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What if your next business idea wasn't about making millions—but helping just one person? In this episode, Tom Livingston, CEO of Rampart IC, shares how a late-night phone call from a friend sparked the idea for a life-saving medical device—and how that simple act of service grew into a globally distributed, 8-figure company. From sketching concepts on a napkin to testing a prototype during a secret cabin weekend, Tom's journey is a masterclass in purpose-driven leadership, calculated risk, and building something that truly matters.Whether you're burning the midnight oil on your own big idea or still in the dreaming phase, this conversation is for you. Tom opens up about building the company while working full time, the coffee table pact that changed everything, and the power of building a team rooted in belief, not just ambition. This is a story of faith, uncertainty, and the quiet courage it takes to bet on what doesn't exist—yet.WILDFLOWER SHOWNOTES : shannaskidmore.com/tom-livingston-rampart-ic
In this episode, Cecile van der Heijden will disclose all the secret of the EHDS or European Health Data Space law. We will talk about the impact on Medical Device manufacturers but also on you as a human being as all this is about manipulation of data. Personal data or anonymized data. But can it be un-anonymized… Listen to this episode. Who is Cecile van der Heijden? Cécile van der Heijden is a senior legal expert at Axon Lawyers, a boutique law firm based in the Netherlands specialized in legal and regulatory affairs for the life sciences sector. With a strong focus on digital health, data protection, and medical device law, Cécile advises companies on navigating complex European regulations such as the MDR, GDPR, and the newly adopted European Health Data Space (EHDS) Regulation. She regularly supports clients developing AI, software as a medical device (SaMD), and connected technologies, helping them align innovation with compliance. Known for her practical approach, Cécile frequently speaks at conferences and publishes insights on digital health law across the EU. 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 Cecile van der Heijden LinkedIn Profile: https://www.linkedin.com/in/cevanderheijden/ Axon Lawyers website: https://www.axonlawyers.com/ EHDS: https://www.european-health-data-space.com/ Article EHDS: https://www.consilium.europa.eu/en/press/press-releases/2025/01/21/european-health-data-space-council-adopts-new-regulation-improving-cross-border-access-to-eu-health-data/ 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/
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Dr. Arun Menawat, Chairman and CEO of Profound Medical. Profound is commercializing the TULSA-PRO system, an alternative approach to prostate cancer treatment that uses MRI-guided thermal ultrasound to target and eliminate cancerous tissue without surgical incisions. Before joining Profound in 2016, Arun served as the Chairman and CEO of Novadaq Technologies for 13 years, guiding the company from a startup to one of the fastest-growing, NASDAQ-listed medical technology businesses with a market cap exceeding one billion USD. Earlier in his career, Arun served as President of Cedara Software, a company that developed the industry's first medical imaging software platform. Today, it's part of IBM's Watson Health.In this interview, Arun shares insights on building credibility with physicians, the strategic approach to clinical trials that led to their recent Medicare reimbursement coverage, and his vision for transforming the future of surgery beyond prostate cancer.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Arun Menawat.
Check out the TIES Sales Showdown at www.tx.ag/TIESVisit The Sales Lab at https://thesaleslab.org and check out all our guests' recommended readings at https://thesaleslab.org/reading-listTo listen to The Sales Lab Podcast on your favorite apps, visit https://thesaleslab.simplecast.com/ and select your preferred method of listening.Connect with us on Facebook at https://www.facebook.com/saleslabpodcastConnect with us on Linkedin at https://www.linkedin.com/company/thesaleslabSubscribe to The Sales Lab channel on YouTube at https://www.youtube.com/channel/UCp703YWbD3-KO73NXUTBI-Q
In part 2 of a critical two-part series, Etienne Nichols and regulatory affairs expert Mike Drues explore the nuanced pathway of switching a medical device from prescription (Rx) to over-the-counter (OTC). This episode dives deep into what triggers a new submission, how usability testing and human factors play an expanded role for lay users, and the regulatory logic that guides these transitions. The conversation highlights the importance of aligning regulatory strategy with business goals, and offers practical insights on leveraging real-world evidence, understanding the limits of FDA databases, and optimizing pre-submission meetings.Key Timestamps02:10 – Starting from a cleared 510(k): Do you need a new submission for OTC?06:45 – Implications of removing the healthcare provider from the equation12:00 – Risk management: Expanding risk profiles when lay users are involved18:15 – When a 510(k) becomes a De Novo or PMA22:50 – Usability testing and the risk of user error in OTC devices31:20 – Clinical investigations and good clinical practices (GCPs)36:00 – Real-world evidence vs. real-world data—what's usable?41:30 – Using Pre-Subs effectively and what “quality data” really means47:10 – Labeling, cleaning, and UDI for OTC products53:40 – OTC software and digital health—when is it a regulated device?01:00:00 – Summary: Aligning regulatory logic with common sense and business strategyQuotes“With an OTC device, we are taking the healthcare professional totally, completely, and utterly out of the loop.”– Mike DruesThis quote encapsulates the core regulatory challenge in moving a device to OTC: every element, from labeling to usability, must assume zero clinical supervision.“If the clinical trial won't tell you anything you don't already know from good real-world evidence, why spend the time and money?”– Mike DruesA powerful argument for using well-documented real-world evidence over unnecessary trials—provided the data truly meets evidentiary standards.Top TakeawaysLabel Expansion ≠ Shortcut: Moving from prescription to OTC usually requires a new submission—especially when removing the healthcare provider introduces new risks.Usability Testing Is Critical: OTC usability studies must go beyond IFU comprehension to include risk of misuse, poor device selection, and user decision-making.Real-World Evidence Can Help—If It's Clean: Real-world data isn't always usable. FDA will expect reproducibility, traceability, and strong justifications.Labeling & Design Must Assume No Clinical Oversight: Cleaning procedures, warnings, and directions must all be validated for home use and layperson comprehension.Use Pre-Subs Wisely: Especially for label expansions or gray-area digital health tools, pre-subs provide critical alignment with FDA and prevent costly errors.References & ResourcesEtienne Nichols on LinkedInFDA Guidance on Real-World Evidence for Regulatory Decision-MakingGreenlight Guru Webinar: What is and Isn't a Regulated Medical Device (feat. Mike Drues)FDA Guidance: Clinical Decision Support SoftwareMedTech 101: OTC vs Prescription DevicesAnalogy: Think of prescription vs. OTC devices like driving a manual vs. automatic car. Prescription devices assume a trained “driver” (the healthcare provider), while OTC devices must be intuitive and safe enough for anyone to “drive”...
As health care advances, our medical devices have to evolve to keep up, which means they have to be connected to networks and the wider internet in ways they never were before. Unfortunately, that also means they're prime targets for hackers who want to steal your information and cause chaos. The recent "Device Talks Boston" conference focused, in part, on how the industry needs to catch up and put stronger security in place for our medical devices. Trevor Slattery, Chief Technology Officer at Blue Goat Cyber in Scottsdale, Arizona attended the conference, and stepped away to talk with Nichole about solutions for this problem.
Send us a textJoin host Aaron Moncur as he sits down with Dr. Stuart Grant, a seasoned med tech innovator with over 25 years of experience at industry giants like Johnson & Johnson and DePuy. Dr. Grant shares his journey from design engineering to founding his own consultancy, offering invaluable insights into medical device development, regulatory challenges, and the future of medical technology.Main Topics:Career progression in medical device engineeringChallenges of starting a medical tech consultancyRegulatory differences across global marketsInnovation strategies in medical technologyAdvice for young engineersFuture trends in surgical robotics and AIAbout the guest: Dr. Stuart Grant is a seasoned expert in the MedTech industry with over 20 years of experience at major companies like Johnson & Johnson and DePuy Synthes. In 2023, he founded Archetype MedTech, a consultancy that helps medical device companies achieve market approval through innovation strategy, technical evaluations, and team training. He holds advanced innovation and project management degrees and is a Chartered Engineer with several medical device patents. In addition to his technical work, Stuart lectures on innovation history and is a visual artist. His international experience and multidisciplinary expertise make him a key advisor for MedTech startups and scale-ups.Links:Dr. Stuart Grant - LinkedIn Archetype MedTech Website The Idea Factory: Bell Labs and the Great Age of American InnovationExactly How Precision Engineers Created the Modern World
Gemma started her career studying Mechanical Engineering at Cardiff University. She quickly discovered the world of Continuous Improvement and spent 20 years working to improve processes and systems within various manufacturing industries including Automotive, Pharmaceutical, Dairy, Cosmetics & Toiletries, Food, and Medical Devices. She has been a CI Manager numerous times and an Operations Manager running a factory of over 500 people.Gemma is hugely passionate about Improvement and developing people and processes. She gets such a kick out of coaching and facilitating, especially when she sees the lightbulb switch on in someone's head – when they solve a problem; when they realize they have the power to change; or when they get excited about all the improvements they could make.In 2019, Gemma left the world of employment to establish her own business, SPARK Improvement, aiming to switch on as many lightbulbs as possible. Her mission is to help organizations and individuals be the BEST they can be, by helping people SEE, helping people THINK, and helping people CHANGE.Gemma is based in Cheshire in the UK, working globally.Link to claim CME credit: https://www.surveymonkey.com/r/3DXCFW3CME credit is available for up to 3 years after the stated release dateContact CEOD@bmhcc.org if you have any questions about claiming credit.
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Claire Dixon, CEO of Neuraura.Neuraura is developing LoOop, an over-the-counter wearable that targets PCOS through low-frequency electrical stimulation.Claire brings over 25 years of international leadership experience to her role as co-founder and CEO of Neuraura. With a master's degree in engineering from Cambridge and an MBA from Harvard, she spent 15 years as a strategic consultant to capital-intensive businesses before transitioning to entrepreneurship. She was recently named among the “Top 200 Trailblazing Leaders in Women's Health and femtech” by Women of Wearables.In this interview, Claire shares insights on navigating regulatory pathways, designing for real user needs, and building strategic partnerships to bring innovative women's health solutions to market through a direct-to-consumer approach.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Claire Dixon.
In this episode, Aouda Ouzza is helping us understand when the Regulatory Affairs person is needed during the design phase. The problem that we will uncover here is the fact that in most cases the design team are calling the Regulatory Affairs person on a project when they have finished everything and they need this person to take care of the registration before launch. But this is wrong, and we'll let you know when and why you should involve them earlier. Listen to this episode. Who is Aouda Ouzzaa? Aouda Ouzzaa brings over 16 years of expertise in Regulatory Affairs (RA) and Quality Assurance (QA), supporting the entire product lifecycle—from development to post-market surveillance. She has successfully led projects across pharmaceuticals, biologics, medical devices (EU MDR), cosmetics, and Software as a Medical Device (SaMD). Her global regulatory knowledge spans EMA, FDA, GCC, and Rest of World (ROW) markets. Aouda has hands-on experience preparing IND, BLA submissions, and securing orphan drug designations. As a certified GMP and GDP auditor, Aouda has worked closely with cross-functional teams to ensure compliance with international standards while optimizing regulatory interactions. Her methodical approach and deep understanding of complex regulatory environments make her a strategic asset for organizations navigating global compliance challenges. Whether you're developing a new drug, launching a medical device, or scaling a digital health solution, Aouda Ouzzaa brings the insight and precision needed to achieve regulatory success. 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 Aouda Ouzza LinkedIn Profile: linkedin.com/in/aouda-ouzzaa-51877a32 SmartQARA website: https://smartqara.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/
In Part 1 of this two-part series, Etienne Nichols sits down with regulatory strategist Dr. Mike Drues to explore the nuanced differences between prescription (Rx) and over-the-counter (OTC) medical devices. They demystify key terms, regulatory classifications, and the growing trend of label expansions from Rx to OTC—highlighting real-world examples like CPAP machines and continuous glucose monitors (CGMs). This episode unpacks how intended users, environments, and risk tolerances shape device categorization, and why usability testing is far more complex than many realize. Whether you're developing a consumer health product or preparing a label expansion strategy, this is a must-listen for your regulatory roadmap.Key Timestamps[03:05] – What defines an OTC vs. prescription medical device?[06:45] – Market size of OTC devices and major product categories10:00 – Label expansion: moving from Rx to OTC status13:22 – The role of intended use environment in OTC classifications20:40 – Examples of devices in each FDA class that are OTC26:30 – Prescription devices used in home settings vs. true OTC31:15 – Characteristics that qualify devices for OTC status37:55 – Self-diagnosis, self-selection, and patient usability challenges43:00 – “Reasonably foreseeable misuse” and how to interpret guidance49:05 – Do you design for the lowest common denominator?56:10 – Representing diverse user populations in usability testing1:01:45 – Can a device launch OTC first? The case for wellness-to-Rx strategies1:08:15 – FDA's perspective on device safety: OTC vs. RxQuotes“The best regulatory professionals don't just know the rules—they know the exceptions.”Dr. Mike Drues reminds us that exceptional regulatory strategy lies in understanding nuance, especially in OTC classifications where edge cases can redefine categories.“Just because a device is used at home doesn't mean it's over the counter.”This insight challenges a common industry assumption, underscoring the importance of carefully defining intended use and environment early in development.Key TakeawaysOTC ≠ Low Risk by Default – Many Class II and even rare Class III devices can be OTC; it's more about intended user, use environment, and risk mitigation than class alone.Label Expansion Requires Strategy – Transitioning a device from prescription to OTC isn't just about removing a doctor's role—it may involve new usability studies, labeling changes, and potentially a 510(k) or de novo submission.Understand the "Intended Use Environment" – FDA doesn't just care about where the device is used, but how those environmental parameters (like light, humidity, and user training) affect safe operation.Usability Testing Must Reflect Real Users – For OTC devices, human factors validation must account for diverse educational backgrounds, not just ideal users.Don't Rely on Labels Alone – Whether or not users read (or understand) instructions must be tested, not assumed. Intuitive design is critical for OTC success.References & ResourcesEtienne Nichols on LinkedInGreenlight Guru Medical Device Classification Webinar with Mike Drues (for explanation on device classes)FDA Guidance: “Factors to Consider When Making Benefit-Risk Determinations in Medical Device...
Roadmap for Medical Device Startups Hello, this is Hall T. Martin with the Startup Funding Espresso -- your daily shot of startup funding and investing. The path for a medical device startup is clearly defined. In building a medical device startup or diligencing one, consider this roadmap. Market requirements -- establish the current state of the market, including size, needs, and current solutions. Product requirements -- define the requirements a medical device product must have to be successful with customers. Clinical unit -- a prototype that is used to run initial clinical tests. Preclinical validation -- initial test results with the clinical unit. First in human test -- clinical trials with human subjects. Clinical validation -- in human clinical test results. CE Mark -- regulatory approval to sell a product in Europe. First European orders -- initial sales of the product in Europe 510 K clearance -- regulatory approval to sell the clinical device in the US. First US orders -- initial sales of the product in the US. Break even -- sales equal operating costs. Growth then scale -- sales continue to grow. In reviewing a medical device startup, it's important to know the steps ahead and plan your fundraising for it. Thank you for joining us for the Startup Funding Espresso where we help startups and investors connect for funding. Let's go startup something today. _______________________________________________________ For more episodes from Investor Connect, please visit the site at: Check out our other podcasts here: For Investors check out: For Startups check out: For eGuides check out: For upcoming Events, check out For Feedback please contact info@tencapital.group Please , share, and leave a review. Music courtesy of .
Podcast de Capital, la Bolsa y la Vida
Podcast de Capital, la Bolsa y la Vida
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.com/podcastWhy your resume isn't the make-or-break factor in landing a job, common mistakes people make with resumes, why relationships matter more than the perfect resume, how to show growth and numbers on your resume even if you're not in sales, creative ways nurses and clinical specialists can showcase their skills, how to avoid overloading your resume with too much information, why clarity and simplicity beat long resumes, what sales managers are actually looking for when scanning resumes, the importance of emotional intelligence for younger candidates, and how building relationships beats obsessing over your resumeKey Takeaways:It's not just about the resume. You need to focus on relationship building to stand out.Numbers and percentages showing growth are critical, even if you're not coming from a sales background.You don't need a flashy or overly detailed resume. Clarity and relevance win every time.Nurses, PTs, and clinical backgrounds can show value by highlighting efficiency, patient outcomes, or communication skills.Keep each role on your resume to 2-4 strong points max. Don't overload it with every task you ever did.For clinical specialist roles, patient-facing skills matter more than showing sales numbers.Stop blaming your resume. If you were truly that strong of a candidate, you'd be moving forward regardless.
Whether you've already gained height or are planning your procedure, figuring out how to explain it to friends, family, or coworkers can be tricky. In this livestream, we'll break down real strategies patients use - from full honesty to creative cover stories - and help you decide what story fits your journey best.________Audio Podcast: will be posted within 24-48hrs after the stream endsTimestamps: Chapters00:00 Intro to Limb Lengthening Surgery and Patient Experiences07:44 Updates from Patients: Progress and Challenges16:55 What to Tell Others About Surgery27:35 Exploring Limb Lengthening Options30:03 Personal Experiences with Lengthening Surgeries33:01 The Controversy Surrounding Height Surgery35:59 Navigating Social Perceptions of Height40:02 Understanding the Psychological Aspects of Height Surgery42:59 The Role of Proportions in Height Perception45:59 Addressing Concerns and Risks of Limb Lengthening51:58 The Stigma and Misunderstandings of Height Surgery54:09 Personal Experiences with Pain and Support55:54 Sharing Personal Stories and Family Support56:19 Surgical Procedures and Costs57:17 Updates on Medical Devices and Market Trends59:20 Industry Pricing and Patient Awareness01:01:40 Technical Difficulties and Community Interaction01:05:06 Financing Options for Surgery01:09:40 Outro________
In this episode, Claire Dyson will clarify to us what is the new PMS requirements from UK MHRA. You have maybe heard recently the UK MHRA saying that there should be a new requirement to perform Post-Marketing Surveillance for Medical Devices in the UK. So what this means? Who is impacted? How to comply? Listen to this episode. Who is Claire Dyson? Claire Dyson began her career in rational drug design and moved into medical device through devices that interact with drugs and drug-delivery systems. Claire entered certification bodies in 2018 and is now the Head of UK Approved Body for DQS, an international, accredited certification body offering ISO 13485, MDSAP and CE conformity assessment to medical device manufacturers. She is involved in DQS's application to become a UK Approved Body and offer UKCA conformity assessment. In parallel, she interacts with DQS's international team developing accessible content to support manufacturers with the regulatory pathways and transitions. 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 from the Video Claire Dyson LinkedIn: Claire Dyson | LinkedIn Blogs – 3 part series on U vs UK PMS UK PMS Regulations: Overview & Key Requirements for Medical Device Safety UK Medical Device Vigilance – Part 2: Vigilance & Reporting Requirements UK PMS vs EU MDR – Key Differences & Impact on CE-Marked 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/
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
From Burnout to Boundaries: The Mindset Shift That Helps You Thrive If you've ever said, “I just need to get through this week…” — this episode is for you, my high-achieving friend. Burnout isn't just exhaustion — it's often hidden behind achievement. In this episode, I'm pulling back the curtain on:
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Vicky Demas, CEO of identifeye HEALTH (formerly Tesseract Health), who's leading the company's efforts to democratize access to retinal imaging. Using advanced algorithms and automated systems, identifeye's technology captures and analyzes retinal images to detect early signs of disease.Before joining identifeye HEALTH, Vicky led new product development at GRAIL, supporting the creation of the company's multi-cancer early detection test (Galleri). She was also a founding member of Google Life Sciences (later Verily) within Google [x], where she led teams focused on diagnostics, medical devices, and translational laboratory science. An engineer and scientist, Vicky holds over 20 patents and has authored numerous scientific publications across multiple disciplines.In this interview, Vicky challenges founders to consider: Are you building a diagnostic solution that can scale globally or a product limited to specialized healthcare settings? She also discusses why understanding real-world implementation challenges early can prevent costly missteps later.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Vicky Demas.
In this episode of Let's Accommodate Drugs and Devices, host Subhi Saadeh shares four pieces of timeless career advice inspired by Morgan Housel's book, 'Same as Ever'. This episode is particularly aimed at bioengineering students and early-career professionals. The tips include: publishing early to build visibility, understanding how industry regulations and processes work, developing interdisciplinary skills, and finding mentors for guidance. Subhi emphasizes the importance of learning for its own sake and seeking out diverse experiences to enhance one's career prospects in the highly regulated field of bioengineering.00:00 Introduction and Purpose of the Episode00:36 Tip 1: Start Publishing Early04:26 Tip 2: Learn How Industry Really Works06:14 Tip 3: Build Skills Across Disciplines09:00 Tip 4: Find Mentors and Network12:08 Conclusion and RecapSubhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.
In the past on the podcast, we've explored health-tech and medical devices leveraging next-generation technologies to improve outcomes, including innovations in heart health, neuro-tech, and deep tech like AI and Machine Learning. While advancements like Brain Computing Interfaces show promise, we're not there yet. Today's devices and technologies focus on enhancing quality of life now, while innovators pave the way for the future.In today's episode we discuss devices and technologies shaping the present and future for individuals with mobility challenges, a growing societal issue as aging demographics rise in developed countries. With 500-700 million people globally affected by mobility issues—such as fall risks, fatigue when walking, or difficulty transitioning from sitting to standing—these trends carry significant economic, healthcare, and workforce impacts. How can addressing mobility issues make a difference?Listen in with us as we discuss all of this and more with Rick Sherak, an Air Force Veteran and seasoned Executive Leader in the Medical Devices, Biotech, and Diagnostics Space who is currently the CEO of Exokinetics, a mobility technology company dedicated to revolutionary advancements in the mobility industry and the continued development of life-changing products to help restore the full range of movement, independence, and a healthier lifestyle for those who struggle with diminished mobility. Invented by Hall-of-Fame and Oscar winning Steadicam creator Garrett Brown and partners, the Zeen®, Exokinetic's core offering, is a state-of-the-art upright walking mobility device designed for those who are at risk of falling, tire easily when walking, and want to move from sitting to standing independently without assistance.Other insights range from how innovations showcased in the movie Rocky ultimately played a role in shaping the future of health and wellness, to best practices for establishing relationships with the US Department of Veteran Affairs, to how mobility is one of the core pillars as we enter the Age of Longevity.For more details visit TechLink Health on the web or connect with Rick on LinkedIn.This episode was hosted by Dr. Sarah Samaan.The episode points to several references with links below:
In this episode, I sit down with my dear friend and Flowpresso founder, Desiree De Spong, for a deep dive into the lymphatic system—and why it's the secret key to modern health. We explore how Flowpresso evolved from a wild idea to a game-changing class 2 medical device, how mechanical compression mimics the body's own fluid dynamics, and why heat, pressure, and vibration can completely reset your nervous system.We unravel the myths around cancer and lymphatic drainage, discuss why chronic stress is the true pandemic, and celebrate the simple acts of grounding, breathing, and reconnecting to your body's natural rhythms. This conversation is rich with gems for anyone looking to heal faster, age gracefully, and thrive in a world that often pulls us away from ourselves.HIGHLIGHTS[02:59] - Why Desiree created Flowpresso: solving for scarcity in lymphatic care[06:54] - Debunking the myth: does lymphatic drainage spread cancer?[11:57] - How Flowpresso's compression system mirrors true lymphatic flow[14:05] - The magic of overlap: why bladder design matters for real drainage[17:18] - Why we push fluid to the heart: the importance of the terminus[19:18] - How gentle heat enhances lymphatic, vascular, and cellular health[21:33] - The FlowVibe tool: facial lymphatics made simple and effective[28:51] - Why daily lymphatic support is essential in today's toxic world[35:38] - Chronic stress: the biggest driver of disease you might be missing[41:45] - Measurable change: shifting fluid from extracellular to intracellular[45:56] - How lymphatic drainage supports wound healing and post-surgical recovery[49:47] - Physical therapy, athletic performance, and the future of healing[53:35] - Why Flowpresso became an FDA Class 2 Medical Device[57:43] - Trauma, memory, and why holding space matters in healing sessionsCONNECT WITH DESIREE DE SPONG + FLOWPRESSOWebsite: https://flowpressousa.com/Instagram: https://www.instagram.com/flowpresso/UPGRADE YOUR WELLNESSBeam Minerals: http://beamminerals.com/beautifullybroken(Use Code: BEAUTIFULLYBROKEN for Discount)Silver Biotics Wound Healing Gel: https://bit.ly/3JnxyDD (30% off)(Use Code: BEAUTIFULLYBROKEN for Discount)StemRegen: https://www.stemregen.co/products/stemregen?_ef_transaction_id=&oid=1&affid=52Code: beautifullybrokenLightPathLED https://lightpathled.pxf.io/c/3438432/2059835/25794Code: beautifullybroken CONNECT WITH FREDDIE Check out my website and store: (http://www.beautifullybroken.world) Instagram: (https://www.instagram.com/beautifullybroken.world/) YouTube: (https://www.youtube.com/@BeautifullyBrokenWorld)
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.comVeteran-turned-medical device rep Edward Dix joins the show to share his story of breaking into orthopedics, transitioning to diagnostics, and launching RepPrep.ai. An AI-powered pre-call tool for sales reps. Topics include military-to-sales transitions, trauma and ortho grind, rep relocation, growing territories, how diagnostics differ from ortho, how RepPrep works, real-life impact on patients, and putting reps first in tech.Key Takeaways
Want To Learn How To Grow Your Territory?? If so → https://www.newtomedicaldevicesales.comVeteran-turned-medical device rep Edward Dix joins the show to share his story of breaking into orthopedics, transitioning to diagnostics, and launching RepPrep.ai. An AI-powered pre-call tool for sales reps. Topics include military-to-sales transitions, trauma and ortho grind, rep relocation, growing territories, how diagnostics differ from ortho, how RepPrep works, real-life impact on patients, and putting reps first in tech.Key Takeaways
In this episode, Adam Isaacs Rae is helping us to register our Medical Devices in Malaysia. We will review the requirements for it. You will see in this episode that some elements will be similar to registration in EU or US but you will also see a lot of differences. We will also talk about cost for the registration and you will see how this is affordable. Who is Adam Isaacs Rae? Chartered quality professional with a Master's Degree focused in Strategic Quality Management from University of Portsmouth. Demonstrated history of working aerospace & defence, medical device and the construction industry. Skilled in Operations Management, Lean Six Sigma, Failure Mode and Effects Analysis (FMEA), Value Stream Mapping and Supply Chain Management. 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 Adam Isaacs Rae LinkedIn: https://www.linkedin.com/in/adam-isaacs-rae/ https://theotherconsultants.substack.com/p/register-your-medical-device-in-malaysia 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
In this episode of the Global Medical Device Podcast, Etienne Nichols speaks with renowned regulatory and reimbursement expert Karandeep Singh Badwal to uncover the complexities of medical device reimbursement across the US, EU, and Asian markets. From the influence of governmental systems to the nuances of coding, coverage, and payments, Karandeep shares real-world insights for MedTech companies developing their global market strategies. Learn why early planning for reimbursement is just as crucial as regulatory approval, and how future-proofing your strategy against political and economic changes can safeguard your device's success.Key Timestamps:00:00 – Intro and Sponsor Message (Greenlight Guru Quality)02:30 – Why Reimbursement Must Be Considered Early07:15 – US Reimbursement System: Medicare, Medicaid, and Private Insurers13:10 – EU Reimbursement: Challenges with Fragmented National Systems17:45 – Asian Market Differences: Japan, China, and South Korea23:20 – The Importance of a Reimbursement Expert28:05 – Navigating Political Changes in Global MedTech Markets33:30 – Special Challenges for AI and Software as a Medical Device40:00 – Direct-to-Consumer vs. Prescription Strategies46:20 – Integrating Real-World Evidence and Post-Market Surveillance52:00 – How Management Reviews Can Align Business and Quality Goals01:03:10 – Pros and Cons: US vs. EU Reimbursement Models01:18:20 – Final Takeaways and Closing ThoughtsStandout Quotes:"Reimbursement isn't just the final step after regulatory approval — it is a core business strategy."Why it matters: Many companies fail by not building reimbursement into their earliest development and design decisions."You can have the most innovative medical device in the world, but without a reimbursement pathway, you won't have a viable business."Why it matters: Innovation alone isn't enough; financial strategy is crucial to survival and growth.Top Takeaways:Start with reimbursement in mind: Align your product claims, indications, and market strategies with potential reimbursement pathways early.Tailor by region: US, EU, and Asian markets all have distinct reimbursement landscapes — success in one doesn't guarantee success in another.Hire jurisdiction-specific experts: Use consultants experienced in your target markets to avoid costly mistakes.Leverage post-market surveillance: Integrate real-world evidence gathering into your QMS and management reviews to support reimbursement claims.Build strategic flexibility: Political and regulatory landscapes shift — maintain backup jurisdictions and alternative market strategies.References:Etienne Nichols on LinkedInGreenlight Guru Quality Management SystemMedtech Podcast hosted by Karandeep Singh BadwalMedTech 101 Section:What is "Reimbursement" in MedTech?Reimbursement refers to how a company gets paid for a medical device after it's cleared for use. This usually involves navigating government programs (like Medicare) or private insurance, and it determines how easily hospitals, clinics, or individuals can buy and use a product.Simple Analogy: Think of it like getting a movie produced: regulatory clearance is getting your movie rated, but reimbursement is making sure theaters agree to pay you to...
How One Leader Came Out of Retirement to Transform Home Healthcare Jasper Freeman, Director of National Accounts at SC Pharmaceuticals, didn't just return to medical sales—he came back with a mission to change it. In this episode, Jasper shares how he helped launch Ferosix, a revolutionary heart failure treatment designed to keep patients out of the hospital and improve care at home. But that's just the beginning. We dive into: The untold story of Pharmacy Benefit Managers (PBMs) and their massive influence over drug pricing and access Why the insurance-sales-patient triangle is the key battleground in healthcare innovation What the U.S. can learn from other countries about lowering costs and improving care Bold reform ideas—from slashing med school tuition to rethinking drug distribution This is a rare, behind-the-scenes look at the business of healthcare, guided by someone who's lived it at the highest levels. If you're in medical sales—or trying to break in—this episode is a masterclass on what's next and how to lead the change. Connect with Jasper: 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!
Want To Learn How To Grow Your Territory?? If so → https://www.newtomedicaldevicesales.com/podcastBreaking into medical device sales, networking for success, finding mentorship, investing in yourself, handling career transitions, balancing work and family, the power of perseverance, personal growth, and lessons from sports and life experiences.Key Takeaways1️⃣ Invest in Yourself – If you're serious about breaking into medical device sales, be willing to invest time and resources into learning and networking.2️⃣ Build Strong Relationships – Networking is key. Focus on building authentic connections instead of just asking for favors.3️⃣ Stay Resilient & Patient – The process can be long and challenging, but success comes to those who stay consistent and persistent.4️⃣ Adopt a Growth Mindset – Always be willing to learn and improve. Every rejection is a lesson that can help you get better.5️⃣ Act Like the Person You Want to Become – Whether it's how you prepare, how you show up, or how you perform, start acting like the high-level rep you aspire to be.00:00 - Start01:07 - Intro02:25 - Who Is Greg Neil06:15 - Managing Blockbuster Was My Cap09:07 - Move Into Banking12:59 - Moving Out Of Banking18:26 - Finding The Program27:28 - Beginnings Of The First Interviews38:37 - How Did Know Medical Device Sales Was The Career For You41:32 - Greg's Advice To Break Into Medical Device Sales
In this episode, Yassine Bader will explain to you the advantage or the risk of quitting your permanent job to become a consultant. You will see within this episode that this is not something made for everyone, so you really need to listen to this to understand if this is the right decision for you. Who is Yassine Bader? Coach expert en transition de carrière et leadership, Yassine Bader cumule plus de 15 ans d'expérience au cœur de l'industrie (automobile, chimique, dispositifs médicaux, transport, pharmaceutique et agroalimentaire), accompagnant avec succès plus de 100 cadres vers une indépendance entrepreneuriale inspirante et un leadership d'excellence. Son approche : pragmatique, percutante, tournée vers l'action et les résultats concrets. Créateur du guide gratuit et fondateur du programme ManagerImpact, il équipe les managers d'outils précis et immédiatement exploitables pour devenir des leaders alignés, confiants et reconnus. Très prochainement, il dévoilera un séminaire exclusif destiné aux cadres industriels décidés à franchir le pas vers le consulting et le management de transition freelance, en leur fournissant toutes les clés indispensables pour réussir avec confiance leur nouvelle vie professionnelle. 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 Yassine Bader LinkedIn: https://www.linkedin.com/in/yassine-bader-yab/ Programme Yassinebader: https://programme.yassinebader.com/manager-impact 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
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
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...
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Randy Pritchard and Erica Rogers, leaders of Axena Health. Axena is transforming pelvic floor therapy with Leva, a device bringing clinically-proven, supervised pelvic floor muscle training into women's homes. Randy, CEO of Axena, brings nearly 25 years of healthcare experience to the company, most recently as CEO of Pillar Biosciences and previously holding leadership positions at Roche Diagnostics, where he spent 18 years developing commercial expertise. Erica, who sits on Axena's Board of Directors, spent a decade as President and CEO of Silk Road Medical, leading the company from early clinical trials through IPO and eventual acquisition by Boston Scientific. A returning guest to the podcast after nearly half a decade, Erica previously held roles at Medicine360, co-founded two other medical device companies, and spent over 12 years at Boston Scientific prior to her role at Silk Road.In this interview, they share essential medtech commercialization insights: identify your specific patient segment, build continuous clinical evidence, and communicate consistently with investors. Their experience offers invaluable lessons for medical device entrepreneurs navigating today's complex healthcare landscape.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Randy Pritchard and Erica Rogers.
Theranos, Medical Devices, and Indigenous Knowledge on Climate Change ft. Kyle Powys Whyte
In this episode of Let's Combinate, host Subhi Saadeh welcomes back Skip Creveling, a global expert in program management and Six Sigma methodologies.Skip shares his extensive experience helping Fortune 500 companies optimize design processes, reduce risks, and drive innovation—especially in highly regulated industries like medical devices, pharmaceuticals, and aerospace.The discussion explores Skip's career transition from Eastman Kodak to the medical device sector, the importance of structured program management, phase gate processes, and the balance between going fast and ensuring thorough planning.Skip also delves into the differences between simple and complex projects and the necessity of having tailored project management templates for various project scales.The episode concludes with insights into how to manage risks effectively through tools like project and portfolio FMEAs, and the importance of data-driven decision-making in project execution.Timestamps:00:00 – Introduction and Guest Welcome00:19 – Skip's Background and Experience01:10 – Transition to Medical Devices and Pharma03:35 – Program and Project Management Insights06:03 – Phases and Gates in Product Development08:59 – Challenges and Strategies in Project Management10:51 – Examples of Project Management in Action13:28 – Importance of Planning and Risk Management18:10 – Templates and Tools for Effective Project Management29:49 – Final Thoughts and Contact InformationAbout the Host:Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations, and R&D, he has worked in large Medical Device and Pharma organizations to support the development and launch of hardware devices, disposable devices, and combination products for vaccines, generics, and biologics.Subhi currently serves as the International Committee Chair for the Combination Products Coalition (CPC), is a member of ASTM Committee E55, and has served on AAMI's Combination Products Committee.For questions, inquiries, or suggestions, please visit letscombinate.com or connect on the show's LinkedIn page.
In this episode of Nurse Converse, Shenell Thompkins is joined by Tiffany Cannon, who shares her powerful story of living with a Left Ventricular Assist Device (LVAD). At just 28, Tiffany experienced heart failure during pregnancy, leading to an emergency C-section and the life-changing decision to receive an LVAD. She opens up about the emotional toll, her return to nursing, and how her dual perspective as both a patient and nurse fuels her passion for advocacy, empathy, and patient empowerment. Tiffany's journey is one of resilience and hope, proving that heart disease is not the end—but a new beginning. >>One Nurse's Journey with LVAD (Left Ventricular Assistive Device)Jump Ahead to Listen: [02:17] Tiffany's journey to heart failure.[05:53] Heart failure diagnosis after childbirth.[09:23] Divine intervention in medical decisions.[13:25] Gratitude through life changes.[21:00] Bridging patient-nurse connection.[22:49] Advocacy and patient awareness.[26:18] Heart disease is not a death sentence.[29:09] Supporting nurses in their careers.Connect with Shenell on social media:Instagram: allonenurse_shenell TikTok: all_one_nurseFor more information, full transcript and videos visit Nurse.org/podcastJoin our newsletter at nurse.org/joinInstagram: @nurse_orgTikTok: @nurse.orgFacebook: @nurse.orgYouTube: Nurse.org
Chapters00:00 Introduction and Company Updates02:49 The Digital Transformation of Ultrasound Imaging06:00 Advancements in Technology and Market Growth09:03 AI Integration in Medical Imaging14:50 Impact on Global Health and Humanitarian Efforts20:55 Challenges in Mainstream Adoption of Handheld Ultrasound29:43 Strategic Sales Approaches in Medical Devices34:11 Finding Product-Market Fit36:12 Simplicity in Medical Technology39:26 Unexpected Use Cases and Market Adoption45:24 Future Innovations in Handheld Ultrasound51:58 The Importance of Patient Data Ownership
In today's episode, we are continuing our “episode swap” series with an episode from the Global Health Pursuit podcast hosted by engineer turned social impact storyteller, Hetal Baman.On her podcast, Hetal tackles tough questions from the vast field of global health with a beginner's mindset. In this interview, Hetal speaks with Sona Shah the co-founder of Neopenda. Neopenda's mission is to develop affordable medical devices addressing neonatal mortality, which are tailored to the unique constraints of underserved healthcare environments in low and middle-income countries.Be sure to visit our podcast website for the full episode transcript. LINKS:Learn more about Sona Shah's company Neopenda at neopenda.comConnect with the Global Health Pursuit podcast at https://www.globalhealthpursuit.comFollow our host: WEBSITE | LINKEDINFollow us: LinkedIn | Instagram Connect with us: narrativespodcast@gmail.com | subscribe to our news Tell us what you think: write a review CHAPTERS:00:08 - Introducing New Voices04:47 - The Journey to Neopenda12:27 - Addressing Healthcare Inequities18:00 - Becoming an Entrepreneur31:03 - The Product Market Fit Journey and Growing Neopenda's Team36:24 - Navigating Challenges During COVID-19 and Restructuring Neopenda44:19 - Advice From a Startup Entrepreneur
Breaking into the medical device market is more complex than just having an innovative product. The real challenge lies in understanding and navigating the intricate business landscape of healthcare. That's why we're diving into the crucial aspects of medical device commercialization, uncovering the common misconceptions that many innovators face, such as the idea that a great product will automatically find its market. In this week's episode, sponsored by Physician Growth Accelerator, we sat down with Chris Hanna, founder and CEO of Walnut Hill Medical, who brings his extensive experience in guiding medical device companies through the commercialization process in the United States. Chris sheds light on the importance of aligning product development with market needs, crafting effective business strategies, and partnering strategically with healthcare providers. We discuss the critical elements that determine whether a medical device will succeed or falter in the competitive healthcare market. What we discuss in the episode: The importance of viewing healthcare as a business and understanding its financial dynamics Strategies for medical device companies to effectively commercialize their innovations The role of comprehensive business planning in securing investment and market entry Insights into the collaboration between engineers, healthcare professionals, and business developers to ensure product viability The impact of regulatory and reimbursement challenges on the commercial success of medical devices Resources from this episode: Get the free MedTech Talk Tracks for Action Physician Growth Accelerator Walnut Hill Medical Social Media: Connect with Chris on LinkedIn Connect with Zed on LinkedIn
WBSRocks: Business Growth with ERP and Digital Transformation
Send us a textWhen evaluating the top ERP systems for the medical device industry, it's essential to recognize the wide range of business models that fall within this sector, from biotech startups to large-scale manufacturers of capital equipment and consumables. This ranking focuses strictly on the ERP solutions themselves—independent of the companies behind them—and considers their applicability across organizations of all sizes. Since ERP requirements differ significantly depending on a company's scale, regulatory obligations, and operational focus, the commentary accompanying each system is critical in helping businesses determine fit. For example, a biotech firm may prioritize robust compliance and research support, while a consumables manufacturer might seek high-efficiency production and traceability. As such, a top-ranked ERP solution may not be universally ideal, but rather excels in particular areas like scalability, automation, or compliance. Choosing the right system involves aligning these strengths with your specific business needs, ensuring the ERP not only supports current operations but is also capable of adapting to future growth and industry demands.In this episode, our host Sam Gupta discusses the top 10 medical device ERP systems in 2025. He also discusses several variables that influence the rankings of these medical device ERP systems. Finally, he shares the pros and cons of each medical device ERP system.Background Soundtrack: Away From You – Mauro SommFor 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.
Get your FREE Cybersecurity Salary Guide: https://www.infosecinstitute.com/form/cybersecurity-salary-guide-podcast/?utm_source=youtube&utm_medium=podcast&utm_campaign=podcastIn this episode of Cyber Work, Ken Zalevsky, founder and CEO of Vigilant Ops, joins us to discuss the importance of a Software Bill of Materials (SBOM) in the medical device industry. Zalevsky shares how SBOMs provide transparency and critical security insights, akin to the ingredients list on food packaging, to help identify and defend against vulnerabilities. We also delve into Zalevsky's extensive career in healthcare cybersecurity, starting from his early tech interests influenced by his father to his pivotal role at Bayer Healthcare. The discussion covers the impact of legacy systems, current security trends, the integration of AI in medical device security, and valuable insights for those looking to build a career in this crucial sector. Tune in to learn more about medical device security and the latest in cybersecurity trends, and get some expert advice straight from a seasoned professional.00:00 Understanding SBOMs in medical devices04:20 The evolution of medical device security07:22 Ken Zalevsky's journey in cybersecurity09:28 Challenges in medical device security13:06 The role of SBOMs in cybersecurity15:56 Implementing SBOMs in organizations18:28 Ken Zalevsky's role at Vigilant Ops22:01 Technical aspects of SBOMs27:14 Legacy devices and security measures28:24 Manufacturer's role in device security30:07 Healthcare industry's response to security threats30:42 Impact of major breaches on policy34:13 Generative AI and machine learning in healthcare security40:22 Skills and certifications for healthcare security careers46:46 Career advice and educational paths49:04 About Vigilant Ops and their services52:15 Outro– View Cyber Work Podcast transcripts and additional episodes: https://www.infosecinstitute.com/podcast/?utm_source=youtube&utm_medium=podcast&utm_campaign=podcastAbout InfosecInfosec's mission is to put people at the center of cybersecurity. We help IT and security professionals advance their careers with skills development and certifications while empowering all employees with security awareness and phishing training to stay cyber-safe at work and home. More than 70% of the Fortune 500 have relied on Infosec Skills to develop their security talent, and more than 5 million learners worldwide are more cyber-resilient from Infosec IQ's security awareness training. Learn more at infosecinstitute.com.
Send Me a Text MessageFor this episode, host Tom Butler dives into the world of Strava apps. Looking for deeper insights into his training, Tom explores some intriguing options beyond the basics. Whether you're a data enthusiast or just curious to learn more, Tom shares a few apps he discovered.Then, Tom takes listeners along to a meeting with the Tacoma Washington Bicycle Club (TWBC). Tune in as they discuss initiatives for the local Cycling Over Sixty program. Tom presents his view that the bike should be seen as a medical device. The collaboration with TWBC is about building community and staying active on two wheels!LinksGreat America Ride: Team Huffing and Puffing sportsbackers.org/event/great-american-ridePassword: GAR2025Beeminder App Video: youtu.be/ILf8yPNSbZY?si=BWrp_d6NJeH5xcK2Thanks for Joining Me! Consider becoming a member of the Cycling Over Sixty Strava Club! www.strava.com/clubs/CyclingOverSixty Cycling Over Sixty is also on Zwift. Look for our Zwift club and join the Zwift Thursdays Group Ride! We have a live Zoom call every Thursday at the same time as the Zwift Thursday ride; 3pm pacific time. Whether you are Zwifting or not, email me for an invite to the Zoom chat. Please send comments, questions and especially content suggestions to me at tom.butler@teleiomedia.com Follow and comment on Cycling Over Sixty on Instagram: https://www.instagram.com/cyclingoversixty/ Show music is "Come On Out" by Dan Lebowitz. Find him here : lebomusic.com
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.comBreaking into medical device sales with a sales background, the truth about B2B experience, understanding the hiring process, making your resume stand out, interview challenges and how to overcome them, learning to sell to surgeons, why confidence alone isn't enough, how to position yourself against the competition, and strategies to speed up the hiring process.Key Takeaways:1️⃣ If you have sales experience but aren't getting hired, it's not just your resume—it's how you position yourself. Make sure you're showing how your experience translates into medical device sales.2️⃣ Hiring managers invest heavily in new hires. They want the best candidate, not just someone with experience. Show them why you are the best fit.3️⃣ Just listing numbers on your resume isn't enough. Use percentages to demonstrate real growth and impact to catch hiring managers' attention.4️⃣ Stop focusing on what you did and start talking about what you're doing now to break into medical sales. Employers want to see proactive effort.5️⃣ Being coachable is more important than being experienced. If you keep hitting a wall, it's time to rethink your approach and be open to learning.00:00 - 01:02 - Intro04:11 - Show Numbers With Growth Whitin Your Resume08:03 - Relate Your Previous Experience To Medical Device Sales11:12 - Keep Your Ego In Check18:34 - Be Open To Continue Learning
In this episode, Cyrille Michaud from MD101 will explain us how to prepare for Cybersecurity compliance for your medical device. We will review the US and EU requirements and provide you a list of legislation and standards you should look at. Cyrille will also share his experience related to the reviews done by a Notified Body and an FDA. Who is Cyrille Michaud? Co-founder and managing partner of MD101 Consulting. Consultant in Quality Assurance and Regulatory Affairs for software in medical devices and software as medical devices. Specialties: Software Processes Management. CE Mark & FDA 510k 21 CFR 820 - ISO 13485 - ISO 14971 - IEC 62304 - IEC 62366 - IEC 60601 - IEC 82304-1 - UL 2900-1 - IEC 81001-5-1 Agile Methods applied to medical device software design. Cybersecurity applied to medical devices. 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 Cyrille Michaud LinkedIn: https://www.linkedin.com/in/cyrillemichaud/ MD101 : www.MD101.io Trainings on Cybersecurity : https://blog.cm-dm.com/pages/Medical-Device-Software-Trainings Blog post sur cyber et normes : https://blog.cm-dm.com/post/2023/10/06/Final-2023-FDA-Premarket-Cybersecurity-guidance-released FDA resources on cybersecurity : https://www.fda.gov/medical-devices/digital-health-center-excellence/cybersecurity IG NB checklists : https://www.ig-nb.de/veroeffentlichungen (page in German but download links in the page are in English) Standard IEC 81001-5-1 and 81001-5-2: https://blog.cm-dm.com/post/2024/10/04/IEC-81001-5-2%3A-AAMI-SW96-cousin-and-IEC-80001-5-1-sister Blog IEC 81001-5-1: https://blog.cm-dm.com/post/2024/02/23/IEC-81001-5-1-Right-Here-Right-Now 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
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Ryan Rhodes, CEO of EDAP TMS. EDAP is changing prostate cancer treatment through Focal One, a robotic high-intensity focused ultrasound (HIFU) system that doesn't require the use of surgery or radiation. Ryan has over 30 years of experience in market development, with two decades focused on medical robotics. Before EDAP, Ryan was CEO of Restoration Robotics, where he guided the company to a successful merger with Venus Concept. He spent 13+ years at Intuitive Surgical, establishing the global Urology franchise, which became the company's entry point for broader adoption of the da Vinci system. He also spent 11 years at Ethicon (J&J) in sales, marketing, and market development.In this interview, Ryan challenges founders to ask: Are you creating a scalable medtech solution or a product with limited growth potential? He unpacks why standardization and scalability are critical for adoption, how clinical data fuels credibility and reimbursement, and why early adopters take the biggest risks — but also reap the biggest rewards.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Ryan Rhodes.
In this episode, Tudor interviews investigative journalist Gardiner Harris about his new book, 'No More Tears: The Dark Secrets of Johnson & Johnson.' The conversation delves into the shocking revelations about the pharmaceutical giant's unethical practices, including the marketing of harmful products, the manipulation of regulatory agencies, and the impact of their actions on public health. Harris shares insights from his five-year investigation, highlighting the need for accountability in the healthcare industry and the importance of informed consumer choices. The Tudor Dixon Podcast is part of the Clay Travis & Buck Sexton Podcast Network. For more visit TudorDixonPodcast.com Follow Gardiner Harris on X Buy No More Tears: The Dark Secrets of Johnson & Johnson HERE #Johnson & #Johnson #healthcare #pharmaceuticalindustry #ethics #investigativejournalism #publichealth #medicaldevices #COVID19 #marketing #regulationSee omnystudio.com/listener for privacy information.
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.comFrom breaking into medical device sales in under three weeks, getting three job offers, jumping from associate to full-line rep in just eight months, learning from trial by fire, dealing with challenging surgeons, building trust through repetition, mastering case prep, learning how to sell without overselling, understanding relationship-building inside the OR, and sharing what it's really like to grow from an EMT and personal trainer to making six figures on the #1 team at a major med device company.Key Takeaways:1️⃣ Grind early, learn fast Your first 6–12 months in the industry should be all about absorbing knowledge. Be in every case you can, take trays home, study them, ask questions, and get your reps in. More exposure = more confidence later.2️⃣ Don't focus on being the expert—focus on being helpful Early on, you won't know everything, and that's okay. Instead of trying to “sell,” build relationships, observe, and support the team. Trust builds influence.3️⃣ Ask more, talk less Surgeons don't want to hear a sales pitch—they want solutions. Lead with questions, not product dumps. The right question opens more doors than the best feature ever will.4️⃣ Volume creates value Danee's fast-track success came from putting in major volume—cases, calls, reps. More time in the OR and with your team puts you ahead faster than any shortcut.5️⃣ It's okay to mess up—just don't stay down You'll get yelled at, make mistakes, and forget things. That's part of the journey. The real flex is how you recover, learn, and keep showing up.6️⃣ Your past is your superpower Danee's used his EMT and personal trainer background to connect with surgeons, patients, and coworkers. Whatever your background is—use it to your advantage.7️⃣ Want the promotion? Act like it before you get it Danee became a full-line rep in 8 months because he already operated like one. Take initiative, own your territory, and deliver value before it's officially your role.00:00 - Start03:06 - Danee's Medical Device Sales Story05:06 - First 6 Months As An Associate09:12 - When Did You Feel Comfortable In The Industry?13:33 - What Helped Make Those First 6 Months Easier?17:10 - What Convinced You To Full Line Rep After 8 Months?21:32 - This Is Not Common, But Doable24:59 - What Was The Biggest Transition Going From Associate To Full Line?30:11 - Danee's Advice For First Year Reps33:10 - Worst Case Ever Experienced36:46 - Best Case Ever Experienced39:43 - Danee's Most Rewarding Feature About Medical Device Sales
In this episode, Tudor and Calley Means discuss the ongoing reforms in the Health and Human Services sector under Secretary Kennedy. They explore the inefficiencies and corruption within the healthcare system, the impact of food and drug regulations on public health, and the urgent need for transparency in medical devices and pharmaceuticals. The conversation highlights the alarming rise in childhood chronic diseases and the cultural and corporate influences that shape health policy. The Tudor Dixon Podcast is part of the Clay Travis & Buck Sexton Podcast Network. For more visit TudorDixonPodcast.com Follow Calley on X #healthcarereform #chronicdisease #food #regulations #lobbying #publichealth #SecretaryKennedy #transparency #state #partnerships #childhood #health #medicaldevicesSee omnystudio.com/listener for privacy information.
We are back from IDS in Cologne, Germany. THANK YOU exocad for hosting us and everyone, be prepared for some amazing new features coming to you soon! Along with a TON of crazy good conversations. So when we got an email from the creators of a device that Elvis uses all the time asking to be on the podcast, we jumped at the opportunity. Luckly we were all going to be at the Cal-Lab Association (https://cal-lab.org/) meeting that happens the same week at Lab Day Chicago. This time, Elvis sits down with Danny Yao and Dr. Russell Crockett. Danny has a long history in sales with implants and full arch workflows. Dr. Crockett is a practicing Prosthodontist that loves to design better ways to do dentistry. Meeting awhile ago, Danny saw Dr. Crockett's prototype for a way to get accurate full arch records using just an iOS scanner. Together they created OptiSplint (https://digitalarches.com/collections/optisplint%C2%AE-the-easiest-and-most-accurate-implant-positioning-system-for-full-arch) and ArchTracer (https://digitalarches.com/collections/archtracer%E2%84%A2-the-only-fiducial-marker-you-will-ever-need). Simply put, they screw onto MUAs, lute together, and you can get a series of scans pretty much guaranteed to perfect. Want to know more about this amazing workflow? Take a listen as we dive deeper into all that Digital Arches (https://digitalarches.com/) does. Take it from Laura Prosser, the digital marketing manager for Ivoclar North America (https://www.ivoclar.com/en_us). She would like to invite you to start following them on Instagram. It's your chance to obtain exclusive updates on product announcements, industry news, upcoming educational events, and heartwarming stories about our local team and industry professionals. Let's get social together. Simply start following us on Instagram @Ivoclar.na (https://www.instagram.com/ivoclar.na/). We'll see you there. Are you a dental lab in need of more talent to improve your bottom line and keep production on schedule? Are you a dental tech with great skills but feel you're being limited at your current lab? Well, the answer is here and this is precisely why WIN WIN GO (https://www.winwingo.com/) was created. The dental lab and dental tech community needed a place where labs and technicians can meet, talk about their needs and connect in ways that foster a win win outcome. As a tech. If you're ready to make a change, thinking about moving in the next year or just curious what's out there, sign up today. It's totally free. As a lab, you might be feeling the frustration of paying the big employment site so much and getting so few tech candidates. We understand they don't much care about our industry. WINWINGO.com is simply the best place for lab techs and lab owners to actively engage in creating their ideal future. WINWINGO.com, how dental techs find paradise. Special Guests: Danny Yao and Dr. Russell Crockett.
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.comTerritory planning, segmenting call points, gap analysis, setting boundaries in sales, working smarter not harder, maintaining work-life balance, time management strategies, challenges with different med device company structures, and how to stay intentional as your career grows.Key Takeaways:1️⃣ Know your plan before your feet hit the ground — Don't just show up and hope. Create a clear territory plan, identify accounts, and know who you need to talk to before you leave the house.2️⃣ Your territory is like running a franchise — Treat it like a business. Even if you're W-2, think and operate like you're building something of your own.3️⃣ Not all accounts are created equal — Ask yourself: is the juice worth the squeeze? Chase opportunity, but make sure it's scalable and smart geographically.4️⃣ Work smarter and harder — Everyone says “work smarter, not harder,” but Jason and Jacob challenge you to do both. That's where the big wins live.5️⃣ Don't lose everything for a paycheck — Med device sales can be rewarding, but don't let it steal your relationships, your peace, or your future. Build a business you can step away from when it counts.00:00 - Start01:06 - Intro02:29 - Territory Planning07:50 - Targeting11:24 - Segmenting15:17 - Gap Analysis15:58 - Geographical Management17:56 - Time Management / Prioritization19:26 - Work-Life Imbalance25:25 - Work Smarter & Harder31:36 - Don't Be A Slave To Your Territory34:48 - Time Audit37:35 - How To Find Jason Elmore
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