#393: Engineering MedTech Success: Simplifying Prototypes, Pivoting Strategy, and Creating Complex Designs with Justin Bushko

Global Medical Device Podcast powered by Greenlight Guru

Global Medical Device Podcast powered by Greenlight Guru

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הוסף לפני nine שנים

תוכן מסופק על ידי Greenlight Guru + Medical Device Entrepreneurs. כל תוכן הפודקאסטים כולל פרקים, גרפיקה ותיאורי פודקאסטים מועלים ומסופקים ישירות על ידי Greenlight Guru + Medical Device Entrepreneurs או שותף פלטפורמת הפודקאסט שלהם. אם אתה מאמין שמישהו משתמש ביצירה שלך המוגנת בזכויות יוצרים ללא רשותך, אתה יכול לעקוב אחר התהליך המתואר כאן https://he.player.fm/legal.

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Richard (Kudo) Couto: The Hidden Horror Behind a Billion-Dollar Brand 42:18

לפני 7 ימים42:18

הפעל מאוחר יותר

רשימות

לייק

אהבתי

42:18

“I used to be the largest dairy consumer on the planet. I used to eat so much dairy and meat. The more that I looked into the dairy industry, the more that I saw that it was the singular, most inhumane industry on the planet, that we've all been lied to, including myself, for years. I always believed that the picture on the milk carton, the cow standing next to her calf in the green field with the red barn in the back was true. It’s certainly the complete opposite.” – Richard (Kudo) Couto Richard (Kudo) Couto is the founder of Animal Recovery Mission (ARM), an organization solely dedicated to investigating extreme animal cruelty cases. ARM has led high-risk undercover operations that have resulted in the shutdown of illegal slaughterhouses, animal fighting rings, and horse meat trafficking networks. Recently, they released a damning investigation into two industrial dairy farms outside of Phoenix, Arizona supplying milk to Coca-Cola’s Fairlife brand. What they uncovered was systemic animal abuse, environmental violations, and a devastating betrayal of consumer trust. While Fairlife markets its products as being sourced "humanely," ARM’s footage tells a very different story—one of suffering, abuse, and corporate complicity. Despite the evidence, this story has been largely ignored by mainstream media—likely due to Coca-Cola’s massive influence and advertising dollars.…

לפני שנה 33:48

MP3•בית הפרקים

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

Standout 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 Bushko

3 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:

MedTech 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 podcast@greenlight.guru and don’t forget to leave a review to help others find us.

430 פרקים

#Business #Consultants; R #Health Industry #Health and Well-Being #Health Care #Tech #Fitness #Medicine #Medical Device

Global Medical Device Podcast powered by Greenlight Guru

#393: Engineering MedTech Success: Simplifying Prototypes, Pivoting Strategy, and Creating Complex Designs with Justin Bushko

Global Medical Device Podcast powered by Greenlight Guru

109 subscribers

published לפני שנה

שתפו

MP3•בית הפרקים

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

Key Timestamps:

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

Standout 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 Bushko

3 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:

MedTech 101:

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:

430 פרקים

#Business #Consultants; R #Health Industry #Health and Well-Being #Health Care #Tech #Fitness #Medicine #Medical Device

כל הפרקים

Global Medical Device Podcast powered by Greenlight Guru

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#405: Over the Counter (OTC) vs. Prescription (RX) Medical Devices, Pt. 1 40:04

לפני יומיים40:04

40:04

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 categories 10:00 – Label expansion: moving from Rx to OTC status 13:22 – The role of intended use environment in OTC classifications 20:40 – Examples of devices in each FDA class that are OTC 26:30 – Prescription devices used in home settings vs. true OTC 31:15 – Characteristics that qualify devices for OTC status 37:55 – Self-diagnosis, self-selection, and patient usability challenges 43:00 – “Reasonably foreseeable misuse” and how to interpret guidance 49:05 – Do you design for the lowest common denominator? 56:10 – Representing diverse user populations in usability testing 1:01:45 – Can a device launch OTC first? The case for wellness-to-Rx strategies 1:08:15 – FDA’s perspective on device safety: OTC vs. Rx Quotes “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 Takeaways OTC ≠ 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 & Resources Etienne Nichols on LinkedIn Greenlight 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 Premarket Approval and De Novo Classifications” MedTech 101: OTC vs Prescription Devices Analogy: Think of a medical device like a power tool. A prescription device is like a chainsaw—powerful, but risky if misused, so it’s only operated by trained professionals. An OTC device is like a screwdriver—still a tool, still regulated, but safe and intuitive enough for the average person to use correctly at home. Audience Engagement Prompt Poll Question: Do you think OTC medical devices should require a minimum standard of in-store or digital education before purchase? Engagement Prompt: Have you ever worked on a product that made the switch from prescription to OTC? What surprised you most about the process? Share your story with us at podcast@greenlight.guru . Feedback Call-to-Action Enjoyed this episode? Help us keep the conversation going: Rate & review us on your favorite podcast platform Got a topic suggestion or question? Email us at: podcast@greenlight.guru We read every email and may feature your question in a future episode. Sponsor Mention This episode is powered by Greenlight Guru , the only QMS platform designed specifically for MedTech companies. Whether you’re launching an OTC wellness device or navigating a PMA, Greenlight Guru helps ensure compliance and accelerate innovation. Learn more at www.greenlight.guru .…

Global Medical Device Podcast powered by Greenlight Guru

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#404: MedTech 101: What You Need to Know About the Medical Device Industry 58:08

לפני 6 ימים58:08

58:08

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 Timestamps 02:20 – What counts as a medical device? Intended use and labeling 06:48 – Differentiating roles: Quality, Regulatory, Clinical, R&D, and Marketing 15:40 – Understanding regulatory bodies: FDA, EU MDR, Health Canada, and more 20:15 – FDA Classifications: Class I, II, III, and what determines risk 26:00 – Standards to know: ISO 13485, 14971, 14155, 21 CFR Part 820 33:05 – FDA pathways: 510(k), De Novo, PMA – when and why they apply 41:55 – The design control matrix explained (User Needs through Validation) 49:00 – Reverse engineering design controls: pitfalls and best practices 55:30 – Clinical trials vs. preclinical studies: When each is required 1:00:45 – Manufacturing & supplier controls: operations meets compliance 1:04:15 – Final advice for MedTech newcomers: Read the regs and know the problem Quotes “Just because you don’t call it a medical device doesn’t mean the FDA agrees with you.” – Sarah Adams This 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 Rush A memorable analogy that demystifies the difference between FDA clearance and approval pathways. Top Takeaways Labeling + Intended Use = Regulatory Trigger Whether 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 Novelty Know 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 Early Reverse-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 Gaps Marketing, 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 Optional A 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 & Resources Etienne Nichols on LinkedIn Chris Rush on LinkedIn Sara Adams on LinkedIn MedTech 101: Key Concepts Explained Design Controls = Your Blueprint for Safe Innovation Think of design controls as a recipe: User Needs = what the customer is hungry for Design Inputs = what you plan to give the customer Design Outputs = the finished dish (specs) Verification = checking the dish matches the recipe Validation = confirming the customer loves it FDA Classes: Think Risk Levels Class I – Low risk: toothbrushes, bandages Class II – Moderate risk: catheters, infusion pumps (often 510(k)) Class III – High risk: pacemakers, implants (typically PMA) 510(k) vs. De Novo vs. PMA – Simplified 510(k) – You’re like someone else De Novo – You’re new, but not high-risk PMA – You’re new and high-risk = prove everything Audience Engagement Poll Question : Where do you currently need the most clarity in the medical device development process? Understanding FDA classification Clinical evidence and trial design Design control implementation Global regulatory expansion Post-market surveillance Discussion Prompt : What’s the most surprising thing you’ve learned about medical device regulation that you wish you knew sooner? Share your stories with us at podcast@greenlight.guru . Feedback & Reviews If this episode helped demystify the MedTech industry for you or someone on your team, we’d love to hear about it. Share your feedback, topic ideas, or guest suggestions at podcast@greenlight.guru . We read and reply to every message. Sponsor Message This episode is brought to you by Greenlight Guru , the only QMS purpose-built for the medical device industry. From design controls to post-market surveillance, our platform helps you stay audit-ready and accelerate product development with confidence. Learn more at www.greenlight.guru .…

Global Medical Device Podcast powered by Greenlight Guru

1
#403: Global Perspective on Medical Device Reimbursement 37:04

לפני 13 ימים37:04

37:04

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 Early 07:15 – US Reimbursement System: Medicare, Medicaid, and Private Insurers 13:10 – EU Reimbursement: Challenges with Fragmented National Systems 17:45 – Asian Market Differences: Japan, China, and South Korea 23:20 – The Importance of a Reimbursement Expert 28:05 – Navigating Political Changes in Global MedTech Markets 33:30 – Special Challenges for AI and Software as a Medical Device 40:00 – Direct-to-Consumer vs. Prescription Strategies 46:20 – Integrating Real-World Evidence and Post-Market Surveillance 52:00 – How Management Reviews Can Align Business and Quality Goals 01:03:10 – Pros and Cons: US vs. EU Reimbursement Models 01:18:20 – Final Takeaways and Closing Thoughts Standout 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 LinkedIn Greenlight Guru Quality Management System Medtech Podcast hosted by Karandeep Singh Badwal MedTech 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 show it! Feedback: We love hearing from you! Share your thoughts, feedback, or topic suggestions by emailing us at podcast@greenlight.guru . We personally respond and value your input to shape future episodes! Sponsor: Discover how Greenlight Guru Quality can unify your SOPs, documents, and product development process into a single living system — from idea to post-market. Learn more at greenlight.guru .…

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1
#402: How to Attract Real Talent in the Medical Device Industry 41:06

לפני 20 ימים41:06

41:06

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 leaders Standout 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 Petyo Takeaways: 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 Profile Talent Factory Medical Website Etienne Nichols' LinkedIn Profile MedTech 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 expectations Attracting candidates from outside the industry Avoiding bad hires Speeding up the hiring process "Have you had a ‘good interviewer, bad employee’ experience? Share your story with us at podcast@greenlight.guru — we’d love to hear your lessons learned!" Feedback If you enjoyed today’s episode, please take a moment to rate and review us! We’d love to hear your feedback and topic suggestions—email us anytime at podcast@greenlight.guru . Personalized responses guaranteed! Sponsors Integration: This episode is sponsored by Greenlight Guru , the only MedTech-specific QMS platform designed to speed up your product development without sacrificing compliance or quality. Learn more at www.greenlight.guru .…

Global Medical Device Podcast powered by Greenlight Guru

1
#401: FDA’s Vital Role in ISO Standards: Ensuring Global MedTech Integrity 48:34

לפני 27 ימים48:34

48:34

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 LinkedIn MedTech 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?" 👉 Email your thoughts to podcast@greenlight.guru Feedback Request: Enjoyed today’s episode? We'd love your feedback! 📩Email us your thoughts and suggestions for future topics at podcast@greenlight.guru 🎧 Don’t forget to leave a review on iTunes or your favorite podcast platform! Sponsor Mention: Brought to you by Greenlight Guru Quality: Greenlight Guru helps MedTech companies stay audit-ready 24/7 with smarter, structured quality management tools that align with FDA and ISO requirements. Visit www.greenlight.guru to learn how your team can innovate faster while staying compliant.…

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1
#400: The State of the Medical Device Industry 53:55

לפני 5 weeks53:55

53:55

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 Timestamps 00:03 – Introduction to the 2025 Medical Device Industry Report 05:00 – Market growth outlook: $800B by 2030 09:40 – Family office investment trends in MedTech 13:15 – Hiring freezes and headcount reductions: what's behind the numbers? 20:22 – Supply chain challenges and supplier qualification issues 28:35 – Why only 11% of companies rate their supply chain management as “excellent” 33:30 – QMS upgrades and the strategic focus on quality systems 39:00 – Fundraising and clinical trials: top priorities for pre-commercial companies 44:55 – Regulatory complexity: QMSR, EU MDR, and FDA staffing pressures 53:50 – FDA Form 483s: top causes and how to avoid them 1:04:00 – Action plan for 2025: technology, collaboration, and performance 1:12:00 – Making quality your competitive edge Memorable 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 🔍 Key Takeaways Latest MedTech Trends Global MedTech market expected to hit $800B by 2030. Quality systems and operational efficiency are becoming top priorities. Regulatory uncertainty is affecting hiring and supply chain strategy. Practical Tips for MedTech Pros Start preparing for QMSR (FDA’s Quality Management System Regulation) now. Prioritize supplier qualification and traceability early in development. Choose purpose-built tools to reduce headcount needs and streamline processes. 🔗 References & Resources 2025 Medical Device Industry Report – Greenlight Guru Etienne Nichols on LinkedIn Sara Adams on LinkedIn Episode 360: Is it Possible to Buy a QMS? with Sara Adams MedTech 101: Beginner’s Corner QMS (Quality Management System): A structured system that documents processes, procedures, and responsibilities for achieving quality and regulatory compliance. QMSR: FDA’s new quality regulation aligning with ISO 13485:2016. 483 Form: Issued by the FDA when investigators find conditions that may violate the FD&C Act. Family Office Investment: Wealth management firms that are increasingly investing in MedTech startups. Feedback Welcome! Enjoyed the episode? Please leave us a review on iTunes and tell us what you want to hear next. Your feedback helps us grow! Drop us a note at podcast@greenlight.guru 🎁 Sponsors This episode is sponsored by Greenlight Guru – the only quality management system (QMS) and electronic data capture (EDC) software built specifically for the MedTech industry. Want to streamline compliance and reduce your time to market? 👉 Learn more at greenlight.guru and mention this podcast for a special demo offer.…

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1
#399: How To Approach Culture Differences 22:41

לפני 11 weeks22:41

22:41

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 sponsorship 02:20 – Meet Olga Chashchina: Olga’s background in MedTech and international work experience 06:45 – Understanding Cultural Missteps: Common mistakes when navigating cultural differences in teams 12:15 – High vs. Low Context Communication: How context affects communication styles across cultures 15:00 – Cultural Impact on Healthcare: How cultural backgrounds influence patient care and medical communication 18:30 – Feedback Across Cultures: Differences in giving and receiving feedback globally 20:00 – Building Personal Connections in Professional Settings: Balancing personal relationships and cultural norms in business 22:00 – Final Thoughts: Olga’s key takeaway for appreciating cultural diversity Quotes: "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 Chashchina Takeaways: 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. Olga Chaschina's LinkedIn - connect with Olga for more information about the work she is doing with Metyos . MedTech 101 – Beginner’s Section: Key Terms: High-Context Communication: Communication where much of the information is implied or derived from context (e.g., Russia, Japan). Low-Context Communication: Direct communication with explicit details (e.g., USA, Germany). Intercultural Management: Strategies to effectively manage teams from diverse cultural backgrounds. Questions for the Audience: Poll: How much does cultural awareness influence team success in MedTech? Very Much Somewhat Not Much Not at All 👉 Share your thoughts! Email us at podcast@greenlight.guru Discussion Question: What cultural differences have you experienced in healthcare or MedTech? How did you navigate them? Share with us via email! Feedback & Call to Action: Enjoyed this episode? Please leave us a review on iTunes! It helps others find us and improve future content. Send your feedback or topic suggestions to podcast@greenlight.guru Sponsors: This episode is sponsored by Greenlight Guru – the leading QMS software built exclusively for the MedTech industry. Stay compliant, accelerate innovation, and simplify your product lifecycle. Learn more at www.greenlight.guru .…

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#398: Game-Changing Connections in MedTech: Inside LSI with Scott Pantel 35:52

לפני 12 weeks35:52

35:52

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] – 🎉 Exclusive! Etienne is joining LSI’s “Game Day” commentary stage at Dana Point Quotes to Remember "Some of the most valuable connections are the ones you never planned for—like meeting someone at the coffee stand or sharing a cab ride to the airport." – Scott Pantel "Investors hear pitches all the time. Tell them how you’re going to make money—clear, concise, compelling." – Scott Pantel "There’s never been a more exciting time to be in medtech. The convergence of AI, wearables, and patient-driven care is revolutionizing healthcare." – Etienne Nichols "Relationships aren’t just nice to have; they’re how deals get done in this industry." – Scott Pantel Top MedTech Insights Relationships Drive Results : Successful deals often stem from unplanned, personal interactions beyond formal meetings. Global Expansion is Essential : Medtech innovators can’t ignore APAC markets—capital and patient demand in Asia are reshaping the industry. 3 Practical Tips for MedTech Innovators Prepare Beyond the Pitch : Articulate how your company makes money early in conversations with investors. Prioritize Presence : Spend time at networking events—connections happen when you least expect them. Know the Culture : Adapt your approach to different markets; relationship-building is key in Europe and APAC. References & Resources Learn more about LSI: Life Science Intelligence Connect with Etienne Nichols: LinkedIn Profile Explore Greenlight Guru’s solutions: Greenlight Guru MedTech 101: What’s LSI? LSI (Life Science Intelligence) hosts premier global events connecting medtech innovators with investors, helping startups scale from idea to commercialization. With flagship events in the U.S., Europe, and now Asia, LSI creates unmatched opportunities for deal-making and knowledge-sharing. Audience Poll & Discussion Poll: What MedTech trend excites you the most? 🔲 AI in diagnostics 🔲 Wearable health monitors 🔲 Surgical robotics 🔲 Patient-owned health data 👉 Email your answer to podcast@greenlight.guru ! We Want Your Feedback! Love this episode? Got suggestions for future topics? Drop us a line at podcast@greenlight.guru . 💬 Leave a review on iTunes! It helps others find the show and keeps us improving. Sponsor Spotlight This episode is brought to you by Greenlight Guru —the only MedTech-specific Quality Management Software that helps companies get products to market faster and with less risk. Ready to streamline your compliance? Visit Greenlight Guru today! 🔥 Don’t miss Etienne’s live commentary at LSI Dana Point’s “Game Day” stage! See you in March!…

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#397: Winning Over Skeptics: the Key to Product Adoption in Healthcare 33:12

לפני 13 weeks33:12

33:12

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 roots 10:30 – Turning skepticism into belief: What clinicians really want to hear 18:45 – Personal experience shaping patient communication and device adoption 25:00 – Case study: Why a vein finder device sits unused in the hospital closet 34:15 – The importance of workflow integration for successful product adoption 41:50 – Grassroots influence: How clinicians share device recommendations 47:20 – Tiffany’s “what’s in your emergency room backpack” essentials 53:00 – Final advice: Talk to your biggest skeptics, not just early adopters 58:15 – Importance of patient education in medical device usage Memorable 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 Ryder Key Takeaways: 🔍 MedTech Trends: Grassroots Advocacy: Clinician word-of-mouth remains a powerful tool in product adoption. Workflow Integration: Devices must improve efficiency without adding complexity. Patient-Centric Design: Products that consider patient education and usability stand out. 🛠️ Practical Tips: Engage Skeptics Early: Prioritize conversations with clinicians who question your device. Tell Compelling Stories: Use real-life patient and clinician testimonials to foster connection. Show Workflow Benefits: Highlight how your product saves time or improves patient outcomes. References: Visit Greenlight Guru for quality management solutions tailored for MedTech. Connect with Etienne Nichols on LinkedIn to share your feedback or ideas. Connect with Tiffany Ryder on LinkedIn Learn more about Red Flag Hero , Tiffany Ryder’s patient advocacy initiative. MedTech 101: Beginner’s Section Product Adoption: The process by which healthcare professionals begin using a new device regularly. Success depends on clinical evidence, ease of use, and workflow integration. Workflow Integration: Ensuring a device fits into a clinician’s existing routine without disrupting patient care. Grassroots Movement: Adoption driven by peers, not just sales teams—often more effective in healthcare environments. Audience Questions & Poll: Poll: What’s the biggest factor influencing your adoption of new medical technology? Clinical evidence Workflow integration Patient outcomes Cost savings 👉 Cast your vote and tell us why at podcast@greenlight.guru ! Discussion Question: What device has made the biggest difference in your clinical or patient care experience? Share your story with us! Feedback & Reviews: Enjoyed the episode? Leave us a ⭐⭐⭐⭐⭐ review on iTunes! Your feedback shapes future topics—email us at podcast@greenlight.guru with suggestions! Sponsor Spotlight: Greenlight Guru – Purpose-built QMS software designed to help MedTech companies ensure compliance, reduce risk, and get to market faster. Visit Greenlight Guru to learn how they can transform your quality management approach. Thank you for tuning in to the Global Medical Device Podcast—your trusted source for MedTech insights! 🎙️…

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#396: Mastering Device Descriptions: The Cornerstone of Medical Device Submissions 50:33

לפני 20 weeks50:33

50:33

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 Quotes Mike 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 Takeaways MedTech Trends Clear 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 Tips Test 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 Questions How 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 & Resources Greenlight Guru: Purpose-built quality management systems for MedTech. Learn more . Stephen Covey: Seven Habits of Highly Effective People —inspiration for improving communication practices. Etienne Nichols on LinkedIn: Connect with Etienne for insights on MedTech and regulatory affairs. Connect now . MedTech 101: Device Descriptions What is a device description? A section of your regulatory submission detailing what your device is, how it works, and its intended use. It includes: Anatomy: Components and materials. Physiology: Function and mechanism of action (MOA). Pathology: Risks or potential failures. Why it matters: Guides regulatory classification and testing requirements. Establishes a clear understanding for reviewers, ensuring smooth approval processes. Audience Poll & Call to Action Poll Question: What challenges have you faced in creating a device description? Ambiguity in regulatory expectations Balancing technical detail with simplicity Miscommunication with reviewers Other (email us at podcast@greenlight.guru ) Feedback & Sponsors We value your feedback! Leave a review on iTunes to help others discover the podcast. Send suggestions for future episodes to podcast@greenlight.guru . Sponsor: This episode is brought to you by Greenlight Guru , the only QMS purpose-built for MedTech. Streamline your submissions, ensure compliance, and get to market faster. See how Greenlight Guru can help you.…

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#395: IEC 60601 Updates: What MedTech Professionals Need to Know for 2025 and Beyond 42:04

לפני 21 weeks42:04

42:04

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 Nichols Key Takeaways Latest Trends in MedTech Standards The 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 Compliance Begin 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 Future How 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 60601 For new listeners, IEC 60601 is a global standard that ensures the safety and effectiveness of medical electrical equipment. It encompasses requirements for design, labeling, testing, and risk management. With updates spanning usability, wireless technologies, and biocompatibility, it’s essential for any MedTech company working with electrical devices. References and Resources Greenlight Guru – The QMS software designed exclusively for MedTech: Learn more Connect with Leo Eisner – Founder of Eisner Safety Consultants and leading expert on IEC 60601: Visit Eisner Safety Consultants Etienne Nichols’ LinkedIn – Connect here Submit comments to standards – Contact your national committee or regulatory body for IEC SC62A involvement. Audience Poll: What aspect of the IEC 60601 update concerns you most—testing, design changes, or regulatory approval? Share your thoughts by emailing us at podcast@greenlight.guru . Sponsor Segment This episode is brought to you by Greenlight Guru , the leading QMS software for the MedTech industry. Simplify compliance and accelerate innovation with tools tailored to your needs. Visit www.greenlight.guru to schedule a demo today and start your journey toward easier compliance! Feedback and Reviews Love the podcast? Leave us a review on iTunes! It helps others find us and improves our content. For feedback or topic suggestions, email us at podcast@greenlight.guru . Stay ahead of MedTech changes by tuning in to the Global Medical Device Podcast. See you next time!…

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#394: Class III PMAs in MedTech: Advantages, Misconceptions, and Competitive Strategies with Dr. Mike Drues 51:18

לפני 22 weeks51:18

51:18

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 message 03:15 – Introduction to Dr. Mike Drues and his background in PMAs 05:45 – Overview of PMAs and when they should be used 11:30 – Are PMAs the only pathway for Class 3 devices? 16:20 – Types of PMAs: Traditional, Modular, and Streamlined 22:40 – Advantages of PMAs compared to 510(k)s and de novos 27:50 – The strategic use of predicates in the PMA process 33:00 – Clinical data requirements and misconceptions for PMAs 41:10 – Post-market requirements and differences for PMA devices 47:25 – Innovation and the future of PMAs: Six-year rule and potential EU approvals 54:30 – Final thoughts on overcoming industry resistance to PMAs Standout 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 Drues 3 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 Drues Greenlight Guru’s QMS Software Etienne Nichols’ LinkedIn MedTech 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 anticipate?" Feedback: We’d love to hear from you! Share your thoughts on this episode, or suggest topics you’d like covered. Email us at podcast@greenlight.guru and don’t forget to leave a review to help others find us.…

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#393: Engineering MedTech Success: Simplifying Prototypes, Pivoting Strategy, and Creating Complex Designs with Justin Bushko 33:48

לפני 23 weeks33:48

33:48

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 message 02:45 – Welcoming Justin Bushko; background in MedTech and engineering 07:20 – Overcoming early-stage engineering challenges, like autoclave and sterility testing 10:45 – Prototyping with a purpose: Ensuring design iterations target risks 16:00 – Balancing innovation, user needs, and cost-effectiveness 20:30 – Defining essential versus “nice-to-have” features in MedTech 26:45 – Strategic pivots in MedTech: When and why to change course 32:50 – The critical role of design freeze and usability studies 39:10 – Lessons from competitive benchmarking and reverse engineering 46:25 – Handling unique challenges in regulated industries like MedTech 52:15 – Opportunities for MedTech innovation and faster regulatory approvals 58:45 – Advice for founders and importance of building the right team Standout 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 Bushko 3 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 LinkedIn Greenlight Guru’s QMS Software Etienne Nichols’ LinkedIn MedTech 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 podcast@greenlight.guru and don’t forget to leave a review to help others find us.…

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#392: Verification and Validation in MedTech: A Practical Guide with Devon Campbell 58:38

לפני 24 weeks58:38

58:38

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 capabilities 03:15 – Setting the stage: Why verification and validation matter 08:30 – Differences between verification and validation explained 12:50 – Importance of strong user needs and design inputs 23:45 – Writing effective user needs and identifying users 33:00 – Creating robust design inputs and their sources beyond user needs 40:10 – From design inputs to design outputs: Key considerations 48:20 – Best practices for conducting design reviews and managing revisions 57:15 – Verification strategies: The importance of pre-verification 01:05:40 – Common challenges in V&V, including sample sizes and justifying tests 01:15:10 – Using feedback during testing and leveraging observations 01:23:00 – Final takeaways and practical advice for V&V success Standout Quotes: "Verification asks if we built the product correctly, while validation asks if we built the right product for the user." – Devon Campbell "You can't do verification or validation without strong, well-informed requirements. Weak requirements lead to validation failures." – Devon Campbell 3 Key Takeaways: Verification and Validation Are Not the Same: Understand that verification ensures your device meets specified design inputs, while validation confirms it meets user needs and functions as intended. Pre-Verification Testing Minimizes Risk: Conducting a "pre-verification" run allows you to refine testing protocols and identify potential design issues before formal verification begins. Define Users Clearly in User Needs: Avoid generic statements; specify which user (e.g., clinician, technician, patient) has which needs to ensure robust validation testing. References: Devon Campbell’s Consulting – Connect with Devon for more insights on product development. Etienne Nichols’ LinkedIn Greenlight Guru’s QMS Software MedTech 101: Verification vs. Validation – Verification checks if a product meets specified requirements, while validation ensures it fulfills the needs and expectations of its intended users. Both are critical steps in medical device development, and their successful execution depends on precise, testable requirements. Audience Engagement: Poll Question: "What’s been your biggest challenge in navigating verification and validation for your medical device? Share your experiences 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 podcast@greenlight.guru and don’t forget to leave a review to help others find us.…

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#391: Creating a Regulatory Roadmap for MedTech Market Success with Adnan Ashfaq 35:58

לפני 25 weeks35:58

35:58

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 Overview 03:10 – Introducing Adnan Ashfaq and his background in medtech 04:45 – Difference between a regulatory strategy and regulatory roadmap 07:00 – What a regulatory roadmap is and why it’s crucial 12:30 – When and why companies need a regulatory roadmap 16:45 – Key elements of a regulatory roadmap: costs, regions, and timelines 23:20 – Importance of classification and its impact on the regulatory path 28:50 – Integrating QMS, clinical investigations, and stakeholder engagement 36:00 – Leveraging a roadmap for strategic market entry and global reach 44:15 – Pitfalls to avoid in creating a regulatory roadmap 54:20 – Using language and intended use statements strategically 01:03:00 – Wrapping Up: Takeaways and Advice for MedTech Professionals Standout Quotes: "A regulatory roadmap is more than just documentation; it’s a strategic guide for accessing markets and securing investor confidence." – Adnan Ashfaq "Understanding whether your device is a medical device, and its classification, can be make-or-break for your entire regulatory strategy." – Adnan Ashfaq 3 Key Takeaways: Regulatory Roadmaps Are Essential: Developing a roadmap early in the process ensures clear regulatory pathways, cost assessments, and market prioritization, helping avoid costly missteps later. Market Entry Strategy Matters: Strategic use of market-specific regulations, such as leveraging faster access opportunities in some regions, can enhance commercialization efforts and post-market success. Language and Classification Are Crucial: Precise language in defining your device's intended use and claims can significantly impact classification, regulatory requirements, and market access speed. References: Simpli Medica – Adnan Ashfaq’s consultancy website. Etienne Nichols’ LinkedIn Greenlight Guru’s QMS Software MedTech 101: Regulatory Roadmap – A strategic document that outlines the costs, timelines, market-specific regulatory requirements, and resources necessary for bringing a medical device to market. Different from a regulatory strategy, it focuses on broader market entry planning and serves as a valuable tool for investor engagement and commercial success. Audience Engagement: Poll Question: "Has your company developed a regulatory roadmap to guide market entry? Share your experience and how it impacted your journey!" Feedback: Enjoyed this episode? Have questions or topics you’d like to hear more about? Reach out to us at podcast@greenlight.guru . Don’t forget to leave us a review—it helps us improve and reach more medtech professionals.…

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Global Medical Device Podcast powered by Greenlight Guru « » #393: Engineering MedTech Success: Simplifying Prototypes, Pivoting Strategy, and Creating Complex Designs with Justin Bushko

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#393: Engineering MedTech Success: Simplifying Prototypes, Pivoting Strategy, and Creating Complex Designs with Justin Bushko

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The Let Them Theory: A Life-Changing Tool That Millions of People Can't Stop Talking About

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#393: Engineering MedTech Success: Simplifying Prototypes, Pivoting Strategy, and Creating Complex Designs with Justin Bushko