Podcasts about medical device industry

Ready to elevate your medical sales game? In the final episode of our Unfiltered Medical Sales mini series, seasoned expert Todd Crowder shares his top strategies for mastering client interactions and building lasting relationships. From choosing the right setting for a meeting to reading the emotional cues of your audience, Todd breaks down the art of creating connection while driving results, comparing the process to learning a manual transmission — smooth, responsive, and always in control. We explore the deeper side of sales, where emotional intelligence, patience, and authenticity matter more than flashy pitches. Todd unpacks how to build trust with the entire medical team, not just decision-makers, and why treating every encounter like a professional first date can lead to stronger relationships and more consistent wins. Through engaging real-life stories, Todd reveals how genuine rapport can lead to long-term partnerships, even if the first meeting doesn't result in a closed deal. He also shares key strategies for maintaining clear boundaries and avoiding the friend zone, where good intentions can sometimes undermine credibility and results. Packed with actionable advice and sharp insights, this episode is a powerful close to our series, perfect for both aspiring reps and seasoned professionals looking to level up. Don't miss this final chapter in the Unfiltered Medical Sales journey. Connect with Todd: LinkedIn Connect with Me: LinkedIn Love the show? Subscribe, rate, review, and share! Here's How » Want to connect with past guests and access exclusive Q&As? Join our EYS Skool Community today!    

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 the Unfiltered Medical Sales Series, Todd Crowder pulls back the curtain on the raw, real-world challenges of breaking into and thriving in medical sales. Through gripping stories and behind-the-scenes insights, Todd shares the high-stakes interview moments that test candidates' resilience, adaptability, and character — giving you a no-nonsense look at what it truly takes to stand out. From navigating uncomfortable conversations to turning interviews into opportunities for authentic connection, Todd shows why top performers in this industry are more than just polished resumes — they're relentless, resourceful, and ready for anything. He also dives into the psychology behind success in medical sales — unpacking how money and fear drive behavior, performance, and leadership. Learn how to identify candidates with the mental toughness to succeed without burning out, and how sales managers can harness those motivators to build unstoppable teams. For clinicians making a career shift or recent grads aiming for their first break, Todd emphasizes the power of relationships over credentials — and why mastering rapport will get you further than memorizing product specs. With actionable strategies, red flags to watch for, and tips for nailing interviews with confidence, this series is your unfiltered guide to launching and leveling up in the medical sales world. Connect with Todd: LinkedIn Connect with Me: LinkedIn Love the show? Subscribe, rate, review, and share! Here's How » Want to connect with past guests and access exclusive Q&As? Join our EYS Skool Community today!

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

Breaking Into Medical Sales: Gina Torres's Journey from Nurse to Industry Expert In this inspiring episode, Gina Torres, a seasoned peripheral vascular representative, shares her incredible transition from a peripheral vascular nurse to a top medical device sales expert at Shockwave. Discover how she leveraged her clinical background to drive innovation and improve patient outcomes, particularly in preventing amputations for those with peripheral arterial disease. Gina dives deep into the transformative power of intravascular lithotripsy technology and the critical role medical sales professionals play in advancing treatment solutions. She also sheds light on the evolving responsibilities of clinical specialists, balancing in-depth product knowledge with the art of sales. If you're considering a career in medical sales, Gina offers invaluable advice on how individuals from non-clinical backgrounds, such as marketing professionals, can successfully break into the industry. She also opens up about the challenges of balancing a demanding career with family life, sharing practical strategies for success. From launching Nurse Elevator to help nurses and techs transition into medical sales to her go-to book recommendation, Influence by Robert Cialdini, Gina's insights are packed with actionable takeaways. And, of course, we wrap up with a fun lightning round, including her must-try meal at Pecan Lodge in Dallas. Whether you're a healthcare professional, an aspiring medical sales rep, or simply curious about this dynamic field, this episode is packed with motivation, industry knowledge, and career-changing insights! Meet Gina: Gina is a former ICU and Interventional Radiology nurse who successfully transitioned into the medical device industry, where she is now an executive sales representative and a recognized expert in peripheral vascular interventions. Despite having no formal sales training, her deep clinical expertise and firsthand understanding of patient care have propelled her to excel in the field. She began her industry journey as a Clinical Support Specialist, where she quickly mastered the sales process with the guidance of exceptional mentors. Her ability to bridge the gap between clinical knowledge and sales strategy led her to secure a sales role, where she has since earned back-to-back President's Club awards. Passionate about helping other healthcare professionals leverage their skills beyond the bedside, Gina founded **Nurse Elevator**—a platform dedicated to guiding nurses, techs, and other clinicians into medical device sales and related non-hospital careers. She firmly believes clinicians bring unmatched value to the industry due to their deep understanding of patients and treatment algorithms. Through Nurse Elevator, Gina is on a mission to create a supportive and educational community that empowers healthcare professionals to confidently explore new opportunities. Connect with Gina: LinkedIn Connect with me: LinkedIn Love the show? Subscribe, rate, review, and share! Here's How » Want to connect with past guests and access exclusive Q&As? Join our EYS Skool Community today! The views and opinions Gina expressed are her own and not a reflection of Shockwave Medical or Johnson and Johnson MedTech.  

Jeanne Lenzer is an award-winning independent medical investigative journalist and author whose hard-hitting investigations and analyses have appeared in medical journals, such as The BMJ and the Journal of Family Practice, and in outlets such as the New York Times, Washington Post, Smithsonian Magazine, the Atlantic, Washington Monthly, Newsweek Japan, Mother Jones, and Discover. Her first book, The Danger Within Us: America's Untested, Unregulated Medical Device Industry and One Man's Battle to Survive It, explores themes that have been at the heart of Lenzer's work over the past three decades: the intersection of money and medicine and how profiteering distorts medical science and undermines the public health, often by gaming or misrepresenting research to obtain a desired outcome. The book served as a basis for the International Consortium of Investigative Journalists' award-winning Implant Files project on medical devices and for the Netflix show, Bleeding Edge . It was used by John Oliver for his segment on medical devices as well as by the television show, The Resident for segments on the vagus nerve stimulator. It was favorably reviewed by Jerome Groopman in The New Yorker.  Her investigations have revealed hidden financial ties between industry and public institutions, including the U.S. Food and Drug Administration, the Centers for Disease Control and Prevention and the National Institutes of Health. In each instance, she documented flawed scientific recommendations that serve to protect profits over public health. Examples include the CDC's recommendation for oseltamivir (Roche, Tamiflu), a campaign that was paid for by Roche; and the FDA's approval of drugs over the (sometimes unanimous) recommendations of their own scientists - after being contacted by politicians beholden to manufacturers. http://www.jeannelenzer.com/

In this episode, Diana Hall shares her motivation behind the innovation, arising from her work with children in poverty who struggled with traditional casts. She explains the benefits of ActivArmor's customizable, waterproof, and hygienic casts, and how they've reshaped fracture care across hospitals and sports teams globally. Diana also delves into the challenges of bringing a medical device to market, the importance of a strong advisory board, and navigating funding and insurance landscapes. The conversation highlights the impact of ActivArmor on patient care, its adoption by leading medical professionals, and Diana's advice for other entrepreneurs in the medical device industry.   Episode Highlights: 08:00 Challenges and Successes in the Medical Device Industry 10:30 Advisory Board and Expert Support 12:42 Navigating Funding and Compliance 14:55 Insurance and Market Adoption 19:24 Digital Process and Implementation   Diana Hall, a Colorado School of Mines Chemical Engineering graduate, has built a career at the intersection of innovation and impact. Inspired by her experiences with her brother in children's hospitals, Diana founded ActivArmor in 2014 to revolutionize medical casting. Combining her engineering expertise and MBA from Colorado State University, she developed custom 3D-printed, recyclable, and hygienic casts that improve patient mobility and comfort. An FDA-registered product, ActivArmor serves professional athletes, leading orthopedic clinics, and hospitals worldwide. Recognized as Colorado Manufacturing Woman of the Year and one of the most Influential Women in 3D Printing, Diana continues to advance medical technology globally.   How to connect with Diana: Website: Www.activarmor.com Facebook, Instagram, and TikTok: @activarmor   For more insights: Follow me on my YouTube Channel: https://bit.ly/47GgMdn  Sign up for my Weekly Newsletter:  https://bit.ly/3T09kVc Sign up for my LinkedIn Newsletter: https://bit.ly/49SmRV3See omnystudio.com/listener for privacy information.

The Deal Scout Newsletter: Unveiling Innovations in Medical TechnologyI'm thrilled to share the latest episode of "The Deal Scout" with you! This week, I had the pleasure of sitting down with Justin, a remarkable guest whose journey from a certified public accountant (CPA) to a key player in the medical device industry is nothing short of inspiring. Here's a sneak peek into our conversation and the key takeaways that you won't want to miss.Key Lessons and Insights:From Numbers to Innovation**: Justin's transition from a CPA to raising capital for groundbreaking medical technologies is a testament to the power of adaptability and passion. His story is a reminder that diverse experiences can lead to impactful innovations.Capital Raising **: Justin's first foray into capital raising was for a gene-editing project aimed at creating pig kidneys for human transplantation. Despite the fear and uncertainty, he successfully helped secure nearly $70 million, showcasing the importance of commitment and relationship-building in the world of venture capital.Aligning Interests**: At SynerFuse, Justin emphasizes the importance of aligning shareholder and patient interests. His approach ensures that both groups benefit from the company's success, working on creating a win-win scenario for all stakeholders.Innovative Pain Management**: SynerFuse is pioneering new technologies that integrate stimulation with spinal surgeries to address chronic pain. Their innovative approach aims to improve patient outcomes and reduce reliance on opioids, a significant step forward in pain management.Intellectual Property and Competition**: With over 80 patents filed globally, they believe they are well-positioned to defend its innovations. Justin discusses the competitive landscape and the challenges faced by smaller companies in the medical device sector.Curiosities and Highlights:Entrepreneurial Roots**: Justin's interest in accounting was sparked by his father's entrepreneurial spirit and a family friend's advice that becoming a CPA would provide insights into numerous businesses.Pioneering Gene-Editing Technology**: Justin's decision to pivot his career and help raise capital for a gene-editing project marked a significant turning point iSend us a textDisclaimer: The content shared on this podcast is for informational purposes only and should not be taken as financial, legal, or tax advice. The views and opinions expressed are those of the host, Josh Wilson, and any guests, and do not necessarily reflect the official policy or position of any agency or organization.Next Steps Share your thoughts with a review - https://www.thedealscout.com/reviews/ Let's connect on LinkedIn - https://www.linkedin.com/in/joshuabrucewilson/ Subscribe and Watch on YouTube - https://www.youtube.com/channel/UCBQN_Y3nhDGClfMxCSBDjOg Disclaimer: The content shared on this podcast is for informational purposes only and should not be taken as financial, legal, or tax advice. The views and opinions expressed are those of the host, Josh Wilson, and any guests, and do not necessarily reflect the official policy or position of any agency or organization. Josh Wilson is a licensed real estate broker and an investment banker, but this podcast is not a substitute for professional advice. We strongly recommend that you consult with a qualified financial advisor, legal counsel, and tax professional before making any financial decisions or taking any actions based on the information provided in this podcast.

Transforming Pain Management with InnovationI'm thrilled to share some incredible insights from our latest podcast episode featuring Justin Zenanko, the co-founder, president, and CEO of SynerFuse. This conversation is packed with valuable lessons and innovative ideas that are sure to resonate with investment groups and growth-stage business owners like you.Here are the key takeaways:

As a fourth installment of this podcast into key industry leaders in neuromodulation, this is our conversation with Milad Girgis, who is the VP and General Manager of the Brain franchise at Boston Scientific. Milad has dedicated over 25 years to the Medical Device Industry, with two decades at Boston Scientific. Before diving into his impressive tenure at Boston Scientific, we explore the earlier phases of his career and identify key turning points that shaped his professional journey. Milad provides insights into what his typical day at Boston Scientific looks like. We also discuss the competitive DBS landscape and how they create unique selling points for their program. Milad shares exciting developments and future plans that are on the roadmap, giving us a glimpse into the innovations driving the industry forward. Finally, we illuminate Boston Scientific's approach to DBS with their unique strategy and focus on image guidance – among other concepts. Our conversation also addresses the academic community's curiosity about transitioning to industry roles, with our guest presenting a compelling case for why a career in the medical device industry can be rewarding. Join us as we explore and map some new potential horizons for neuromodulation.

Philippe AghionCollège de FranceÉconomie des institutions, de l'innovation et de la croissanceAnnée 2023-2024Colloque - Conference on the Economics of Innovation in Memory of Zvi Griliches : Ariel Stern, "Who Drives Digital Innovation: Evidence from the U.S. Medical Device Industry" (Co-authors: A. Everhart, C. Foroughi) Discussant: Iain CockburnColloque en anglais organisé par Philippe Aghion, Lee Branstetter et Adam Jaffe.Intervenant(s)Ariel Stern, "Who Drives Digital Innovation: Evidence from the U.S. Medical Device Industry"(Co-authors: A. Everhart, C. Foroughi)Discussant: Iain Cockburn

Artificial intelligence enabled devices are changing the landscape of medical devices and are subject to evolving regulation. Listen back to a replay of our webinar from late last year as team of lawyers from Covington & Burling LLP discuss key considerations for the AI-enabled medical device space, including current best practices for industry participants seeking to take advantage of this powerful new technology.Panelists from Covington included:Andrew MentPam ForrestAdrian PerryTo watch a video replay of the webinar, you can find it on Medical Alley's YouTube page.Follow Medical Alley on social media on LinkedIn, Facebook, Twitter and Instagram.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.The FDA has posted guidance on cybersecurity for medical device companies seeking authorization for new devices. Mass General Brigham is collaborating with the FDA to create a brain-computer interface group to address challenges facing developers of such devices. Moody's predicts that AI will expand medtech portfolios and revenue streams in the next two years. Abbott has recalled its HeartMate LVAD communication system due to reported injuries linked to the device malfunctioning. 3M has named William Brown as CEO, replacing Michael Roman. The medical device industry is seeing a trend towards incorporating AI and digital health technologies.The FDA has raised safety concerns about early patient deaths in those treated with Bristol Myers Squibb's Abecma and Johnson & Johnson's Carvykti ahead of an advisory committee meeting. In other news, the Alabama Supreme Court's ruling on in vitro fertilization has caused political blowback and uncertainty in the market. Additionally, Lilly has made its weight-loss drug Zepbound available through Amazon Pharmacy, and Ionis' antisense molecule has shown positive results in a Phase II trial for liver disease. Novartis has acquired IFM Due in a deal potentially worth $835 million, and the FDA is questioning the benefit-risk profile of Geron's MDS candidate.Heinz is launching a campaign to promote gravy as more than just a holiday condiment, leveraging its iconic status to encourage consumers to use gravy like they use ketchup. "Godzilla x Kong" has released Roblox's first immersive movie trailer, allowing players to be swept into a virtual game after watching a 2D teaser. Meta announced updates to Advantage+ and shopping ads, while Barkley and OKRP have merged to create a "big indie" agency. Marketing Dive provides insights into news and trends shaping the marketing and advertising industry, covering topics such as marketing technology, social media, video marketing, analytics, and more.

The FDA announced the alignment of QMSR to the ISO 13485 standard. So now the question is: What does it change for me? Do you need to update your full QMS? Will you need to go through another audit or inspection? Is this really a revolution?  Naveen Agarwal from Exceed will answer this question. So don't miss this episode to know more about QMSR.  Who is Naveen Agarwal?  Dr. Naveen Agarwal has 20+ years of diverse industry experience in leadership roles ranging from R&D to Product Quality and Business Analytics. He holds a Ph.D. in Polymer Science & Engineering from the University of Massachusetts, Amherst. He is an ASQ certified Quality Engineer, a Manager of Quality and Operational Excellence, and a certified Project Management Professional. In his consulting practice, he works on strategic projects in Risk Management, Design Control, Post-Market Surveillance, and Quality Culture in the Medical Device Industry. In his spare time, he enjoys distance running, community work, and spending time with his family. Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link:  Naveen Agarwal Linkedin Profile: https://www.linkedin.com/in/naveenagarwal/  Learn more about Let's Talk Risk! here ans subscribe: https://naveenagarwalphd.substack.com/about  Webinar recording - Getting Ready for QMSR: https://naveenagarwalphd.substack.com/p/webinar-5-getting-ready-for-qmsr   Risk management training on ACHIEVE:  https://www.achievexl.com/    Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

The Biden administration is expected to finalize a new air regulation that's pitting its environmental justice work, cancer prevention goals, and efforts to ensure the stability of the medical device industry against each other. POLITICO's Annie Snider breaks down how the administration is trying to balance its public health priorities and the pushback against the rule. Plus, EPA announced that the remaining $1 billion in Superfund money from the bipartisan infrastructure law will go toward work at over 110 sites around the U.S.   For more news on energy and the environment, subscribe to Power Switch, our free evening newsletter: https://www.politico.com/power-switch And for even deeper coverage and analysis, read our Morning Energy newsletter by subscribing to POLITICO Pro: https://subscriber.politicopro.com/newsletter-archive/morning-energy   Josh Siegel is an energy reporter for POLITICO.  Annie Snider covers water issues for POLITICO Pro.  Nirmal Mulaikal is a POLITICO audio host-producer.  Annie Rees is a senior audio producer-host at POLITICO.  Gloria Gonzalez is the deputy energy editor for POLITICO.  Matt Daily is the energy editor for POLITICO.

This week, we sit down with our Thematic Investments Spezialist, Martina Oetiker and talk about MedTech. DISCLAIMER This publication is for information- and marketing purposes only. The provided information is not legally binding and neither constitutes a financial analysis, nor an offer for investment-transactions or an investment advice and does not substitute any legal, tax or financial advice. Bergos AG does not accept any liability for the accuracy, correctness or completeness of the information. Bergos AG excludes any liability for the realisation of forecasts or other statements contained in the publication. The reproduction in part or in full without prior written permission of Bergos is not permitted.

In this episode of Executive Decisions, guest hosted by Seth Whicker, guest Tim Early, CEO of DreamOn Group, shares his insightful journey from an early career decision to move from New York to Florida, leading to a pivotal role in the medical device industry with Cordis Corporation. Tim reflects on his educational transitions, notably from West Point to Rochester Institute of Technology, and his shift from accounting to packaging engineering, emphasizing the importance of aligning one's strengths with career choices. The episode delves into Tim's experiences with changing industry regulations and the challenges they presented, highlighting his adaptability and growth in various roles, including quality engineering at companies like CR Bard Corporation and Johnson & Johnson. Tim discusses the nuances of different corporate cultures, and the significance of effective communication and diverse skill sets in executive leadership. The narrative also touches on his venture into entrepreneurship, offering valuable lessons on risk-taking, resilience, and the critical balance of opportunity and decision-making in an executive's journey.   About our guest, Tim Early: Tim Early, the CEO of DreamOn Group is known by many as the Founder and former CEO of Network Partners Group and a visionary in the life sciences industry. Tim brings with him a rich history of innovation, evidenced by his contributions to medical technology and packaging. He holds patents for advancements in laparoscopic packaging. His leadership in companies like Network Partners, Zimmer, and Johnson & Johnson has centered around building teams of passionate professionals and developing solutions that emphasize client and colleague needs. With a Master's in Packaging from RIT, Tim continues to shape the industry with forward-thinking approaches and a commitment to excellence.   Summary and highlights from the show:  • Early Career Decisions: Tim Early shares his journey of moving from New York to Florida without a job and how he seized an opportunity in the medical device industry with Cordis Corporation, reflecting the importance of adaptability and initiative in leadership. • Educational Shift and Career Relevance: Discussing his transition from West Point to Rochester Institute of Technology, Tim highlights the significance of recognizing one's strengths and interests, as he shifted from accounting to packaging engineering. • On-the-Job Learning and Growth: Tim talks about his early career experiences in medical device packaging, emphasizing the value of learning on the job and adapting to roles beyond formal education, a key skill for successful executive leadership. • Facing Industry Regulations and Challenges: Tim's experience with FDA regulations at Cordis Corporation illustrates the importance of compliance and adaptability in executive roles, especially when navigating changing industry standards. • Career Development at CR Bard Corporation and Johnson & Johnson: Tim recounts his roles at these companies, focusing on the impact of corporate culture on his professional growth. His experiences underline the importance of aligning with a company's culture and values for effective leadership. • Quality Engineering and Interdisciplinary Skills: Tim's transition from packaging to quality engineering demonstrates the need for executives to possess diverse skill sets and the ability to handle various aspects of a business. • Leadership and Communication Skills: Discussing his role at Johnson & Johnson, Tim emphasizes the importance of effective communication with both peers and executives, a crucial skill for leadership, especially when delivering challenging news. • Insights on Corporate Culture: Reflecting on his time at different companies, Tim shares insights into various corporate cultures (technology-driven, sales and marketing-driven, financially-driven) and how understanding these cultures is vital for effective leadership and decision-making. • Professional Risks and Learning from Mistakes: Tim's story of starting ISO Pack and the challenges faced provides insights into risk-taking and learning from failures, highlighting resilience as a key attribute of executive leadership. • Final Reflections on Career and Leadership: In his closing remarks, Tim reflects on his career, emphasizing the importance of understanding the full breadth of business operations and the challenges of transitioning from a corporate executive to a business owner. He also shares his regret of not starting his entrepreneurial venture earlier, illustrating the balance of risk and opportunity in executive decision-making.   Connect with Tim Early: Email LinkedIn   About SYM Financial Advisors and the Executive Decisions Podcast: Executive Decisions is a podcast designed for current and aspiring business leaders, offering an in-depth look at the evolving nature of executive roles. Hosted by SYM Financial Advisors Principal and Senior Financial Advisor Sarah Delahanty, the show delves into the personal and professional journeys of its guests, exploring the challenges they've overcome and the learning experiences that have shaped their paths to success. The podcast provides insights into how executives manage the increasing complexity of both their professional and personal lives. Featuring a range of guests from diverse industries, each episode aims to enlighten listeners on the continuous state of learning and adaptation necessary for effective leadership. Whether discussing career progression, leadership strategies, or personal growth, Executive Decisions is a valuable resource for anyone interested in the multifaceted world of executive leadership.   Disclosure: Certain links above are to third-party sites and are not affiliated with SYM Financial Corporation (“SYM”). SYM is an independent investment adviser registered under the Investment Advisers Act of 1940, as amended. Registration does not imply a certain level of skill or training. More information about SYM including our investment strategies, fees and objectives can be found in our ADV Part 2, which is available upon request.    

Loren Deren has over 20 years of experience in the pharmaceutical and medical device industries, initially as a field sales representative and then working her way up to managing representatives and distributors in large geographic areas.   Continuing education, she has a Masters in Biotechnology, and sharing her passion for orthobiologics has always been a priority, which led her to write and conduct training programs for those aspiring to break into medical device sales.   She is currently a VP at APEX Biologix, shaping the company into a market leader in regenerative medicine. Please take 30 minutes to listen to her conversation with Linda Robertson on the Lifesciences Professional Podcast.

When you look at ISO 13485 or EU MDR or US FDA, they all want to see that you are reducing the risk for your products. But to do that you have to brainstorm and identify those risks. Usually, we follow ISO 14971 for that. But not all of your team is aware of this, and we are now short on time. So, what to do? Draft it by yourself or work with some colleagues. Naveen Agarwal will be sharing with us the best way to collaborate to create a successful Risk Management process. So, let's listen to that.  Who is Naveen Agarwal?  Dr. Naveen Agarwal has 20+ years of diverse industry experience in leadership roles ranging from R&D to Product Quality and Business Analytics. He holds a Ph.D. in Polymer Science & Engineering from the University of Massachusetts, Amherst. He is an ASQ certified Quality Engineer, a Manager of Quality and Operational Excellence, and a certified Project Management Professional. In his consulting practice, he works on strategic projects in Risk Management, Design Control, Post-Market Surveillance, and Quality Culture in the Medical Device Industry. In his spare time, he enjoys distance running, community work, and spending time with his family.  Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link:  Naveen Agarwal Linkedin : https://www.linkedin.com/in/naveenagarwal/ Linkedin Post: https://naveenagarwalphd.substack.com/p/collaboration-is-the-secret-sauce-for-riskmgmt  Achieve Website: https://www.achievexl.com  Let Us Talk Risk Newsletter: https://naveenagarwalphd.substack.com/  Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice Authorized Representative and Importer services: https://easymedicaldevice.com/authorised-representative-and-importer/ Subscribe to our LinkedIn Newsletter: https://www.linkedin.com/build-relation/newsletter-follow?entityUrn=7051455462466023424

Artificial Intelligence is the actual hot topic that everyone is talking about. A lot of countries are starting to regulate this technology. But what are we talking about. This episode will help you understand AI and also understand what the risks to it are. This is really an interesting topic, but a lot of people are really afraid when we talk about AI. We will try to give you some tips to clarify the situation.  For that I have invited Christophe Girardey from Wega to answer my questions as he is helping companies who use Artificial Intelligence for their software.  Who is Christophe Girardey?  Christophe Girardey is Managing Director at Wega, a life science consulting company specializing in digitalization. Christophe is responsible for the Quality Assurance Team which supports Pharmaceutical and Medical Device companies when it comes to compliance of Software. Wega supports you through the software lifecycle with its expertise in the regulatory field, allowing you to concentrate on your expertise in medical software development. Wega can help you to optimize your Software Development processes to reach compliance/quality by design. This includes performing gap analysis, advising on how to implement agile methodologies in a compliant way, configuring and validating the different Software tools to reach an optimal and qualitative Software Development.  Christophe has 15 years of experience within the regulated industry and started his career as Software Developer prior moving to Quality Management activities and can hence best make the bridge between the SW Development and Quality Assurance Team by fostering innovation combined with compliance.  Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link:  Christophe Girardey Linkedin : https://www.linkedin.com/in/christophe-girardey-77ab6027/ Wega Website : https://www.wega-it.com/  Medical Device Compliance: https://www.wega-it.com/computer-systems-validation-quality-assurance#medical-device-compliance  Data Sciences: https://www.wega-it.com/clinical-development-it#data-science  Wega Breakfast: Artificial Intelligence in GxP environments: https://www.youtube.com/watch?v=dCDwEkXd9jU&t=11s  Nature Article (co-authored):  https://www.nature.com/articles/s41582-020-00448-7FDA list of Software with AI: https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices? Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/ Subscribe to our LinkedIn Newsletter: https://www.linkedin.com/build-relation/newsletter-follow?entityUrn=7051455462466023424

Episode 021: Harsh Thakkar (@harshvthakkar) interviews Monir El Azzouzi (@melazzouzi), Founder & CEO at Easy Medical Device.Monir emphasizes the importance of following people in the medical device industry, learning as much as possible, and providing the right vocabulary and language to build self-confidence. Monir also shares his favorite LinkedIn creators, the importance of understanding medical device regulations, and the challenges he faces in consulting.Harsh and Monir discuss the importance of staying up-to-date with medical device regulations and the challenges that come with consulting in the life sciences industry. Harsh and Monir also discuss the importance of building a personal brand and give tips on leveraging social media to grow a business. -----Links:* Easy Medical Device* Do you love LS 360 and want to see Harsh's smiling face? Subscribe to our YouTube channel.-----Show Notes:(7:29) How to be an online marketer. (15:25) What Monir loves about being a consultant.(19:34) How to use LinkedIn to help your clients. (24:50) Advice on medical device classifications.(29:41) How do you track and share information with your audience?(34:49) The importance of content marketing.(37:56) Advice for people just starting out in the industry.For more, check out the podcast website - www.lifesciencespod.com

Richard Williams is Linda's guest on the Lifesciences Professional Podcast this week. He has 20+ years of national channel and direct sales leadership experience in the Canadian healthcare market. Richard has represented top-tier dental, medical device and pharmaceutical, distributors and manufacturers and has a vast continuum of care background in Acute Care, Primary Care, Alt Site, LTC, Ret, Complex Care, Hospice, Home Care, HHC, EMS, Schools, Pharmacy Chains, Drug Wholesalers, Medical Distributors and Labs. He is currently the Director of Sales - Central & Western Canada for SteriMax Inc. Success has been the hallmark of Richard's journey after he completed his undergraduate degree at Savannah State University in Georgia. He earned his master's in Public Health from Georgia Southern University and has held commercial sales, clinical specialist, business development, key account management and sales leadership roles ever since.  Richard is a proud and caring father of one beautiful daughter and is a community mentor and board member for several not-for profit organizations.

On this episode of Medical Marketing Executive, Dorra Draoui, Director of Global Marketing at Endologix, shares her experience in marketing and engineering and how it has helped her in her current role. She also discusses the impact of COVID-19 on planning and the importance of flexibility in strategies.

Dr. Sanjay Shrivastava is the founder and CEO of Innova Vascular, Inc., a company engaged in developing innovative cardiovascular medical devices. Prior to founding Innova, Sanjay cofounded BlackSwan Vascular, which is a medical device startup company that developed the first liquid embolic agent approved for a peripheral vascular use in the USA and has a strategic alliance with Sirtex Medical Limited. Sanjay also serves as a member of the board of directors at enVVeno Medical Corporation, which is a Nasdaq traded medical device company headquartered in Irvine, CA. Sanjay has been involved in developing, commercializing, evaluating, and acquiring medical devices for over 20 years. During his career, Sanjay has held positions at leading medical device companies including senior director, business development at Johnson & Johnson, vice president, upstream marketing and strategy at BTG, plc. (a publicly traded company that was acquired by Boston Scientific Corporation), director global marketing at Medtronic and director, research & development at Covidien/ev3 (merged with Medtronic). Sanjay holds 31 issued US patents and numerous International patents in medical devices and has edited two books including one titled “Medical Device Materials” published by ASM International. He was named among 100 Notable People in Medical Device Industry by the prestigious MD&DI (Medical Devices and Diagnostics Industry) magazine. He has been an invited speaker at clinical, business, and engineering conferences to speak about medical device innovation and commercialization. Sanjay holds a doctorate in materials science and engineering from the University of Florida and a bachelor's from the Indian Institute of Technology.   -- Critical Mass Business Talk Show is Orange County, CA's longest-running business talk show, focused on offering value and insight to middle-market business leaders in the OC and beyond. Hosted by Ric Franzi, business partner at Renaissance Executive Forums Orange County. Learn more about Ric at www.ricfranzi.com. Catch up on past Critical Mass Business Talk Show interviews... YouTube: https://lnkd.in/gHKT2gmF LinkedIn: https://lnkd.in/g2PzRhjQ Podbean: https://lnkd.in/eWpNVRi Apple Podcasts: https://lnkd.in/gRd_863w Spotify: https://lnkd.in/gruexU6m #orangecountyca #mastermind #ceopeergroups #peergroups #peerlearning  

The Medical Device industry faces a host of different issues and considerations which impact their IP strategy.  Sandy Chan of IP Counsel Cafe speaks with Derek Minihane, Vice President, R&D at Cochlear, a global leader in implantable hearing solutions, and Miku Mehta, Partner at Procopio law firm where he focus on Asia-Pacific Practice.  They will discuss where Cochlear decides to file for IP protection and why, how busiess and IP protection have evolved over the past three years, and much more.      

Today's Flash Back Friday Episode is from Episode #288, which originally aired on September 4, 2020. Mike's early real estate experience comes from the family construction business where he worked his way through college and was able to gain the skills necessary to manage all aspects of construction and project management. After college, Mike entered the corporate world and has had a successful 20+ year career in Medical Sales with the last 15 years spent in the Medical Device Industry. This unique combination of skill sets served him well as he built a personal real estate portfolio of over $6M across multiple asset classes while working full time. He enjoys educating people on real estate investment and has been featured on multiple podcasts and speaks at local REI meetups. Mike currently lives in Springfield, MO with his wife Aline and their two children. He enjoys spending time with family, hunting, fishing, and snow skiing. Mike has a heart for mission work and believes that “We are blessed to be a blessing to others”. He lives this out through serving others locally, nationally, and internationally. Recommended Resources:  Accredited Investors, you're invited to Join the Cashflow Investor Club to learn how you can partner with Kevin Bupp on current and upcoming opportunities to create passive cash flow and build wealth. Join the Club! If you're a high net worth investor with capital to deploy in the next 12 months and you want to build passive income and wealth with a trusted partner, go to InvestWithKB.com for opportunities to invest in real estate projects alongside Kevin and his team.  Looking for the ultimate guide to passive investing? Grab a copy of my latest book, The Cash Flow Investor at KevinBupp.com.  Tap into a wealth of free information on Commercial Real Estate Investing by listening to past podcast episodes at KevinBupp.com/Podcast. Learn more about Kevin's investment company and opportunities for Lifetime Cashflow at sunrisecapitalinvestors.com.

Today's Flash Back Friday Episode is from Episode #300, which originally aired on December 8, 2020. Mike's early real estate experience comes from the family construction business where he worked his way through college and was able to gain the skills necessary to manage all aspects of construction and project management. After college, Mike entered the corporate world and has had a successful 20+ year career in Medical Sales with the last 15 years spent in the Medical Device Industry. This unique combination of skill sets served him well as he built a personal real estate portfolio of over $6M across multiple asset classes while working full time. He enjoys educating people on real estate investment and has been featured on multiple podcasts and speaks at local REI meetups. Mike currently lives in Springfield, MO with his wife Aline and their two children. He enjoys spending time with family, hunting, fishing, and snow skiing. Mike has a heart for mission work and believes that “We are blessed to be a blessing to others”. He lives this out through serving others locally, nationally, and internationally.  Recommended Resources:  Accredited Investors, you're invited to Join the Cashflow Investor Club to learn how you can partner with Kevin Bupp on current and upcoming opportunities to create passive cash flow and build wealth. Join the Club! If you're a high net worth investor with capital to deploy in the next 12 months and you want to build passive income and wealth with a trusted partner, go to InvestWithKB.com for opportunities to invest in real estate projects alongside Kevin and his team.  Looking for the ultimate guide to passive investing? Grab a copy of my latest book, The Cash Flow Investor at KevinBupp.com.  Tap into a wealth of free information on Commercial Real Estate Investing by listening to past podcast episodes at KevinBupp.com/Podcast. Learn more about Kevin's investment company and opportunities for Lifetime Cashflow at sunrisecapitalinvestors.com.

Lisa Jacobs is a high-performing executive sales leader known for formulating and executing scalable strategies to accelerate business expansion, revenue generation, and team development in startup, turnaround, and rapid-growth environments across domestic and global markets. She has spent much of her career in the orthopedic and spine, launching innovative robotic navigation platforms and implantable products. She is also an active mentor passionate about helping others achieve their potential. To be successful in medical sales, she recommends that women work with their managers to move their careers forward. Currently, only 23% of women hold management and director-level job titles in medical sales. She wants to pay it forward, as many individuals have helped her throughout her career.  Join Linda and Lisa as they discuss tips on entering and being successful in the medical device space.

Engineering Success interviews Mo Oyetunji is a Quality Specialist in the Medical Device Industry. Mo has previously worked as a Materials & Corrosion Engineer within the Oil and Gas industry for over a decade and is very much passionate about teaching and inspiring kids about STEM subjects. She is the Owner of Asa West - a UK based fashion retailer established in 2017 and is also the founder of ‘More Blessed to Give' charity established in 2012 which provides outreach and support for homeless men, women and kids as well as financially supporting individuals for higher education in Nigeria. Mo is the host of ‘The 360 Lady Podcast' - a podcast that inspires and equips women to be the highest and healthiest version of themselves. She became a member of AFBE in 2018 and currently a Board Member leading the Gala Awards 2023.

George was invited to converse with Naveen Argarwal on a recent post he put up on Linkedin about seatbelts.  They talk CAPA, risk management, quality culture, and leadership (to name a few!)  Dr. Naveen Agarwal has 20+ years of diverse industry experience in leadership roles ranging from R&D to Product Quality and Business Analytics. He holds a Ph.D. in Polymer Science & Engineering from the University of Massachusetts, Amherst. He is an ASQ certified Quality Engineer, a Manager of Quality and Operational Excellence, and a certified Project Management Professional. In his consulting practice, he works on strategic projects in Risk Management, Design Control, Post-Market Surveillance, and Quality Culture in the Medical Device Industry. In his spare time, he enjoys distance running, community work, and spending time with his family.You can find him and information about his work, especially regarding risk management for medical devices here:   https://www.achievexl.com/https://www.linkedin.com/in/naveenagarwal/You can also watch this episode here:  https://www.youtube.com/watch?v=DERVviyppL0 

The evaluation of the Risk-Benefit ratio is key for Risk Management Files per ISO 14971 or when you build your Clinical Evaluation Report or when you need to define the risk of using a particular technology against another. I mean that risk-benefit evaluation is mainly what helps us to decide that our product is safe and performant. So on this episode, Naveen Agarwal from Achieve will be my guest and help us understand the best way to measure your benefit-risk ratio. Who is Naveen Agarwal? Dr. Naveen Agarwal has 20+ years of diverse industry experience in leadership roles ranging from R&D to Product Quality and Business Analytics. He holds a Ph.D. in Polymer Science & Engineering from the University of Massachusetts, Amherst. He is an ASQ certified Quality Engineer, a Manager of Quality and Operational Excellence, and a certified Project Management Professional. In his consulting practice, he works on strategic projects in Risk Management, Design Control, Post-Market Surveillance, and Quality Culture in the Medical Device Industry. In his spare time, he enjoys distance running, community work, and spending time with his family. Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Links: Naveen LinkedIn profile: https://www.linkedin.com/in/naveenagarwal Exceed consulting solution: www.exeedqm.com Achieve training: www.achievexl.com Case study https://www.achievexl.com/benefit-risk-analysis-fda-case-study Downloadable white paper from the FDA: https://www.fda.gov/medical-devices/products-and-medical-procedures/weight-loss-and-weight-management-devices

Today's guest, Chris Larsen is the founder and Principal of Next-Level Income. Chris has been investing in and managing real estate for over 20 years. While still a college student, he bought his first rental property at age 21. From there, Chris expanded into development, private-lending, buying distressed debt as well as commercial offices, and ultimately syndicating commercial properties. He began syndicating deals in 2016 and has been actively involved in over $1B of real estate acquisitions. Chris is passionate about helping investors become financially independent.   Get in touch with Chris: www.NextLevelIncome.com   If you want to know more about Dr. Jason Balara and the Know your Why Podcast: https://linktr.ee/jasonbalara Audio Track: Back To The Wood by Audionautix is licensed under a Creative Commons Attribution 4.0 license. https://creativecommons.org/licenses/by/4.0/   Artist: http://audionautix.com/ 

Welcome to our Podcast #2,184! Here's a link to our Costa Rica Pura Vida Amazon Products Store! Happy Shopping! https://www.costaricagoodnewsreport.com/costaricaproductsamazon.html We appreciate your listening and hope you find the time to go through the 100's of episodes that we have recorded already. They're short, so listen to a few every day! I promise you will learn all you need to know about one of the happiest countries on the planet! Here's some links that will get you started in learning more about Costa Rica! If you're thinking about moving to Costa Rica, we can assist! Visit "Royal Palms Costa Rica Real Estate". . we are DEDICATED BUYER'S AGENTS. Check out our website at www.costaricaimmigrationandmovingexperts.com/buyersagent.html Here's our NEW Costa Rica Good News Report YouTube Channel. Over 200 Short, Entertaining Videos that will get you excited about Costa Rica: https://www.youtube.com/@thecostaricagoodnewsreport/videos Check out an amazing travel website catering to those travelers age 50 and over! Dozens of incredible expert contributors writing about so many destinations: https://www.travelawaits.com/ Here's our 1st contribution to the TravelAwaits website: https://www.travelawaits.com/2789789/questions-to-ask-if-thinking-about-retiring-in-costa-rica/ Here's a link to our 2nd article on the TravelAwaits website as promised: https://www.travelawaits.com/2798638/tips-for-driving-in-costa-rica/ Here's a link to our 3rd article on the TravelAwaits website: https://www.travelawaits.com/2794704/how-to-gain-residency-status-in-costa-rica/ Check out our NEW COSTA RICA LOVE STORIES! There's ONE THING BETTER than falling in love. . falling in love in COSTA RICA! Here's the link: https://www.costaricagoodnewsreport.com/lovestories.html So many GOOD-NEWS stories coming out of Costa Rica. We'd love to share them with all of you! Way over 100 stories ready right now. Learn all about one if the Happiest Countries on the Planet. . Costa Rica! Here's a link: https://vocal.media/authors/skip-licht Become a "COSTA RICA PURA VIDA" Brand Ambassador & Share the LIFESTYLE with EVERYONE! Here's the link: https://www.costaricagoodnewsreport.com/brandambassador.html Here's a link to the US Embassy here in Costa Rica: https://cr.usembassy.gov/ --- Send in a voice message: https://anchor.fm/costa-rica-pura-vida/message

Welcome to The MedTech Hustlers Podcast Series. In this episode, we had a productive conversation with our prominent guest, Sonal Matai, who is the Managing Director of Karl Storz Endoscopy America. We discussed Medical Device Industry from an overview to discussing value-based healthcare, trending medical device therapies, Covid-19 impact, and artificial intelligence in MedTech. The discussion revolved around what does the future holds in the medical device industry.

Dr. Josh Makower is one of the few multidisciplinary leaders making a tremendous and broad-reaching impact on the medical device and consumer product industries. As an inventor, professor, CEO, and venture capitalist with experiences in medicine, bioengineering, business, and big pharma, Makower has led the charge in creating some of the most unique and practical designs.  In this episode, host Geoff Pardo speaks with Makower about his interests in science and technology at an early age, his college transition from music to engineering, and what he believes is the future of biodesign. Makower details the mechanics of his inventions for incontinence, chronic sinusitis, benign prostatic hyperplasia, and women's health as part of the nine companies he created in the past 25 years. Finally, he speaks about the joy of teaching and offers sage advice to up-and-coming medtech innovators: “My classic piece of advice for anyone getting into any health-related field is you really have to be perseverant. You have to never give up because there are so many reasons to turn away and give up, but if you have a dream and believe in what you're doing and are willing to listen and adapt, that's key. I think anyone can win, and it's just about believing in yourself and your vision.” Links from this episode:  Stanford University Stanford University School of Medicine ExploraMed, a medical device incubator Coravin Willow 

Luís Meireles is currently CEO and co-owner of MDI Industrial a Medical Device Industry in Brazil and a senior consultant for European companies. Luís is Portuguese, Ph.D. in Biotechnology but moved to Brazil, spending the last decade helping to introduce medical devices into Latin America he was responsible for the introduction of Mortara Instruments in Brazil with a successful plan growing from almost zero to one of the market leaders. He was a senior consultant for Hill-Rom visiting almost all countries in Latin America, being perfectly aware of the difficulties of implementing and growing the health market in LATAM, especially in Brazil.

The new Blue Guide is out. So what are the changes for Medical Device Manufacturers? Erik Vollebregt will give us his analysis and also some revelation on the Swiss MRA process if you are still in need of the situation in Switzerland. Who is Erik Vollebregt? Erik specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software, and personal data protection. He is an expert in life sciences regulation at the EU and Dutch level, with a focus on contracts, and regulatory litigation against competent authorities and M&A. Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms. He actively contributes to law and policy development at the national and EU levels via membership in specialized committees at branch associations and the European Commission. Erik also works as an arbitrator in medical devices-related disputes and is regularly retained as an expert witness in foreign litigation. Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish. Chambers Europe 2017: Erik is known for his specialism in regulatory work, which covers medical technology, devices, and products as well as biotechnology. Clients confirm his strong capabilities, with one saying “he stands out to me. Whenever I work with lawyers he has been the best, with a solid scientific background. He has the perfect combination of skills and experience.” Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He has created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… Is company is also acting as Authorized Representative for the EU, UK, and Switzerland? Easy Medical Device has become a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Links Erik Vollebregt Linkedin: https://www.linkedin.com/in/erikvollebregt Axon Lawyers: https://www.axonlawyers.com/ Blue Guide link: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:C:2022:247:TOC Blog Blue Guide: 2022 Update: https://medicaldeviceslegal.com/2022/08/07/the-blue-guide-2022-update-new-elements-regarding-applicability-of-eu-law-on-products/

Jasmine Jones, CEO of Cherry Blossom Intimates is an Innovator with a capital "I". After witnessing her grandmother's struggle to find post-masectomy bras and breast forms that fit her body shape & color, Jasmine set out to revolutionize the medical device industry and make the world a better place for Breast Cancer Survivors. Jasmine is a TedX speaker, Miss District of Columbia 2016 & Miss Black District of Columbia USA, a Forbes 30 Under 30 entrepreneur, Tory Burch Foundation Fellow, & TechStars Award Winner. She is changing the way that women of all walks of life find comfort in their skin. This conversation is loaded with applicable wisdom on how to be paid to learn about what you're excited about, disrupting an industry (one lesson at a time),  how to find your niche, and putting your money to work.  

What are the differences between 3D printing and additive manufacturing? What are the quality and regulatory considerations around 3D printing? What is FDA's approach to whether or not this technology should be regulated?In this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols talk to Mike Drues of Vascular Sciences about the pros and cons of 3D printing in the medical device industry and key considerations manufacturers should make with regard to this technology. Some of the highlights of this episode include:Although additive manufacturing and 3D printing are often used interchangeably, Mike explains that 3D printing is a very broad category with at least a dozen different technologies under that category, including additive manufacturing.FDA describes 3D printing as, “a process that creates a three-dimensional object by building successive layers of raw material. Each new layer is attached to the previous one until the object is complete.”Classic or traditional manufacturing is more subtractive than additive. What if the intended patient population is for one person, can a clinical trial be performed for validation? Additive manufacturing poses regulatory and quality challenges.FDA has sought input from the medical device industry, manufacturers, healthcare providers and facilities to explore appropriate regulatory approaches for Point-of-Care (PoC) 3D printing of medical devices.For example, Mike discusses that the regulation of today was not intended for 3D printing face masks and other protective gear. The lack of regulation should not hold back manufacturers from getting products on the market and through FDA.FDA, as well as Mike, recommends software certification for people using 3D printing in a controlled environment to make safe and effective products.Memorable quotes from this episode:“There's been now about 100, a little more, medical devices that have come through the FDA onto the market that have been 3D printed.” Mike Drues“The phrase, ‘additive manufacturing,' comes from the fact that many of these technologies, certainly not all, but many of them are based on layer-by-layer-by-layer technology.” Mike Drues“Additive manufacturing is 3D printing, but not all 3D printing is additive manufacturing.” Jon Speer“There's two ways you can do a validation. One way is to validate the product. The way we do clinical trials today is we essentially validate the product, but the other way we can do a validation is to validate the process.” Mike Drues“The blending of tech and med device, it's scary on one hand, but it can be exciting, as well. I'm looking forward to seeing how this impacts and hopefully improves our health care in the world.” Jon SpeerLinks:FDA - 3D Printing of Medical DevicesFDA - Technical Considerations for Additive Manufactured Medical Devices GuidanceFDA's Role in 3D PrintingFDA - Process of 3D Printing Medical DevicesFDA - 3D Printing Medical Devices at the Point of Care: Discussion PaperFDA - Classify Your Medical DeviceFDA - The 3Rs of 3D Printing: FDA's RolePART 820 - Quality System Regulation (QSR)Mike Drues on LinkedInGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru AcademyGreenlight Guru

In this episode, we are joined by Parimal Shah, the General Manager of Ultrasound Radiology at Siemens Healthineers. Parimal is a recognized transformational MedTech leader who focuses on clinicians and patients. We discuss the changes in the MedTech industry over the last twenty-five years, the key challenges that the industry is facing right now, and the interrelationship between customer relationships and product experience. Tune in to learn more about the current status of leadership in the industry and why it needs to evolve. Finally, Parimal shares his predictions on the industry and digitalization for the next two years.   In This Episode, We Cover:   [04:23] Key challenges the MedTech industry is facing right now.  [09:24] The interrelationship between customer relationships and product experience. [13:27] The issues that need to be solved to succeed in customer experience expectations. [15:25] Why does leadership need to evolve? [17:50] Parimal shares where he sees the digital transformation in the next two years.   Key Takeaways:   Customer experience in the MedTech industry is viewed in two different ways. First, what it takes to get this product in the hands of customers in the way in which it can be managed and used. Second, business continuity is seen as a higher priority in the minds of our customers, and this is coupled with how they use it, the convenience of use, the cost at which it comes, and how it can be digitized so that it can be used by clinicians who are not as well versed with the products. Leadership in the MedTech industry needs to evolve. The industry requires leadership who can be versatile and diverse enough to look at current technologies and trends and how they will impact the customer's business.  The nature of digital is majorly influencing the buying decisions. It is about who owns the data, what you can do with it, and what outcomes you can change with it.   About Speaker   Meet Parimal:   Parimal Shah is currently the General Manager of ultrasound radiology at Siemens Healthineers. Before Siemens, he served in various leadership roles offering increasing responsibilities at Becton Dickinson, Baxter, and GE healthcare. He's a recognized transformational MedTech leader, focusing on clinicians and patients. He has held many positions in product development and R&D including Senior Vice President of product development for innovation and clinical research specific to ultrasound. He has done key investments and product portfolios, front-end innovation, and strategic external partnerships. Parimal has achieved above-market growth and P&L across multiple market segments with different customer needs. He has significant experience in executing with large teams and building technical and operational organizational capability. And if this was not enough, he rounds off all this experience with a proven track record for launching medical devices globally and new and established markets.   Resources   Parimal Shah on LinkedIn: https://www.linkedin.com/in/parimalshah/   Axtria on LinkedIn: https://www.linkedin.com/company/axtria/ 

In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Ken Zalevsky, Certified CyberSecurity Leader and CEO of Vigilant Ops, about software bill of materials (SBOMs) and cybersecurity in the medical device industry.Ken has collaborated with the FDA, U.S. Department of Homeland Security (DHS), and National Telecommunications and Information Administration (NTIA) on cybersecurity initiatives, including cyber simulation exercises, industry guidance documents, and SBOMs. Ken's written work advises medical device manufacturers on cybersecurity best practices and coaches hospitals on handling record numbers of breaches.Some of the highlights of this episode include:Ken defines an SBOM as a list of software components that compose any system, application, or device. In health care, medical devices are computer-based systems with software components.Engineers may know all about software and security, but not with medical devices and SBOMs. Medical device manufacturers are familiar with safety and efficacy in a regulated industry and may need to overcome software challenges.Most medical device software teams don't build everything that is in a medical device. Scope appropriately because third-party components may involve risk.Safety is not the same as security, but both should be included early in the product life cycle. Cybersecurity standards include authorization, authentication, and encryption versus safety recalls, use cases, and vulnerabilities.SBOMs are not evergreen documents. They need to be maintained and updated regularly to act, react, and take action.Health care is the primary target for hackers over other verticals and the response time in health care has always been the slowest. Today, it takes about 160 days for a healthcare organization to discover a security breach. Memorable quotes from Ken Zalevsky:“A detailed list of those software components is really the essence of an SBOM.”“At the heart of it, the idea and the purpose of the SBOM is to give that transparency into software components that are utilized in medical devices.”“Most software companies, especially medical device software teams, don't build everything that's in the device. They take components from other third parties and there's risk associated with those components.”“You can't blame it all on the hospital because the hospital has no idea what's running in those devices.”“Providing that transparency, understanding what you're deploying on your network, just is common sense.”Links:Medical Device Security Made Easy - InSight Platform by Vigilant OpsSBOM - National Telecommunications and Information Administration (NTIA)NTIA - Minimum Elements For a Software Bill of MaterialsFDA - Guidance Documents (Medical Devices and Radiation-Emitting Products)FDA - Medical Device OverviewAAMI TIR57: Principles for medical device security - Risk managementThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru AcademyGreenlight Guru

The year 2021 was really full of updates for the Medical Device Industry. I can understand that it goes so fast you cannot follow. So I tried to summarize the year 2021 and also tell you some objectives that we are planning for 2022. So I hope this will give you some important information. Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses… Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice The post What happened in 2021? Summary for the Medical Device Industry appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

In this episode of the Global Medical Device Podcast, Jon Speer talks to Herschel “Buzz” Peddicord, founder and CEO of InControl Medical, which designs and manufactures patented devices for the control of incontinence.Listen to Buzz share his valuable insights from spending four decades in the medical device industry, developing products that address and improve quality of life and truly make a difference in patient lives.Some of the highlights of this episode include:Guard Cash: It takes some medical device startups to raise additional rounds of funding and capital, but don't give up or be ashamed to ask for advice about designing and developing devices to get them to market.Anytime you develop a medical device product, you must test, maybe redesign, connect with target customers, and overcome the FDA's regulatory challenges.More than 60 million women experience female urinary incontinence and another 17 million deal with fecal incontinence. Yet, treatments such as medications and surgery aren't effective.The two types of female incontinence are stress urinary incontinence due to weak pelvic floor muscles caused by childbirth or high-impact exercise and urge incontinence caused by the overactive detrusor bladder muscle.Herschel decided to develop a device that treats both types of incontinence. Attain is a transvaginal device that delivers dual stimulation signals to all muscles involved in causing incontinence.No woman has ever died from urinary incontinence, but it dramatically changes their lifestyle. Attain allows women to get away from using pads and diapers to stay dry and avoid leakage.Memorable quotes from Herschel Peddicord:“Female urinary incontinence - it is an absolutely huge market. More than 60 million women deal with urinary incontinence and another 17 million deal with fecal incontinence.”“Incontinence in 90% of the cases is a muscle issue.”“We have about a 93% success rate at stopping urinary incontinence.”“As far as we know, no woman has ever died from urinary incontinence, but it dramatically changes their lifestyle.”Links:InControl MedicalKeiretsu Capital, LLCFDA - 510(k) ClearancesAffordable Care ActGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

Quality is a concept that is often overcomplicated in the medical device industry. With complexity comes mistakes, which is why it's so important for manufacturers to simplify!In this episode of the Global Medical Device Podcast Jon Speer is joined by Mark Alpert, director of quality at Greenlight Guru with thirty years of industry experience in quality, about the past, present, and future global landscape of medical device quality.Some of the highlights of this episode include:Mark and Jon agree that the medical device industry is at a crossroads currently because Europe is a ‘hot mess' when it comes to quality. Countries with different agendas and requirements led to inconsistencies and interpretations of laws.It takes time, often several years, for companies to transition to new or revised regulations and standards. Some companies are only beginning to implement, adopt, and change their processes in a way that they understand what risk-based approach means for their management systems.Some medical device companies have lost their way when it comes to quality, and many believe the quality profession is partly to blame for being driven by tools, not data.Mark describes a do versus don't do mindset to bring creativity, objectivity, and ability to scale back into the procedure process, such as during audits.Do not seek or expect perfection. Do the best you can to move forward and know that there are opportunities for improvements. Demonstrate confidence, compliance, and processes in place that drive improvement.Memorable quotes from this episode:“I think today, we're also at a very interesting crossroads when it comes to quality. There's a number of different facets.” Jon Speer“It's going to take years before companies can really adopt, implement, flow down, and make it inherent in how they do business every day.” Mark Alpert“Once complexity creeps into the system, you're just about guaranteeing mistakes will be made that will result in some non-conformances.” Mark Alpert“A lot of companies, I think their quest is towards compliance.” Jon SpeerLinks:ISO 13485ISO 9001FDA - Medical DevicesFDA - Quality System RegulationEuropean Union Medical Device Regulation (EU MDR)European Union In Vitro Diagnostics Regulation (EU IVDR)Mark Alpert on LinkedInThe Global Medical Device Podcast: Quality - Who, What, When with Christie Johnson from Kasota EngineeringGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

There are many schools of thought when it comes to the 'who, what, and when' of quality management for medical devices.In this episode of the Global Medical Device Podcast Jon Speer talks to Christie Johnson with Kasota Engineering, a consulting firm focused on quality in the medical device industry. Listen to this episode as Jon and Christie offer their insights and guidance on medical device quality management best practices.Some of the highlights of this episode include:Who manages quality? Most startups first hire someone with years of experience, but Christie encourages early firms to embrace the teach mentality. Christie enjoys training teams to build an understanding of quality from scratch.What is quality? Those with a willingness and capability to learn can be coached to know what a quality management system is and needs to include initially.Two Schools of Thought: Companies either view quality as, do it later when the time is right or that's not my job. Quality is a way for companies to ensure safety and efficacy. Put your products and services at the center of your universe.Christie's philosophy is to never do what traditional consultants in the industry do. She never just shows up, throws some documents down, and walks away.Which QMS to implement? The system that you should implement is the one that your team will use. Make it simple and fast. If your team cannot understand and readily use the tool, they're not going to do it or follow the procedure/process.Delivering a QMS without providing step-by-step training can lose functionality. Start with baby steps into processes, especially for those without experience.What to include? You don't need to comply with regulations right away. Put things in place - early data, suppliers - document/record what you're doing during the research and discovery phase. Tell your story and take credit for your hard work.Why are you struggling? The reality is it takes longer than six months to one year to get your idea or product on the market. Trial knowledge can reduce risk.Memorable quotes from Christie Johnson:“If you can read and understand the regulation and if you can sit and work with me and help me understand your background and I can coach you, we can start putting in place your early quality system.”“Our philosophy is very much to never do what traditional consultants in the industry do, which is show up, throw some documents down, and walk away.”“The system that you should implement is the one that your team will use and make it easy.”“It's really easy to get lost or just ignore the quality system that's in place, especially if you come into an organization that already has way more than they need.”Links:Christie Johnson on LinkedInKasota EngineeringNational Institutes of Health (NIH) - Rapid Acceleration of Diagnostics (RADx)Devon Campbell with ProdctFDA - Medical DevicesISO 13485Meet a Guru - Taylor BrownGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

Complying with regulatory bodies is more than just producing the documentation when they ask for it. If the regulatory body is as stringent as FDA, they look for several red flags, including completeness and thoroughness of the documentation and confidence level. But speed is typically the most critical factor. Manufacturers with manual processes and fragmented systems might struggle with the speed expectations of these regulatory bodies.In today's episode, we have our guest, Tom Rodden, who discusses the nuances of medical device manufacturing and how it differs from generalized manufacturing. He also discusses several processes and system needs that are driven by regulatory bodies such as FDA. Finally, he shares several stories where poorly maintained systems and methods may have had catastrophic results for the company.For more information on growth strategies for SMBs using ERP and digital transformation, visit our community at wbs.rocks or elevatiq.com. To ensure that you never miss an episode of the WBS podcast, subscribe on your favorite podcasting platform.

Is the widespread panic over the EU In-vitro Diagnostics Regulation (IVDR) justified? For many device professionals, the one year countdown to the IVDR deadline in May 2022 is almost here, causing much anxiety about whether compliance is even possible.In this episode of the Global Medical Device Podcast, Jon Speer and his guest Joanne LeBrun, VP of Quality Systems at MDC Associates, shine light on EU IVDR transition concerns and the challenges the medical device industry faces, like the notified body shortage.Some highlights of this episode include:Why are some notified bodies not interested? There's a ton of work, audits, and corrective actions. They don't view it as necessary to move forward and pursue.First, notified bodies plan a wait-and-see approach to find out how the EU MDR goes on May 27. The notified bodies are overwhelmed and resources are limited.The EU MDR has more constituents involved and is a bit more straightforward to implement than the IVDR. The IVDR has less constituents but more things that are different, such as product classification.The opportunity to self-certify for MDR has passed and certain notified bodies are no longer accepting new clients. You can contact your authorized representative about cut-off dates to get your CE mark.Even if you don't have to submit a technical documentation file, you still need to have one and review it constantly. Make it part of your change controls,For ISO/MDSAP certifications and audits, do not have duplicates of files and documentation. Only have one source of information or you are setting yourself up for failure and will be out of compliance. Notified bodies are not designed to teach regulatory and quality professionals what they should know to be ready. Prepare and reach out before it is too late.Memorable quotes from Joanne LeBrun:“One of the conditions of going live for the IVDR is that they have seven notified bodies by the time we're supposed to go live. They have a year to get more notified bodies.”“I think that notified bodies are very overwhelmed.”“While the MDR has more constituents involved, I think that it's going to be a little more straightforward to implement than the IVDR. The IVDR has less constituents but way more things that are different - particularly product classification.” “That honor system is now gone, and we all have to keep up on it. You really do need to update your technical file all the time.”Links:Joanne LeBrun on LinkedInMDC AssociatesFDA - Medical DevicesEU IVDREU MDRNotified BodiesNew Approach Notified and Designated Organizations (NANDO)ISO 13485:2016ISO 14971:2019 ISO/TR 24971:2020Medical Device Single Audit Program (MDSAP)Overview of the 510(k) ProcessAllison Komiyama from AcKnowledge Regulatory StrategiesGlobal Medical Device Podcast, EP 193: Quality Management for IVD Devices vs Medical Devices with Joanne LeBrun Greenlight Guru AcademyGreenlight Guru AcademyGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

Today's guest in Mike Vann. Mike's early real estate experience comes from the family construction business where he worked his way through college and was able to gain the skills necessary to manage all aspects of construction and project management. After college, Mike entered the corporate world and has had a successful 20+ year career in Medical Sales with the last 15 years spent in the Medical Device Industry. This unique combination of skill sets served him well as he built a personal real estate portfolio of over $6M across multiple asset classes while working full time. He enjoys educating people on real estate investment and has been featured on multiple podcasts and speaks at local REI meetups. Mike currently lives in Springfield, MO with his wife Aline and their two children. He enjoys spending time with family, hunting, fishing and snow skiing. Mike has a heart for mission work and believes that “We are blessed to be a blessing to others”. He lives this out through serving others locally, nationally and internationally. Today's Topics Include: How Mike got started in multifamily real estate Why his first deal was a 100 unit in Prior, OK How he makes investing in a rural community work How he managed to build his portfolio while working his full-time medical sales job How he likes to give back to his community How his properties have performed through COVID And much more Connect with Mike Vann: Website: www.tridentmultifamily.com Connect with Us: Connect with Us: Website: www.themultifamilytakeoff.com Instagram: http://instagram.com/themultifamilytakeoff Email: Mike: Mike@themultifamilytakeoff.com Shawn: shawn@themultifamilytakeoff.com Rich: rich@themultifamilytakeoff.com DON'T FORGET TO SUBSCRIBE, RATE, REVIEW, AND SHARE