Global Medical Device Podcast powered by Greenlight Guru

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.

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 informedQuotes:"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 DuValKey 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 Nichols on LinkedInMedTech 101:Classification of Medical Devices: Medical devices are classified into three categories based on their risk level: Class I (low risk), Class II (moderate risk), and Class III (high risk). The FDA's proposed rule aims to classify certain wound dressings, potentially impacting their regulatory requirements.510(k) Clearance: A premarket submission to the FDA demonstrating that the device to be marketed is at least as safe and effective, substantially equivalent, to a legally marketed device.Questions for the Audience:Poll: How do you think the FDA's proposed rule on wound dressings will impact innovation in the medical device industry? Email us at podcast@greenlight.guruFeedback:We'd love to hear your thoughts on this episode! Please leave us a review on iTunes and let us know how we're doing. For suggestions on future topics, email us at podcast@greenlight.guruSponsors:This episode is brought to you by Greenlight Guru, the only quality management software designed specifically for the medical device industry. Elevate your quality, boost your productivity, and bring your devices to market faster with Greenlight Guru. Check out www.greenlight.guru for more information and special offers for our listeners.

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 LebovicTakeaways: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 health.Nasal Hygiene:Nasal hygiene refers to the practice of cleaning and maintaining the nasal passages to prevent infection and improve overall respiratory health. Similar to brushing teeth, regular nasal cleansing can help remove pollutants, allergens, and pathogens.Discussion Question:What are your expectations for future healthcare changes due to advancements in MedTech? Email us at podcast@greenlight.guruFeedback:We'd love to hear your thoughts on this episode! Please leave us a review on iTunes and email us your feedback and suggestions for future topics at podcast@greenlight.guruSponsors:This episode is sponsored by Greenlight Guru, the industry's leading eQMS software designed to ensure compliance, accelerate innovation, and simplify the entire product lifecycle for medical device companies. Visit Greenlight Guru to learn more and get a special offer for podcast listeners.

In this episode, Etienne Nichols is joined by Shaherah Yancy, CEO of Research Lifecycle Solutions. They dive deep into the critical importance of developing robust clinical and regulatory strategies for MedTech companies. Shaherah shares her extensive experience in the field, providing practical advice on securing funding, ensuring market access, and achieving market adoption. They explore the nuances of clinical evidence, the significance of strategic planning, and the role of advisory panels in navigating the MedTech landscape.Key Timestamps:00:00 - 03:00 Introduction and Sponsor Message03:01 - 05:20 Introduction to Shaherah Yancy and her background05:21 - 10:30 Importance of Clinical and Regulatory Strategies10:31 - 17:15 Challenges of Securing Funding and Developing Strategy17:16 - 25:45 Differences Between Market Access and Market Adoption25:46 - 33:50 Developing Effective Clinical Plans for Market Adoption33:51 - 39:40 Importance of Evidence and Study Design39:41 - 48:00 Examples and Case Studies from Early Stage Companies48:01 - 55:15 Endpoints for Market Adoption55:16 - 01:02:30 Strategies for Novel Technologies01:02:31 - 01:07:45 Final Advice and Contact InformationNotable Quotes:"Market access is a milestone. Market adoption is the goal." - Shaherah Yancy"Understanding the problem you’re solving is crucial for your strategy." - Shaherah Yancy"Don’t be afraid of clinical evidence; it’s your key to success." - Shaherah YancyKey Takeaways:MedTech Trends:Strategic Planning is Essential: Early and comprehensive planning for clinical and regulatory strategies can significantly enhance a company's chances of success.Clinical Evidence is Critical: Collecting robust clinical data is vital for both market access and long-term market adoption.Market Adoption Over Market Access: The ultimate goal should be market adoption, not just getting to market.Practical Tips:Form Advisory Panels: Engage with surgeons and clinical experts early to guide product development and market entry strategies.Comprehensive Studies: Design studies that include both primary endpoints for regulatory approval and secondary endpoints for market adoption.Prepare for Limited Market Releases: Use limited market releases to gather real-world evidence and refine products before a full launch.References:Research Lifecycle Solutions: Shaherah Yancy's company, specializing in clinical and regulatory strategies for MedTech. RLC SolutionsGreenlight Guru Clinical: The sponsor of this episode, offering a platform for streamlining clinical trials. Greenlight Guru ClinicalEtienne Nichols LinkedIn: Connect with Etienne on LinkedIn for more insights. Etienne Nichols LinkedInMedTech 101:Clinical Evidence: Data collected from clinical trials and studies to demonstrate the safety and efficacy of a medical device.510(k) Clearance: A premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device.PMA (Pre-Market Approval): The FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.Audience Questions:Poll: What MedTech advancements are you most excited about in 2024? Email us at podcast@greenlight.guru with your thoughts!Discussion: What changes do you expect to see in healthcare due to MedTech innovations in the next five years? Share your thoughts at podcast@greenlight.guruFeedback:We'd love to hear your feedback on this episode! Leave us a review on iTunes and let us know what topics you’d like us to cover in future episodes. Email us at podcast@greenlight.guru with your suggestions and feedback.Sponsors:Greenlight Guru Clinical: Revolutionize your clinical trials with Greenlight Guru Clinical. Discover how our platform can help you streamline processes, ensure compliance, and accelerate your time to market. Visit Greenlight Guru Clinical for more information and special offers for our listeners.

In this episode of the Global Medical Device Podcast, host Etienne Nichols, along with part-time co-host Stephanie Hinton, dives into the art of clinical trial recruitment with Dr. Kelly Palmer, Assistant Professor at the University of Arizona. Dr. Palmer shares her extensive experience and innovative strategies for overcoming recruitment challenges, emphasizing the importance of community engagement, tailored approaches, and flexibility. The discussion highlights how to recruit diverse populations, manage logistical complexities, and ensure participant engagement, ultimately enhancing the success of clinical trials.Key Timestamps:[00:02] – Introduction by Etienne Nichols[00:52] – Introduction of Dr. Kelly Palmer by Stephanie Hinton[03:15] – Kelly Palmer’s background and approach to recruitment[06:45] – Strategies for effective participant recruitment[12:30] – Building relationships with community organizations[18:00] – Overcoming practical challenges in clinical trials[26:45] – Using technology for data capture and improving efficiency[36:10] – Stories of recruitment challenges and solutions[45:00] – Key takeaways and advice for clinical trial professionalsQuotes:"Recruitment is not just about numbers; it's about building trust and relationships within the community." - Dr. Kelly Palmer"Think outside the box and always track your efforts to understand what works best." - Dr. Kelly Palmer"In research, you have to be flexible and ready to adapt to the needs of your participants." - Stephanie HintonTakeaways:MedTech Trends:Community engagement is crucial for successful recruitment in clinical trials.Leveraging technology can streamline data capture and reduce errors.Flexibility and adaptability are key to managing logistical challenges in research.Practical Tips:Develop strong relationships with community organizations to build trust and facilitate recruitment.Implement electronic data capture systems to improve efficiency and accuracy.Always have backup plans for logistics and be prepared to pivot quickly.Future Predictions:Increased use of AI and technology to enhance recruitment and data management.Growing emphasis on diversity and inclusion in clinical trial populations.Greater collaboration between researchers and community organizations.References:Greenlight Guru Clinical – Learn more about their all-in-one clinical development platform.IU School of Medicine – Collaboration with community organizations for recruitment.Dr. Kelly Palmer on LinkedInStephanie Hinton on LinkedInEtienne Nichols on LinkedInMedTech 101:Clinical Trial Recruitment: The process of enrolling participants into clinical trials, crucial for gathering data to test the efficacy and safety of new medical devices or treatments. Effective recruitment strategies ensure diverse and representative sample sizes, enhancing the reliability of study outcomes.Electronic Data Capture (EDC): A digital system for collecting and managing clinical trial data in real-time, reducing errors associated with manual data entry and improving data accuracy and efficiency.Call to Action: Share your thoughts by emailing us at podcast@greenlight.guru and participate in our audience poll on MedTech advancements!Feedback:Enjoyed this episode? Leave us a review on iTunes! Your feedback helps us improve and reach more listeners. Connect with Etienne Nichols on LinkedIn and share your thoughts or suggest future topics.Sponsors:This episode is brought to you by Greenlight Guru Clinical. Simplify your clinical evidence generation with their powerful platform. Visit Greenlight Guru Clinical to request a personalized demo and learn more about their special offers for our listeners.

In this episode of the Global Medical Device Podcast, host Etienne Nichols talks with Mitch Robbins, founder of the Anthony Michael Group, about the evolving landscape of hiring and job seeking in the MedTech industry in 2024. They discuss strategies for both employers and job seekers, emphasizing the importance of preparation, effective communication, and proactive networking. Mitch shares actionable tips to enhance the interview experience and improve hiring outcomes, making this episode essential listening for anyone involved in MedTech recruitment.Key Timestamps:[00:00] - Introduction and overview of the episode[03:15] - Mitch Robbins on the current state of the MedTech job market[07:30] - Importance of candidate experience in the hiring process[12:45] - Preparing for job interviews: Insights and tips[25:10] - Effective networking strategies for job seekers[35:00] - Onboarding new hires: Best practices[45:30] - Overcoming the challenges of layoffs and finding new opportunities[55:00] - Final thoughts and advice from Mitch RobbinsQuotes:"The more value you demonstrate throughout the interview process, the more leverage you create for yourself." - Mitch Robbins"Hiring is a team sport. It takes a team to court a candidate." - Mitch Robbins"Always try to think above the line, like, how can I get to this person warmly?" - Mitch RobbinsTakeaways:Key Insights about the Latest MedTech Trends:The current job market has shifted to favor employers, making candidate experience crucial.Networking and leveraging personal connections are more important than ever for job seekers.Proactive follow-ups and personalized communication can significantly increase your chances of landing a job.Practical Tips for Listeners Interested in MedTech:Prepare thoroughly for interviews by researching the company and understanding their needs.Utilize LinkedIn and other professional networks to connect with potential employers and peers.Be proactive in your job search by reaching out directly to hiring managers and using creative approaches like video introductions.Questions Predicting Future Developments in the Field:How will the increasing reliance on remote work impact hiring practices in the MedTech industry?What new technologies will emerge to assist with the hiring and onboarding process?How will the balance of power between employers and job seekers continue to evolve in the next few years?References:Greenlight Guru - The game-changing solution for medical device companies looking to streamline their quality and clinical processes. Anthony Michael Group - Mitch Robbins' executive search firm specializing in the MedTech industry. Mitch Robbins on LinkedInEtienne Nichols on LinkedInMedTech 101:For new listeners, here are some basic terms and concepts discussed in this episode:EQMS (Enterprise Quality Management Software): Software that helps manage quality processes within an organization.EDC (Electronic Data Capture): Systems used to collect clinical trial data electronically.Regulatory Submissions: Documentation required by regulatory bodies to approve new medical devices for market release.Questions for the Audience:Audience Poll: What MedTech advancement do you think will have the biggest impact on patient care in the next five years? Email us at podcast@greenlight.guru.Discussion Question: How do you see the role of remote work evolving in the MedTech industry? Share your thoughts with us at podcast@greenlight.guru.Feedback:We value your feedback! Please leave a review on iTunes and let us know how we're doing. Your input helps us improve and bring you more valuable content. For suggestions on future topics, email us at podcast@greenlight.guru.Sponsors:This episode is sponsored by Greenlight Guru. Streamline your quality and clinical data management with Greenlight Guru's EQMS and EDC platforms. Visit Greenlight Guru to learn more and take your medical device company to the next level.

In this episode of the Global Medical Device Podcast, host Etienne Nichols is joined by Jamie Bihary, a Medical Device Guru at Greenlight Guru. Jamie shares her journey from biomedical engineering to her current role, where she helps companies transition from legacy quality management systems (QMS) to cutting-edge electronic QMS (EQMS). They discuss the common challenges faced during these transitions, the importance of environmental monitoring in clean rooms, and practical advice for managing QMS implementations. Jamie also highlights the value of Greenlight Guru’s resources, including their robust partner network and support systems.Key Timestamps:00:00 - 02:00 Introduction and Jamie Bihary’s background02:01 - 05:30 A day in the life of a Medical Device Guru at Greenlight Guru05:31 - 10:15 Common challenges faced by new MedTech companies10:16 - 15:00 Jamie’s journey from biomedical engineering to Greenlight Guru15:01 - 20:30 Implementing EQMS and document migration process20:31 - 25:45 Importance of environmental monitoring in clean rooms25:46 - 30:10 Transitioning from legacy systems to EQMS30:11 - 35:00 The value of internal audits and giving/receiving feedback35:01 - 40:15 Greenlight Guru’s partner and alliance network40:16 - 45:00 Key advice for companies starting or transitioning QMSQuotes:"Our system had done really well with past audits, so it was crucial that we made the transition smoothly and accurately." – Jamie Bihary"Everyone in your organization impacts product quality in some capacity." – Jamie BiharyTakeaways:Key Insights:Transitioning from legacy QMS to EQMS can significantly streamline quality management processes and enhance efficiency.Internal audits and open communication are vital for continuous improvement and compliance in the MedTech industry.Practical Tips:Establish a detailed implementation plan for QMS transitions to ensure a clear and documented process.Utilize the resources and support offered by partners and consultants to manage workload and expertise gaps.Regularly conduct internal audits and encourage a culture of feedback to identify and rectify potential issues early.Future Questions:How can smaller MedTech companies best leverage partnerships to stay competitive?References:Greenlight Guru: Learn more about their EQMS solutions and support network.FDA Database: Reference for regulatory guidelines and compliance.LinkedIn Profile of Jamie Bihary: Connect with Jamie for more insights and support.MedTech 101:Quality Management System (QMS): A QMS is a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. It helps coordinate and direct an organization's activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis.Electronic Quality Management System (EQMS): An EQMS is a digital version of a QMS, offering automated processes, real-time data access, and integration with other enterprise systems to enhance compliance, efficiency, and overall quality management.Questions for the Audience:Poll: What is the biggest challenge you face when transitioning from a legacy QMS to an EQMS? Email us your answers at podcast@greenlight.guru.Feedback:We’d love to hear your feedback on this episode! Please leave a review on iTunes and share your suggestions for future topics. Email us at podcast@greenlight.guru.Sponsors:Greenlight Guru: Elevate your QMS with Greenlight Guru’s cutting-edge EQMS solutions, designed specifically for the MedTech industry. Visit Greenlight Guru to learn more and take advantage of special offers for our listeners.