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In this engaging episode of the Global Medical Device Podcast, Etienne Nichols and Devon Campbell dive into the complexities of verification and validation (V&V) in medical device development.
Whether you’re a medtech startup founder or an industry veteran, this conversation offers essential insights on creating robust V&V processes. Devon shares practical advice on defining user needs, writing strong design inputs, conducting pre-verification testing, and ensuring that verification protocols provide meaningful evidence.
The discussion explores how to avoid common pitfalls, optimize your design reviews, and strategically approach V&V for complex devices, offering listeners a wealth of actionable takeaways for navigating regulatory challenges and accelerating market access.
Key Timestamps:00:01 – Introduction to Greenlight Guru’s QMS capabilities03:15 – Setting the stage: Why verification and validation matter08:30 – Differences between verification and validation explained12:50 – Importance of strong user needs and design inputs23:45 – Writing effective user needs and identifying users33:00 – Creating robust design inputs and their sources beyond user needs40:10 – From design inputs to design outputs: Key considerations48:20 – Best practices for conducting design reviews and managing revisions57:15 – Verification strategies: The importance of pre-verification01:05:40 – Common challenges in V&V, including sample sizes and justifying tests01:15:10 – Using feedback during testing and leveraging observations01:23:00 – Final takeaways and practical advice for V&V success
Standout Quotes:"Verification asks if we built the product correctly, while validation asks if we built the right product for the user." – Devon Campbell"You can't do verification or validation without strong, well-informed requirements. Weak requirements lead to validation failures." – Devon Campbell
3 Key Takeaways:Verification and Validation Are Not the Same: Understand that verification ensures your device meets specified design inputs, while validation confirms it meets user needs and functions as intended.Pre-Verification Testing Minimizes Risk: Conducting a "pre-verification" run allows you to refine testing protocols and identify potential design issues before formal verification begins.Define Users Clearly in User Needs: Avoid generic statements; specify which user (e.g., clinician, technician, patient) has which needs to ensure robust validation testing.
References:Devon Campbell’s Consulting – Connect with Devon for more insights on product development.Etienne Nichols’ LinkedInGreenlight Guru’s QMS Software
MedTech 101:Verification vs. Validation – Verification checks if a product meets specified requirements, while validation ensures it fulfills the needs and expectations of its intended users. Both are critical steps in medical device development, and their successful execution depends on precise, testable requirements.
Audience Engagement:Poll Question: "What’s been your biggest challenge in navigating verification and validation for...
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In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with Adnan Ashfaq, a seasoned quality, regulatory, and validation specialist, to explore the critical role of developing a regulatory roadmap for medical device companies.
Adnan breaks down the differences between a regulatory strategy and a regulatory roadmap, highlighting how a well-designed roadmap serves as a guiding document for market access and investor confidence. The conversation delves into how to navigate complex market regulations, assess classification and compliance needs, and identify opportunities for strategic global market entry.
Adnan’s 25+ years of experience provide actionable insights for medtech startups and established companies alike.
Key Timestamps:00:02 – Introduction to Greenlight Guru and Episode Overview03:10 – Introducing Adnan Ashfaq and his background in medtech04:45 – Difference between a regulatory strategy and regulatory roadmap07:00 – What a regulatory roadmap is and why it’s crucial12:30 – When and why companies need a regulatory roadmap16:45 – Key elements of a regulatory roadmap: costs, regions, and timelines23:20 – Importance of classification and its impact on the regulatory path28:50 – Integrating QMS, clinical investigations, and stakeholder engagement36:00 – Leveraging a roadmap for strategic market entry and global reach44:15 – Pitfalls to avoid in creating a regulatory roadmap54:20 – Using language and intended use statements strategically01:03:00 – Wrapping Up: Takeaways and Advice for MedTech Professionals
Standout Quotes:"A regulatory roadmap is more than just documentation; it’s a strategic guide for accessing markets and securing investor confidence." – Adnan Ashfaq"Understanding whether your device is a medical device, and its classification, can be make-or-break for your entire regulatory strategy." – Adnan Ashfaq
3 Key Takeaways:Regulatory Roadmaps Are Essential: Developing a roadmap early in the process ensures clear regulatory pathways, cost assessments, and market prioritization, helping avoid costly missteps later.Market Entry Strategy Matters: Strategic use of market-specific regulations, such as leveraging faster access opportunities in some regions, can enhance commercialization efforts and post-market success.Language and Classification Are Crucial: Precise language in defining your device's intended use and claims can significantly impact classification, regulatory requirements, and market access speed.
References:Simpli Medica – Adnan Ashfaq’s consultancy website.Etienne Nichols’ LinkedInGreenlight Guru’s QMS Software
MedTech 101:Regulatory Roadmap – A strategic document that outlines the costs, timelines, market-specific regulatory requirements, and resources necessary for bringing a medical device to market. Different from a regulatory strategy, it focuses on broader market entry planning and serves as a valuable tool for investor engagement and commercial success.
Audience Engagement:Poll Question: "Has your company developed a regulatory roadmap to guide market entry? Share your experience and
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In this episode of the Global Medical Device Podcast, host Etienne Nichols is joined by quality and regulatory expert Ashkon Rasooli to explore the essentials of creating a high-impact, non-burdensome Quality Management System (QMS).
Ashkon shares his four guiding principles for building an effective QMS—emphasizing quality over proceduralism, culture over mandate, redundancy over duplication, and conciseness over verbosity.
This conversation dives into strategies for optimizing QMS implementation, reducing overhead, and integrating quality culture company-wide. The episode wraps with tactical advice for new medical device founders on setting up their QMS for long-term success.
Key Timestamps:00:02 – Intro to Greenlight Guru and Episode Topic03:30 – Introducing Ashkon Rasooli and his background05:15 – Defining the “Non-BS QMS” approach06:45 – Principle #1: Quality Over Proceduralism12:00 – Navigating deviations in QMS and avoiding extremes14:45 – Principle #2: Culture Over Mandate22:10 – Principle #3: Redundancy Over Duplication29:30 – Principle #4: Conciseness Over Verbosity37:00 – The Importance of Designing for Regulatory and Quality from the Start46:30 – Tactical QMS advice for new medtech founders57:00 – Wrapping Up and Key Takeaways
Standout Quotes:"There is a cost to quality. But quality done right can also be an enormous value-add, not just a regulatory checkbox." – Ashkon Rasooli"A QMS should serve quality and compliance, but it has to be intuitive for every person in your company. Complexity does not mean quality." – Ashkon Rasooli
3 Key Takeaways:Quality Over Proceduralism: Focus on the intent and impact of QMS processes rather than rigid adherence to procedures that may not reflect the realities of your business.Culture Over Mandate: Building a culture of quality involves engaging every employee, not just those in quality roles, to ensure shared responsibility and proactive efforts.Design for Quality Early On: Engaging with quality and regulatory advisors at the architecture and design phase can prevent costly rework and optimize compliance pathways.
References:Ashkon Rasooli on LinkedInEtienne Nichols’ LinkedInGreenlight Guru’s QMS Software: www.greenlight.guru
MedTech 101:QMS (Quality Management System) – A structured system of procedures and processes covering all aspects of design, development, manufacturing, and distribution to ensure product safety, effectiveness, and regulatory compliance. Essential for medtech companies seeking to market devices in most global markets.
Audience Engagement:Poll Question: "Does your company treat quality as a compliance necessity or a business differentiator? Share your thoughts!"
Feedback:Love this episode? Have ideas or topics you want us to cover? Email us at [email protected] and leave a review to help others discover the Global Medical Device Podcast.
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In this episode of the Global Medical Device Podcast, Etienne Nichols and regulatory expert Mike Drues discuss FDA's new framework, the Predetermined Change Control Plan (PCCP), designed to streamline change approvals for medical devices.
Originally developed for AI-based devices, the PCCP framework is now available for all types of medical devices, providing a way for manufacturers to get pre-approval for certain future device changes.
Etienne and Mike explore the origins of PCCPs, the intricacies of implementing them, and how this regulatory tool may allow for faster device modifications without additional market submissions. They also examine the benefits and limitations of PCCPs for both AI-driven and physical medical devices and provide practical tips for incorporating this into regulatory and quality management strategies.
Key Timestamps:
[03:15] Introduction to PCCPs and Change Management[08:40] PCCP’s origin and application for AI-driven devices[14:20] Expansion of PCCPs to all medical devices[25:10] Practical challenges and best uses for PCCPs[34:55] Submitting PCCPs: Considerations and tips[45:30] Potential of PCCPs for non-software devices: 3D-printed knees case[52:40] FDA guidance and limitations for label changes[1:06:20] Final recommendations and quality system implications for PCCPsMemorable Quotes:
“PCCPs could allow us to get anticipated changes approved without a new market submission — but that isn’t a blank check. It’s a pre-validation of boundaries.” — Mike DruesTop Takeaways:
Consider PCCPs for High-Impact Changes: PCCPs are valuable for anticipated changes to AI-driven or complex devices, potentially reducing regulatory delays.Limit Scope for Efficiency: Keep PCCPs specific, with only a few anticipated changes, as this simplifies review and helps secure approvals faster.Integrate PCCPs in QMS: Adding PCCP protocols to quality systems may streamline change implementation and regulatory compliance for future device iterations.References:
Mike Drues on LinkedInFDA PCCP Guidance (2023 & 2024) on anticipated changes and market submissionsMedTech 101:
Predetermined Change Control Plan (PCCP): A regulatory tool from the FDA allowing manufacturers to gain pre-approval for anticipated changes to a medical device, simplifying future modifications. Initially created for AI-driven devices, PCCPs now apply to all device types.
Audience Engagement:
Have you considered or implemented a PCCP for your device? What changes would you include if you could pre-approve future modifications?
Feedback:
We’d love your thoughts on the PCCP framework! Email us at [email protected] with your feedback, questions, or ideas for future topics.
Sponsors:
Special thanks to Greenlight Guru — the industry’s eQMS & EDC platform designed for medical devices. Learn more about how Greenlight Guru can streamline your change management at greenlight.guru.
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In this episode of the Global Medical Device Podcast, Etienne Nichols hosts Georg Digel, a seasoned expert in Corrective and Preventive Action (CAPA) systems.
Georg shares insights into setting up an effective CAPA program, discussing essential topics like identifying CAPA triggers, executing root cause analysis, and implementing corrective actions that not only ensure compliance but also drive meaningful improvement within medical device companies.
With over a decade of experience, Georg brings practical knowledge on avoiding common pitfalls such as "death by CAPA" or failing to recognize high-risk systemic issues. The episode also delves into the importance of verification of effectiveness (VoE) checks, the distinctions between corrective actions and preventive actions, and how to balance a proactive approach with pragmatic solutions.
Key Timestamps:[03:15] – Defining CAPA and its critical role in Quality Management Systems[10:45] – Common CAPA triggers: Balancing overuse and underuse[18:20] – Root cause analysis vs. corrective action: A step-by-step approach[25:40] – Containment vs. correction: Key differences in addressing nonconformities[38:10] – Verification of effectiveness: Best practices for ensuring long-term solutions[50:30] – Continuous improvement through CAPA: Avoiding system overload[1:00:05] – Practical tips for balancing CAPA triggers with company priorities
Memorable Quotes:“CAPA isn't just about compliance; it's about driving real improvement in your organization." – Georg Digel“The worst thing that can happen is losing oversight on the serious issues because your system is flooded with trivial ones.” – Georg Digel“Root cause analysis isn’t about fixing the symptom, it’s about ensuring the issue never comes back.” – Etienne Nichols
Key Takeaways:MedTech Trends:CAPA as a Key to Continuous Improvement – How CAPA systems fuel company growth by addressing both high-risk and systemic issues.Data-Driven CAPA Triggers – Integrating post-market surveillance and production data for more proactive corrective actions.Regulatory Impact on CAPA – The importance of understanding evolving regulations and their influence on product safety and quality management.
Practical Tips for CAPA Implementation:Sharpen Your Triggers – Clearly define CAPA triggers to avoid flooding the system with low-risk issues.Effective VoE – Ensure VoE checks are specific to root causes, not just symptoms, for long-term success.Cross-Site CAPA Learning – Use internal audits and external findings from similar companies to prevent systemic failures across sites.
Future Questions in MedTech:How will advances in AI and machine learning improve CAPA systems in the future?Can companies move toward more preventive action frameworks, or is CAPA inherently reactive?How will stricter global regulatory updates reshape CAPA strategies in medical device manufacturing?
References:FDA 483 and Warning Letters Database – A resource to monitor common CAPA violations and avoid systemic errors.LinkedIn Profile - Georg Digel – Follow Georg Digel for daily insights... -
In this insightful episode of the Global Medical Device Podcast, host Etienne Nichols is joined by Simon Mason, President of NEST (National Evaluation System for Health Technology), to explore how real-world evidence (RWE) is shaping the future of medical device regulation.
Simon breaks down NEST's critical role in catalyzing the use of RWE to streamline submissions, accelerate time-to-market, and lower costs for MedTech companies. With a focus on post-market data, off-label use, and pivotal test cases like pediatric devices and robotic surgery, this conversation reveals the immense potential of RWE to improve patient outcomes and advance medical innovation.
Simon also touches on the evolution of NEST since its creation under the FDA's MDUFA commitment and provides real-world examples of how RWE has led to FDA clearances, including collaborations with industry giants like Johnson & Johnson and Intuitive Surgical.
Key Timestamps:[00:02:05] – Introduction to Simon Mason and NEST's mission.[00:06:30] – The importance of real-world evidence in medical device submissions.[00:10:50] – NEST's relationship with FDA and industry stakeholders.[00:18:25] – Real-world examples: How RWE led to device clearances.[00:25:10] – Challenges in using real-world data for submissions.[00:32:45] – NEST's role in pediatric devices and the potential for off-label approvals.[00:38:30] – The financial and time-saving benefits of using real-world evidence.[00:50:00] – How companies can engage with NEST to accelerate device approvals.
Quotes:Simon Mason: “Real-world evidence has the potential to accelerate device approval and save millions in clinical trial costs. It's all about leveraging existing data to support regulatory submissions.”Etienne Nichols: "The opportunity to use off-label real-world data to expand indications opens a whole new world of innovation for MedTech companies."Simon Mason: “Speed is everything in business and in patient care. RWE is all about moving faster while maintaining safety and effectiveness.”
Key Takeaways:Latest MedTech Trends:Real-World Evidence (RWE) Revolution: RWE is transforming regulatory pathways by utilizing data already being collected in real-world settings, reducing the need for costly clinical trials.Off-Label Use for Approvals: NEST is helping companies harness off-label data, particularly in pediatric and robotic surgery, to expand product indications.FDA Collaboration: NEST serves as a bridge between the FDA and industry, simplifying the regulatory process for device companies.
Practical Tips for MedTech Innovators:Engage Early: Medical device companies should consider engaging with NEST early in their product lifecycle to identify potential RWE opportunities.Data Accessibility: Companies should explore existing registries or datasets that could support their submissions, saving time and resources.Clear Project Goals: When approaching NEST, companies should have a clear understanding of their product claims and the available data to support them.
Questions for Future Development:How will the widespread adoption of RWE change the landscape for early-stage MedTech startups?Can RWE become the default pathway for medical device approvals, replacing traditional clinical trials?What role will AI play in streamlining data collection and analysis for real-world evidence?
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In this episode of the Global Medical Device Podcast, host Etienne Nichols continues his conversation with regulatory expert Mike Drues in part two of their series on home use medical devices.
The discussion centers on critical topics such as labeling, usability challenges, and the future of medical devices in home settings. They explore how these devices, increasingly used by non-healthcare professionals, face unique hurdles such as user training, environmental factors, and technological concerns like cybersecurity and data security.
Together, Etienne and Mike also delve into how regulatory frameworks need to adapt for home use, and they highlight potential future issues with devices as AI and robotic assistance grow in prominence.
Key Timestamps:[02:20] - Recap of Part 1 & Introduction to Home Use DevicesMike revisits key topics from part 1, focusing on why home use devices matter.[10:45] - Defining the Intended User and EnvironmentDiscussion about how labeling must account for who will use the device and where.[15:30] - Technological and Environmental Challenges for Home Use DevicesExploring temperature, humidity, and power inconsistencies affecting performance.[30:05] - Reprocessing and Cleaning Devices at HomeThe challenges and risks associated with reusing and cleaning devices like CPAPs.[40:15] - Usability Testing & Human FactorsImportance of considering non-healthcare users when designing home devices.[55:12] - Cybersecurity Risks in Home DevicesThe growing significance of data security and strategies for protecting devices in non-clinical settings.[1:05:30] - Post-Market Surveillance and Reporting for Home DevicesThe complexities of tracking device performance and recalls when used in home environments.
Memorable Quotes:"When we talk about intended users, we must shift our thinking from healthcare professionals to patients. Designing for non-clinicians is crucial because usability directly impacts safety." – Mike Drues"If your device has to be recalibrated, why not have a mechanism that disables it when calibration is overdue? That’s a much stronger safeguard than relying on users to remember." – Mike Drues"Cybersecurity is a growing challenge in home devices. It’s not just about protecting personal data—imagine if a critical medical device was hacked." – Etienne Nichols
Key Takeaways:Latest MedTech Trends:Increasing Use of Home Medical Devices: Patients are increasingly managing their own health at home, necessitating devices that are user-friendly and adaptable to various home environments.AI & Robotics in Home Devices: With the rise of AI and robotic assistance, the definition of an "intended user" is evolving, requiring future-proof regulatory considerations.Data Security: As more devices become connected, cybersecurity is becoming a top priority, particularly for critical, life-sustaining technologies.
Practical Tips for MedTech Professionals:Understand the End-User: When designing devices, consider that patients, not healthcare professionals, will be the primary users. Usability is key.Incorporate Environmental Testing: Take environmental factors like humidity, power outages, and storage conditions into account during the device development phase.Push Updates Automatically: For connected devices, push software updates automatically to mitigate cybersecurity risks, rather than relying on users to pull... -
In this episode, Etienne Nichols hosts regulatory expert Mike Drues to discuss the evolving landscape of home use medical devices. The conversation covers critical topics such as regulatory definitions, safety challenges, and compliance hurdles for devices intended for use outside traditional clinical settings.
They explore how home use devices, such as CPAP machines and infusion pumps, can differ significantly from hospital-based devices in terms of design, post-market surveillance, and user interaction.
The discussion is grounded in real-world examples, most notably the Philips Respironics recall, which became the largest medical device recall in history due to design oversights and failure in post-market surveillance.
This episode sets the stage for a deeper dive into technical, regulatory, and user-related challenges in the next installment.
Key Timestamps:[00:01] – Introduction: Etienne introduces the episode and topic of home use medical devices, along with a quick sponsor message.[02:30] – Defining Home Use Devices: Mike Drues explains what qualifies as a home use medical device from a regulatory standpoint.[07:50] – Why Home Use Devices Matter: Discussion on why home use medical devices are a strategic priority for CDRH in 2025 and the safety issues identified by the Emergency Care Research Institute (ECRI).[12:15] – Case Study: Philips Respironics Recall: Mike discusses the technical and regulatory issues behind the Philips Respironics recall and its implications for manufacturers.[25:45] – Post-Market Surveillance and Complaint Handling: The challenges of post-market surveillance and complaint handling for home use devices, and the role of regulatory compliance.[35:30] – The Importance of Intended Use Environment: Exploring how intended use environment should influence design and usability considerations.[45:20] – Teaser for Part 2: Mike and Etienne preview topics for the next episode, including labeling challenges, human factors, and usability testing for home use medical devices.
Key Quotes:“A home use device isn’t just a device that could be used at home; it’s one that’s intended and labeled for use outside traditional clinical settings.” — Mike Drues“When post-market surveillance fails, it’s not just a compliance issue—it’s a safety issue that can put lives at risk.” — Mike Drues“Regulatory logic goes beyond the written rules—it’s about understanding the intent behind them to ensure devices are safe wherever they’re used.” — Mike Drues
Key Takeaways:Latest MedTech Trends:
Home Use Device Surge: There is a growing trend toward designing devices for non-clinical environments, driven by technological advancements and patient demand for convenience.Regulatory Focus on Safety: Regulatory bodies like the FDA are increasingly prioritizing the safety of home use devices, as seen in CDRH’s 2025 strategic priorities.Impact of High-Profile Recalls: Large-scale recalls, like the Philips Respironics case, highlight the need for robust design controls and post-market surveillance practices for home use devices.Practical Tips:
Design for Real-World Use: When designing home use devices, consider environmental factors like temperature, humidity, and patient handling to prevent unintended failures.Emphasize Post-Market... -
In this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Vincent Cafiso, Director of Quality and Regulatory Services at Creo Consulting and former FDA investigator.
Vincent brings 30 years of life sciences and regulatory expertise, offering a unique perspective on navigating FDA inspections, building robust quality systems, and managing innovation within the MedTech industry. They dive deep into the challenges faced by MedTech companies, particularly small startups, and how to balance regulatory requirements with creativity and innovation.
Vincent also highlights the common pitfalls companies encounter with design controls and shares strategies to ensure R&D and production teams work in harmony.
Key Timestamps:[00:01] – Introduction: Vincent Cafiso’s background as an FDA investigator and transition into industry.[04:15] – Crayo Consulting’s Scope: How Creo Consulting supports MedTech companies from launch strategy to compliance.[12:40] – Bridging R&D and Production: Overcoming challenges when R&D environments don’t align with production standards.[19:50] – Top Trends in Quality Systems: Addressing documentation gaps and missing standards in design history files.[27:10] – Management’s Role in Supporting Quality: The importance of management’s involvement in enforcing quality controls and processes.[38:30] – From FDA to Industry: How Vincent’s FDA background influences his approach to quality and compliance.[54:25] – Skip-Level Meetings and Breaking Silos: Enhancing collaboration and communication within large organizations.[1:06:00] – Final Takeaways and Advice: Building a culture of quality and fostering innovation while staying compliant.
Key Quotes:“The regulations are written for tongue depressors and pacemakers—two very different devices. It’s up to the companies to interpret how to apply those rules to their specific products.” – Vincent Cafiso“Documentation shouldn’t just be a checkbox for submission. There’s a lot more innovation happening that doesn’t make it onto paper because companies don’t realize its value.” – Vincent Cafiso
Key Takeaways:1. MedTech Trends:Alignment of R&D and Production: Ensure that testing environments and protocols in R&D align with the standards of production to avoid costly discrepancies and rework.Regulatory Understanding Across Teams: Companies need to educate teams on the specific regulatory standards that apply to their product types to avoid misinterpretation and gaps in compliance.Cross-Departmental Collaboration: Maintaining a startup-like collaborative culture, even as the company scales, is crucial for innovation and quality.
2. Practical Tips for MedTech Professionals:Integrate Quality Early: Implement quality controls and validation processes at the R&D stage to avoid repeating tests or redesigns during production.Leverage Skip-Level Meetings: Encourage direct communication between upper management and employees for better understanding and faster issue resolution.Document Everything: Don’t treat documentation as a formality. Capture all the engineering studies and real data to support design decisions and regulatory submissions.
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In this episode, Etienne Nichols talks with Leo Eisner, renowned as the "IEC 60601 Guy" and founder of Eisner Safety Consultants, about the importance of selecting the right standards in medical device development.
Leo shares his journey into the world of medical device standards, offering a detailed look into the role that standards play in ensuring product safety and regulatory compliance. They dive deep into IEC 60601, ISO 15223, and the regulatory landscape across global markets.
Leo also shares actionable advice on avoiding pitfalls, prioritizing standards, and ensuring compliance to bring safe, effective devices to market without delays.
Key Timestamps:[03:20] – Introduction to Leo Eisner and his background in medical device standards[10:15] – Why standards like IEC 60601 are crucial for medical device development[18:45] – Steps for identifying the right standards for your product[27:00] – Common mistakes and the consequences of ignoring standards[38:50] – How to integrate standards into your design process[47:35] – How startups can navigate standards with limited resources[58:00] – Tools for staying updated on changing standards and regulations[1:09:40] – Final advice from Leo on ensuring regulatory success
Notable Quotes:"When you really think about it, all this work leads to safer medical devices on the market—that’s crucial." – Leo Eisner"Standards may seem like obstacles, but they’re design inputs that ensure your device will work as intended in every scenario." – Etienne Nichols"If you don’t integrate standards early in the design phase, you bring design risk later into the project, which can be very costly." – Leo Eisner
Key Takeaways:MedTech Trends:Regulatory Compliance as a Design Input – Standards such as IEC 60601 are not just hurdles but key design inputs.Global Market Variations – Different countries have unique regulatory demands; understanding these early can avoid costly delays.Atomic Standards – Future standards are becoming more "atomic," meaning they’ll be broken down into more easily applicable, smaller parts.
Practical Tips for MedTech Professionals:Start Early with Standards – Review applicable standards in the initial design phase to avoid costly delays later.Use the Right Tools – Tools like MedBoard and the FDA’s guidance database can help you stay updated.Seek Expert Help – If you're a startup or lack in-house resources, work with a qualified consultant to navigate the regulatory landscape efficiently.
Questions for Future Developments in MedTech:Will the move toward "atomic" standards streamline regulatory processes for startups?How will global regulatory bodies harmonize standards across different markets?What emerging standards will impact next-gen MedTech innovations like AI and robotic surgery?
References:Greenlight Guru - Quality Management System & Electronic Data Capture solutions built by Medtech professionals for Medtech professionals.Leo Eisner on LinkedIn – Connect with Leo for expert insights on compliance and regulatory standards.IEC Standards – The international standard for... -
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... -
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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