streamline your quality processes and focus on innovation. Visit www.greenlight.guru to learn more!Rook Quality Systems: Ready to ensure your QMS is audit-ready? Rook Quality Systems offers comprehensive QMS audits and training tailored to your organization’s needs. From gap analysis to corrective actions, Rook helps you maintain compliance and efficiency. Schedule your audit at www.rookqs.com.

In this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Vincent Cafiso, Director of Quality and Regulatory Services at Creo Consulting and former FDA investigator. Vincent brings 30 years of life sciences and regulatory expertise, offering a unique perspective on navigating FDA inspections, building robust quality systems, and managing innovation within the MedTech industry. They dive deep into the challenges faced by MedTech companies, particularly small startups, and how to balance regulatory requirements with creativity and innovation. Vincent also highlights the common pitfalls companies encounter with design controls and shares strategies to ensure R&D and production teams work in harmony.Key Timestamps:[00:01] – Introduction: Vincent Cafiso’s background as an FDA investigator and transition into industry.[04:15] – Crayo Consulting’s Scope: How Creo Consulting supports MedTech companies from launch strategy to compliance.[12:40] – Bridging R&D and Production: Overcoming challenges when R&D environments don’t align with production standards.[19:50] – Top Trends in Quality Systems: Addressing documentation gaps and missing standards in design history files.[27:10] – Management’s Role in Supporting Quality: The importance of management’s involvement in enforcing quality controls and processes.[38:30] – From FDA to Industry: How Vincent’s FDA background influences his approach to quality and compliance.[54:25] – Skip-Level Meetings and Breaking Silos: Enhancing collaboration and communication within large organizations.[1:06:00] – Final Takeaways and Advice: Building a culture of quality and fostering innovation while staying compliant.Key Quotes:“The regulations are written for tongue depressors and pacemakers—two very different devices. It’s up to the companies to interpret how to apply those rules to their specific products.” – Vincent Cafiso“Documentation shouldn’t just be a checkbox for submission. There’s a lot more innovation happening that doesn’t make it onto paper because companies don’t realize its value.” – Vincent CafisoKey Takeaways:1. MedTech Trends:Alignment of R&D and Production: Ensure that testing environments and protocols in R&D align with the standards of production to avoid costly discrepancies and rework.Regulatory Understanding Across Teams: Companies need to educate teams on the specific regulatory standards that apply to their product types to avoid misinterpretation and gaps in compliance.Cross-Departmental Collaboration: Maintaining a startup-like collaborative culture, even as the company scales, is crucial for innovation and quality.2. Practical Tips for MedTech Professionals:Integrate Quality Early: Implement quality controls and validation processes at the R&D stage to avoid repeating tests or redesigns during production.Leverage Skip-Level Meetings: Encourage direct communication between upper management and employees for better understanding and faster issue resolution.Document Everything: Don’t treat documentation as a formality. Capture all the engineering studies and real data to support design decisions and regulatory submissions.3. Questions for Future Consideration:How can large organizations maintain the flexibility and collaborative spirit of a startup?What creative approaches can be used to align R&D and production standards in smaller companies?What role will emerging technologies like AI and IoT play in shaping future regulatory landscapes?References:Vincent Cafiso on LinkedInEtienne Nichols on LinkedInCreo Consulting: Vincent Cafiso’s current company offering regulatory and quality services to MedTech organizations.FDA Guidance on Design Controls: Essential reading for understanding how to document and verify design history files.Greenlight Guru's EQMS Software: A quality management system built specifically for the MedTech industry, aiding in compliance and product development.Connect with Etienne Nichols on LinkedIn.MedTech 101:What is FDA Inspection Readiness?FDA inspection readiness refers to the ongoing state of compliance and preparedness for an FDA audit or inspection. It involves having robust quality systems, complete documentation, and trained personnel to demonstrate adherence to applicable regulations and standards. This ensures that a company can efficiently respond to any FDA inquiries and avoid costly delays or compliance issues.What are Design Controls?Design controls are a set of quality practices and procedures integrated into the product development process to ensure that medical devices meet user needs, intended uses, and specified requirements. They include stages like design planning, design inputs and outputs, verification, validation, and design transfer.Poll for the Audience:What is the biggest challenge your MedTech company faces when preparing for FDA inspections?a) Documentation and record-keepingb) Cross-departmental communicationc) R&D and production alignmentd) Understanding complex regulationsShare your answer and thoughts by emailing us at podcast@greenlight.guru!Feedback:Did you enjoy this episode? Leave us a review on iTunes and share your thoughts! Your feedback helps us improve and curate content that matters most to you. Feel free to email us at podcast@greenlight.guru with any suggestions for future topics or guest recommendations.Sponsor Segment:This episode is brought to you by Greenlight Guru, the only quality management software designed by MedTech professionals for MedTech companies. With a robust EQMS platform, Greenlight Guru helps streamline compliance and innovation processes, ensuring faster market access and safer medical devices. Visit greenlight.guru to learn more and schedule a demo today!

In this episode, Etienne Nichols talks with Leo Eisner, renowned as the "IEC 60601 Guy" and founder of Eisner Safety Consultants, about the importance of selecting the right standards in medical device development. Leo shares his journey into the world of medical device standards, offering a detailed look into the role that standards play in ensuring product safety and regulatory compliance. They dive deep into IEC 60601, ISO 15223, and the regulatory landscape across global markets. Leo also shares actionable advice on avoiding pitfalls, prioritizing standards, and ensuring compliance to bring safe, effective devices to market without delays.Key Timestamps:[03:20] – Introduction to Leo Eisner and his background in medical device standards[10:15] – Why standards like IEC 60601 are crucial for medical device development[18:45] – Steps for identifying the right standards for your product[27:00] – Common mistakes and the consequences of ignoring standards[38:50] – How to integrate standards into your design process[47:35] – How startups can navigate standards with limited resources[58:00] – Tools for staying updated on changing standards and regulations[1:09:40] – Final advice from Leo on ensuring regulatory successNotable Quotes:"When you really think about it, all this work leads to safer medical devices on the market—that’s crucial." – Leo Eisner"Standards may seem like obstacles, but they’re design inputs that ensure your device will work as intended in every scenario." – Etienne Nichols"If you don’t integrate standards early in the design phase, you bring design risk later into the project, which can be very costly." – Leo EisnerKey Takeaways:MedTech Trends:Regulatory Compliance as a Design Input – Standards such as IEC 60601 are not just hurdles but key design inputs.Global Market Variations – Different countries have unique regulatory demands; understanding these early can avoid costly delays.Atomic Standards – Future standards are becoming more "atomic," meaning they’ll be broken down into more easily applicable, smaller parts.Practical Tips for MedTech Professionals:Start Early with Standards – Review applicable standards in the initial design phase to avoid costly delays later.Use the Right Tools – Tools like MedBoard and the FDA’s guidance database can help you stay updated.Seek Expert Help – If you're a startup or lack in-house resources, work with a qualified consultant to navigate the regulatory landscape efficiently.Questions for Future Developments in MedTech:Will the move toward "atomic" standards streamline regulatory processes for startups?How will global regulatory bodies harmonize standards across different markets?What emerging standards will impact next-gen MedTech innovations like AI and robotic surgery?References:Greenlight Guru - Quality Management System & Electronic Data Capture solutions built by Medtech professionals for Medtech professionals.Leo Eisner on LinkedIn – Connect with Leo for expert insights on compliance and regulatory standards.IEC Standards – The international standard for the safety of electrical medical equipment.ISO 15223 – Standard for symbols to be used with medical device labeling.MedBoard – A platform for regulatory intelligence, tracking medical device standards.Etienne Nichols on LinkedIn – Connect with the podcast host for ongoing discussions on medical device development.MedTech 101:Consensus Standards – These are standards developed by experts in the field and recognized by regulatory bodies like the FDA. While they are technically voluntary, using them greatly simplifies the regulatory approval process.Audience Poll:What aspect of medical device standards do you find most challenging?Understanding which standards applyIncorporating standards into product designKeeping up with regulatory changesManaging costs associated with complianceSend us your thoughts at podcast@greenlight.guru!Sponsor Mentions:Greenlight Guru – Today’s episode is brought to you by Greenlight Guru, the only quality management software designed specifically for the medical device industry. Built for MedTech professionals by MedTech professionals, Greenlight Guru’s EQMS software helps you manage compliance, quality, and innovation all in one. Learn more at greenlight.guru.Rook Quality Systems – Need quality expertise on demand? Rook Quality Systems provides “quality as a service,” giving you access to their seasoned quality professionals as quickly as you need them. Whether it’s for a project or ongoing support, Rook offers tailored consulting services to help meet your quality and compliance needs. Learn more at rookqs.com.Feedback Call-to-Action:Enjoyed this episode? We’d love your feedback! Please leave us a review on iTunes and let us know what you’d like to hear next. Have questions or suggestions? Email us at podcast@greenlight.guru.

In this episode, Etienne Nichols interviews Perry Parendo, an expert in Design of Experiments (DOE), about the practical application of DOE in medical device development. They discuss how DOE can be used to better understand systems, reduce risk, and solve complex problems, especially in R&D and manufacturing processes. Perry shares insights from his extensive career, offering actionable strategies to simplify complex variables, avoid common pitfalls, and ensure a more effective and efficient development process.Key Timestamps:[00:02] – Introduction to Perry Parendo and his background in DOE[05:50] – What is DOE? Perry’s simple, non-technical definition[12:00] – Common problems DOE solves and its application in R&D[22:30] – Risk management and DOE’s role in reducing uncertainty[35:20] – Using DOE in manufacturing processes and real-world examples[48:10] – Common pitfalls and best practices when using DOEKey Quotes:Perry Parendo: “Design of Experiments is a tool to assist in understanding a system. It’s not just a test plan; it’s a way to create structure and strategy in how you approach testing.”Etienne Nichols: “The life of an engineer really happens in that space between input and output—there’s so much to dial in, and that’s where tools like DOE really help.”Takeaways:Key Insights on MedTech Trends:DOE reduces risk: It plays a crucial role in risk management, especially in R&D, where understanding system behaviors early is key to mitigating issues down the line.Structured problem-solving: DOE provides a data-driven, structured way to isolate variables and pinpoint causes, streamlining troubleshooting and optimization in product development.Adaptability of DOE: It can be applied to both small and large-scale problems, from manufacturing issues to high-stakes R&D, making it essential for MedTech innovation.Practical Tips for MedTech Professionals:Start small with DOE: Focus on fewer variables when beginning to ensure you don’t get overwhelmed. Three to seven variables are typically manageable for early experiments.Understand the limits of your tests: Avoid putting all variables into one test; break them down to ensure results are meaningful and actionable.Validate your DOE: Don’t rely solely on DOE results—validate with real-world testing to confirm your findings.References:Perry Parendo: Founder of Perry Solutions, specializing in product development and process optimization through DOE. LinkedInConnect with Etienne Nichols on LinkedIn.MedTech 101: Explainer on DOE:Design of Experiments (DOE) is a statistical method used to determine how different variables (inputs) affect a process or product outcome (output). It’s widely used in MedTech for optimizing processes and solving manufacturing or product development issues by systematically testing different variables to identify the most influential factors.Questions for the Audience:Poll: How often do you use DOE in your medical device development process?FrequentlyOccasionallyRarelyNeverSend your responses to podcast@greenlight.guru.Feedback & Sponsors:Feedback: Loved this episode? Leave a review on iTunes! Your feedback helps us improve and reach more MedTech professionals.Contact us at: podcast@greenlight.guruSponsor: This episode is brought to you by Greenlight Guru, the only quality management software designed specifically for the medical device industry. Learn how Greenlight Guru can help streamline your product development process at greenlight.guru.Sponsor: Today's episode is sponsored by Rook Quality Systems. Rook offers Quality as a Service solutions to help medical device companies navigate the complexities of regulatory compliance. Their team of experts ensures your quality processes meet the highest industry standards, giving you peace of mind while you focus on innovation. Whether you're preparing for an audit or need ongoing quality support, trust Rook to keep your compliance on track. Learn more at RookQS.com.

Dr. Asha Parekh, CEO and co-founder of Frontline Medical Technologies, shares her inspiring journey from biomedical engineer to entrepreneur. She reveals her passion-driven pursuit to develop the COBRA-OS, a vital tool for trauma care, and recounts the pivotal moment she recognized its life-saving potential. Asha discusses the challenges of securing funding, navigating regulations, and the importance of storytelling in pitching MedTech innovations. She emphasizes the value of resilience and community support on the path to making a meaningful impact in healthcare.

In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with Subhi Saadeh, host of the Combinate Podcast and an expert in the field of combination products. They explore the complexities of combination products—those that integrate drugs, devices, and biologics—highlighting the regulatory challenges and industry growth. Subhi shares his personal journey in podcasting, the impact of consistent content production, and the importance of lifelong learning. They also dive into the intricacies of combination product definitions, regulatory pathways, and trends, offering listeners a well-rounded view of the current state and future potential of this evolving industry.Key Timestamps:[00:02] – Introduction of Subhi Saadeh and his background in combination products.[03:45] – The origin story of the Combinate Podcast and its impact on Subhi’s career.[12:32] – Overview of combination products and regulatory differences between the US and EU.[18:50] – Common misconceptions in drug-device integration.[28:10] – The evolving landscape of combination products and industry growth.[34:22] – Balancing technical and business aspects in MedTech.[46:15] – Notable episodes and guests from the Combinate Podcast.[56:30] – Final thoughts on lifelong learning and producing valuable content.Quotes:Subhi Saadeh: "If I want to be a master at my craft, I need to be producing something in a way that is consistent."Etienne Nichols: "Teaching others is one of the best ways to instill that knowledge into yourself."Subhi Saadeh: "Drugs and devices aren’t as different as people think; it’s how they measure product quality that varies."References:Combinate Podcast: let’s combinate.comSubhi Saadeh’s LinkedIn Profile: Connect with SubhiFDA Regulatory Guidelines for Combination Products: Important for understanding the regulatory landscape.Book Reference: Quality is Free by Philip Crosby - A must-read for quality management professionals.Book Reference: Bottle of Lifes by Katherine EbanEtienne Nichols’ LinkedIn Profile: Connect with EtienneMedTech 101:Combination Products: Products that integrate two or more regulated components (drug, device, biologic) into a single entity. Regulatory pathways for these products can vary significantly depending on the primary mode of action (PMOA), which determines which FDA center will lead the review.Questions for the Audience:Poll: What do you see as the biggest challenge in the development of combination products today?Discussion: How do you think global harmonization of MedTech regulations will shape the future of combination products? Share your thoughts with us at podcast@greenlight.guru.Feedback:Enjoyed the episode? We’d love to hear from you! Leave us a review on iTunes and let us know what topics you’d like to hear about in future episodes. You can also email us at podcast@greenlight.guru.Sponsors:This episode is brought to you by:Rook Quality Systems - stay ahead of the curve with Rook Quality Systems' 'Quality As A Service.' Rooks proactive approach to compliance ensures you're always prepared for the latest regulations and industry standards. Don't wait for issues to arise—be proactive with Rook. Learn more at RookQS.com! Greenlight Guru - the only eQMS built by medical device professionals, for medical device professionals. Get to market faster with confidence. Learn more at greenlight.guru.

In this episode of the Global Medical Device Podcast, host Etienne Nichols speaks with Vernon Baker, a medical device guru, about key strategies for early-stage MedTech companies, particularly around implementing Quality Management Systems (QMS), supplier management, and compliance. Vernon shares his experience of transitioning from engineering to quality and regulatory roles, emphasizing the importance of being a "jack of all trades" when hiring early quality managers. They discuss how small companies can navigate the complexities of ISO 13485, supplier audits, and regulatory intelligence. This episode is a must-listen for startup founders and quality professionals seeking to establish a strong foundation in MedTech.Key Timestamps:[00:02] – Introduction: Etienne Nichols introduces the topic of early-stage MedTech QMS implementation and guest Vernon Baker.[04:30] – Vernon’s Background: From mechanical engineer to quality expert in MedTech.[13:00] – Wearing Many Hats: How early hires in quality roles manage multiple responsibilities in small companies.[22:10] – Supplier Management: The importance of supplier audits and choosing the right partners.[35:45] – Management Reviews & Communication: Aligning quality efforts with company goals.[47:00] – Regulatory Intelligence: Staying updated with regulatory changes and standards.[59:20] – Final Advice: Qualities to look for in an early-stage quality manager.Notable Quotes:“You don’t have to be an expert in everything, but you do need to know where to find the answers.” – Vernon Baker on managing quality systems.“A good management review should feel like a real conversation about the direction of the company, not just a checkbox exercise.” – Vernon Baker on management reviews.“Supplier management is critical in small organizations. You’re outsourcing a lot, and you need to vet and audit your suppliers well.” – Vernon Baker on supplier controls.Key Takeaways:MedTech Trends:Focus on Flexibility: Early hires in MedTech quality roles need to be adaptable, covering everything from product development to regulatory compliance.Supplier Audits Are Essential: Strong supplier management, including on-site audits, is vital to mitigate risks and ensure high-quality materials and components.Regulatory Intelligence: Regularly updating your team on changing regulations and standards is crucial for maintaining compliance and avoiding costly mistakes.Practical Tips:Leverage Consultants: For niche areas like biocompatibility and regulatory changes, hiring external consultants can provide critical insights.Invest in Training: Encourage your team to undergo formal training in ISO 13485, risk management, and process validation to build internal competency.Use Document Templates: Start with pre-existing QMS templates and refine them according to your company’s specific needs.References:ISO 13485: The international standard for medical device quality management systems, which is essential for compliance in various jurisdictions.FDA Recognized Standards: Lists that guide device manufacturing and safety, critical for ensuring that products meet U.S. regulatory requirements.EU MDR: A sweeping update to European medical device regulations, requiring stricter quality and reporting standards.Connect with Etienne Nichols on LinkedIn for more insights into quality management in the MedTech industry: Etienne Nichols on LinkedInMedTech 101:QMS (Quality Management System): A structured system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. For MedTech, this typically involves compliance with ISO 13485.Supplier Management: The process of vetting, auditing, and maintaining relationships with external suppliers to ensure they meet your quality and regulatory standards.Management Review: A formal meeting where top management reviews the performance of the QMS to ensure its effectiveness and alignment with business objectives.Questions for the Audience:How do you manage regulatory changes in your MedTech company? What tools or resources do you rely on most?What are your predictions for how supplier management will evolve with advancing technologies in MedTech?Let us know by emailing your thoughts to podcast@greenlight.guru!Feedback:We’d love your feedback on this episode! Please leave us a review on iTunes, or send your thoughts and suggestions for future topics to podcast@greenlight.guru.Sponsor Message:This episode is brought to you by Rook Quality Systems, specializing in custom QMS solutions for MedTech startups. Rook helps streamline processes and ensure regulatory compliance. Visit rookqs.com to learn more and start building your ideal QMS today!

In this episode of the Global Medical Device Podcast, Etienne Nichols hosts Laura Maher to discuss the critical role of design assurance in medical device development. They explore the importance of ownership in design and development documentation, delve into the complexities of design controls, and share practical insights on how to ensure compliance and streamline product development. Laura shares her unique journey from quality control to product development, emphasizing the need for a multidisciplinary approach to create effective and safe medical devices.Key Timestamps[00:00] - Introduction and Sponsor Messages[03:10] - Introducing Laura Maher and her background[06:45] - Who should own design and development documentation?[12:20] - The importance of understanding design controls[18:35] - The role of design assurance professionals[25:50] - Audience of design and development documentation[33:40] - The intersection of quality and product development[40:55] - Differences between design reviews and stage reviews[47:15] - Collaborative nature of risk management[55:30] - Essential skills for a design assurance professional[1:02:40] - Closing thoughts and resourcesQuotes"The value of design assurance professionals lies in their ability to bridge the gap between quality and development." - Laura Maher"Understanding the spirit of quality and innovation is as important as knowing the definitions in design controls." - Etienne Nichols"A design file is not just for launch; it’s a living document that supports the entire lifecycle of a device." - Laura MaherTakeawaysKey InsightsMultidisciplinary Approach: Combining quality, regulatory, and product development knowledge is crucial for effective design assurance.Documentation Ownership: Assigning clear ownership of design documentation can streamline development and ensure compliance.Design Controls Understanding: A deep understanding of design controls helps in creating documentation that satisfies regulatory requirements and is audit-ready.Practical TipsTraining and Education: Seek out training programs on design controls and quality management to build foundational knowledge.Collaboration: Foster a collaborative environment where engineers, quality assurance, and regulatory teams work together on documentation.Technical Writing: Develop strong technical writing skills to create clear and comprehensive design documentation.ReferencesGreenlight Guru - Quality management software tailored for medical devices.Rook Quality Systems - Comprehensive compliance services for medical device companies.Ultimate Guide to Bringing a Medical Device to Market - A detailed resource for new and experienced MedTech professionals.MedTech 101Design Controls: A set of practices and procedures for managing the design of medical devices to ensure they meet user needs and regulatory requirements.Trace Matrix: A document that maps user needs to design inputs and outputs, ensuring all requirements are met.Risk Management: The systematic process of identifying, evaluating, and mitigating risks associated with medical devices.Questions for the AudiencePoll: Who should own the design and development documentation for medical devices in your organization? (Options: Product Development, Quality Assurance, Regulatory Affairs, Other)Discussion Question: How do you see the role of design assurance professionals changing in the next decade with the rise of AI and digital health technologies? Share your thoughts with us at podcast@greenlight.guru.FeedbackWe value your feedback! Please leave us a review on iTunes and share your thoughts on this episode. If you have suggestions for future topics or questions, email us at podcast@greenlight.guru.SponsorsGreenlight Guru: Streamline your medical device processes with Greenlight Guru’s quality management and electronic data software. Visit Greenlight Guru to learn more.Rook Quality Systems: Achieve FDA and ISO compliance effortlessly with Rook Quality Systems. Visit rookqs.com for more information.

In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with Dr. Matthew Wettergreen, Director of the Global Medical Innovation Master of Bioengineering program at Rice University. Dr. Wettergreen shares his extensive experience in developing client-based engineering design courses and discusses the importance of global and contextual perspectives in medical device innovation. They delve into the unique approaches of the Global Medical Innovation program, highlighting the critical role of diverse healthcare settings in shaping future medtech innovators.Key Timestamps:[00:01:00] Introduction of Dr. Matthew Wettergreen and his background.[00:03:30] Overview of the Global Medical Innovation program at Rice University.[00:07:45] Importance of contextual and global perspectives in medical device innovation.[00:14:00] Experiences and lessons learned from Costa Rica’s healthcare system.[00:22:15] Discussing out-of-context healthcare settings in Brownsville, Texas.[00:30:00] Navigating healthcare hierarchies and observer bias in medical device innovation.[00:45:00] Differences between student learning processes and typical industry practices.[00:55:20] Practical tips for companies to broaden their medtech innovation perspectives.[01:05:30] Final thoughts on the importance of diverse lenses in medtech innovation.Quotes:"Understanding healthcare from a 360-degree view is important because it helps you to understand why those specific practices are done." - Dr. Matthew Wettergreen"Our goal is to prepare students to enter the medtech industry in a range of jobs by simulating professional practice in diverse contexts." - Dr. Matthew Wettergreen"Recognize that you're wearing a lens and train yourself to try and take off that lens and put on a new one." - Dr. Matthew WettergreenKey Takeaways:Latest MedTech Trends:The significance of global and contextual perspectives in medical device innovation.The rising role of telemedicine in reaching low-income and underserved populations.The importance of functional, cost-effective solutions in global healthcare settings.Practical Tips for MedTech Enthusiasts:Engage in clinical needs-finding activities to better understand the healthcare environment.Encourage facilitated discussions and case studies within your organization.Explore and appreciate diverse healthcare systems to innovate effectively.Questions Predicting Future Developments:How will telemedicine evolve to cater to the needs of the lowest SES populations?What are the potential impacts of integrating global healthcare perspectives in local innovations?How can medtech companies better prepare their employees to understand upstream and downstream processes?References:Rice University's Global Medical Innovation ProgramPumani CPAP DeviceDr. Matthew Wettergreen on LinkedInEtienne Nichols LinkedInMedTech 101:Telemedicine: Remote diagnosis and treatment of patients through telecommunications technology.Clinical Needs Finding: The process of observing and identifying unmet clinical needs in healthcare settings.Global Healthcare: Understanding and incorporating diverse healthcare systems and practices from around the world.Questions for the Audience:Audience Poll: What is the most significant challenge you face in medical device innovation? Email us your thoughts at podcast@greenlight.guruDiscussion Question: How do you think advancements in MedTech will transform healthcare in the next decade? Share your insights with us!Feedback:We value your feedback! Please leave a review on iTunes to help others find us. Reach out to us at podcast@greenlight.guru with suggestions for future topics.Sponsors:This episode is sponsored by Greenlight Guru. Greenlight Guru offers the only quality management system (QMS) and electronic data capture (EDC) software designed specifically for the medical device industry. Streamline your processes and ensure compliance with ease. Visit their website for a special offer for our listeners.