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  • AI Is a Tool, Not a Replacement for MedTech Expertise with Mike Stuedemann, Co-Founder and Principal Consultant at agilityIRL

    AI Is a Tool, Not a Replacement for MedTech Expertise with Mike Stuedemann, Co-Founder and Principal Consultant at agilityIRL
    2026/08/06
    Move faster without losing focus: why medtech innovation must balance agility, regulation, and patient needs. In this episode, Mike Stuedemann, Co-Founder and Principal Consultant at agilityIRL, discusses how medical device companies can use agile techniques to accelerate product development while maintaining FDA compliance. He explores the regulatory challenges surrounding AI-enabled devices, particularly as technologies continue to learn and evolve after launch. Mike also explains how AI can support quality and regulatory teams by identifying potential risks, flagging requirements for review, and reducing manual work without replacing human expertise. Finally, he shares why personalized medicine, responsible data use, and practical applications of "boring AI" can drive more meaningful innovation while keeping accessibility, affordability, and patient outcomes at the center. Tune in to learn how agile development, human oversight, and patient-centered innovation can help medtech companies navigate a rapidly changing industry! Resources: Connect with and follow Mike Stuedemann on LinkedIn. Follow agilityIRL on LinkedIn and explore their website. Listen to the Take5 IRL podcast here.
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    14 分
  • ASC Insights: Making Advanced Monitoring More Accessible For Surgery Centers

    ASC Insights: Making Advanced Monitoring More Accessible For Surgery Centers
    2026/08/05
    Advanced patient monitoring becomes more practical for ASCs when innovation is integrated, scalable, and built around real outpatient workflows. In this episode, Blake Tatum, Vice President of US Commercial for Medtronic Acute Care and Monitoring, and Mike Lessick, Vice President of Sales and Marketing, Patient Monitoring, and Life Support for Mindray North America, discuss how their expanded partnership is helping ambulatory surgery centers access hospital-level monitoring technology in a simpler, more affordable way. They explain how Medtronic technologies, including Nellcor™ SpO2 monitoring, Microstream™ capnography, BIS™ brain monitoring, and INVOS™ tissue oximetry, can be integrated into Mindray’s ASC-focused monitoring platform. Blake highlights how the partnership reduces complexity, enables faster access to innovation, and provides ASCs with flexible options to scale technology over time. Mike shares how a single integrated platform can reduce cognitive load for clinicians, streamline purchasing and training, and support stronger connectivity with electronic medical records. Tune in to learn how integrated monitoring partnerships can help ASCs improve efficiency, support clinical quality, and prepare for the next wave of outpatient care. Resources: Connect with and follow Blake Tatum on LinkedIn. Follow Medtronic on LinkedIn and discover their website! Follow and connect with Michael Lessick on LinkedIn. Follow Mindray on LinkedIn and discover their website!
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    19 分
  • When Success Starts to Feel Misaligned: How Leaders Can Recognize Drift and Return to Clarity with Kristi Huber

    When Success Starts to Feel Misaligned: How Leaders Can Recognize Drift and Return to Clarity with Kristi Huber
    2026/08/04
    Burnout often does not happen all at once. For many leaders, it starts with small moments of drift away from their vision, voice, values, and vitality. In this episode, Kristi Huber, Founder of Perspective Shift Consulting, discusses how leaders can recognize and prevent leadership drift before it leads to burnout. Drawing from her own lived experience, she explains why high achievers are especially vulnerable to overcommitting, losing alignment, and operating on autopilot. Kristi introduces the Radical Clarity Compass as a practical framework for helping leaders and teams pause, reflect, and reconnect with what matters most. The conversation explores how greater self-awareness and intentional leadership can create healthier, more sustainable success. Tune in to hear how intentional pauses, clearer priorities, and stronger alignment can help leaders return to clarity, energy, and purpose! Resources: Connect with and follow Kristi Huber on LinkedIn and visit her website. Follow Perspective Shift Consulting on LinkedIn and explore their website.
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    30 分
  • Start Earlier Than You Think: A Proactive Approach to MedTech Quality with Joseph McGonnigal, Account Manager at Rook Quality Systems

    Start Earlier Than You Think: A Proactive Approach to MedTech Quality with Joseph McGonnigal, Account Manager at Rook Quality Systems
    2026/08/04
    Start earlier than you think: why proactive quality and regulatory planning can save medtech companies time, money, and costly remediation. In this episode, Joseph McGonnigal, Account Manager at Rook Quality Systems, discusses how medtech companies can build stronger quality management systems and better prepare for regulatory submissions. He explains how AI can help teams lay the foundation for high-quality documentation, while emphasizing that experienced professionals remain essential to review outputs, address technical details, and ensure compliance. Joseph also explores the growing regulatory complexity surrounding software-as-a-medical-device, AI-enabled technologies, and de novo submissions. Finally, he shares why startups should document decisions early, establish quality processes from the outset, and avoid waiting until regulatory issues become costly problems. Tune in to learn how early documentation, expert guidance, and proactive quality management can help medtech companies move toward regulatory approval with greater confidence! Resources: Connect with and follow Joseph McGonnigal on LinkedIn. Follow Rook Quality Systems on LinkedIn and explore their website!
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    8 分
  • Why MedTech Must Stop Using New Technology to Build Old Solutions with Anekant Jain, Manager, Polymer Technologies at EOS

    Why MedTech Must Stop Using New Technology to Build Old Solutions with Anekant Jain, Manager, Polymer Technologies at EOS
    2026/07/30
    From generic implants to patient-specific solutions: how additive manufacturing is expanding what is possible across medtech. In this episode, Anekant Jain, Manager, Polymer Technologies at EOS, discusses how industrial additive manufacturing is transforming healthcare by enabling the production of customized implants, prosthetics, dental devices, and other patient-specific technologies. He explains why additive manufacturing extends far beyond traditional 3D printing, requiring scalable production, qualified materials, reliability, and repeatable outcomes. Anekant also explores how advances in sensors, materials, and manufacturing are creating more responsive prosthetics with haptic feedback and stronger integration with the human body. Finally, he examines the barriers to broader adoption, including qualification processes, reimbursement, cost, and access, and explains why the industry must rethink what is possible rather than simply reproducing traditional solutions. Tune in to learn how additive manufacturing, customization, and cross-industry collaboration are pushing the boundaries of medical innovation! Resources: Connect with and follow Anekant Jain on LinkedIn. Follow EOS on LinkedIn and explore their website at eos.info.
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    18 分
  • From Portfolio to Pipeline: Caitlin Mayer's Playbook for Modern MedTech Growth

    From Portfolio to Pipeline: Caitlin Mayer's Playbook for Modern MedTech Growth
    2026/07/28
    What separates companies that consistently grow from those that simply launch products? In this episode, Caitlin Mayer, Senior Director of U.S. Marketing for Medtronic's Acute Care & Monitoring business, shares the go-to-market principles that have helped her team build stronger customer partnerships, align cross-functional teams, and accelerate growth through portfolio-based marketing. Drawing on real-world experience leading commercialization strategies in one of healthcare's fastest-growing care settings, Caitlin explains why today's customers expect more than products. They expect solutions that improve workflows, deliver economic value, and solve meaningful operational challenges. She also shares the planning process her team uses to unite marketing, sales, clinical, and product teams around a single business objective, creating the alignment needed to execute consistently and drive measurable results. What you'll learn: 1. Why portfolio selling creates stronger customer partnerships than product-centric selling. 2. How customer insights should shape positioning, segmentation, and go-to-market strategy. 3. How cross-functional alignment creates better execution and measurable business results. 4. A practical framework for moving from product launches to sustainable revenue growth. About Caitlin Mayer: Caitlin Mayer is the Senior Director of U.S. Marketing for Medtronic's Acute Care & Monitoring business. With more than 15 years of experience in healthcare marketing, she specializes in customer-centered go-to-market strategy, cross-functional alignment, and building commercial programs that drive measurable growth. Resources: • Connect with Caitlin Mayer on LinkedIn • Follow Medtronic on LinkedIn • Explore the Medtronic website
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    12 分
  • Why FDA Guardrails Still Matter in a Fast-Moving MedTech Industry with Suzanne Levy Friedman, Partner at Honigman

    Why FDA Guardrails Still Matter in a Fast-Moving MedTech Industry with Suzanne Levy Friedman, Partner at Honigman
    2026/07/23
    As AI and software become embedded in more medical technologies, companies must balance the pressure to innovate quickly with the responsibility to protect patients. In this episode, Suzanne Levy Friedman, Partner at Honigman, discusses how medical device and digital health companies can navigate evolving FDA regulations and bring products to market more efficiently. She explains how regulatory counsel helps organizations determine whether products fall under FDA oversight, distinguish wellness technologies from regulated devices, and build effective commercialization strategies. Suzanne also explores the growing tension between rapid innovation, particularly in AI, and the FDA's responsibility to protect public health. Finally, she shares how clearer regulatory guidance and early legal involvement can help manufacturers avoid costly setbacks and better operationalize compliance. Tune in to learn how early regulatory planning can help medtech companies innovate responsibly, reduce risk, and bring valuable technologies to patients more efficiently! Resources: Connect with and follow Suzanne Levy Friedman on LinkedIn. Follow Honigman on LinkedIn and explore their website. Contact Suzanne at sfriedman@honigman.com.
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    10 分
  • What Medtech Leaders Need to Know About AI Adoption with Danny Chu, VP of High Tech at Globant

    What Medtech Leaders Need to Know About AI Adoption with Danny Chu, VP of High Tech at Globant
    2026/07/22
    In fast-moving technology markets, innovation only creates value when companies can connect it to real business outcomes and bring people along through change. In this episode, Danny Chu, VP of High Tech at Globant, shares what he is seeing at the intersection of AI, robotics, and medtech from the floor of DeviceTalks in Boston. He discusses how minimally invasive technologies are reshaping care delivery and why AI represents a major inflection point for both service providers and customers. Danny explains that successful adoption requires more than advanced technology, emphasizing change management, human safety, and measurable business outcomes such as revenue growth, cost reduction, and operational efficiency. He also highlights the importance of modeling edge cases before scaling automation and maintaining a people-first approach throughout technology transformation. Tune in to learn how leaders can approach AI and robotics with a stronger focus on people, outcomes, and long-term adoption. Resources: Connect with and follow Danny Chu on LinkedIn or reach out via email. Follow Globant on LinkedIn and explore their website.
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    14 分