In our 400th episode of the Global Medical Device Podcast, host Etienne Nichols is joined by Greenlight Guru’s Sara Adams to unpack the findings of the 2025 Medical Device Industry Benchmark Report. From the rise of family office investments to QMS upgrades and the impact of regulatory uncertainty, this episode delivers a candid and comprehensive look at the current MedTech landscape. Sara brings her quality expertise and industry anecdotes to life, while Etienne adds sharp insights on strategic planning and product development.

Whether you're facing supply chain complexity, preparing for QMSR, or trying to navigate market shifts, this episode is your roadmap for the year ahead.

• 00:03 – Introduction to the 2025 Medical Device Industry Report
• 05:00 – Market growth outlook: $800B by 2030
• 09:40 – Family office investment trends in MedTech
• 13:15 – Hiring freezes and headcount reductions: what's behind the numbers?
• 20:22 – Supply chain challenges and supplier qualification issues
• 28:35 – Why only 11% of companies rate their supply chain management as “excellent”
• 33:30 – QMS upgrades and the strategic focus on quality systems
• 39:00 – Fundraising and clinical trials: top priorities for pre-commercial companies
• 44:55 – Regulatory complexity: QMSR, EU MDR, and FDA staffing pressures
• 53:50 – FDA Form 483s: top causes and how to avoid them
• 1:04:00 – Action plan for 2025: technology, collaboration, and performance
• 1:12:00 – Making quality your competitive edge

1. Global MedTech market expected to hit $800B by 2030.
2. Quality systems and operational efficiency are becoming top priorities.
3. Regulatory uncertainty is affecting hiring and supply chain strategy.

1. Start preparing for QMSR (FDA’s Quality Management System Regulation) now.
2. Prioritize supplier qualification and traceability early in development.
3. Choose purpose-built tools to reduce headcount needs and streamline processes.

• 2025 Medical Device Industry Report – Greenlight Guru
• Etienne Nichols on LinkedIn
• Sara Adams on LinkedIn
• Episode 360: Is it Possible to Buy a QMS? with Sara Adams

QMS (Quality Management System): A structured system that documents processes, procedures, and responsibilities for achieving quality and regulatory compliance.

QMSR: FDA’s new quality regulation aligning with ISO 13485:2016.

483 Form: Issued by the FDA when investigators find conditions that may violate the FD&C Act.

Family Office Investment: Wealth management firms that are increasingly investing in MedTech startups.

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Drop us a note at [email protected]

This episode is sponsored by Greenlight Guru – the only quality management system (QMS) and electronic data capture (EDC) software built specifically for the MedTech industry. Want to streamline compliance and reduce your time to market?

👉 Learn more at greenlight.guru and mention this podcast for a special demo offer.

In this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Olga Chashchina, a MedTech startup founder with extensive international experience. They explore how cultural differences affect communication in the medical device industry and the importance of understanding intercultural nuances.

Drawing from the book The Culture Map by Erin Meyer, Olga shares practical insights on managing global teams, the role of context in communication styles, and how cultural awareness can improve both workplace dynamics and patient care.

• 00:00 – Intro & Sponsor: Introduction to the episode and Greenlight Guru sponsorship
• 02:20 – Meet Olga Chashchina: Olga’s background in MedTech and international work experience
• 06:45 – Understanding Cultural Missteps: Common mistakes when navigating cultural differences in teams
• 12:15 – High vs. Low Context Communication: How context affects communication styles across cultures
• 15:00 – Cultural Impact on Healthcare: How cultural backgrounds influence patient care and medical communication
• 18:30 – Feedback Across Cultures: Differences in giving and receiving feedback globally
• 20:00 – Building Personal Connections in Professional Settings: Balancing personal relationships and cultural norms in business
• 22:00 – Final Thoughts: Olga’s key takeaway for appreciating cultural diversity

1. Global Teams Need Cultural Awareness: Effective communication hinges on understanding cultural contexts.
2. Healthcare is Deeply Cultural: Patient care varies across cultures due to differences in symptom expression and medical expectations.
3. Feedback Styles Differ Greatly: Recognizing how cultures approach feedback can prevent misunderstandings and improve collaboration.

1. Educate Yourself: Read books like The Culture Map to understand global communication styles.
2. Ask, Don’t Assume: Always ask clarifying questions rather than assuming shared context.
3. Balance Praise and Constructive Feedback: Be specific and culturally sensitive when providing feedback.

1. How will global team dynamics evolve with remote work becoming the norm?
2. Can AI tools help bridge cultural communication gaps in healthcare?
3. What future training will be essential for MedTech leaders to manage diverse teams effectively?

• The Culture Map by Erin Meyer – A pivotal resource discussed in the episode for understanding intercultural communication.
• Etienne Nichols’ LinkedIn – Connect with Etienne for more insights and MedTech discussions.
• Olga Chaschina's LinkedIn - connect with Olga for more information about the work she is doing with Metyos.

• High-Context Communication: Communication where much of the information is implied or derived from context (e.g., Russia, Japan).
• Low-Context Communication: Direct communication with explicit details (e.g., USA, Germany).
• Intercultural Management: Strategies to effectively manage teams from diverse cultural backgrounds.

How much does cultural awareness influence team success in MedTech?

• Very Much
• Somewhat
• Not Much
• Not at All

👉 Share your thoughts! Email us at [email protected]

What cultural differences have you experienced in healthcare or MedTech? How did you navigate them? Share with us via email!

Enjoyed this episode? Please leave us a review on iTunes! It helps others find us and improve future content.

Send your feedback or topic suggestions to [email protected]

This episode is sponsored by Greenlight Guru – the leading QMS software built exclusively for the MedTech industry. Stay compliant, accelerate innovation, and simplify your product lifecycle. Learn more at www.greenlight.guru.

In this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Scott Pantel, CEO and founder of Life Science Intelligence (LSI), to explore how LSI bridges the gap between medtech innovation and commercialization.

Scott shares LSI’s origin story, the evolution of its events, and the importance of cultivating meaningful relationships within the medtech ecosystem. Learn how LSI’s global meetings—from Dana Point to Portugal, London, and Singapore—create spaces where deals happen, ideas flourish, and the future of patient care is shaped. Plus, Scott offers actionable advice for medtech founders preparing for investor pitches and shares inspiring stories of industry impact.

• [02:10] – LSI’s partnership with Greenlight Guru and the value of ecosystem collaboration
• [05:30] – Scott Pantel’s journey into medtech and how LSI was born
• [12:20] – Reinventing the investor meeting experience: “There’s got to be a better way”
• [18:45] – The power of unexpected connections: Coffee chats, cab rides, and transformative deals
• [25:10] – Heartfelt story: How an Edwards Lifesciences valve saved Scott’s aunt’s life
• [31:00] – The role of fun and social events in serious deal-making (yes, golf included!)
• [39:20] – Global expansion: Why LSI is heading to Singapore in 2025
• [45:50] – What makes a medtech pitch stand out to investors
• [53:15] – The importance of patient-centered innovation and next-gen leadership
• [59:00] – 🎉 Exclusive! Etienne is joining LSI’s “Game Day” commentary stage at Dana Point

1. Relationships Drive Results: Successful deals often stem from unplanned, personal interactions beyond formal meetings.
2. Global Expansion is Essential: Medtech innovators can’t ignore APAC markets—capital and patient demand in Asia are reshaping the industry.

1. Prepare Beyond the Pitch: Articulate how your company makes money early in conversations with investors.
2. Prioritize Presence: Spend time at networking events—connections happen when you least expect them.
3. Know the Culture: Adapt your approach to different markets; relationship-building is key in Europe and APAC.

• Learn more about LSI: Life Science Intelligence
• Connect with Etienne Nichols: LinkedIn Profile
• Explore Greenlight Guru’s solutions: Greenlight Guru

LSI (Life Science Intelligence) hosts premier global events connecting medtech innovators with investors, helping startups scale from idea to commercialization. With flagship events in the U.S., Europe, and now Asia, LSI creates unmatched opportunities for deal-making and knowledge-sharing.

Poll: What MedTech trend excites you the most?

🔲 AI in diagnostics

🔲 Wearable health monitors

🔲 Surgical robotics

🔲 Patient-owned health data

👉 Email your answer to [email protected]!

Love this episode? Got suggestions for future topics? Drop us a line at [email protected].

💬 Leave a review on iTunes! It helps others find the show and keeps us improving.

This episode is brought to you by Greenlight Guru—the only MedTech-specific Quality Management Software that helps companies get products to market faster and with less risk. Ready to streamline your compliance? Visit Greenlight Guru today!

🔥 Don’t miss Etienne’s live commentary at LSI Dana Point’s “Game Day” stage! See you in March!

In this episode, Etienne Nichols sits down with Tiffany Ryder—healthcare advocate, physician assistant, and founder of Red Flag Hero—to discuss the complexities of product adoption in healthcare. Tiffany shares her journey from rural Louisiana to the NFL cheerleading squad and into emergency medicine, highlighting how personal experience shapes her patient advocacy.

The conversation dives deep into why healthcare professionals are skeptical of new devices, how authenticity and storytelling improve adoption, and what MedTech professionals often overlook when pitching to clinicians. Tiffany also reveals the importance of grassroots movements within medical communities, why workflow integration matters more than flashy features, and how patient education should never be an afterthought.

• 00:00 – Introduction & Sponsor Message (Greenlight Guru)
• 02:15 – Tiffany Ryder’s unique career path and patient advocacy roots
• 10:30 – Turning skepticism into belief: What clinicians really want to hear
• 18:45 – Personal experience shaping patient communication and device adoption
• 25:00 – Case study: Why a vein finder device sits unused in the hospital closet
• 34:15 – The importance of workflow integration for successful product adoption
• 41:50 – Grassroots influence: How clinicians share device recommendations
• 47:20 – Tiffany’s “what’s in your emergency room backpack” essentials
• 53:00 – Final advice: Talk to your biggest skeptics, not just early adopters
• 58:15 – Importance of patient education in medical device usage

“Authenticity comes through. You can’t sell snake oil to a clinician who’s sacrificed years of their life to help patients.” – Tiffany Ryder

“If your device saves me time or helps my patients, I’ll listen. Otherwise, it’s just another thing in the closet.” – Tiffany Ryder

“Find your harshest critic, not your biggest fan. That’s where real product improvement happens.” – Tiffany Ryder

1. Grassroots Advocacy: Clinician word-of-mouth remains a powerful tool in product adoption.
2. Workflow Integration: Devices must improve efficiency without adding complexity.
3. Patient-Centric Design: Products that consider patient education and usability stand out.

1. Engage Skeptics Early: Prioritize conversations with clinicians who question your device.
2. Tell Compelling Stories: Use real-life patient and clinician testimonials to foster connection.
3. Show Workflow Benefits: Highlight how your product saves time or improves patient outcomes.

• Visit Greenlight Guru for quality management solutions tailored for MedTech.
• Connect with Etienne Nichols on LinkedIn to share your feedback or ideas.
• Connect with Tiffany Ryder on LinkedIn
• Learn more about Red Flag Hero, Tiffany Ryder’s patient advocacy initiative.

Product Adoption: The process by which healthcare professionals begin using a new device regularly. Success depends on clinical evidence, ease of use, and workflow integration.

Workflow Integration: Ensuring a device fits into a clinician’s existing routine without disrupting patient care.

Grassroots Movement: Adoption driven by peers, not just sales teams—often more effective in healthcare environments.

Poll: What’s the biggest factor influencing your adoption of new medical technology?

• Clinical evidence
• Workflow integration
• Patient outcomes
• Cost savings

👉 Cast your vote and tell us why at [email protected]!

Discussion Question: What device has made the biggest difference in your clinical or patient care experience? Share your story with us!

Enjoyed the episode? Leave us a ⭐⭐⭐⭐⭐ review on iTunes!

Your feedback shapes future topics—email us at [email protected] with suggestions!

Greenlight Guru – Purpose-built QMS software designed to help MedTech companies ensure compliance, reduce risk, and get to market faster. Visit Greenlight Guru to learn how they can transform your quality management approach.

Thank you for tuning in to the Global Medical Device Podcast—your trusted source for MedTech insights! 🎙️

In this episode of the Global Medical Device Podcast, Etienne Nichols and regulatory consultant Mike Drues delve into the often-overlooked yet critical topic of device descriptions in FDA submissions.

Discover why this foundational element can determine the success of your regulatory pathway, influence classification, and impact the required testing for your device. With actionable tips and real-world examples, this discussion highlights how to craft effective, clear, and concise device descriptions that resonate with both reviewers and regulators.

• [00:01] Introduction: Why device descriptions are foundational for regulatory submissions.
• [07:15] Common challenges: Why device descriptions are often poorly written.
• [14:30] Purpose and impact: How descriptions influence classification, testing, and approval pathways.
• [25:45] Practical advice: Balancing simplicity with technical detail for diverse audiences.
• [36:10] Pre-sub meetings: Communicating device descriptions effectively with the FDA.
• [50:30] Final recommendations: Testing the efficacy of your device description.

1. Mike Drues: "If the FDA doesn’t understand your device, it’s not their fault—it’s the manufacturer’s responsibility to communicate effectively."
2. Etienne Nichols: "Uncertainty in your device description leads to questions, delays, and potential rejection."
3. Mike Drues: "A picture’s worth a thousand words, but a video is worth a thousand pictures—use it to demonstrate your device clearly."

1. Clear communication is essential in the increasingly complex regulatory environment, especially with AI and software-based devices.
2. Ambiguity in device descriptions can lead to unnecessary testing or inappropriate classification.
3. Visual aids, like images and videos, are becoming standard tools to enhance submissions.

1. Test your description’s efficacy by asking someone unfamiliar with the device to explain it back to you.
2. Write layered descriptions—simple overviews for general audiences and detailed appendices for specialists.
3. Incorporate visuals or videos to clarify complex mechanisms or testing processes.

1. How might advancements in AI reshape the expectations for device descriptions?
2. Could the FDA eventually require interactive or multimedia submissions as standard?
3. What new tools or technologies can help manufacturers streamline the description-writing process?

• Greenlight Guru: Purpose-built quality management systems for MedTech. Learn more.
• Stephen Covey: Seven Habits of Highly Effective People—inspiration for improving communication practices.
• Etienne Nichols on LinkedIn: Connect with Etienne for insights on MedTech and regulatory affairs. Connect now.

What is a device description?

A section of your regulatory submission detailing what your device is, how it works, and its intended use. It includes:

• Anatomy: Components and materials.
• Physiology: Function and mechanism of action (MOA).
• Pathology: Risks or potential failures.

Why it matters:

• Guides regulatory classification and testing requirements.
• Establishes a clear understanding for reviewers, ensuring smooth approval processes.

Poll Question:

What challenges have you faced in creating a device description?

• Ambiguity in regulatory expectations
• Balancing technical detail with simplicity
• Miscommunication with reviewers
• Other (email us at [email protected])

We value your feedback!

• Leave a review on iTunes to help others discover the podcast.
• Send suggestions for future episodes to [email protected].

Sponsor:

This episode is brought to you by Greenlight Guru, the only QMS purpose-built for MedTech. Streamline your submissions, ensure compliance, and get to market faster. See how Greenlight Guru can help you.

In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with Leo Eisner, founder of Eisner Safety Consultants and a leading voice in IEC 60601 standards development.

They unpack the upcoming revisions to the fourth edition of IEC 60601, focusing on the rationale behind these changes, their impact on medical device design, and how MedTech professionals can prepare for the future.

Leo provides insights into the intricate process of updating global standards, shares practical advice for compliance, and discusses the role of risk management in ensuring safer, more effective medical devices.

• [02:30] – Introducing Leo Eisner and his expertise in IEC 60601 and global standards.
• [06:45] – The complexities of updating IEC 60601 and its 12 working groups.
• [12:20] – Expected timeline for the fourth edition (2029-2030) and why companies need to plan now.
• [18:50] – Overview of the most significant upcoming changes, including wireless coexistence and integration of collateral standards.
• [27:00] – Practical advice for navigating new standards during product development.
• [36:15] – How to engage in the standards development process and submit comments.
• [48:30] – Benefits of proactive planning and test preparation for regulatory success.
• [53:45] – The importance of staying informed and embracing continuous learning in MedTech.

1. "The biggest mistake you can make is waiting too long to plan for changes. Compliance is about foresight." – Leo Eisner
2. "IEC 60601 is often thought of as just an electrical standard, but it’s so much more—it’s about mitigating risks across all aspects of a device." – Leo Eisner
3. "Standards aren’t just rules; they’re lessons learned from history, guiding us to safer, better devices." – Etienne Nichols

1. The modular approach in the new IEC 60601 simplifies updates and aligns better with global regulations.
2. Wireless coexistence and other cutting-edge technologies will soon become international requirements.
3. Consolidating collateral standards improves consistency and reduces redundancies.

1. Begin designing for new standards early, even before they are finalized.
2. Stay informed by engaging with industry groups and standards organizations.
3. Use test planning to streamline development and meet regulatory expectations efficiently.

1. How will integrating advanced hazard mitigation strategies impact device innovation?
2. What role will emerging technologies like AI and IoT play in future standards revisions?
3. How can smaller MedTech companies effectively adapt to these significant changes?

For new listeners, IEC 60601 is a global standard that ensures the safety and effectiveness of medical electrical equipment. It encompasses requirements for design, labeling, testing, and risk management. With updates spanning usability, wireless technologies, and biocompatibility, it’s essential for any MedTech company working with electrical devices.

• Greenlight Guru – The QMS software designed exclusively for MedTech: Learn more
• Connect with Leo Eisner – Founder of Eisner Safety Consultants and leading expert on IEC 60601: Visit Eisner Safety Consultants
• Etienne Nichols’ LinkedIn – Connect here
• Submit comments to standards – Contact your national committee or regulatory body for IEC SC62A involvement.

Audience Poll: What aspect of the IEC 60601 update concerns you most—testing, design changes, or regulatory approval?

Share your thoughts by emailing us at [email protected].

This episode is brought to you by Greenlight Guru, the leading QMS software for the MedTech industry. Simplify compliance and accelerate innovation with tools tailored to your needs. Visit www.greenlight.guru to schedule a demo today and start your journey toward easier compliance!

Love the podcast? Leave us a review on iTunes! It helps others find us and improves our content. For feedback or topic suggestions, email us at [email protected].

Stay ahead of MedTech changes by tuning in to the Global Medical Device Podcast. See you next time!

In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with regulatory expert Dr. Mike Drues to demystify the pre-market approval (PMA) process for medical devices.

They delve into the key differences between PMAs, 510(k)s, and de novos, bust common myths, and explore strategic advantages for companies willing to pursue the rigorous PMA pathway.

Mike explains the nuances of the “six-year rule,” alternatives like the humanitarian device exemption (HDE), and the evolving role of clinical data.

With insights on using PMAs as a competitive strategy and overcoming internal resistance to high-risk device development, this discussion is essential for MedTech innovators looking to turn regulatory challenges into opportunities.

• 00:00 – Intro and Greenlight Guru's Quality Management System software sponsor message
• 03:15 – Introduction to Dr. Mike Drues and his background in PMAs
• 05:45 – Overview of PMAs and when they should be used
• 11:30 – Are PMAs the only pathway for Class 3 devices?
• 16:20 – Types of PMAs: Traditional, Modular, and Streamlined
• 22:40 – Advantages of PMAs compared to 510(k)s and de novos
• 27:50 – The strategic use of predicates in the PMA process
• 33:00 – Clinical data requirements and misconceptions for PMAs
• 41:10 – Post-market requirements and differences for PMA devices
• 47:25 – Innovation and the future of PMAs: Six-year rule and potential EU approvals
• 54:30 – Final thoughts on overcoming industry resistance to PMAs

1. "Don't be afraid of the big bad PMA—often, the regulatory burden is justified for complex devices tackling high-risk conditions." – Dr. Mike Drues
2. "Regulatory professionals know the rules; the best ones know the exceptions. When it comes to PMAs, there are more options than many realize." – Dr. Mike Drues

1. PMA Isn’t the Only Path for Class 3 Devices: Companies can consider alternatives like the Humanitarian Device Exemption (HDE) and Product Development Protocol (PDP) to reduce the regulatory burden.
2. Strategic Use of PMAs Can Provide a Competitive Edge: By choosing the PMA route, companies can create barriers for competitors, potentially driving smaller rivals out of the market.
3. Clinical Data Isn’t Always Mandatory for PMAs: While most PMAs involve clinical trials, there is flexibility in requirements, offering an opportunity to minimize the scope and cost of clinical studies.

• Previous Greenlight Guru Webinars by Dr. Mike Drues
• Greenlight Guru’s QMS Software
• Etienne Nichols’ LinkedIn

PMA Pathway Explained – Pre-market approval (PMA) is the FDA's strictest regulatory pathway, typically reserved for Class 3 medical devices with higher risks. Unlike the 510(k) pathway, PMA requires evidence of safety and efficacy, often through clinical trials, but the scope can vary. There are traditional, modular, and streamlined PMA types, each with unique requirements.

Poll Question: "Have you considered using a PMA as a strategic advantage for your MedTech device? What challenges do you anticipate?"

We’d love to hear from you! Share your thoughts on this episode, or suggest topics you’d like covered. Email us at [email protected] and don’t forget to leave a review to help others find us.

In this episode of the Global Medical Device Podcast, Etienne Nichols talks with Justin Bushko, president of Concise Engineering and founder of MedTech Man.

Justin shares his extensive experience in MedTech, guiding startups and major players alike through complex engineering challenges. From simplifying prototypes to pivoting product strategies, Justin emphasizes the importance of clear user needs, iterative testing, and knowing when to focus or adapt.

Whether you’re an early-stage founder or an industry veteran, this conversation is filled with insights on navigating design, reducing costs, and succeeding in MedTech’s complex regulatory landscape.

• 00:00 – Introduction and Greenlight Guru sponsor message
• 02:45 – Welcoming Justin Bushko; background in MedTech and engineering
• 07:20 – Overcoming early-stage engineering challenges, like autoclave and sterility testing
• 10:45 – Prototyping with a purpose: Ensuring design iterations target risks
• 16:00 – Balancing innovation, user needs, and cost-effectiveness
• 20:30 – Defining essential versus “nice-to-have” features in MedTech
• 26:45 – Strategic pivots in MedTech: When and why to change course
• 32:50 – The critical role of design freeze and usability studies
• 39:10 – Lessons from competitive benchmarking and reverse engineering
• 46:25 – Handling unique challenges in regulated industries like MedTech
• 52:15 – Opportunities for MedTech innovation and faster regulatory approvals
• 58:45 – Advice for founders and importance of building the right team

1. "Prototype with purpose: Focus on the biggest risks and test early to eliminate costly mistakes down the road." – Justin Bushko
2. "MedTech is a complex dance of regulation, innovation, and simplicity—knowing when to add and when to strip away is key to success." – Justin Bushko

1. Test Prototypes with a Purpose: Focus on high-risk areas and essential features early to prevent costly mistakes in later stages.
2. Simplicity is Often the Key: Resist the urge to over-engineer; clarify core features and eliminate unnecessary ones to save on costs and improve usability.
3. MedTech Requires Unique Knowledge: Navigating regulations, usability studies, and design iterations requires industry-specific experience and collaboration.

• Connect with Justin Bushko on LinkedIn
• Greenlight Guru’s QMS Software
• Etienne Nichols’ LinkedIn

Formative vs. Summative Usability Testing – Formative testing occurs early in the design process to gather feedback and iterate quickly, while summative testing is conducted later to validate that the design meets user needs and regulatory requirements.

Poll Question: "Have you ever had to pivot your MedTech product development strategy due to user feedback or regulatory hurdles? Share your story below!"

We’d love to hear from you! Share your thoughts on this episode, or suggest topics you’d like covered. Email us at [email protected] and don’t forget to leave a review to help others find us.

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.

• 00:01 – Introduction to Greenlight Guru’s QMS capabilities
• 03:15 – Setting the stage: Why verification and validation matter
• 08:30 – Differences between verification and validation explained
• 12:50 – Importance of strong user needs and design inputs
• 23:45 – Writing effective user needs and identifying users
• 33:00 – Creating robust design inputs and their sources beyond user needs
• 40:10 – From design inputs to design outputs: Key considerations
• 48:20 – Best practices for conducting design reviews and managing revisions
• 57:15 – Verification strategies: The importance of pre-verification
• 01:05:40 – Common challenges in V&V, including sample sizes and justifying tests
• 01:15:10 – Using feedback during testing and leveraging observations
• 01:23:00 – Final takeaways and practical advice for V&V success

1. "Verification asks if we built the product correctly, while validation asks if we built the right product for the user." – Devon Campbell
2. "You can't do verification or validation without strong, well-informed requirements. Weak requirements lead to validation failures." – Devon Campbell

1. 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.
2. 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.
3. 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.

• Devon Campbell’s Consulting – Connect with Devon for more insights on product development.
• Etienne Nichols’ LinkedIn
• Greenlight Guru’s QMS Software

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.

Poll Question: "What’s been your biggest challenge in navigating verification and validation for your medical device? Share your experiences below!"

We’d love to hear from you! Share your thoughts on this episode, or suggest topics you’d like covered. Email us at [email protected] and don’t forget to leave a review to help others find us.

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.

• 00:02 – Introduction to Greenlight Guru and Episode Overview
• 03:10 – Introducing Adnan Ashfaq and his background in medtech
• 04:45 – Difference between a regulatory strategy and regulatory roadmap
• 07:00 – What a regulatory roadmap is and why it’s crucial
• 12:30 – When and why companies need a regulatory roadmap
• 16:45 – Key elements of a regulatory roadmap: costs, regions, and timelines
• 23:20 – Importance of classification and its impact on the regulatory path
• 28:50 – Integrating QMS, clinical investigations, and stakeholder engagement
• 36:00 – Leveraging a roadmap for strategic market entry and global reach
• 44:15 – Pitfalls to avoid in creating a regulatory roadmap
• 54:20 – Using language and intended use statements strategically
• 01:03:00 – Wrapping Up: Takeaways and Advice for MedTech Professionals

1. "A regulatory roadmap is more than just documentation; it’s a strategic guide for accessing markets and securing investor confidence." – Adnan Ashfaq
2. "Understanding whether your device is a medical device, and its classification, can be make-or-break for your entire regulatory strategy." – Adnan Ashfaq

1. 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.
2. 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.
3. 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.

• Simpli Medica – Adnan Ashfaq’s consultancy website.
• Etienne Nichols’ LinkedIn
• Greenlight Guru’s QMS Software

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.

Poll Question: "Has your company developed a regulatory roadmap to guide market entry? Share your experience and how it impacted your journey!"

Enjoyed this episode? Have questions or topics you’d like to hear more about? Reach out to us at [email protected]. Don’t forget to leave us a review—it helps us improve and reach more medtech professionals.