Episódios
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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... -
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 ParekhKey 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... -
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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: -
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... -
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:...
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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 -
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... -
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...
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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 Information
Notable 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 Yancy
Key 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 LinkedIn
MedTech 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...
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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...
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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... -
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 QMS
Quotes:"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 Bihary
Takeaways: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 -
In this episode of the Global Medical Device Podcast, host Etienne Nichols chats with Weronika Michaluk and Zach Markin from HTD Health about their journey to achieving ISO 13485 certification. The discussion covers the importance of gap analysis, the value of a compliant agile approach, and the benefits of using Greenlight Guru’s eQMS software. Listeners will gain valuable insights into maintaining compliance and continuous improvement in the MedTech industry, as well as practical advice for navigating ISO 13485 certification.
Key Timestamps00:00 - 02:00 - Introduction by Etienne Nichols02:00 - 05:30 - Introduction to HTD Health and their focus05:30 - 10:45 - Discussion on the importance of ISO 13485 certification10:45 - 14:30 - Steps and preparations for achieving ISO 13485 certification14:30 - 20:00 - Benefits and features of using Greenlight Guru’s eQMS20:00 - 25:00 - Challenges and changes faced during the certification process25:00 - 30:00 - Practical tips for preparing for an ISO 13485 audit30:00 - 35:00 - Continuous improvement and future goals for HTD Health35:00 - 40:00 - Closing thoughts and advice from Weonika Michaluk and Zach Markin
Notable QuotesWeronika Michaluk: "Do a proper gap analysis and also think whether you have enough knowledge internally... it will make your life easier to reach out to a partner or consultant."Zach Markin: "In services, there’s not one ideal agile, but the right flavor of agile for the work that needs to be done."Weronika Michaluk: "Using Greenlight Guru made our lives easier, especially in managing traceability and ensuring compliance."
Key TakeawaysPractical Tips for MedTech EnthusiastsGap Analysis: Conduct a thorough gap analysis to understand current capabilities and areas needing improvement.Internal Expertise: Ensure you have the necessary internal expertise or consult with experienced partners.Continuous Improvement: Regularly update and improve your processes to maintain compliance and efficiency.
ReferencesISO 13485 Certification: Learn about the ISO 13485 standard for medical devicesVisit Greenlight Guru for eQMS software solutionsHTD HealthWeronika Michaluk on LinkedInZack Markin on LinkedInConnect with Etienne Nichols on LinkedIn.
MedTech 101Explainer for New ListenersISO 13485: An international standard that outlines the requirements for a quality management system specific to the medical device industry. It ensures that organizations consistently meet customer and regulatory requirements related to medical devices.
QMS (Quality Management System): A structured system of procedures and processes covering all aspects of design, manufacturing, and distribution to ensure products meet regulatory standards and customer expectations.
CAPA (Corrective and Preventive Action): A process within a QMS to investigate and correct the root causes of identified issues and prevent their recurrence.
Audience EngagementPoll QuestionWhat MedTech innovation are you most excited about?
Email your thoughts to
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In this engaging episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Ron Richard, a seasoned expert in the medical device industry with over 35 years of experience. The discussion delves into the essentials of bringing a medical device to market, from the inception of an idea to commercialization. Ron shares his journey, the importance of effective elevator pitches, the nuances of regulatory pathways, and practical tips for aspiring inventors. With insights on avoiding common pitfalls and strategies for securing funding, this episode is a treasure trove for anyone interested in MedTech innovations.
Key Timestamps:[00:00] - Introduction and Ron Richard’s background[04:50] - Early successes in inventing and bringing products to market[10:30] - Validating ideas and market need[17:15] - Regulatory pathways: 510(k) vs. PMA[24:00] - Class I products and direct-to-consumer strategies[30:45] - Funding strategies: Family and friends, VC, and IPO[42:20] - Overcoming pitfalls and avoiding shiny object syndrome[49:10] - The importance of having a clear cap table[55:30] - The chasm: Making the leap from idea to market[01:01:45] - Final takeaways and advice for MedTech innovators
Quotes:Ron Richard: “One of the biggest things I tell inventors is that in order for you to raise money, people have to trust you and like you. You have to share within 30 seconds what your product does and what problem it solves.”Etienne Nichols: “Pioneers get shot, settlers get rich. You can be innovative with a 510(k) product by making evolutionary improvements.”Ron Richard: “The road to success is always under construction. Be prepared for obstacles and have a plan to navigate through them.”
Key Takeaways:Practical Tips:Elevator Pitch: Develop a concise and compelling elevator pitch that clearly communicates your product’s value.Validate Early: Use focus groups and stakeholder interviews to validate your idea before heavily investing.Funding Strategy: Start with family and friends for initial funding, then approach VCs once you have patents and prototypes.
Future Predictions:Increased Scrutiny: Regulatory bodies like the FDA may become more stringent, requiring more comprehensive testing and validation.Telemedicine Integration: Future medical devices will likely need to integrate telemedicine capabilities to stay competitive.AI and Diagnostics: Artificial Intelligence will play a significant role in diagnostics and personalized medicine, offering new avenues for innovation.
References:Ron Richard's Book: "Someday is Today: Get Your Ideas Out of Your Coffee Cup and on the Market" - [Amazon Link]Etienne Nichols' LinkedIn: Etienne Nichols on LinkedInRon Richard’s Website: Inventing Starts Today
MedTech 101:Basics of Medical Device Classification:Class I: Low risk, often exempt from premarket notification (510(k)).Class II: Moderate risk, typically requires 510(k) premarket notification.Class III: High risk, requires PMA (Premarket Approval) with extensive data.
Questions for the Audience:Poll: What MedTech innovation do you think will have the most significant impact in the next five years? (Options: AI-driven diagnostics, wearable health monitors, surgical robots)Share your thoughts with us at [email protected]
Feedback:We’d...
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In this episode of the Global Medical Device Podcast, host Etienne Nichols welcomes back Dr. Mike Drues to discuss the critical aspects of obtaining Institutional Review Board (IRB) approval and interacting with the FDA for medical device clinical trials. They explore the roles of IRBs, the difference between significant and non-significant risk devices, and share invaluable advice on mitigating risks associated with clinical trials. Whether you're a newcomer or a seasoned professional in the MedTech industry, this episode offers essential insights to ensure your clinical studies are compliant and efficient.
Key Timestamps:00:01:20 – Introduction to Dr. Mike Drues and his accolades.00:05:30 – Explanation of IRBs and their role in clinical trials.00:15:10 – Differences between traditional and commercial IRBs.00:22:40 – Discussion on significant vs. non-significant risk devices.00:32:00 – Importance of pre-submission meetings with the FDA.00:44:15 – Steps to take when an IRB disapproves your clinical trial.01:00:30 – Practical tips for choosing the right IRB for your study.
Quotes:"Most 510 devices do not need clinical data. But if you do, even for a non-significant risk device, vetting that with the FDA in advance is wise." – Dr. Mike Drues"You don't want to create a problem where none exists, but avoiding FDA consultation can lead to costly surprises later." – Dr. Mike Drues"The primary mission of an IRB is to ensure the safety of the patients at that institution." – Dr. Mike Drues
Takeaways:Key Insights:Understanding IRBs: IRBs are local entities responsible for the ethical oversight of clinical trials, ensuring patient safety and compliance.Risk Classification: The classification of your device as significant or non-significant risk dictates whether FDA approval is needed for your clinical trial.Strategic Pre-Submission: Engaging in a pre-submission meeting with the FDA can prevent costly delays and ensure your clinical trial meets all necessary endpoints.
Practical Tips:IRB Shopping: If faced with an IRB denial, consider alternative institutions or commercial IRBs to avoid delays.Comprehensive Submissions: Prepare thorough submissions for IRBs, including device descriptions, clinical trial protocols, and informed consent forms.Physician Champions: Having a physician advocate at the institution can streamline the approval process and facilitate patient enrollment.
Future Questions:How will the evolving landscape of MedTech regulations impact the approval process for new devices?What role will real-world evidence play in future clinical trials for medical devices?How can smaller companies navigate the complexities of FDA and IRB requirements effectively?
References:Etienne Nichols on LinkedInMike Drues on LinkedInGreenlight Guru can help with Clinical InvestigationsGood Clinical Practices (GCP) regulations for IRBs
MedTech 101:What is an IRB?An Institutional Review Board (IRB) is a committee established to review and approve research involving human subjects. The primary purpose of an IRB is to ensure the ethical and safe treatment of participants in clinical trials.
What is an IDE?An Investigational Device...
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In this special episode of the Global Medical Device Podcast, Etienne Nichols switches roles from host to guest as Devon Campbell turns the tables to explore the invaluable lessons Etienne has learned from over 100 podcast episodes. Delve into key insights on product development, quality management, and the power of vulnerability and networking. Etienne shares practical tips and personal anecdotes that reveal the nuances of the MedTech industry, making this episode a treasure trove of knowledge for both new and seasoned professionals.
Key Timestamps:
[02:15] - Introduction and Etienne’s journey to becoming a podcast host[12:30] - The importance of vulnerability and honesty in product development[22:45] - Balancing quality for audits versus operational benefits[30:10] - Human factors and usability in MedTech product development[37:55] - Simplifying quality management systems[45:00] - The mantra of learn, lead, and love in networking[54:20] - Encouraging emerging entrepreneurs to own their expertise and impact regulationsQuotes:
"The heart of the problem is the seed of the solution.""Quality management documents should benefit your company first and be audit-ready second.""Be genuinely curious. Assume the person in front of you knows something worth listening to."Takeaways:
Key Insights on the Latest MedTech Trends:
Human factors and usability are often misunderstood but crucial in MedTech product development.Quality management systems should be practical and beneficial for the company, not just for audits.Networking is more than collecting business cards; it's about building meaningful connections.Practical Tips for MedTech Professionals:
Be vulnerable and honest about the state of your projects.Focus on solving the right problems and avoid over-engineering.Create quality management documents that are easy to understand and useful for your team.Questions Predicting Future Developments:
How will AI and machine learning shape the future of MedTech product development?What emerging trends in usability and human factors will impact regulatory changes?How can MedTech companies better prepare for cybersecurity challenges?References:
Greenlight Guru - Quality management software for medical devices.Etienne Nichols - LinkedInDevon Campbell - LinkedInProdct LLC - Devon's advisory firmFred Crosby’s Quality is Free - A book on quality management principles.Beginner's Section: MedTech 101
Quality Management System (QMS): The system that outlines the processes and procedures to ensure product quality.Human Factors and Usability: The study of how people interact with products to improve design and user experience.Regulatory Strategy: The plan for complying with regulations to bring a medical device to market.Questions for the Audience:
Poll: What do you think will be the most impactful MedTech advancement in the next five years? Email us your thoughts at -
In this episode of the Global Medical Device Podcast, host Etienne Nichols engages with Howard Root, former CEO of Vascular Solutions and author of "Cardiac Arrest: Five Heart-Stopping Years as a CEO on the Fed’s Hit List," and Mark Duval, President and CEO of DuVal & Associates.
The episode delves into the harrowing experiences of navigating severe legal battles over off-label promotions, highlighting crucial insights into maintaining innovation while managing legal risks in the MedTech field. Additionally, Mark DuVal, a noted regulatory attorney, provides his expertise on the responsible corporate officer doctrine and its implications for industry executives.
Key Timestamps:[00:00:15] - Introduction by Etienne Nichols.[00:01:30] - Howard Root's background and the origins of Vascular Solutions.[00:05:00] - Mark DuVal introduces Howard Root, detailing his legal battles.[00:10:00] - Howard Root discusses the intricacies of his federal indictment and the subsequent trial.[00:30:00] - Discussion on corporate responsibility and regulatory implications in the MedTech industry.[00:50:00] - Audience Q&A session with Howard Root and Mark DuVal.[01:10:00] - Closing remarks and takeaways.
Quotes:Howard Root: "We're not imposing rules at the bare legal minimum...we want to have a gray area. It’s why you drive 55 in a 60 zone."Mark DuVal: "Always be truthful, fairly balanced, and not misleading when discussing device applications."
Takeaways:Latest MedTech Trends:
Increased scrutiny on off-label promotions highlights the need for clear regulatory strategies.Growing legal precedents emphasize the importance of corporate responsibility at all levels of operation.The role of ethical practices in sustaining innovation within the MedTech industry.Practical Tips for MedTech Professionals:
Ensure thorough understanding and compliance with FDA guidelines and local regulations.Implement robust training and compliance programs for all staff, particularly in sales and marketing.Engage experienced legal counsel to navigate complex regulatory landscapes.Future Predictions in MedTech:
Enhanced regulatory frameworks to better define and manage off-label use.Greater use of AI and data analytics to monitor compliance and ethical practices.Increased advocacy for legislative changes to protect innovators from aggressive legal challenges.
References:Howard Root's book, "Cardiac Arrest: Five Heart-Stopping Years as a CEO on the Fed’s Hit List"Mark DuVal on LinkedInDuVal & Associates Client AlertsFDA guidelines on off-label promotions -
In this episode, Lisa Van Ryn, a seasoned expert from Greenlight Guru, shares her extensive knowledge on the FDA’s Medical Device Reporting (MDR). We unpack the nuances of when and how to report incidents, the definition of serious injuries, and the importance of effective complaint management systems. Lisa provides practical advice on setting up robust reporting processes and explains how manufacturers can avoid common pitfalls.
Key Timestamps:
[01:20] Introduction of Lisa Van Ryn and discussion on FDA's Medical Device Reporting[05:45] Lisa's transition from the restaurant industry to medical devices[10:30] What triggers a medical device report to the FDA?[15:25] Role-play on handling complaints and determining reportability[25:00] Detailed explanation of the decision tree for reporting[35:15] Differentiating between device malfunctions and serious injuries[40:10] Real-life examples and clarifying complex reporting scenarios[50:30] The repercussions of late reporting and the importance of timing[55:20] Wrapping up and resources for deeper understandingInsightful Quotes:
"Every complaint needs to be evaluated to determine if it is reportable under 21 CFRR Part 803." - Lisa Van Ryn"Having a beginner’s mindset but the heart of a teacher is essential in the medical device industry." - Etienne Nichols"If you’re not considering the feedback as important, whether it’s reportable or not, you are missing valuable data." - Lisa Van RynKey Takeaways:
Understanding MDR: The importance of being thoroughly familiar with Medical Device Reporting guidelines to ensure proper reporting and compliance.Setting Up Processes: Tips on setting up an effective complaint handling system to manage and report incidents correctly.Common Pitfalls: Common issues manufacturers face and how to avoid them by implementing efficient and compliant processes.References and Resources:
Medical Device Reporting (MDR): How to Take Advantage of Your Electronic RecordsLisa Van Ryn on LinkedInEtienne Nichols on LinkedInBeginner’s Section: MedTech 101
Medical Device Reporting (MDR): This refers to the regulatory process in which manufacturers are required to report certain types of incidents and malfunctions related to medical devices to the FDA.Serious Injury: A serious injury in the context of MDR is defined as an injury that is life-threatening, results in permanent impairment, or necessitates medical or surgical intervention to prevent permanent damage.Complaint Handling: The process by which manufacturers receive, review, and respond to customer complaints about the safety and quality of their medical devices.Questions for the Audience:
Poll: Do you believe current regulations on medical device reporting are sufficient for ensuring patient safety?Feedback Request:
We value your thoughts! Please leave us a review on iTunes and share your feedback. Your suggestions help us improve and guide our future topics. Email your thoughts and topic suggestions to [email protected].
Sponsors:
This episode is brought to you by Greenlight Guru, a leading platform that offers MedTech companies a...
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In this insightful episode of the Global Medical Device Podcast, host Etienne Nichols delves into the journey of Dr. Lee Hunter, an orthopedic surgeon and innovator in elbow surgery devices. Dr. Hunter shares his experience from the conception of a simple yet effective surgical device through its development, struggles with initial licensing, and ultimate success in the market. The discussion highlights the importance of perseverance, the impact of regulatory insights, and the significant role of strategic innovation in enhancing patient outcomes.
Key Timestamps:[00:45] - Introduction of Dr. Lee Hunter and his medical device journey.[05:30] - Challenges and breakthroughs in designing elbow surgery devices.[14:20] - The licensing journey and learning from initial failures.[22:50] - Insights into the current medical device market and innovations.[35:40] - Discussion on the importance of simplicity and efficiency in medical devices.[48:15] - Future directions in MedTech and advice for new innovators.
Memorable Quotes:"Sometimes the simplest solutions are the hardest to find but the most effective once implemented." - Lee Hunter
Key Takeaways:Innovation in MedTech: Dr. Hunter's journey emphasizes that true innovation often stems from a deep understanding of specific medical needs rather than broad technological applications.Challenges and Resilience: Early failures are often stepping stones to success, highlighting the importance of resilience and adaptability in the medical device industry.Future of MedTech: The potential for simpler, more effective devices that streamline medical procedures and improve outcomes is vast, urging current and future innovators to focus on practical and impactful innovations.
MedTech 101:In today's episode, terms like "elbow arthroscopy" and "lateral decubitus position" were discussed. Elbow arthroscopy involves a minimally invasive surgical procedure on the elbow using an arthroscope, while lateral decubitus position refers to the patient lying on their side, which is common during such surgeries.
Call to Action:Did this episode on medical device innovation resonate with you? We would love to hear your thoughts and feedback. Leave us a review on iTunes and share your views on the future of MedTech innovations! For suggestions on future topics, please email us at [email protected]
References:Hunter Medical DevicesDr. Lee hunter on LinkedInTennessee Orthopedic AllianceEtienne Nichols on LinkedIn
Sponsors:This episode is brought to you by Greenlight Guru, a leading company in medical device consulting. Their expertise and services align seamlessly with the needs of the MedTech community, helping bring revolutionary devices to the market efficiently. Check out their special offers for podcast listeners today!
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In this episode, host Etienne Nichols speaks with Christine Luk, Associate Regulatory Affairs Manager at Proxima, about her journey through the medical device sector. From her academic beginnings in biochemistry and biomedical engineering to founding a startup and navigating FDA regulatory pathways, Christine offers a wealth of knowledge. The discussion delves into the intricacies of working with regulatory consultants, the significance of FDA interactions, and practical tips for medical device startups aiming to maneuver through regulatory challenges successfully.
Key Timestamps:[00:02:30] Christine's journey from biochemistry to medical device innovation[00:15:00] Insights on starting a medtech startup and the early failures[00:30:45] Effective collaboration with regulatory consultants[00:45:10] Handling FDA interactions and strategic submissions[01:00:20] Advice for medtech startups on navigating regulatory environments
Notable Quotes:"You're pitching all these awesome capabilities of your device, meanwhile on the FDA side, we're asking, who are you most like?" – Christine Luk"Every meeting is money. Making sure everybody is aligned and on the same page is crucial when dealing with consultants." – Christine Luk
Key Takeaways:Engage with local medtech communities and resources, such as accelerators or innovation hubs.Early interactions with the FDA can significantly influence your device’s regulatory pathway.Thorough documentation and clear communication with consultants are essential for effective project management.
References and Resources:Texas Medical Center Innovation InstituteProxima Clinical ResearchChristine Luk on LinkedInEtienne Nichols on LinkedIn
Call to Action:Feedback is crucial! Please email us your thoughts on this episode and suggestions for future topics at [email protected]
Don’t forget to leave us a review on iTunes!
Sponsor Segment:This episode is proudly sponsored by Greenlight Guru, a global leader in MedTech-specific software solutions. Whether you're in the clinical trial phase or ensuring compliance with quality standards, Greenlight Guru offers tailored solutions to streamline your processes. Their software is designed specifically for the medical device industry, helping companies accelerate their product development with confidence and compliance. Learn more about how Greenlight Guru can illuminate your path to market success by visiting their website at Greenlight Guru. Equip your team with the tools to simplify quality management and keep your focus on innovation and patient safety.
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