Global Medical Device Podcast powered by Greenlight Guru

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Global Medical Device Podcast powered by Greenlight Guru Podcast

The Global Medical Device Podcast, powered by Greenlight Guru, is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

  1. 12 SEPT

    #382: Design of Experiments - How and When to Use DOE

    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 DOE Key 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...

    42 min

  2. 5 SEPT

    #381: MedTech Advice from an Accidental Entrepreneur

    In this episode of the Global Medical Device Podcast, host Etienne Nichols speaks with Dr. Asha Parekh, CEO and co-founder of Frontline Medical Technologies, about her path from a biomedical engineer to an "accidental entrepreneur." Dr. Parekh shares how her desire to create impactful medical devices led to the development of the COBRA-OS, a life-saving tool used in trauma care, including military and postpartum hemorrhage situations. The conversation touches on the challenges and victories of securing funding, navigating regulatory hurdles, and maintaining a mission-driven company focused on patient impact. For those interested in MedTech, this episode provides inspiration, practical insights, and a behind-the-scenes look at innovation in healthcare. Key Timestamps: [03:22] – Asha Parekh shares her transition from biomedical engineer to accidental entrepreneur.[12:35] – Developing the COBRA-OS and the moment Asha realized the life-saving potential of her product.[22:10] – The role of passion in overcoming challenges as a MedTech entrepreneur.[35:42] – The importance of securing funding and the challenges of working with quality and regulatory partners.[52:20] – How to craft a compelling pitch to secure funding for your MedTech device.[01:04:30] – Asha's milestone moments, including the COBRA-OS being used at Formula One race tracks. Quotes: "Passion is what drives you through the tough days. It's what makes the challenges bearable because the impact you're making is worth it." – Asha Parekh"Pitching is an art form. Telling a compelling story about your product, especially one that saves lives, can make all the difference." – Asha Parekh"You are the expert on your device. Never forget that, even when you're leaning on regulatory experts. Trust your own knowledge of your product." – Asha Parekh"The moment I realized that COBRA-OS could save lives, I knew we had to pursue it full-time." – Asha Parekh Key Takeaways: Top 3 MedTech Trends: Growing Impact of Trauma Care Devices – Devices like the COBRA-OS are becoming critical in high-risk environments such as military and emergency settings.Regulatory Complexity – Expanding into international markets (e.g., achieving CE mark) requires navigating a web of regulatory requirements.Funding & Innovation – Securing funding is pivotal for early-stage MedTech companies, especially when aiming for large-scale regulatory testing. Top 3 Practical Tips for MedTech Entrepreneurs: Find a Mission You’re Passionate About – It will sustain you through difficult phases.Master the Art of Pitching – A compelling story can unlock funding opportunities.Be Proactive in Regulatory Knowledge – Don’t rely solely on consultants; know your product’s regulatory pathway inside and out. References: Frontline Medical Technologies – Learn more about COBRA-OS and its use in trauma care at Frontline MedTech.Greenlight Guru – For quality and regulatory management solutions, visit Greenlight Guru.Rook Quality Systems – Learn more about QMS consulting at Rook Quality Systems.Connect with Etienne Nichols on LinkedIn...

    43 min

  3. 30 AUG

    #380: Navigating the Complex World of Combination Products with Subhi Saadeh

    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: a...

    39 min

  4. 15 AUG

    #379: Meet the Guru - Building Quality Management in Early-Stage Medical Device Companies and other Insights from a Veteran Engineer

    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...

    36 min

  5. 8 AUG

    #378: Who Owns the Design Controls Process?

    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 resources Quotes"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 Maher TakeawaysKey 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:...

    35 min

  6. 25 JUL

    #377: Designing a Medical Device for a Global User

    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 Wettergreen Key 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 LinkedIn MedTech 101: Telemedicine: Remote diagnosis and treatment of patients

    44 min

  7. 18 JUL

    #376: FDA's Proposed Wound Dressing Rule: Industry Impacts and Regulatory Insights

    In this episode, host Etienne Nichols is joined by Mark DuVal, President and CEO of DuVal & Associates, and Kathy Herzog, Senior Regulatory, Quality, and Compliance Associate at DuVal & Associates. They delve into the recent FDA proposed rule for wound dressings, addressing the classification and regulatory impacts on medical device manufacturers. The discussion covers the historical context, the potential implications for the industry, and strategies for companies to navigate these changes. Key Timestamps:[00:00] - Introduction to the episode and guests[02:15] - Overview of Greenlight Guru's QMS software[04:30] - Introduction to the FDA's proposed rule on wound dressings[06:00] - Mark DuVal discusses the broad implications of the proposed rule[12:45] - Kathy Herzog explains the performance requirements and administrative record[22:00] - Discussion on industry response and potential litigation[30:30] - Impacts on existing and new products in the market[40:20] - Strategies for companies to navigate the proposed changes[50:00] - Broader implications for the FDA and potential future regulations[60:00] - Final thoughts and ways to stay informed Quotes:"This proposed rule feels like a solution in search of a problem." - Mark DuVal"It's unsustainable that small wound dressing manufacturers would have to bear that burden on the back of an individual wound dressing." - Kathy Herzog"FDA's move to over-regulate well-settled product categories is deeply concerning." - Mark DuVal Key Takeaways:MedTech Trends: The FDA's proposed rule could significantly impact the classification and regulation of wound dressings.There is substantial industry opposition to the proposed rule, with many companies and trade associations voicing their concerns.The broader implications of the FDA's actions suggest a shift towards more aggressive regulatory measures. Practical Tips: Stay informed about regulatory changes and participate in comment periods to voice concerns.Prepare for potential new testing and data requirements by reviewing current performance testing protocols.Engage with industry groups and legal experts to understand the full impact of proposed regulations. Future Developments: How will the FDA address industry pushback and potential litigation against the proposed rule?Will there be additional guidance from the FDA to help manufacturers navigate the new requirements?What other product categories might the FDA target for reclassification in the near future? References:Greenlight Guru QMS SoftwareFDA Proposed Ruling on Wound DressingsDuVal & Associates Client Alert on FDA Proposed RuleAlliance of Wound Care StakeholdersWashington Legal FoundationConnect with Etienne...

    40 min

  8. 11 JUL

    #375: Direct to Consumer - The Future of Healthcare

    In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with Dr. Gail Lebovic, an internationally recognized oncoplastic surgeon and innovative entrepreneur. They delve into the evolving landscape of MedTech, focusing on the shift from traditional reimbursement models to direct-to-consumer strategies. Dr. Lebovic shares her journey of pioneering nasal health products during the COVID-19 pandemic, emphasizing the importance of flexibility and addressing real clinical needs. The conversation explores the broader implications for the future of healthcare, prevention, and patient empowerment. Key Timestamps:[02:15] – Introduction to Dr. Gail Lebovic and her background.[06:45] – Discussing the shift from traditional payer models to direct-to-consumer strategies.[12:30] – Challenges faced during the COVID-19 pandemic and pivoting strategies.[20:00] – The importance of flexibility in MedTech innovation.[30:10] – The significance of nasal health and hygiene.[40:25] – Going to market on Amazon and its impact on the business.[50:50] – Future trends in MedTech and women's healthcare.[01:05:15] – Advice for aspiring MedTech entrepreneurs. Quotes:"People are smart, our patients are smart, and all of our patients are consumers." – Dr. Gail Lebovic"Healthcare is really not healthcare; it's really sick care." – Dr. Gail Lebovic Takeaways:Key Insights: The shift from traditional reimbursement models to direct-to-consumer strategies can enhance patient care and accessibility.Prevention and self-care are becoming increasingly important in the healthcare landscape.Innovation in MedTech requires flexibility, robust research, and addressing real clinical needs. Practical Tips: Stay open to changing strategies based on market demands and environmental factors.Ensure your product stands out by maintaining high clinical standards, even in consumer markets.Utilize platforms like Amazon to reach a broader audience while maintaining rigorous quality controls. Future Questions: What new preventive health products will emerge in the next five years?How will the healthcare system adapt to increasing patient empowerment and self-care trends? References:Greenlight Guru – For all-in-one QMS software designed specifically for the medical device industry. Visit Greenlight Guru.Silicon Valley Innovations – Founded by Dr. Gail Lebovic, introducing anatomically directed drug delivery. Learn More.Dr. Gail Lebovic on LinkedIn – Connect with Dr. Lebovic for more insights into MedTech innovations. Connect on LinkedIn.Nasoclenz on Amazon - Check out how Silicon Valley Innovations is marketing their products direct-to-consumer on Amazon. Learn more. MedTech 101:Direct-to-Consumer (DTC) Strategy: A direct-to-consumer (DTC) strategy involves marketing and selling products directly to consumers, bypassing traditional healthcare providers or payers. This approach can increase accessibility, reduce costs, and empower patients to take control of their...

    48 min
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The Global Medical Device Podcast, powered by Greenlight Guru, is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

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