Global Medical Device Podcast powered by Greenlight Guru

In this episode recorded live at LSI Dana Point, Etienne Nichols sits down with Ed Muzio, author of Iterate, to explore how iterative management helps MedTech companies move faster as they scale. Muzio breaks down the pitfalls of traditional management—including siloed execution and backward-looking metrics—and offers a proven alternative grounded in over 70 years of research. With real-world analogies, like orchestras and dashboards, Muzio explains how leaders can create alignment, drive faster decisions, and unlock collaborative problem-solving by focusing on the future instead of the past. Whether you're part of a startup or an established MedTech firm, this episode delivers actionable strategies to help your team iterate with purpose.Key Timestamps[00:01] Introduction and sponsor message from Greenlight Guru[01:13] Meet Ed Muzio and the premise of Iterate[03:15] Why most management meetings don't drive real action[06:40] The “Alice” video case study and how it exemplifies iterative management[11:50] Common objections and barriers to implementing iterative processes[17:00] Using forward-looking data instead of status updates[22:08] MedTech example: anticipating 510(k) review delays[29:15] Making decisions early to gain planning time[34:20] How to get started if you're a small or early-stage company[37:40] Cultural barriers in iterative team models[41:20] Handling matrixed environments and CEO-level priorities[47:10] Why clarity of decision-makers matters in early teams[51:45] The biggest mistake mature companies make in team meetings[55:05] Final advice: focus on behavior, not buzzwordsStandout Quotes“If you walk into a meeting and it's 26 minutes in and you haven't made a decision yet—and that's normal—you're probably not solving anything.”—Ed Muzio on the inefficiency of status-only meetings in traditional management culture.“We don't need to forecast history. We need to plan around the future.”—Ed Muzio explaining why forward-looking metrics are the only actionable data in iterative teams.These quotes challenge conventional meeting norms and emphasize a proactive mindset crucial to success in fast-moving MedTech environments.Top TakeawaysBackward-looking metrics kill momentum. Most leadership teams spend meetings reviewing past progress. Instead, focus on forecasting future outcomes and addressing variances before they become problems.Accountability must be systemic, not personal. A team can only normalize issue-raising if the entire culture shifts to expect it—making it safe and standard to surface concerns early.“Succeed or fail together” breaks silos. When departments align to shared goals, cross-functional collaboration becomes natural. Incentives that isolate progress undermine execution speed.Don't vote—decide. In small teams, designate a clear decision-maker and avoid democratic processes that lead to politicking instead of clarity.Adopt flexible systems over rigid charts. Org charts don't reflect reality. Iterative management embraces the messiness of matrixed teams and adapts meetings and collaboration structures fluidly.References

In this live episode from the LSI conference, Etienne Nichols sits down with Justin Bushko—known as the "MedTech Man" and author of Medical Device Fireside Chats—to dive into what separates thriving medical device companies from those that fail. From costly engineering missteps like ignoring tolerance stack-ups to the human factors issues that derail usability in the OR, Justin shares battle-tested advice based on his experience reviewing hundreds of device designs. He also delivers a wake-up call to startups overly focused on licensing or acquisition as the endgame. Whether you're an engineer, founder, or CEO, this episode offers critical insights into how to build a product that works—and a company that lasts.Key Timestamps00:00 – Introduction & Greenlight Guru Sponsor Message01:26 – Live from LSI: Introducing Justin Bushko02:55 – Why Early-Stage Engineering Mistakes Derail Companies04:12 – The Critical Role of DFM and Tolerance Analysis06:20 – Real-World Usability Failures: FDA Warning on Cranial Fixation Devices08:10 – Human Factors Oversights & Surgeon Behavior10:25 – What CEOs Should Focus On vs. Engineers12:20 – Economic Buyers, KOLs, and Commercialization Challenges14:05 – Don't Chase the Exit: Why Founders Should Build for Longevity16:00 – Final Thoughts and TakeawaysStandout Quotes“If your partners can't explain how and why they did your tolerance analysis, they probably didn't do it right—and it'll cost you nine months later.”—Justin Bushko, on the hidden dangers of relying too heavily on outsourced design partners.“Founders aiming for a quick exit send the wrong message. Build something sustainable. Acquisition should be a byproduct—not the goal.”—Justin Bushko, challenging the exit-first mindset common in early-stage MedTech.Top TakeawaysDFM & Tolerance Analysis Are Non-Negotiable: Skipping detailed design-for-manufacturing and tolerance stack analysis often leads to failure right before tooling and commercialization—when funds are already tight.Human Factors Must Be Built-In Early: Surgeons may not use your product as intended. Validate with a wide range of KOLs to uncover unintended use or misuse.Test for High-Risk Use Cases Early: For devices like inserters, test mechanical thresholds that could lead to field failures. Don't wait until post-market feedback.Understand Economic Buyers, Not Just KOLs: A surgeon's support doesn't guarantee adoption. You need champions who can advocate to hospital boards and procurement teams.Stop Chasing Exits—Build Real Companies: Investors and acquirers see through the “quick flip” mentality. A sustainable business model attracts more serious interest.ReferencesGreenlight Guru – Sponsor and end-to-end MedTech quality management platformJustin Bushko on LinkedInEtienne Nichols on LinkedInMedical Device Fireside Chats –

Christian Espinosa, founder of Blue Goat Cyber and leading voice in medical device cybersecurity, joins Etienne Nichols to unpack the urgent and often misunderstood topic of cybersecurity in MedTech. From FDA's 2023 regulatory overhaul to real-world hacking scenarios that could harm patients, Christian provides practical advice for innovators, RA/QA professionals, and software teams. He also shares why waiting until the last minute on cybersecurity could cost startups millions—or even kill a project entirely.Whether you're a quality professional trying to build compliant systems or an innovator racing toward FDA submission, this episode lays out exactly what you need to know to stay ahead of cyber threats and within regulatory guardrails.Key Timestamps:00:01 – Intro to guest Christian Espinosa and Blue Goat Cyber06:28 – Why medical device cybersecurity is different from traditional IT security11:49 – Real-world hacking example: acne laser device turned skin-burner13:57 – FDA expectations post-September 2023: what changed17:12 – Secure boot: a microcontroller mistake that derailed a launch20:35 – Common cybersecurity vendor mistake MedTech companies make23:40 – SBOM: Software Bill of Materials and why it's legally critical27:58 – Cyberattacks in hospitals: assuming a hostile network35:44 – AI in medical devices: data bias and cybersecurity challenges41:10 – Developers ≠ cybersecurity experts: the training gap nobody talks about45:20 – What RA/QA professionals need to know now49:30 – Why cybersecurity must be iterative, not a final-phase add-on55:20 – Espinosa's final advice for MedTech professionals57:52 – The story behind “Blue Goat Cyber”Standout Quotes:“Cybersecurity for medical devices isn't about data breaches—it's about patient harm. You could paralyze someone or misdiagnose sepsis. This isn't theoretical.”— Christian Espinosa, on the real risks of insecure devices“Most developers don't understand cybersecurity. We assume they do—but that's like expecting an architect to be a locksmith.”— Christian Espinosa, on why so many devices fail security assessmentsTop Takeaways:Cybersecurity isn't just about data—it's about patient safety. From burning skin to missed sepsis diagnoses, vulnerabilities in devices have real-world harm potential.FDA now requires more than just a basic security plan. Post-September 2023 rules mandate testing (SAST, DAST, fuzzing), SBOMs, and risk assessments tied to patient harm.Start cybersecurity planning during the requirements phase. Hardware like microcontrollers must support secure boot and other protections—retrofits can cripple product plans.Iterate cybersecurity like any core development activity. One-time testing near submission is too late; build security into your pipeline just like QA or usability.Traditional cybersecurity vendors aren't enough. Many fail to meet FDA's nuanced expectations for medical devices, causing costly submission rejections.References & Resources:Christian Espinosa on LinkedInBlue Goat CyberEtienne Nichols on LinkedInMedTech 101 – Understanding SBOM (Software Bill of...

In part 2 of a critical two-part series, Etienne Nichols and regulatory affairs expert Mike Drues explore the nuanced pathway of switching a medical device from prescription (Rx) to over-the-counter (OTC). This episode dives deep into what triggers a new submission, how usability testing and human factors play an expanded role for lay users, and the regulatory logic that guides these transitions. The conversation highlights the importance of aligning regulatory strategy with business goals, and offers practical insights on leveraging real-world evidence, understanding the limits of FDA databases, and optimizing pre-submission meetings.Key Timestamps02:10 – Starting from a cleared 510(k): Do you need a new submission for OTC?06:45 – Implications of removing the healthcare provider from the equation12:00 – Risk management: Expanding risk profiles when lay users are involved18:15 – When a 510(k) becomes a De Novo or PMA22:50 – Usability testing and the risk of user error in OTC devices31:20 – Clinical investigations and good clinical practices (GCPs)36:00 – Real-world evidence vs. real-world data—what's usable?41:30 – Using Pre-Subs effectively and what “quality data” really means47:10 – Labeling, cleaning, and UDI for OTC products53:40 – OTC software and digital health—when is it a regulated device?01:00:00 – Summary: Aligning regulatory logic with common sense and business strategyQuotes“With an OTC device, we are taking the healthcare professional totally, completely, and utterly out of the loop.”– Mike DruesThis quote encapsulates the core regulatory challenge in moving a device to OTC: every element, from labeling to usability, must assume zero clinical supervision.“If the clinical trial won't tell you anything you don't already know from good real-world evidence, why spend the time and money?”– Mike DruesA powerful argument for using well-documented real-world evidence over unnecessary trials—provided the data truly meets evidentiary standards.Top TakeawaysLabel Expansion ≠ Shortcut: Moving from prescription to OTC usually requires a new submission—especially when removing the healthcare provider introduces new risks.Usability Testing Is Critical: OTC usability studies must go beyond IFU comprehension to include risk of misuse, poor device selection, and user decision-making.Real-World Evidence Can Help—If It's Clean: Real-world data isn't always usable. FDA will expect reproducibility, traceability, and strong justifications.Labeling & Design Must Assume No Clinical Oversight: Cleaning procedures, warnings, and directions must all be validated for home use and layperson comprehension.Use Pre-Subs Wisely: Especially for label expansions or gray-area digital health tools, pre-subs provide critical alignment with FDA and prevent costly errors.References & ResourcesEtienne Nichols on LinkedInFDA Guidance on Real-World Evidence for Regulatory Decision-MakingGreenlight Guru Webinar: What is and Isn't a Regulated Medical Device (feat. Mike Drues)FDA Guidance: Clinical Decision Support SoftwareMedTech 101: OTC vs Prescription DevicesAnalogy: Think of prescription vs. OTC devices like driving a manual vs. automatic car. Prescription devices assume a trained “driver” (the healthcare provider), while OTC devices must be intuitive and safe enough for anyone to “drive”...

In Part 1 of this two-part series, Etienne Nichols sits down with regulatory strategist Dr. Mike Drues to explore the nuanced differences between prescription (Rx) and over-the-counter (OTC) medical devices. They demystify key terms, regulatory classifications, and the growing trend of label expansions from Rx to OTC—highlighting real-world examples like CPAP machines and continuous glucose monitors (CGMs). This episode unpacks how intended users, environments, and risk tolerances shape device categorization, and why usability testing is far more complex than many realize. Whether you're developing a consumer health product or preparing a label expansion strategy, this is a must-listen for your regulatory roadmap.Key Timestamps[03:05] – What defines an OTC vs. prescription medical device?[06:45] – Market size of OTC devices and major product categories10:00 – Label expansion: moving from Rx to OTC status13:22 – The role of intended use environment in OTC classifications20:40 – Examples of devices in each FDA class that are OTC26:30 – Prescription devices used in home settings vs. true OTC31:15 – Characteristics that qualify devices for OTC status37:55 – Self-diagnosis, self-selection, and patient usability challenges43:00 – “Reasonably foreseeable misuse” and how to interpret guidance49:05 – Do you design for the lowest common denominator?56:10 – Representing diverse user populations in usability testing1:01:45 – Can a device launch OTC first? The case for wellness-to-Rx strategies1:08:15 – FDA's perspective on device safety: OTC vs. RxQuotes“The best regulatory professionals don't just know the rules—they know the exceptions.”Dr. Mike Drues reminds us that exceptional regulatory strategy lies in understanding nuance, especially in OTC classifications where edge cases can redefine categories.“Just because a device is used at home doesn't mean it's over the counter.”This insight challenges a common industry assumption, underscoring the importance of carefully defining intended use and environment early in development.Key TakeawaysOTC ≠ Low Risk by Default – Many Class II and even rare Class III devices can be OTC; it's more about intended user, use environment, and risk mitigation than class alone.Label Expansion Requires Strategy – Transitioning a device from prescription to OTC isn't just about removing a doctor's role—it may involve new usability studies, labeling changes, and potentially a 510(k) or de novo submission.Understand the "Intended Use Environment" – FDA doesn't just care about where the device is used, but how those environmental parameters (like light, humidity, and user training) affect safe operation.Usability Testing Must Reflect Real Users – For OTC devices, human factors validation must account for diverse educational backgrounds, not just ideal users.Don't Rely on Labels Alone – Whether or not users read (or understand) instructions must be tested, not assumed. Intuitive design is critical for OTC success.References & ResourcesEtienne Nichols on LinkedInGreenlight Guru Medical Device Classification Webinar with Mike Drues (for explanation on device classes)FDA Guidance: “Factors to Consider When Making Benefit-Risk Determinations in Medical Device...

Are you new to the medical device industry—or mentoring someone who is? In this foundational episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Sara Adams and Chris Rush from Greenlight Guru to deliver a MedTech 101 masterclass. They unpack the roles, regulations, and realities of medical device development in a heavily regulated space. From defining what actually counts as a medical device to navigating FDA classifications and global regulations, the trio offers practical insights, industry analogies, and personal war stories that make this episode as entertaining as it is educational. Whether you're in R&D, marketing, clinical, or quality, this is the episode to bookmark and share with every new hire.Key Timestamps02:20 – What counts as a medical device? Intended use and labeling06:48 – Differentiating roles: Quality, Regulatory, Clinical, R&D, and Marketing15:40 – Understanding regulatory bodies: FDA, EU MDR, Health Canada, and more20:15 – FDA Classifications: Class I, II, III, and what determines risk26:00 – Standards to know: ISO 13485, 14971, 14155, 21 CFR Part 82033:05 – FDA pathways: 510(k), De Novo, PMA – when and why they apply41:55 – The design control matrix explained (User Needs through Validation)49:00 – Reverse engineering design controls: pitfalls and best practices55:30 – Clinical trials vs. preclinical studies: When each is required1:00:45 – Manufacturing & supplier controls: operations meets compliance1:04:15 – Final advice for MedTech newcomers: Read the regs and know the problemQuotes“Just because you don't call it a medical device doesn't mean the FDA agrees with you.” – Sarah AdamsThis quote highlights a key regulatory pitfall: your marketing claims, not just your label, determine if the FDA considers your product a medical device.“A 510(k) is like someone checking your wristband at the door—you're cleared to go in. A PMA? That's a locked door and you need full approval to enter.” – Chris RushA memorable analogy that demystifies the difference between FDA clearance and approval pathways.Top TakeawaysLabeling + Intended Use = Regulatory TriggerWhether it's software or a simple tool, if your product makes medical claims or supports medical decision-making, it may fall under FDA or other international regulatory oversight.Regulatory Pathways Are Tied to Risk and NoveltyKnow the difference between a 510(k), De Novo, and PMA. Class II “me-too” devices may avoid clinical trials, while Class III and novel devices usually require significant evidence.Understand Design Controls EarlyReverse-engineering documentation late in development is risky and inefficient. Start early with user needs and build forward through the five pillars: inputs, outputs, verification, and validation.Cross-functional Understanding Prevents Compliance GapsMarketing, clinical, and R&D all influence regulatory standing. Even social media likes can trigger off-label scrutiny—every department needs to understand their regulatory impact.Reading Regulations Is Not OptionalA strong regulatory foundation is key to faster development, better audits, and smoother market access. Resources like 21 CFR Part 820 and ISO 13485 are surprisingly readable and essential.References & ResourcesEtienne Nichols on LinkedInChris Rush on LinkedIn

In this episode of the Global Medical Device Podcast, Etienne Nichols speaks with renowned regulatory and reimbursement expert Karandeep Singh Badwal to uncover the complexities of medical device reimbursement across the US, EU, and Asian markets. From the influence of governmental systems to the nuances of coding, coverage, and payments, Karandeep shares real-world insights for MedTech companies developing their global market strategies. Learn why early planning for reimbursement is just as crucial as regulatory approval, and how future-proofing your strategy against political and economic changes can safeguard your device's success.Key Timestamps:00:00 – Intro and Sponsor Message (Greenlight Guru Quality)02:30 – Why Reimbursement Must Be Considered Early07:15 – US Reimbursement System: Medicare, Medicaid, and Private Insurers13:10 – EU Reimbursement: Challenges with Fragmented National Systems17:45 – Asian Market Differences: Japan, China, and South Korea23:20 – The Importance of a Reimbursement Expert28:05 – Navigating Political Changes in Global MedTech Markets33:30 – Special Challenges for AI and Software as a Medical Device40:00 – Direct-to-Consumer vs. Prescription Strategies46:20 – Integrating Real-World Evidence and Post-Market Surveillance52:00 – How Management Reviews Can Align Business and Quality Goals01:03:10 – Pros and Cons: US vs. EU Reimbursement Models01:18:20 – Final Takeaways and Closing ThoughtsStandout Quotes:"Reimbursement isn't just the final step after regulatory approval — it is a core business strategy."Why it matters: Many companies fail by not building reimbursement into their earliest development and design decisions."You can have the most innovative medical device in the world, but without a reimbursement pathway, you won't have a viable business."Why it matters: Innovation alone isn't enough; financial strategy is crucial to survival and growth.Top Takeaways:Start with reimbursement in mind: Align your product claims, indications, and market strategies with potential reimbursement pathways early.Tailor by region: US, EU, and Asian markets all have distinct reimbursement landscapes — success in one doesn't guarantee success in another.Hire jurisdiction-specific experts: Use consultants experienced in your target markets to avoid costly mistakes.Leverage post-market surveillance: Integrate real-world evidence gathering into your QMS and management reviews to support reimbursement claims.Build strategic flexibility: Political and regulatory landscapes shift — maintain backup jurisdictions and alternative market strategies.References:Etienne Nichols on LinkedInGreenlight Guru Quality Management SystemMedtech Podcast hosted by Karandeep Singh BadwalMedTech 101 Section:What is "Reimbursement" in MedTech?Reimbursement refers to how a company gets paid for a medical device after it's cleared for use. This usually involves navigating government programs (like Medicare) or private insurance, and it determines how easily hospitals, clinics, or individuals can buy and use a product.Simple Analogy: Think of it like getting a movie produced: regulatory clearance is getting your movie rated, but reimbursement is making sure theaters agree to pay you to...

Episode Summary:In this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Kirk Petyo, Managing Partner at Talent Factory Recruiting, to explore the art and science of hiring in MedTech. Kirk shares strategies for building magnetic employer brands, explains the difference between competencies and capabilities in candidates, and warns about the hidden costs of bad hires or delayed recruitment. They also discuss how to attract top talent from outside traditional MedTech backgrounds, and why companies must clearly define their values to thrive in today's competitive hiring landscape.Key Timestamps:[00:02:00] – Introduction to Kirk Petyo and Talent Factory Recruiting's unique approach[00:05:30] – What makes a company a "magnet" for top talent in MedTech[00:12:20] – How to recruit candidates from outside traditional MedTech backgrounds[00:20:00] – How to differentiate between a good worker and a good interviewer[00:30:10] – The ripple effects of a single bad hire in a MedTech company[00:35:50] – The cost of leaving key roles unfilled for too long[00:44:00] – Outdated hiring practices that repel top candidates[00:50:00] – Trends in hiring and workforce planning for 2025[01:02:00] – Final advice for MedTech hiring managers and company leadersStandout Quotes:"If you treat hiring like a transaction, you'll get transactional results. But if you treat hiring as a critical strategy for growth, you'll flourish." – Kirk Petyo"Your candidate's life must be better at your organization than it was at their last job—if you can't tell that story, you'll struggle to attract top talent." - Kirk PetyoTakeaways:Define your value drivers clearly: Understand what makes your company unique before trying to attract top talent.Focus on capability, not just competency: Prioritize what candidates can learn and contribute over time, not just what they know today.Structure your interview process: Build a consistent, benchmark-driven approach to avoid gut-feel hiring mistakes.Partner with strategic recruiters: Seek recruiters who genuinely understand your company culture and goals, not just resume matchers.Act early on critical hires: Don't delay filling strategic roles; the opportunity cost and cultural risk multiply with time.References:Kirk Petyo's LinkedIn ProfileTalent Factory Medical WebsiteEtienne Nichols' LinkedIn ProfileMedTech 101 Section:Competency vs. Capability (Simplified):Think of competency like what's already in a candidate's toolbox—their current skills and experiences. Capability is their potential—the size of the projects they could build if you give them the right tools and environment.Audience Engagement Prompt:Poll Question: What's the biggest challenge you face when hiring MedTech talent?Defining clear job expectationsAttracting candidates from outside the industryAvoiding bad hiresSpeeding up the hiring...

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.Key Timestamps00:03 – Introduction to the 2025 Medical Device Industry Report05:00 – Market growth outlook: $800B by 203009:40 – Family office investment trends in MedTech13:15 – Hiring freezes and headcount reductions: what's behind the numbers?20:22 – Supply chain challenges and supplier qualification issues28:35 – Why only 11% of companies rate their supply chain management as “excellent”33:30 – QMS upgrades and the strategic focus on quality systems39:00 – Fundraising and clinical trials: top priorities for pre-commercial companies44:55 – Regulatory complexity: QMSR, EU MDR, and FDA staffing pressures53:50 – FDA Form 483s: top causes and how to avoid them1:04:00 – Action plan for 2025: technology, collaboration, and performance1:12:00 – Making quality your competitive edgeMemorable Quotes“Money is the air companies breathe, but safety is the ground they walk on.” – Etienne Nichols“If you're not reaching out to your FDA review team, you're already behind.” – Sara Adams“Dig the well before you're thirsty — especially in MedTech.” – Etienne Nichols

In this compelling episode, Etienne Nichols chats with regulatory powerhouse Sarah Moeller about the crucial intersection between the FDA's regulatory oversight and international ISO standards development. They uncover the profound impact of FDA's participation—or absence—in shaping global standards, especially ISO 14155 and ISO 18969 updates. The conversation also tackles the shifting landscape caused by administrative changes in the U.S., the effects on clinical trials, AI-driven digital evidence, and what companies must do to stay compliant and innovative in a volatile regulatory environment.Key Timestamps:[02:30] – Introduction to Sarah Moeller and her role in ISO 18969 updates.[07:00] – Overview of ISO standards update processes and FDA's critical role.[15:20] – The impact of AI and digital evidence on clinical evaluations.[22:10] – Why FDA's temporary absence from standards writing matters.[31:45] – Resumed communications: FDA's current engagement status.[41:00] – Implications of leadership changes at the FDA.[50:15] – Strategic advice for MedTech companies amidst regulatory uncertainty.[58:00] – Passionate case for FDA's continued involvement and defense of public service.[1:12:30] – Big updates in ISO 14155 and 18969 and what they mean for clinical trials.Memorable Quotes:"Without FDA at the standards table, we risk global disharmony—and patients pay the price." – Sarah Moeller"Taking care of each other must be our number one goal in both hospitality and healthcare." – Sarah MoellerKey Takeaways:Practical Tips:Maintain proactive and open communications with your FDA reviewers.Incorporate rigorous digital evidence management to future-proof clinical evaluations.Advocate for clear regulatory processes by contacting your congressional representatives.References Mentioned:ISO 14155: Good Clinical Practice for Medical Device Trials—Updated to reflect decentralized trials and enhanced CRO oversight.ISO 18969: Clinical Evaluation Standard aligning evaluations across the total product lifecycle.MDUFA and PDUFA: Critical funding mechanisms supporting timely FDA review processes.Etienne Nichols on LinkedInMedTech 101:ISO Standards: International standards that ensure quality, safety, and efficacy in products across global markets.MDUFA (Medical Device User Fee Agreement): Agreement where companies pay fees to FDA for timely device reviews.Clinical Evaluation: Systematic process for assessing and analyzing clinical data to verify the safety and performance of a medical device.Audience Interaction:Poll Question: "Do you believe the FDA should have a permanent seat at all ISO standards committees?"

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.Key Timestamps:00:00 – Intro & Sponsor: Introduction to the episode and Greenlight Guru sponsorship02:20 – Meet Olga Chashchina: Olga's background in MedTech and international work experience06:45 – Understanding Cultural Missteps: Common mistakes when navigating cultural differences in teams12:15 – High vs. Low Context Communication: How context affects communication styles across cultures15:00 – Cultural Impact on Healthcare: How cultural backgrounds influence patient care and medical communication18:30 – Feedback Across Cultures: Differences in giving and receiving feedback globally20:00 – Building Personal Connections in Professional Settings: Balancing personal relationships and cultural norms in business22:00 – Final Thoughts: Olga's key takeaway for appreciating cultural diversityQuotes:"The biggest problem in intercultural management is thinking everybody thinks the same way." – Olga Chashchina"Positive feedback should be well-measured and well-argued; a vague 'amazing' doesn't help anyone improve." – Etienne Nichols"Sometimes you need the culture map in the beginning, but eventually, you just see the person in front of you." – Olga ChashchinaTakeaways:Key Insights on MedTech Trends:Global Teams Need Cultural Awareness: Effective communication hinges on understanding cultural contexts.Healthcare is Deeply Cultural: Patient care varies across cultures due to differences in symptom expression and medical expectations.Feedback Styles Differ Greatly: Recognizing how cultures approach feedback can prevent misunderstandings and improve collaboration.Practical Tips for MedTech Professionals:Educate Yourself: Read books like The Culture Map to understand global communication styles.Ask, Don't Assume: Always ask clarifying questions rather than assuming shared context.Balance Praise and Constructive Feedback: Be specific and culturally sensitive when providing feedback.Future-Focused Questions:How will global team dynamics evolve with remote work becoming the norm?Can AI tools help bridge cultural communication gaps in healthcare?What future training will be essential for MedTech leaders to manage diverse teams effectively?References: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.

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.Key Timestamps[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] –

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.Key Timestamps:00:00 – Introduction & Sponsor Message (Greenlight Guru)02:15 – Tiffany Ryder's unique career path and patient advocacy roots10:30 – Turning skepticism into belief: What clinicians really want to hear18:45 – Personal experience shaping patient communication and device adoption25:00 – Case study: Why a vein finder device sits unused in the hospital closet34:15 – The importance of workflow integration for successful product adoption41:50 – Grassroots influence: How clinicians share device recommendations47:20 – Tiffany's “what's in your emergency room backpack” essentials53:00 – Final advice: Talk to your biggest skeptics, not just early adopters58:15 – Importance of patient education in medical device usageMemorable Quotes:“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 RyderKey Takeaways:

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.Key Timestamps[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.Memorable QuotesMike Drues: "If the FDA doesn't understand your device, it's not their fault—it's the manufacturer's responsibility to communicate effectively."Etienne Nichols: "Uncertainty in your device description leads to questions, delays, and potential rejection."Mike Drues: "A picture's worth a thousand words, but a video is worth a thousand pictures—use it to demonstrate your device clearly."Key TakeawaysMedTech TrendsClear communication is essential in the increasingly complex regulatory environment, especially with AI and software-based devices.Ambiguity in device descriptions can lead to unnecessary testing or inappropriate classification.Visual aids, like images and videos, are becoming standard tools to enhance submissions.Practical TipsTest your description's efficacy by asking someone unfamiliar with the device to explain it back to you.Write layered descriptions—simple overviews for general audiences and detailed appendices for specialists.Incorporate visuals or videos to clarify complex mechanisms or testing processes.Future QuestionsHow might advancements in AI reshape the expectations for device descriptions?Could the FDA eventually require interactive or multimedia submissions as standard?What new tools or technologies can help manufacturers streamline the description-writing process?References & ResourcesGreenlight 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.MedTech 101: Device DescriptionsWhat 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...

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.Key Timestamps[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.Top Quotes from the Episode"The biggest mistake you can make is waiting too long to plan for changes. Compliance is about foresight." – Leo Eisner"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"Standards aren't just rules; they're lessons learned from history, guiding us to safer, better devices." – Etienne NicholsKey TakeawaysLatest Trends in MedTech StandardsThe modular approach in the new IEC 60601 simplifies updates and aligns better with global regulations.Wireless coexistence and other cutting-edge technologies will soon become international requirements.Consolidating collateral standards improves consistency and reduces redundancies.Practical Tips for ComplianceBegin designing for new standards early, even before they are finalized.Stay informed by engaging with industry groups and standards organizations.Use test planning to streamline development and meet regulatory expectations efficiently.Questions to Ponder for the FutureHow will integrating advanced hazard mitigation strategies impact device innovation?What role will emerging technologies like AI and IoT play in future standards revisions?How can smaller MedTech companies effectively adapt to these significant changes?MedTech 101: Understanding IEC 60601For 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.References and ResourcesGreenlight Guru – The QMS software designed exclusively for MedTech: Learn moreConnect with Leo Eisner – Founder of Eisner Safety Consultants and leading expert on IEC 60601:

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.Key Timestamps:00:00 – Intro and Greenlight Guru's Quality Management System software sponsor message03:15 – Introduction to Dr. Mike Drues and his background in PMAs05:45 – Overview of PMAs and when they should be used11:30 – Are PMAs the only pathway for Class 3 devices?16:20 – Types of PMAs: Traditional, Modular, and Streamlined22:40 – Advantages of PMAs compared to 510(k)s and de novos27:50 – The strategic use of predicates in the PMA process33:00 – Clinical data requirements and misconceptions for PMAs41:10 – Post-market requirements and differences for PMA devices47:25 – Innovation and the future of PMAs: Six-year rule and potential EU approvals54:30 – Final thoughts on overcoming industry resistance to PMAsStandout Quotes:"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"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 Drues3 Key Takeaways: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.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.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.References:Previous Greenlight Guru Webinars by Dr. Mike DruesGreenlight Guru's QMS SoftwareEtienne Nichols' LinkedInMedTech 101: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.Audience Engagement:Poll Question: "Have you considered using a PMA as a strategic advantage for your MedTech device? What challenges do you...

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.Key Timestamps:00:00 – Introduction and Greenlight Guru sponsor message02:45 – Welcoming Justin Bushko; background in MedTech and engineering07:20 – Overcoming early-stage engineering challenges, like autoclave and sterility testing10:45 – Prototyping with a purpose: Ensuring design iterations target risks16:00 – Balancing innovation, user needs, and cost-effectiveness20:30 – Defining essential versus “nice-to-have” features in MedTech26:45 – Strategic pivots in MedTech: When and why to change course32:50 – The critical role of design freeze and usability studies39:10 – Lessons from competitive benchmarking and reverse engineering46:25 – Handling unique challenges in regulated industries like MedTech52:15 – Opportunities for MedTech innovation and faster regulatory approvals58:45 – Advice for founders and importance of building the right teamStandout Quotes:"Prototype with purpose: Focus on the biggest risks and test early to eliminate costly mistakes down the road." – Justin Bushko"MedTech is a complex dance of regulation, innovation, and simplicity—knowing when to add and when to strip away is key to success." – Justin Bushko3 Key Takeaways:Test Prototypes with a Purpose: Focus on high-risk areas and essential features early to prevent costly mistakes in later stages.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.MedTech Requires Unique Knowledge: Navigating regulations, usability studies, and design iterations requires industry-specific experience and collaboration.References:Connect with Justin Bushko on LinkedInGreenlight Guru's QMS SoftwareEtienne Nichols' LinkedInMedTech 101: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.Audience Engagement:Poll Question: "Have you ever had to pivot your MedTech product development strategy due to user feedback or regulatory hurdles? Share your story below!"Feedback:We'd love to hear from you! Share your thoughts on this episode, or suggest topics you'd like covered. Email us at

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 successStandout 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 Campbell3 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 SoftwareMedTech 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...

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 ProfessionalsStandout 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 Ashfaq3 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:Simply Medica – Adnan Ashfaq's consultancy website.Etienne Nichols' LinkedInGreenlight Guru's QMS SoftwareMedTech 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...

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 TakeawaysStandout 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 Rasooli3 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.guruMedTech 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 podcast@greenlight.guru and leave a review to help others discover the Global Medical Device Podcast.

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 podcast@greenlight.guru 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.

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 prioritiesMemorable 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 NicholsKey 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?References:

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 NicholsKey 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 DruesKey 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 CafisoKey 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.3. Questions for Future...

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 successNotable 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 EisnerKey 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 DOEKey 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:

Explore the essential role of quality management in small medical device companies with Vernon Baker, a seasoned engineer. Learn about core QMS activities, regulatory intelligence, effective communication with top management, and key skills for aspiring quality managers. Gain valuable insights on supplier management, risk assessment, and regulatory compliance for startups and growing medical device firms.

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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 informedQuotes:"This proposed rule feels like a solution in search of a problem." - Mark DuVal"It's unsustainable that small wound dressing manufacturers would have to bear that burden on the back of an individual wound dressing." - Kathy Herzog"FDA's move to over-regulate well-settled product categories is deeply concerning." - Mark DuValKey Takeaways:MedTech Trends:The FDA's proposed rule could significantly impact the classification and regulation of wound dressings.There is substantial industry opposition to the proposed rule, with many companies and trade associations voicing their concerns.The broader implications of the FDA's actions suggest a shift towards more aggressive regulatory measures.Practical Tips:Stay informed about regulatory changes and participate in comment periods to voice concerns.Prepare for potential new testing and data requirements by reviewing current performance testing protocols.Engage with industry groups and legal experts to understand the full impact of proposed regulations.Future Developments:How will the FDA address industry pushback and potential litigation against the proposed rule?Will there be additional guidance from the FDA to help manufacturers navigate the new requirements?What other product categories might the FDA target for reclassification in the near future?References:Greenlight Guru QMS SoftwareFDA Proposed Ruling on Wound DressingsDuVal & Associates Client Alert on FDA Proposed RuleAlliance of Wound Care StakeholdersWashington Legal FoundationConnect with Etienne...

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

In this episode, Etienne Nichols is joined by Shaherah Yancy, CEO of Research Lifecycle Solutions. They dive deep into the critical importance of developing robust clinical and regulatory strategies for MedTech companies. Shaherah shares her extensive experience in the field, providing practical advice on securing funding, ensuring market access, and achieving market adoption. They explore the nuances of clinical evidence, the significance of strategic planning, and the role of advisory panels in navigating the MedTech landscape.Key Timestamps:00:00 - 03:00 Introduction and Sponsor Message03:01 - 05:20 Introduction to Shaherah Yancy and her background05:21 - 10:30 Importance of Clinical and Regulatory Strategies10:31 - 17:15 Challenges of Securing Funding and Developing Strategy17:16 - 25:45 Differences Between Market Access and Market Adoption25:46 - 33:50 Developing Effective Clinical Plans for Market Adoption33:51 - 39:40 Importance of Evidence and Study Design39:41 - 48:00 Examples and Case Studies from Early Stage Companies48:01 - 55:15 Endpoints for Market Adoption55:16 - 01:02:30 Strategies for Novel Technologies01:02:31 - 01:07:45 Final Advice and Contact InformationNotable Quotes:"Market access is a milestone. Market adoption is the goal." - Shaherah Yancy"Understanding the problem you're solving is crucial for your strategy." - Shaherah Yancy"Don't be afraid of clinical evidence; it's your key to success." - Shaherah YancyKey Takeaways:MedTech Trends:Strategic Planning is Essential: Early and comprehensive planning for clinical and regulatory strategies can significantly enhance a company's chances of success.Clinical Evidence is Critical: Collecting robust clinical data is vital for both market access and long-term market adoption.Market Adoption Over Market Access: The ultimate goal should be market adoption, not just getting to market.Practical Tips:Form Advisory Panels: Engage with surgeons and clinical experts early to guide product development and market entry strategies.Comprehensive Studies: Design studies that include both primary endpoints for regulatory approval and secondary endpoints for market adoption.Prepare for Limited Market Releases: Use limited market releases to gather real-world evidence and refine products before a full launch.References:Research Lifecycle Solutions: Shaherah Yancy's company, specializing in clinical and regulatory strategies for MedTech. RLC SolutionsGreenlight Guru Clinical: The sponsor of this episode, offering a platform for streamlining clinical trials. Greenlight Guru ClinicalEtienne Nichols LinkedIn: Connect with Etienne on LinkedIn for more insights. Etienne Nichols LinkedInMedTech 101:Clinical Evidence: Data collected from clinical trials and studies to demonstrate the safety and efficacy of a medical device.510(k) Clearance: A premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally...

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...

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

In this episode of the Global Medical Device Podcast, host Etienne Nichols chats with Weronika Michaluk and Zach Markin from HTD Health about their journey to achieving ISO 13485 certification. The discussion covers the importance of gap analysis, the value of a compliant agile approach, and the benefits of using Greenlight Guru's eQMS software. Listeners will gain valuable insights into maintaining compliance and continuous improvement in the MedTech industry, as well as practical advice for navigating ISO 13485 certification.Key Timestamps00:00 - 02:00 - Introduction by Etienne Nichols02:00 - 05:30 - Introduction to HTD Health and their focus05:30 - 10:45 - Discussion on the importance of ISO 13485 certification10:45 - 14:30 - Steps and preparations for achieving ISO 13485 certification14:30 - 20:00 - Benefits and features of using Greenlight Guru's eQMS20:00 - 25:00 - Challenges and changes faced during the certification process25:00 - 30:00 - Practical tips for preparing for an ISO 13485 audit30:00 - 35:00 - Continuous improvement and future goals for HTD Health35:00 - 40:00 - Closing thoughts and advice from Weonika Michaluk and Zach MarkinNotable QuotesWeronika Michaluk: "Do a proper gap analysis and also think whether you have enough knowledge internally... it will make your life easier to reach out to a partner or consultant."Zach Markin: "In services, there's not one ideal agile, but the right flavor of agile for the work that needs to be done."Weronika Michaluk: "Using Greenlight Guru made our lives easier, especially in managing traceability and ensuring compliance."Key TakeawaysPractical Tips for MedTech EnthusiastsGap Analysis: Conduct a thorough gap analysis to understand current capabilities and areas needing improvement.Internal Expertise: Ensure you have the necessary internal expertise or consult with experienced partners.Continuous Improvement: Regularly update and improve your processes to maintain compliance and efficiency.ReferencesISO 13485 Certification: Learn about the ISO 13485 standard for medical devicesVisit Greenlight Guru for eQMS software solutionsHTD HealthWeronika Michaluk on LinkedInZack Markin on LinkedInConnect with Etienne Nichols on LinkedIn.MedTech 101Explainer for New ListenersISO 13485: An international standard that outlines the requirements for a quality management system specific to the medical device industry. It ensures that organizations consistently meet customer and regulatory requirements related to medical devices.QMS (Quality Management System): A structured system of procedures and processes covering all aspects of design, manufacturing, and distribution to ensure products meet regulatory standards and customer expectations.CAPA (Corrective and Preventive Action): A process within a QMS to investigate and correct the root causes of identified issues and prevent their recurrence.Audience EngagementPoll QuestionWhat MedTech innovation are you most excited about?Email your thoughts to

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

In this engaging episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Ron Richard, a seasoned expert in the medical device industry with over 35 years of experience. The discussion delves into the essentials of bringing a medical device to market, from the inception of an idea to commercialization. Ron shares his journey, the importance of effective elevator pitches, the nuances of regulatory pathways, and practical tips for aspiring inventors. With insights on avoiding common pitfalls and strategies for securing funding, this episode is a treasure trove for anyone interested in MedTech innovations.Key Timestamps:[00:00] - Introduction and Ron Richard's background[04:50] - Early successes in inventing and bringing products to market[10:30] - Validating ideas and market need[17:15] - Regulatory pathways: 510(k) vs. PMA[24:00] - Class I products and direct-to-consumer strategies[30:45] - Funding strategies: Family and friends, VC, and IPO[42:20] - Overcoming pitfalls and avoiding shiny object syndrome[49:10] - The importance of having a clear cap table[55:30] - The chasm: Making the leap from idea to market[01:01:45] - Final takeaways and advice for MedTech innovatorsQuotes:Ron Richard: “One of the biggest things I tell inventors is that in order for you to raise money, people have to trust you and like you. You have to share within 30 seconds what your product does and what problem it solves.”Etienne Nichols: “Pioneers get shot, settlers get rich. You can be innovative with a 510(k) product by making evolutionary improvements.”Ron Richard: “The road to success is always under construction. Be prepared for obstacles and have a plan to navigate through them.”Key Takeaways:Practical Tips:Elevator Pitch: Develop a concise and compelling elevator pitch that clearly communicates your product's value.Validate Early: Use focus groups and stakeholder interviews to validate your idea before heavily investing.Funding Strategy: Start with family and friends for initial funding, then approach VCs once you have patents and prototypes.Future Predictions:Increased Scrutiny: Regulatory bodies like the FDA may become more stringent, requiring more comprehensive testing and validation.Telemedicine Integration: Future medical devices will likely need to integrate telemedicine capabilities to stay competitive.AI and Diagnostics: Artificial Intelligence will play a significant role in diagnostics and personalized medicine, offering new avenues for innovation.References:Ron Richard's Book: "Someday is Today: Get Your Ideas Out of Your Coffee Cup and on the Market" - [Amazon Link]Etienne Nichols' LinkedIn: Etienne Nichols on LinkedInRon Richard's Website: Inventing Starts TodayMedTech 101:Basics of Medical Device Classification:Class I: Low risk, often exempt from premarket notification (510(k)).Class II: Moderate risk, typically requires 510(k) premarket notification.Class III: High risk, requires PMA (Premarket Approval) with extensive data.Questions for the Audience:Poll: What MedTech innovation do you think will have the most significant impact in the next five years? (Options: AI-driven diagnostics, wearable health monitors, surgical robots)Share your thoughts with us at podcast@greenlight.guruFeedback:We'd...

In this episode of the Global Medical Device Podcast, host Etienne Nichols welcomes back Dr. Mike Drues to discuss the critical aspects of obtaining Institutional Review Board (IRB) approval and interacting with the FDA for medical device clinical trials. They explore the roles of IRBs, the difference between significant and non-significant risk devices, and share invaluable advice on mitigating risks associated with clinical trials. Whether you're a newcomer or a seasoned professional in the MedTech industry, this episode offers essential insights to ensure your clinical studies are compliant and efficient.Key Timestamps:00:01:20 – Introduction to Dr. Mike Drues and his accolades.00:05:30 – Explanation of IRBs and their role in clinical trials.00:15:10 – Differences between traditional and commercial IRBs.00:22:40 – Discussion on significant vs. non-significant risk devices.00:32:00 – Importance of pre-submission meetings with the FDA.00:44:15 – Steps to take when an IRB disapproves your clinical trial.01:00:30 – Practical tips for choosing the right IRB for your study.Quotes:"Most 510 devices do not need clinical data. But if you do, even for a non-significant risk device, vetting that with the FDA in advance is wise." – Dr. Mike Drues"You don't want to create a problem where none exists, but avoiding FDA consultation can lead to costly surprises later." – Dr. Mike Drues"The primary mission of an IRB is to ensure the safety of the patients at that institution." – Dr. Mike DruesTakeaways:Key Insights:Understanding IRBs: IRBs are local entities responsible for the ethical oversight of clinical trials, ensuring patient safety and compliance.Risk Classification: The classification of your device as significant or non-significant risk dictates whether FDA approval is needed for your clinical trial.Strategic Pre-Submission: Engaging in a pre-submission meeting with the FDA can prevent costly delays and ensure your clinical trial meets all necessary endpoints.Practical Tips:IRB Shopping: If faced with an IRB denial, consider alternative institutions or commercial IRBs to avoid delays.Comprehensive Submissions: Prepare thorough submissions for IRBs, including device descriptions, clinical trial protocols, and informed consent forms.Physician Champions: Having a physician advocate at the institution can streamline the approval process and facilitate patient enrollment.Future Questions:How will the evolving landscape of MedTech regulations impact the approval process for new devices?What role will real-world evidence play in future clinical trials for medical devices?How can smaller companies navigate the complexities of FDA and IRB requirements effectively?References:Etienne Nichols on LinkedInMike Drues on LinkedInFDA Guidance on Artificial Intelligence and Medical DevicesFDA Guidance on Avoiding Potential Issues with Your 510(k) SubmissionGood Clinical Practices (GCP) regulations for IRBsMedTech 101:What is an IRB?An Institutional Review Board (IRB) is a committee established to review and approve research involving human subjects. The primary purpose of an IRB is to ensure the ethical and safe treatment of participants in clinical trials.What is an IDE?An Investigational Device Exemption (IDE) allows a medical device to be used in a clinical study to collect safety and effectiveness data. An IDE must be approved by the FDA for significant risk devices before a clinical study can begin.Questions for the...

In this special episode of the Global Medical Device Podcast, Etienne Nichols switches roles from host to guest as Devon Campbell turns the tables to explore the invaluable lessons Etienne has learned from over 100 podcast episodes. Delve into key insights on product development, quality management, and the power of vulnerability and networking. Etienne shares practical tips and personal anecdotes that reveal the nuances of the MedTech industry, making this episode a treasure trove of knowledge for both new and seasoned professionals.Key Timestamps:[02:15] - Introduction and Etienne's journey to becoming a podcast host[12:30] - The importance of vulnerability and honesty in product development[22:45] - Balancing quality for audits versus operational benefits[30:10] - Human factors and usability in MedTech product development[37:55] - Simplifying quality management systems[45:00] - The mantra of learn, lead, and love in networking[54:20] - Encouraging emerging entrepreneurs to own their expertise and impact regulationsQuotes:"The heart of the problem is the seed of the solution.""Quality management documents should benefit your company first and be audit-ready second.""Be genuinely curious. Assume the person in front of you knows something worth listening to."Takeaways:Key Insights on the Latest MedTech Trends:Human factors and usability are often misunderstood but crucial in MedTech product development.Quality management systems should be practical and beneficial for the company, not just for audits.Networking is more than collecting business cards; it's about building meaningful connections.Practical Tips for MedTech Professionals:Be vulnerable and honest about the state of your projects.Focus on solving the right problems and avoid over-engineering.Create quality management documents that are easy to understand and useful for your team.Questions Predicting Future Developments:How will AI and machine learning shape the future of MedTech product development?What emerging trends in usability and human factors will impact regulatory changes?How can MedTech companies better prepare for cybersecurity challenges?References:Greenlight Guru - Quality management software for medical devices.Etienne Nichols - LinkedInDevon Campbell - LinkedInProdct LLC - Devon's advisory firmFred Crosby's Quality is Free - A book on quality management principles.Beginner's Section: MedTech 101Quality Management System (QMS): The system that outlines the processes and procedures to ensure product quality.Human Factors and Usability: The study of how people interact with products to improve design and user experience.Regulatory Strategy: The plan for complying with regulations to bring a medical device to market.Questions for the Audience:Poll: What do you think will be the most impactful MedTech advancement in the next five years? Email us your thoughts at

In this episode of the Global Medical Device Podcast, host Etienne Nichols engages with Howard Root, former CEO of Vascular Solutions and author of "Cardiac Arrest: Five Heart-Stopping Years as a CEO on the Fed's Hit List," and Mark Duval, President and CEO of DuVal & Associates. The episode delves into the harrowing experiences of navigating severe legal battles over off-label promotions, highlighting crucial insights into maintaining innovation while managing legal risks in the MedTech field. Additionally, Mark DuVal, a noted regulatory attorney, provides his expertise on the responsible corporate officer doctrine and its implications for industry executives.Key Timestamps:[00:00:15] - Introduction by Etienne Nichols.[00:01:30] - Howard Root's background and the origins of Vascular Solutions.[00:05:00] - Mark DuVal introduces Howard Root, detailing his legal battles.[00:10:00] - Howard Root discusses the intricacies of his federal indictment and the subsequent trial.[00:30:00] - Discussion on corporate responsibility and regulatory implications in the MedTech industry.[00:50:00] - Audience Q&A session with Howard Root and Mark DuVal.[01:10:00] - Closing remarks and takeaways.Quotes:Howard Root: "We're not imposing rules at the bare legal minimum...we want to have a gray area. It's why you drive 55 in a 60 zone."Mark DuVal: "Always be truthful, fairly balanced, and not misleading when discussing device applications."Takeaways:Latest MedTech Trends:Increased scrutiny on off-label promotions highlights the need for clear regulatory strategies.Growing legal precedents emphasize the importance of corporate responsibility at all levels of operation.The role of ethical practices in sustaining innovation within the MedTech industry.Practical Tips for MedTech Professionals:Ensure thorough understanding and compliance with FDA guidelines and local regulations.Implement robust training and compliance programs for all staff, particularly in sales and marketing.Engage experienced legal counsel to navigate complex regulatory landscapes.Future Predictions in MedTech:Enhanced regulatory frameworks to better define and manage off-label use.Greater use of AI and data analytics to monitor compliance and ethical practices.Increased advocacy for legislative changes to protect innovators from aggressive legal challenges.References:Howard Root's book, "Cardiac Arrest: Five Heart-Stopping Years as a CEO on the Fed's Hit List"Mark DuVal on LinkedInDuVal & Associates Client AlertsFDA guidelines on off-label promotions

In this episode, Lisa Van Ryn, a seasoned expert from Greenlight Guru, shares her extensive knowledge on the FDA's Medical Device Reporting (MDR). We unpack the nuances of when and how to report incidents, the definition of serious injuries, and the importance of effective complaint management systems. Lisa provides practical advice on setting up robust reporting processes and explains how manufacturers can avoid common pitfalls.Key Timestamps:[01:20] Introduction of Lisa Van Ryn and discussion on FDA's Medical Device Reporting[05:45] Lisa's transition from the restaurant industry to medical devices[10:30] What triggers a medical device report to the FDA?[15:25] Role-play on handling complaints and determining reportability[25:00] Detailed explanation of the decision tree for reporting[35:15] Differentiating between device malfunctions and serious injuries[40:10] Real-life examples and clarifying complex reporting scenarios[50:30] The repercussions of late reporting and the importance of timing[55:20] Wrapping up and resources for deeper understandingInsightful Quotes:"Every complaint needs to be evaluated to determine if it is reportable under 21 CFRR Part 803." - Lisa Van Ryn"Having a beginner's mindset but the heart of a teacher is essential in the medical device industry." - Etienne Nichols"If you're not considering the feedback as important, whether it's reportable or not, you are missing valuable data." - Lisa Van RynKey Takeaways:Understanding MDR: The importance of being thoroughly familiar with Medical Device Reporting guidelines to ensure proper reporting and compliance.Setting Up Processes: Tips on setting up an effective complaint handling system to manage and report incidents correctly.Common Pitfalls: Common issues manufacturers face and how to avoid them by implementing efficient and compliant processes.References and Resources:Medical Device Reporting (MDR): How to Take Advantage of Your Electronic RecordsLisa Van Ryn on LinkedInEtienne Nichols on LinkedInBeginner's Section: MedTech 101Medical Device Reporting (MDR): This refers to the regulatory process in which manufacturers are required to report certain types of incidents and malfunctions related to medical devices to the FDA.Serious Injury: A serious injury in the context of MDR is defined as an injury that is life-threatening, results in permanent impairment, or necessitates medical or surgical intervention to prevent permanent damage.Complaint Handling: The process by which manufacturers receive, review, and respond to customer complaints about the safety and quality of their medical devices.Questions for the Audience:Poll: Do you believe current regulations on medical device reporting are sufficient for ensuring patient safety?Feedback Request:We value your thoughts! Please leave us a review on iTunes and share your feedback. Your suggestions help us improve and guide our future topics. Email your thoughts and topic suggestions to podcast@greenlight.guru.Sponsors:This episode is brought to you by Greenlight Guru, a leading platform that offers MedTech companies a...

In this episode, host Etienne Nichols speaks with Christine Luk, Associate Regulatory Affairs Manager at Proxima, about her journey through the medical device sector. From her academic beginnings in biochemistry and biomedical engineering to founding a startup and navigating FDA regulatory pathways, Christine offers a wealth of knowledge. The discussion delves into the intricacies of working with regulatory consultants, the significance of FDA interactions, and practical tips for medical device startups aiming to maneuver through regulatory challenges successfully.Key Timestamps:[00:02:30] Christine's journey from biochemistry to medical device innovation[00:15:00] Insights on starting a medtech startup and the early failures[00:30:45] Effective collaboration with regulatory consultants[00:45:10] Handling FDA interactions and strategic submissions[01:00:20] Advice for medtech startups on navigating regulatory environmentsNotable Quotes:"You're pitching all these awesome capabilities of your device, meanwhile on the FDA side, we're asking, who are you most like?" – Christine Luk"Every meeting is money. Making sure everybody is aligned and on the same page is crucial when dealing with consultants." – Christine LukKey Takeaways:Engage with local medtech communities and resources, such as accelerators or innovation hubs.Early interactions with the FDA can significantly influence your device's regulatory pathway.Thorough documentation and clear communication with consultants are essential for effective project management.References and Resources:Texas Medical Center Innovation InstituteProxima Clinical ResearchChristine Luk on LinkedInEtienne Nichols on LinkedInCall to Action:Feedback is crucial! Please email us your thoughts on this episode and suggestions for future topics at podcast@greenlight.guruDon't forget to leave us a review on iTunes!Sponsor Segment:This episode is proudly sponsored by Greenlight Guru, a global leader in MedTech-specific software solutions. Whether you're in the clinical trial phase or ensuring compliance with quality standards, Greenlight Guru offers tailored solutions to streamline your processes. Their software is designed specifically for the medical device industry, helping companies accelerate their product development with confidence and compliance. Learn more about how Greenlight Guru can illuminate your path to market success by visiting their website at Greenlight Guru. Equip your team with the tools to simplify quality management and keep your focus on innovation and patient safety.

In this insightful episode of the Global Medical Device Podcast, host Etienne Nichols delves into the journey of Dr. Lee Hunter, an orthopedic surgeon and innovator in elbow surgery devices. Dr. Hunter shares his experience from the conception of a simple yet effective surgical device through its development, struggles with initial licensing, and ultimate success in the market. The discussion highlights the importance of perseverance, the impact of regulatory insights, and the significant role of strategic innovation in enhancing patient outcomes.Key Timestamps:[00:45] - Introduction of Dr. Lee Hunter and his medical device journey.[05:30] - Challenges and breakthroughs in designing elbow surgery devices.[14:20] - The licensing journey and learning from initial failures.[22:50] - Insights into the current medical device market and innovations.[35:40] - Discussion on the importance of simplicity and efficiency in medical devices.[48:15] - Future directions in MedTech and advice for new innovators.Memorable Quotes:"Sometimes the simplest solutions are the hardest to find but the most effective once implemented." - Lee HunterKey Takeaways:Innovation in MedTech: Dr. Hunter's journey emphasizes that true innovation often stems from a deep understanding of specific medical needs rather than broad technological applications.Challenges and Resilience: Early failures are often stepping stones to success, highlighting the importance of resilience and adaptability in the medical device industry.Future of MedTech: The potential for simpler, more effective devices that streamline medical procedures and improve outcomes is vast, urging current and future innovators to focus on practical and impactful innovations.MedTech 101:In today's episode, terms like "elbow arthroscopy" and "lateral decubitus position" were discussed. Elbow arthroscopy involves a minimally invasive surgical procedure on the elbow using an arthroscope, while lateral decubitus position refers to the patient lying on their side, which is common during such surgeries.Call to Action:Did this episode on medical device innovation resonate with you? We would love to hear your thoughts and feedback. Leave us a review on iTunes and share your views on the future of MedTech innovations! For suggestions on future topics, please email us at podcast@greenlight.guruReferences:Hunter Medical DevicesDr. Lee hunter on LinkedInTennessee Orthopedic AllianceEtienne Nichols on LinkedInSponsors:This episode is brought to you by Greenlight Guru, a leading company in medical device consulting. Their expertise and services align seamlessly with the needs of the MedTech community, helping bring revolutionary devices to the market efficiently. Check out their special offers for podcast listeners today!

In this episode of the Global Medical Device Podcast, host Etienne Nichols engages with Helene Quie, an expert in medical device regulations and clinical investigations. They delve into the dual aspects of risk management: ensuring product safety and the procedural risks associated with clinical protocols. Helene emphasizes the importance of a measurable, data-driven approach to balancing risks and benefits and discusses the challenges companies face in aligning their clinical investigations with stringent regulatory standards.Key Timestamps00:00:45 - Introduction to Helene Quie and the topic of risk management in clinical investigations.00:05:22 - Discussing the first leg of risk management: managing residual risks in product safety.00:17:50 - Exploring the second leg: the procedural risks in clinical protocols.00:28:30 - Challenges of enrollment and protocol design.00:35:45 - The impact of regulatory changes on clinical investigations.00:49:10 - Addressing the integration of artificial intelligence in medical devices.01:03:15 - Closing thoughts and call to action from Helene Quie.Provocative Quotes"It's not just about managing risks; it's about ensuring that the benefits are powerful enough to justify those risks." - Helene Quie"Every clinical investigation introduces its own set of risks, not just from the product but from the study protocol itself." - Helene Quie"We must not only wear different glasses to see through the regulatory and practical aspects but also validate our views with the actual stakeholders involved." - Helene QuieKey Takeaways1. Insights on MedTech Trends:The increasing importance of data in justifying product safety and efficacy.The shift from intuition-based to evidence-based risk assessment.Regulatory bodies are placing greater emphasis on comprehensive clinical evaluations.2. Practical Tips for MedTech Professionals:Ensure that risk assessments are detailed and backed by solid data.Consider the practical aspects of clinical trial protocols from multiple perspectives.Stay updated on regulatory changes to adapt protocols and product development effectively.3. Future Predictions in MedTech:Enhanced scrutiny and requirements for clinical investigations.Greater integration of AI and digital tools in medical devices.Potential regulatory adaptations to accommodate innovations.ReferencesHelene Quie on LinkedInEtienne Nichols on LinkedInQMED ConsultingQuestions to ask for Clinical PreparationEUMDR and MDD Comparisons: Insights into how regulatory frameworks have evolved and their impact on medical device development.MedTech 101For new listeners, this episode touches upon fundamental concepts like residual risk, clinical protocol, and risk-benefit assessment in the context of medical device clinical investigations. Understanding these terms is crucial for grasping the detailed discussions of the episode.Audience EngagementDiscussion Question: "What are your expectations for the future of healthcare with advancements in MedTech?"Feedback Request:...

In this episode of the Global Medical Device Podcast, host Etienne Nichols delves into the intricate world of in vitro diagnostics (IVDs) with Christie Hughes, a principal consultant and IVD expert at Qserve Group. With over 25 years of experience, Christie shares her extensive knowledge, discussing the nuances of IVDs, regulatory landscapes, and practical insights for professionals transitioning into or within the IVD sector.Key Timestamps:[00:00:45] - Christie Hughes's introduction and background in IVDs[00:03:30] - Discussion on the regulatory challenges and trends in 2023[00:15:22] - Differences between IVDs and other medical devices in terms of regulatory and operational frameworks[00:25:50] - Impact of regulatory changes on labs and manufacturers[00:40:10] - Detailed exploration of user needs and design controls in IVD development[00:52:00] - Advice for medical device professionals entering the IVD spaceNotable Quotes:"Understanding the user—whether a lab technician or a layperson—is critical in IVD development to ensure safety and effectiveness." - Christie HughesKey Takeaways:Trends in MedTech: The regulatory environment for IVDs is rapidly evolving, with increased scrutiny and changes in compliance requirements globally.Practical Tips: For those entering the IVD field, familiarize yourself with FDA decision summaries and EUA documentation to understand current regulatory expectations.Future Predictions: Expect continued integration of IVDs with digital health technologies, raising both opportunities and regulatory complexities.References and Resources:FDA decision summaries for recent IVD clearancesEuropean In Vitro Diagnostic Regulation (IVDR) updatesCDRH LearnFDA Proposed Rule for LDTsEpisode on LDTs with Shannon BennettChristie Hughes on LinkedInEtienne Nichols on LinkedInMedTech 101:In Vitro Diagnostic (IVD) Devices: Tools that analyze human samples (like blood or tissue) outside the body, used to diagnose diseases, conditions, or to monitor a person's overall health.Audience Interaction:Discussion Question: "How do you envision IVDs changing everyday healthcare practices in the future?"Call for Feedback:Love this episode? Leave us a review on iTunes and share your thoughts. Feedback drives our growth and allows us to improve. Reach out directly via email at podcast@greenlight.guru with your suggestions for future topics.Special Thanks to Our Sponsor:This episode is brought to you by Greenlight Guru, a quality management system and electronic data capture software designed...

In this episode of the Global Medical Device Podcast, Etienne Nichols engages with Sara Adams to discuss Quality Management Systems (QMS) in the medical device industry. The discussion unveils the complexities and common misconceptions surrounding QMS, drawing an intriguing analogy between building a QMS and crafting sourdough bread. Sara shares her extensive experience with FDA inspections and audits, emphasizing the essential, tailored approach needed for effective quality management.Sponsor:This episode is brought to you by Cleio Medical Device Design. Discover how Cleio can transform your medical device concepts into market-ready products at cleio.com.Key Timestamps:[02:15] - Sara recounts her experiences with FDA inspections.[05:30] - Etienne introduces the sponsor and the episode's focus on QMS.[12:00] - Sara explains what a QMS is and is not, breaking down the layers of quality control.[19:45] - Discussion on the practical steps to build and customize a QMS.[34:10] - Sara's sourdough analogy to illustrate the process of developing a robust QMS.[48:55] - Examples of how different QMS systems can meet specific regulatory requirements.[1:02:30] - Closing thoughts on keeping the patient in mind when building a QMS.Notable Quotes:"You can't buy a QMS off the shelf; it's like trying to bake sourdough bread without understanding the process or the ingredients." – Sara Adams"The patient should be the focus of everything we do in the medical device industry." – Sara AdamsKey Takeaways:Latest MedTech Trends:Increasing regulatory scrutiny on how QMS are implemented.More companies are moving from paper-based to electronic QMS for better compliance and efficiency.Growing emphasis on customizing QMS components to fit specific medical device regulatory needs.Practical Tips for MedTech Listeners:Understand the components of your QMS and ensure they align with regulatory requirements.Regularly review and update your QMS to adapt to new regulations and technologies.Consider electronic solutions for better traceability and compliance.Future Questions:What are the potential impacts of global regulatory harmonization on QMS?How can startups efficiently implement a compliant QMS with limited resources?References:FDA Quality System Regulation (21 CFR Part 820)ISO 13485 standards for medical devicesQuestions for the Audience:Poll: Do you believe that advances in electronic QMS will significantly reduce compliance issues in the next 5 years?Call for Feedback:Enjoy this episode? Leave us a review on iTunes and suggest topics you'd like to hear about in future episodes. Email us your feedback and ideas at podcast@greenlight.guruConnect with Us:Follow Etienne on LinkedIn: Etienne NicholsFollow Sara on LinkedIn: Sara AdamsJoin us next time for more insights and expert advice in the medical device industry!

This episode of the Global Medical Device Podcast features a compelling conversation with Perry Parendo, a seasoned expert in product development and project management within the MedTech sector. Host Etienne Nichols and Perry delve into the challenges and opportunities facing medical device development, emphasizing the critical role of agile practices, risk management, and the necessity for a patient-focused approach. The discussion sheds light on how companies can navigate regulatory landscapes, manage project risks, and drive innovation to enhance patient care.Key Timestamps:00:00:15 - Introduction of Perry Parendo and the episode's focus00:03:50 - Discussing the challenges of MedTech product development and regulatory hurdles00:12:20 - Agile methodologies vs. traditional project management in MedTech00:22:35 - The importance of risk management and Monte Carlo simulation in project planning00:34:10 - Perry's perspective on innovation, compliance, and balancing project priorities00:45:55 - Strategies for efficient and effective product development processesQuotes:"We're so focused from a compliance point of view on patient and health risk, we're not focused on project risk. And when I worked in the defense industry, we were hugely focused on project risk," Perry Parendo"There's waterfall, there's agile, there's Toyota, there's set based design, and there's APQP in the automotive industry. They're all a blend. There's no organization that's doing purely the theoretical of any one of those processes," Perry ParendoTakeawaysInsights on MedTech Trends:The convergence of agile and traditional methodologies tailored to MedTech's unique demands.The rising importance of advanced risk management techniques, like Monte Carlo simulations, in navigating project uncertainties.A call for innovation that transcends regulatory compliance to genuinely benefit patient care.Practical Tips for Listeners:Adopt a flexible approach to project management by integrating various methodologies based on project needs.Prioritize risk management early in the development process to foresee and mitigate potential challenges.Always align product development objectives with the ultimate goal of improving patient outcomes.Questions for Future Developments:How will evolving regulatory standards shape the next generation of medical devices?What role will patient feedback play in the design and development of future MedTech innovations?Can MedTech sustain its pace of innovation while ensuring safety and compliance?References:Perry Parendo on LinkedInEtienne Nichols on LinkedInBehavioral Grooves podcast with Annie Duke - Thinking in BetsBook - Someday is Today, Ron RichardYoutube video - the Heartbeat of New Product DevelopmentQuality Culture for Product Design Success