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Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.com/youtube-podIf you're new to my channel, my name is Jacob McLaughlin. I'm the founder of New to Medical Device Sales, an exclusive training program designed to help people break into the competitive field of medical device sales. Our average person lands a six-figure role in just 8.5 weeks, earning $105,502 annually. With thousands of success stories from candidates with all kinds of backgrounds, our program equips you with the tools to succeed in this industry.4 years ago I moved out to Arizona not knowing anyone and had $1200 to my name.I came to this exact spot to journal and share how excited I was to be starting my journey in life.Last night I took time to reflect over the past 4 years. It's truly amazing how you can change your life in such a small amount of time.My take aways:1. Go after your dream because even if it doesn't workout like you thought it would, it will bring your right where you're suppose to be.2. Believe in yourself. Nobody is going to believe in you as much as you will, know that good things will happen.3. Change is inevitable. Change is going to happen so you can either accept it and keep moving forward or not.Please bet on yourself and go after your dreams because your life can be better than you ever thought it could be if you do
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Young Juhn, CEO of Wellysis.Wellysis is the Samsung spinout behind S-Patch, a lightweight wearable that enables long-term ECG monitoring without the discomfort of established cardiac monitoring devices.Young has spent more than two decades bridging hospital and home-based care — from his early career at Johnson & Johnson, to more than a decade at Kaiser Permanente, to leading healthcare innovation at Samsung before spinning out Wellysis in 2019.In this interview, Young shares why patient interviews should shape product design, how regulatory clearance is just the starting point for global commercialization, and why building a medical foundation before branching into consumer markets is critical for lasting adoption.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 Young Juhn.
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.com/youtube-podIf you're new to my channel, my name is Jacob McLaughlin. I'm the founder of New to Medical Device Sales, an exclusive training program designed to help people break into the competitive field of medical device sales. Our average person lands a six-figure role in just 8.5 weeks, earning $105,502 annually. With thousands of success stories from candidates with all kinds of backgrounds, our program equips you with the tools to succeed in this industry.4 years ago I moved out to Arizona not knowing anyone and had $1200 to my name.I came to this exact spot to journal and share how excited I was to be starting my journey in life.Last night I took time to reflect over the past 4 years. It's truly amazing how you can change your life in such a small amount of time.My take aways:1. Go after your dream because even if it doesn't workout like you thought it would, it will bring your right where you're suppose to be.2. Believe in yourself. Nobody is going to believe in you as much as you will, know that good things will happen.3. Change is inevitable. Change is going to happen so you can either accept it and keep moving forward or not.Please bet on yourself and go after your dreams because your life can be better than you ever thought it could be if you do
The barriers to market entry for medical devices -- everything from hearing aids to MRI machines -- here and abroad are significant. Some researchers suggest that more than 95 percent of proposed medical device innovations fail to launch. Host Llewellyn King and Co-host Adam Clayton Powell III talk to Alex Gorrie, founder and CEO of London-based Dromeda.ai.
Send us a textMedicaid covers nearly 90 million Americans, but coverage doesn't always equal health.What if the real driver of outcomes isn't the doctor's office or an app, but the communityitself?In this episode of CareTalk Executive Features, WiderCircle co-founder and CEO Darin Buxbaum joins David Williams to share how peer-led circles and community engagement are improving health outcomes, boosting member trust, and delivering value for health plans.
This episode tackles the often-overlooked but critical topic of medical device reimbursement. Host Etienne Nichols speaks with Haley King, co-founder and CEO of Paxos Health, about why this process is just as vital as FDA approval for a device's commercial success. They explore the journey a medical device takes, highlighting the distinction between FDA approval and securing reimbursement from payers.Haley explains the three key pillars of reimbursement: coding, coverage, and payment. She delves into the complexities of CPT codes and the significant difference between a temporary Category 3 code and the gold-standard Category 1. The discussion also covers the immense challenges medical device companies face, including the lengthy timeline—sometimes years—to secure payer coverage, which can be a make-or-break factor for startups. The conversation wraps up with a look at how artificial intelligence is beginning to streamline the cumbersome, manual process of patient access and appeals.Key Timestamps1:45 - The initial challenge of making coverage match medical need.3:30 - The three-part reimbursement pathway: coding, coverage, and payment.5:50 - Navigating CPT codes and the difference between Category 1 and Category 3.10:15 - Common challenges for medical device companies seeking payer coverage.13:20 - The multi-year timeline to achieve Medicare coverage for innovative devices.15:00 - Advice for regulatory and quality professionals on speeding up reimbursement.20:10 - How AI is currently being used in patient access and reimbursement.24:45 - Debating the accuracy of AI and its role in replacing human expertise.Quotes"A lot of times patients are not going to be able to pay out of pocket for expensive medical treatments, and a lot of times providers are not going to be able to write off those treatments on their side. So somebody needs to pay for this. And that's usually the health insurance companies..." — Haley King"I think that for this sort of a use case [AI], you're always going to want some human in the loop... AI has the potential to be super, super powerful in this space, but I think you're always going to want to have human experts involved." — Haley KingTakeawaysIntegrate reimbursement strategy early: Unlike FDA approval, which focuses on safety and efficacy, payers also demand evidence of a device's clinical and economic value. Medical device companies, particularly startups, should integrate reimbursement planning into their pitch decks and product development timelines from the outset.Recognize the two-step process: FDA approval is not a golden ticket to reimbursement. Companies must understand the subsequent and often lengthy process of securing coding, coverage, and payment from payers like CMS and private insurance companies, which can take several years.Enhance clinical trials for payers: Regulatory and quality professionals can speed up the reimbursement process by designing clinical trials that not only meet FDA requirements but also generate robust data to prove a device's clinical and economic value. This may involve including additional endpoints to justify the cost.Harness AI for efficiency, not replacement: AI is a powerful tool for automating the tedious parts of reimbursement, such as sifting through patient records and payer policies. However, it should be viewed as a way to enhance, not replace, the work of human experts who can handle complex edge cases and appeals.Be aware of coding complexities: The distinction...
In this conversation, I talk with Jason Scherer, the CEO and founder of VitaTek, to learn about the innovative approach his company takes in the medical device manufacturing industry. He shares insights on the challenges faced with bringing medical devices to market, the importance of technology in reducing healthcare costs, and the experiences of innovators in the field. The discussion also touches on the future of robotic surgery and AI, as well as the investment risks associated with medical device development. We hope you enjoy the show! Godspeed. ~ James 00:00 Introduction to Vita Tech Group 02:22 The Stages of Medical Device Manufacturing 05:14 Challenges in Medical Device Development 08:21 Innovative Solutions in Medical Device Production 11:01 The Impact of Technology on Healthcare Costs 13:58 Future of Robotic Surgery and AI 16:31 Navigating the Medical Device Market 18:54 The Role of Innovators in Medical Devices 21:45 Investment and Risk in Medical Device Development 24:25 Conclusion and Future Outlook
Jacques the Party Scientist is Bringing Joy to the WorldJacques The Party Scientist ditched his career in pharmacology to, among other things, develop the Joy Bootcamp, the first joy-based leadership retreat. We chatted about his corporate life in Medical Devices (something we have in common), his transition to self-employment, and the ways in which he uses speaking to spread his message of joy.To learn more about the Party Scientist and Jacques, visit https://thepartyscientist.com/__TEACH THE GEEK (http://teachthegeek.com) Prefer video? Visit http://youtube.teachthegeek.comGet Public Speaking Tips for STEM Professionals at http://teachthegeek.com/tips
Medboard Europe TToo much Incomplete Tech File - Let's explain to you how to do it: https://www.team-nb.org/wp-content/uploads/2025/09/Team-NB-PositionPaper-BPG-IVDR-V2-20250903.pdf 2025/1920 on Master UDI-DI - Not only lenses but also Spectacle frames and Ready-to-wear: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202501920 Borderline manual Update - New products included: https://health.ec.europa.eu/document/download/71a87df8-5ca1-4555-b453-b65bdf8de909_en?filename=md_borderline_manual_en.pdf red blood cell additive solutions containing adenine dual action cream with menthol and capsaicin Lactose tablets for vaginal use microabrasion dental stain removers medical examination table covers Mobile sterile air system EU asks your feedback on EU MDR and IVDR - Enjoy reading some 100 feedbacks: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14808-Medical-devices-and-in-vitro-diagnostics-targeted-revision-of-EU-rules_en Switzerland Swissdamed Technical Documentation - XML upload: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank/swissdamed-informationen/swissdamed-technical-documents.html Business Rules Swissdamed: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw630_40_002e_pu_swissdamed_business_rules.pdf.download.pdf/BW630_40_002e_PU_swissdamed_Business_Rules.pdf UK UK PMS guidance for Report - Template available: https://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements/requirements-of-the-manufacturers-pms-system PMSR Template: https://www.gov.uk/government/publications/medical-devices-standardised-format-for-the-post-market-surveillance-report Magazine Issue 1: Sept/Oct 2025 - Next one will come November 2025: https://easymedicaldevice.com/emd-mag/ Events Medtech Conf events - Be listed on the MAP: https://medtechconf.com/events-map-2/ EasyIFU Free trial for eIFU with EASYIFU - Compliant EU 2025/1234: https://easyifu.com ROW US FDA Computer System Assurance - SOP offered on the show notes: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/computer-software-assurance-production-and-quality-system-software-0 Malaysia affiliate member of MDSAP - What does it change?: https://portal.mda.gov.my/index.php/announcement/1636-malaysia-is-now-mdsap-medical-device-single-audit-program-mdsap-member Australia Essential Principles Checklist Update -: Update the templates V1.2: https://www.tga.gov.au/resources/resource/checklists/essential-principles-checklist Egypt guidance to import your devices - Medical Devices, Accessories, IVD: All type of devices: https://edaegypt.gov.eg/media/lafopofx/1-regulatory-guideline-of-issuance-of-import-approvals-of-all-types-of-medical-devices_gd.pdf Medical Equipment and Accessories: https://edaegypt.gov.eg/media/fltnd1qc/4-regulatory-guideline-of-issuing-import-approvals-for-medical-equipment-and-their-accessories_gd.pdf IVD: https://edaegypt.gov.eg/media/e2rf4qg5/2-regulatory-guideline-of-the-procedures-and-rules-of-obtaining-import-approvals-for-iaboratory-and-diagnostic-equipment-gd.pdf Podcast Episode 353: Cybersecurity in Medical Devices: What QA/RA must do Today: https://podcast.easymedicaldevice.com/353-2/ Episode 354: From Surgeon to CEO: Building Neurogyn AG: https://podcast.easymedicaldevice.com/354-2/ Episode 355: Postmarket Surveillance for SaMD and AI: https://podcast.easymedicaldevice.com/355-2/ Easy Medical Device Service Support for Consulting (QA RA projects) Support for Authorized Representative and Market Access Integration to an eQMS 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 Josh Vose, CEO of Tulavi Therapeutics.Tulavi is advancing hydrogel-based implants like the allay Hydrogel Cap, which is designed to optimize nerve injury recovery and reduce the risk of neuroma formation.Josh is a physician, engineer, and entrepreneur with more than 20 years of experience in medical devices. He has held leadership roles at Medtronic following its acquisition of PEAK Surgical and drove growth at startups including SIA Health, which he led through commercialization and acquisition by Integra LifeSciences.In this interview, Josh shares why defining the clinical problem with absolute clarity is the foundation of medtech success, and how leaning into the harder regulatory path can create lasting moats.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 Josh Vose.
Pharmac believes it makes sense to leave the day-to-day stuff to Health NZ. The Associate Health Minister and Minister Simeon Brown have jointly announced the national agency and drug-buyer can both procure medical devices. Pharmac will focus on more-technical equipment —due to its level of clinical input and assessment— and Health NZ on bulk-buying standard items. Pharmac Chair Paula Bennett told Mike Hosking it clears up uncertainty around who does what. LISTEN ABOVE See omnystudio.com/listener for privacy information.
In this episode, host Etienne Nichols sits down with Jose Bohorquez and Mohamad Foustok from CyberMed to dissect the complex world of Software as a Medical Device (SaMD) and cybersecurity. They emphasize that SaMD is first and foremost a medical device and should be treated as such from the very beginning of the development process. The conversation highlights the most common mistakes companies make, like treating security as an afterthought and jumping straight into coding without a solid architectural plan.Mohamad Foustok introduces the concept of "zero trust" and the critical importance of designing for security across the entire product lifecycle, from initial concept to post-market surveillance. The discussion clarifies that cybersecurity is not limited to network-connected devices but applies to any medical device with a software function, regardless of its connectivity. They also touch on the historical context of FDA guidance, noting a significant shift in recent years that has raised the regulatory bar and put a greater emphasis on robust cybersecurity documentation.The guests provide actionable advice for MedTech professionals, stressing the value of a balanced approach that integrates security and functionality from day one. They explain that a well-thought-out process, though seemingly slower at the outset, ultimately saves time and resources by preventing costly and time-consuming redesigns later on. This episode serves as a vital guide for anyone looking to build a secure and compliant medical device in today's evolving regulatory landscape.Key Timestamps[01:50] Common pitfalls in developing SaMD, including overlooking regulatory guidance like IEC 62304.[03:20] The critical mistake of treating cybersecurity as an afterthought in product development.[05:00] Who cybersecurity applies to beyond software, including patients, manufacturers, and supply chains.[06:30] The FDA's stance on cybersecurity for any device with a software function, even if not network-connected.[08:00] A discussion on "reasonable assurance of cybersecurity" and what it means for manufacturers.[10:00] The "zero trust" principle and why you should never assume a network is secure.[14:00] How hospitals and other stakeholders are demanding more rigorous cybersecurity standards.[15:40] The ideal process for a "security-first" development lifecycle.[21:00] Why rushing development without a proper architecture can lead to significant delays and cost overruns.[23:00] A brief history of FDA's cybersecurity guidance and the major shift in 2023.Quotes"Software as a medical device ultimately is a medical device, and so you want to be developing it from the get-go with that mindset." — Jose Bohorquez"Security can't be an afterthought. You have to consider security at the inception of your approach to a product." — Mohamed FustokTakeawaysA "Security-First" Mindset is Essential: Integrate cybersecurity from the initial architectural phase of your project. This proactive approach saves significant time and money by avoiding costly redesigns and delays later in the development process or after an FDA submission.Cybersecurity is for All Software-Driven Devices: Don't assume that only cloud-connected devices need cybersecurity documentation. The FDA requires documentation for any device with a software function, including embedded systems and programmable logic, even if it's not connected to a network.Regulatory Compliance is a Process, Not a...
Prashant Yadav joins Tommy to talk about what does this mean for our healthcare system?
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.comToday we have the pleasure of having Mr. James Watkins who went from being an Associate Sales Rep all the way a former Vice President at Medtronic. He goes into his journey on how he was able to break in and the journey it took to make it to VP
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.comToday we have the pleasure of having Mr. James Watkins who went from being an Associate Sales Rep all the way a former Vice President at Medtronic. He goes into his journey on how he was able to break in and the journey it took to make it to VP
In this episode of the Medical Sales Podcast, Samuel Adeyinka sits down with Kat Hurd, medical device sales coach and former Fortune 500 leader with 15 years of experience. From athletic training to rep of the year, to VP-level leadership and now founder of her own coaching business, Kat's journey is proof that you don't need a biology degree to thrive—you need grit, process, and the right mindset. Kat shares the pivotal moment that led her to leave corporate leadership and launch her coaching business, why so many reps fail without a clear sales process, and the three biggest gaps she sees holding reps back: lack of process, lack of ownership, and inconsistent follow-through. She also unpacks the truth about work ethic, limiting beliefs, and how managers can spot red flags before making a bad hire. Whether you're trying to break into med device, hit President's Club, or grow into leadership, this episode is packed with real-world strategies from someone who's been a top rep, a respected leader, and now a coach guiding the next generation of sales professionals. Connect with Kat Hurd: 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!
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Ahmed Elmouelhi, CEO of TRiCares. TRiCares is developing Topaz, the first purpose-built transcatheter tricuspid valve replacement system — a technology designed specifically for the right side of the heart, where complex anatomy has made durable solutions elusive.Ahmed is a 20-year medtech veteran with leadership experience across electrophysiology, men's health, neuromodulation, and structural heart. Before joining TRiCares, he helped build multiple businesses at AtriCure and held key roles at Medtronic during the early days of TAVR. He also serves as Chairman of the American Heart Association in Minnesota.In this interview, Ahmed shares why adoption — not added complexity — is the ultimate measure of medtech innovation, how a small group of physician champions can accelerate clinical studies faster than internal resources alone, and why treating your board like collaborators in the “sandbox” leads to stronger partnerships and better outcomes.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 Ahmed Elmouelhi.
This episode with Stuart Grant of Archetype MedTech demystifies the "front end of innovation," a critical yet often overlooked phase of medical device development. Stuart, a seasoned MedTech veteran with over two decades of experience at Johnson & Johnson, shares insights from his doctoral research on this topic. He breaks down the process, defining the front end as the crucial period between applied science and new product development, where teams identify unmet clinical needs and shape a product concept. This conversation offers a clear roadmap for balancing creativity with structure, using the Design Council's Double Diamond model and Stuart's 10 key insights for observing user behavior.Stuart Grant's discussion on the front end of innovation highlights the importance of deeply understanding the user and the environment in which a device will be used. He introduces a number of tools and techniques, such as the Pugh Matrix and the NVivo software, to help teams transition from a broad exploration of ideas to a focused, viable product concept. Stuart explains that while the front end may seem "fuzzy," it can be a systematic process that uncovers the true clinical and market needs that will determine a product's success. He emphasizes that the most successful devices aren't just incrementally better, but are born from a deep understanding of customer insights.This episode is an essential guide for anyone involved in MedTech innovation, from academic researchers to seasoned engineers. Stuart's insights challenge the conventional reliance on key opinion leaders and provide a framework for a more holistic, user-centric approach. He outlines how to identify and interpret subtle user behaviors, from workarounds and unconventional uses to unspoken frustrations, all of which are critical for developing a truly impactful and user-friendly medical device. Whether you're at the very beginning of a project or looking to improve your current innovation process, this episode provides actionable strategies to bridge the gap between a great idea and a marketable product.Key Timestamps(2:00) Defining the "Front End": Stuart explains what the front end of innovation is and why its name has evolved from the "fuzzy front end."(8:00) The Double Diamond Model: An explanation of the UK Design Council's Double Diamond, illustrating the divergent and convergent phases of problem-solving.(12:30) Common Pitfalls: Discussing the three critical questions to answer: Is there a market (viability)? Is the technology possible (feasibility)? Do users want it (desirability)?(15:00) Balancing Creativity and Structure: The roles of different team members and how to manage the creative (divergent) and critical (convergent) phases of innovation.(21:00) 10 Ways to Find User Insights: Stuart breaks down the specific techniques and red flags to look for when observing users, including workarounds, affordances, and areas of disjuncture.(26:00) The Problem with KOLs: Why relying solely on key opinion leaders can be a mistake and the importance of observing a wider range of users.(30:00) Triggers of Use: How unconventional uses of a device can reveal new product opportunities.Standout Quotes"A craftsman will build you exactly what you ask for. An artist will build you what you didn't know you need." - Etienne Nichols"You don't just do what the customer says because that could lead to a terrible product." - Stuart GrantTakeawaysObservation is Key: Go beyond interviews. The most valuable insights come from observing users in their natural environment,...
In this episode of Dare to Disrupt, host Ryan Newman speaks with Robert Chisena, co-founder and CTO of Amplitude Vascular Systems (AVS). AVS is a medical device company focused on safely and effectively treating severely calcified arterial disease. Robert shares his journey from growing up on Long Island in a family of physicians, to discovering his passion for research and entrepreneurship at Penn State, to co-founding an innovative medical device startup.Robert reflects on formative experiences at Penn State, including joining the Schreyer Honors College, diving into biomedical engineering research, and participating in Invent Penn State's first cohort of the Summer Founders Program. He then traces how his graduate work at the University of Michigan—collaborating closely with physicians—led to the development of AVS's intravascular lithotripsy technology, a novel approach to restoring blood flow in hardened arteries.Along the way, Robert discusses the challenges of taking research from lab to market, securing venture capital, and convincing physicians of a new device's safety and efficacy.Later in the episode, Penn State Ph.D. Candidate Marzia Momin joins the conversation. Marzia is working on a neuro-tech startup developing personalized, 3D-printed neural implants for neurological disorders, with applications in therapy and brain-computer interfaces. Marzia recently participated in both the Invent Penn State NSF I-Corps regional short course program and the NSF I-Corps National Teams program. She asks Robert about how to build the best startup team, raising funding as a research-based startup, and what advice he'd give to his younger self.This episode gives an inside look at the intersection of engineering, medicine, and entrepreneurship — and how Penn State alumni are driving innovation in healthcare.Episode Chapters1:30 No avoiding a medical-based career3:25 Choosing and navigating Penn State05:42 Exploring research as an undergrad at Penn State8:24 Launching first medical device startup at Penn State, Summer Founders Program11:54 Moving forward with startup through graduate school at Michigan14:43 Meeting co-founder, learning about the tech behind AVS16:07 The potential to create tremendous impact in cardiovascular disease treatment19:43 Translating and commercializing research out of a university20:49 Where AVS is today, looking to the future22:45 Rapid Fire Round24:27 Student Section25:13 Building the right startup team27:15 Filling in the blanks of business acumen28:04 Advice for securing early funding29:57 Navigating FDA regulations31:02 Advice for aspiring entrepreneursAbout Robert ChisenaRobert Chisena is the co-founder and CTO of AVS. He graduated from the Penn State College of Engineering with a bachelor's degree in mechanical engineering with honors from the Penn State Schreyer Honors College. Robert went on to receive his Ph.D. in mechanical engineering at the University of Michigan.About Marzia MominMarzia Momin is a Ph.D. candidate in the Engineering Science and Mechanics Department at Penn State, specializing in neural engineering. She is working on a neuro-tech startup developing personalized, 3D-printed neural implants for neurological disorders, with applications in therapy and brain-computer interfaces. Marzia recently participated in both the Invent Penn State NSF I-Corps regional short course program and the NSF I-Corps National Teams program The Dare to Disrupt podcast is made possible by the generous support of the Penn State Smeal College of Business.
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.com/podcastToday we get to learn from Cade Cook who broke into Medical Device Sales right out of college with a distributorship! Today he goes over the difference of working at a distributorship and a Large Medical Device CompanyHe also shares why he pursued Medical Device Sales over nursing and how he has been able to change his life because of it
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.com/podcastToday we get to learn from Cade Cook who broke into Medical Device Sales right out of college with a distributorship! Today he goes over the difference of working at a distributorship and a Large Medical Device CompanyHe also shares why he pursued Medical Device Sales over nursing and how he has been able to change his life because of it
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Marc Penna, CEO of Voyager Biomedical. Voyager is a clinical-stage company tackling one of the most persistent challenges in dialysis care: reliable vascular access. Marc has more than 20 years of experience leading clinical research and regulatory programs across cardiology, vascular disease, and oncology. Since 2014, he has focused on early-stage ventures, with leadership roles at Intact Vascular and Vesper Medical — both acquired by Philips — as well as senior positions at Edwards Lifesciences, Boston Scientific, and AngioDynamics.In this interview, Marc shares how to pressure-test new medtech ideas, why collaboration with regulators and trial sites builds lasting credibility, and how disciplined fundraising and smart exit planning can set startups apart.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 Marc Penna.
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.com/youtube-podIf you're new to my channel, my name is Jacob McLaughlin. I'm the founder of New to Medical Device Sales, an exclusive training program designed to help people break into the competitive field of medical device sales. Our average person lands a six-figure role in just 8.5 weeks, earning $105,502 annually. With thousands of success stories from candidates with all kinds of backgrounds, our program equips you with the tools to succeed in this industry.4 years ago I moved out to Arizona not knowing anyone and had $1200 to my name.I came to this exact spot to journal and share how excited I was to be starting my journey in life.Last night I took time to reflect over the past 4 years. It's truly amazing how you can change your life in such a small amount of time.My take aways:1. Go after your dream because even if it doesn't workout like you thought it would, it will bring your right where you're suppose to be.2. Believe in yourself. Nobody is going to believe in you as much as you will, know that good things will happen.3. Change is inevitable. Change is going to happen so you can either accept it and keep moving forward or not.Please bet on yourself and go after your dreams because your life can be better than you ever thought it could be if you do
Episode 313 hosts Dr Konstantin Frank (Aesthetic Doctor from Regensberg, Germany) In our ‘Masterclass Series' we host global experts to teach us about fillers, bio-stimulators, bio-remodellers, polynucleotides, exosomes and other products. (For toxin insights, check out our other mini-series, ‘The Tox Talks') In Chapter 9 we do something different by discussing the entire range of fillers made by Croma. We learn about who Croma are, get an understanding about their portfolio of products and what features to look out for when choosing a filler. 00:00 Introduction to Inside Aesthetics 00:46 Live from the Fresh Life Conference 01:08 Masterclass Series: Fillers Discussion 02:22 Introducing Dr. Konstantin Frank 03:44 Exploring the Aesthetic Industry in Europe 05:59 Dr. Konstantin's Background and Journey 10:05 Deep Dive into Croma Fillers 20:37 Manufacturing Insights and BDDE Discussion 27:30 Croma Fillers: Unique Selling Points 29:23 Differences in Syringe Design Between Europe and Australia 29:51 Colour Coding and Safety in Injectables 30:05 Regulatory Approvals and Quality Control 30:48 Medical Devices vs. Drugs: A Legal Perspective 31:28 Minimally Invasive Procedures and Safety 31:48 Using Croma Products: A Detailed Guide 34:21 Tips for Practitioners Using New Products 36:59 The Importance of Proper Training and Education 37:19 The Role of Anatomy in Successful Injections 47:08 The Impact of Social Media on Aesthetic Medicine 51:27 Global Perspectives on Aesthetic Practices 56:29 Concluding Thoughts and Future Episodes NEW - WATCH THIS EPISODE ON YOUTUBE NEW - OR WATCH THIS EPISODE ON SPOTIFY CHECK OUT OUR PATREON & GET A 7 DAY FREE TRIAL ACCESS THE IA OFFER MENTIONED IN THIS PODCAST (& use the discount code IA10) CLICK HERE IF YOU'RE A BRAND OR COMPANY & WANT TO WORK WITH US CLICK HERE TO APPLY TO BE A GUEST ON OUR PODCAST CONTACT US
Sales legend and trainer Steve Gielda—co-founder of Ignite Selling—joins Samuel to break down what truly drives performance in medical device, pharma, biotech, and diagnostics. Steve traces his path from selling 3M copiers out of a van to leading life-sciences consulting with Neil Rackham (of SPIN Selling) and building Ignite's simulation-based, gamified training that accelerates pipelines and product launches. We get tactical fast: how today's top reps think strategically, map real stakeholders (beyond the “friendly” contacts), and use smarter questions that challenge clinical and business assumptions—not just needs. Steve explains when SPIN still shines, where Challenger-style questions raise the bar, and why role-playing strategy is as critical as role-playing the call. For frontline managers, Steve lays out the playbook: coach early in the pipeline, ask more than you tell, know when to sell vs. when to coach, and—yes—let your reps fail on safe calls so they learn to win without you. We dive into work ethic vs. knowledge, turning average reps into top performers, and the signals that a high producer is (or isn't) ready for leadership. If you want practical frameworks to sharpen your questioning, focus your account strategy, and elevate your team's coaching culture, this episode delivers candid insights you can apply on your very next call. Connect with Steve: 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!
bersecurity in Medical Devices – A QA/RA Perspective Cybersecurity is often seen as an IT or engineering issue—but in reality, regulators and auditors turn to QA and Regulatory Affairs professionals for evidence. In this article (based on the podcast episode), we explore: How to prepare cybersecurity documentation for audits and inspections Building post-market processes for vulnerability handling and reporting Linking cybersecurity with standards (ISO 13485, ISO 14971, IEC 62304, ISO 27001…) Managing supplier and open-source component risks Implementing and maintaining an SBOM Key trends like the NIS2 Directive and the EU AI Act
The University of Galway is leading three new projects that aim to make medical treatments safer, faster and more effective after researchers secured the support of one of Europe's most prestigious funding programmes. The awards were made by the European Commission's Marie Sklodowska Curie Actions-Doctoral Network programme (MSCA DN), as part of Horizon Europe 2020. The programme supports researchers to become future leaders while investing in the University of Galway projects to improve lives and pave the way for better, more affordable healthcare. The network also provides training to make the researchers more creative, entrepreneurial and innovative, boosting their employability in the long term. One University of Galway project has an emphasis on sustainability and a move away from animal testing for brain disease; a second is looking at cardiovascular issues, specifically around improving heart stent durability and longevity; and a third seeks to advance equity, diversity and inclusion in clinical trials. Professor Fidelma Dunne, Director of the Institute for Clinical Trials at the University of Galway, said: "These projects show how research can make a real difference in people's lives. University of Galway is proud to be leading the way in creating smarter, safer, and more sustainable healthcare solutions." Professor Ted Vaughan, Interim Director of the Institute for Health Discovery and Innovation at the University of Galway, said: "These projects exemplify the mission of our new Institute - to accelerate fundamental and applied understanding of disease and enable disruptive solutions to health-based challenges. By combining cutting-edge science with collaborative training, we are not only advancing medical technologies but also shaping the next generation of research leaders. This investment from the European Commission underscores the importance of innovation that is ethical, inclusive, and focused on improving patient outcomes across society." The University of Galway projects funded by the Marie Sklodowska Curie Actions-Doctoral Network are: Dr Mihai Lomora leads the €4.2 million CerebroMachinesTrain Doctoral Network research project - Smarter Drug Delivery for Brain Diseases. Using advanced 3D brain models that mimic real brain tissue, the project will test tiny machines which are being developed to bring medicine exactly where it is needed. It avoids animal testing, making research faster, more ethical, and more accurate. Dr Lomora is a Lecturer and Principal Investigator in Bio(material) Chemistry at the University's School of Biological and Chemical Sciences in the College of Science and Engineering and a Funded Investigator at CÚRAM - the Research Ireland Centre for Medical Devices. This network project involves 14 partners from eight countries, including the US. Four PhD students will be supported through the project at the University of Galway. Dr William Ronan leads the €2.71 million MEDALLOY research project - Stronger, Safer Materials for Life-Saving Devices. It focuses on making materials used in minimally invasive medical devices - like stents and heart valve supports - stronger and longer lasting. Dr Ronan is a Lecturer and Principal Investigator in Biomedical Engineering at the University's College of Science and Engineering. The project includes partners from six countries - the US, Ireland, Italy, Germany, Czechia and Sweden. It will train nine PhD students, who will spend at least half of their time working directly in industry, earning hands-on skills ranging from material science to patient care. Dr Eimear Morrissey leads the €4.4 million EDICT research project - Advancing Equity, Diversity and Inclusion in Clinical Trials. It is a research and training network led by the Health Research Board-Trials Methodology Research Network, based at the University of Galway, which seeks to include older adults, ethnic minorities, people with disabilities, or those from lower-income backgrounds in clinica...
AJ Reiter, Growth Director at Medcrypt, joins Pathmonk Presents to discuss their mission to secure medical devices for patient safety. Medcrypt provides cybersecurity solutions for top medical device manufacturers, focusing on surgical robotics and diabetes devices, ensuring FDA compliance and secure data transit. Reiter emphasizes the role of their website in guiding customer conversations and the importance of face-to-face engagements at industry events. Learn how Medcrypt's proactive approach and thought leadership help manufacturers expedite market entry while prioritizing patient safety and data integrity.
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.com/podcastGot the opportunity to sit down with Dr. Brian Blackwood and discuss what he looks for in his reps. Dr. Brian Blackwood is a board-certified orthopedic expert who specializes in joint replacement of the hip and knee, including Mako SmartRobotics™ joint replacement. With extensive training in the latest joint replacement and revision techniques, Dr. Blackwood is dedicated to providing the advanced orthopedic care his patients need to get back to an active lifestyle.In addition to being Boulder's first fellowship-trained hip and knee replacement specialist, Dr. Blackwood is a nationally renowned robotic-assisted total joint surgeon. By specializing in this minimally invasive technique, he is able to reduce pain, restore mobility, and promote a quick return to normal activities for patients suffering from joint pain. Dr. Blackwood is also a certified national educator for robotic-arm assisted surgery and has trained hundreds of other providers in this technique.
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.com/podcastGot the opportunity to sit down with Dr. Brian Blackwood and discuss what he looks for in his reps. Dr. Brian Blackwood is a board-certified orthopedic expert who specializes in joint replacement of the hip and knee, including Mako SmartRobotics™ joint replacement. With extensive training in the latest joint replacement and revision techniques, Dr. Blackwood is dedicated to providing the advanced orthopedic care his patients need to get back to an active lifestyle.In addition to being Boulder's first fellowship-trained hip and knee replacement specialist, Dr. Blackwood is a nationally renowned robotic-assisted total joint surgeon. By specializing in this minimally invasive technique, he is able to reduce pain, restore mobility, and promote a quick return to normal activities for patients suffering from joint pain. Dr. Blackwood is also a certified national educator for robotic-arm assisted surgery and has trained hundreds of other providers in this technique.
Podcast: Error Code (LS 27 · TOP 10% what is this?)Episode: EP70: Securing Medical Devices You Might Not Have Thought to SecurePub date: 2025-09-02Get Podcast Transcript →powered by Listen411 - fast audio-to-text and summarizationHealthcare organizations are prone to the same weaknesses that any other office or manufacturing site may have. Sonu Shankar, Chief Product Officer at Phosphorus Cybersecurity, explains how the devices you might not suspect might be the ones to bring down your organization if they're not secured. That includes the printer used to print patient wristbands.The podcast and artwork embedded on this page are from Robert Vamosi, which is the property of its owner and not affiliated with or endorsed by Listen Notes, Inc.
Medboard EUROPE Guidance on the implementation of the Master UDI-DI - MDCG 2024-14 - rev.1 : https://health.ec.europa.eu/document/download/c8c6cca5-460e-410e-a325-be08bfc7dea6_en?filename=mdcg_2024-14_en.pdf Updated - Notified bodies survey on certificates under MDR and IVDR: https://health.ec.europa.eu/document/download/59b9d90e-be42-4895-9f6f-bec35138bb0a_en?filename=md_nb_survey_certifications_applications_en.pdf There's a significant backlog: far more applications submitted than certificates issued, especially for IVDs. Time for certification: between 13 to 18 months on average Delay due to application missing critical information and refusal due to submission outside NB scope No transparency on capacity Germany new radiation protection regulation - Start July 1st, 2025: https://www.bfarm.de/DE/Arzneimittel/Klinische-Pruefung/Strahlenschutz/_artikel.html?nn=986770If device emit radiation and need clinical investigation in germany: Include a radiation risk assessment in your clinical investigation dossier Coordinate with Radiation protection authorities Update investigator brochure and patient information Stricter Monitoring & Reporting Impact on Timelines So stricter documentation, more authorities involved and longer approval times UK MHRA launches Route B notification pilot Clinical trials regulations rollout: https://www.gov.uk/government/news/mhra-launches-route-b-notification-pilot-as-part-of-clinical-trials-regulations-rollout - https://www.gov.uk/guidance/notify-mhra-about-a-clinical-investigation-for-a-medical-device Switzerland New in Swissdamed - Medical Device registration with UDI Device Module: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank/swissdamed-informationen/registrierung-mepprodukte-moeglich.html 1 july-2026 Magazine Easy Medical Device Mag - Your QA RA Magazine: https://mailchi.mp/easymedicaldevice/emdmag1 Podcast: Best 40 Medical Device Podcast - Thanks: https://www.millionpodcasts.com/Medical-Device-podcasts/ REST OF THE WORLD SaMD and/or Artificial Intelligence on the spotlight - All countries want their regulation on it: USA: PCCP - https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence SFDA: Workshop September 9th: https://www.sfda.gov.sa/en/workshop/4387139 TGA: Understanding regulation of software-based medical devices: https://www.tga.gov.au/resources/guidance/understanding-regulation-software-based-medical-devices#samd-and-ai-medical-device-compliance SAHPRA: Regulatory Requirements of AI/ML: https://www.sahpra.org.za/document/regulatory-requirements-of-artificial-intelligence-and-machine-learning-ai-ml-enabled-medical-devices/ Medical Device or Wellness device - Choose your side: https://www.sfda.gov.sa/sites/default/files/2025-08/MDS-G027.pdf
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Christopher Haig, co-founder and CEO of Efemoral Medical. Efemoral is developing bioresorbable scaffold technology for peripheral arterial disease. Chris has over 25 years of experience in cardiovascular devices, holding leadership roles at strategics including Guidant Corporation and Abbott Vascular, and driving growth at startups such as Calypso Medical and QT Vascular, where he built commercial infrastructure and launched multiple products ahead of its $55 million IPO.In this interview, Chris shares how bioresorbable scaffold technology found new life for peripheral arterial disease — and the lessons on matching tech to significant needs and choosing trial sites for lasting data.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 Christopher Haig.
In this episode of Let's ComBinate: Drugs + Devices, we welcome back Susan Neadle, author of The Combination Products Handbook. Susan explores the persistent and evolving challenge of terminology in combination products—a problem that continues to create confusion and regulatory risk even in 2025.Susan emphasizes the need for alignment on terminology and regulatory expectations, highlighting that true progress requires a science- and risk-based perspective. The discussion also covers how GMP requirements are interpreted differently in pharma versus medtech, the ongoing challenges of global harmonization, and why cohesive language is essential for compliance, inspection readiness, and effective product development.Episode Chapters00:00 Introduction and Welcome00:25 The Lexicon Problem in Drug-Device Combination Products01:01 Historical Efforts and Challenges02:12 Regulatory Frameworks and Definitions04:47 Industry and Regulatory Alignment Issues06:55 Science and Risk-Based Perspectives10:08 Terminology and Definitions in Practice14:05 Global Regulatory Differences17:22 Challenges in Harmonizing Standards23:13 Key Terms and Their Impact32:23 Conclusion and Contact InformationSusan Neadle is a recognized international Combination Products, Medical Device, and Digital Health expert with over 35 years industry experience. She has just published “The Combination Products Handbook: A Practical Guide” through Taylor & Francis Group/Routledge/CRC Press. Her leadership, innovation, and best practices have been recognized with several awards, including the 2022 ISPE Joseph X. Philips Professional Achievement Award for extraordinary contributions to the industry; 2021 TOPRA Award Finalist for Regulatory Affairs Excellence; and the Johnson Medal, Johnson & Johnson's highest honor for excellence in Research & Development. Susan retired from a distinguished and impactful career at Johnson & Johnson and is now Principal Consultant at Combination Products Consulting Services LLC, providing international quality, regulatory affairs, and design excellence services, to the biopharma, biotech, and medical device industries. She continues to fulfill her passion in this space as Chair of the ISPE Combination Products CoP, and Lead Author in Combination Products Working Groups through ASTM International and AAMI standards committees. Susan teaches curricula in Combination Products through UMBC, AAMI, and DIA, as well as customized training upon request. She is also active in multiple industry working groups including CPC, AFDO/RAPS, DIA, TOPRA and PQRI, and enjoys speaking at a variety of industry forums. Susan can be reached at sneadle@combinationprod.com Subhi 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.
We're at the ACPA Annual Meeting with returning guest and CozeeCoo founder and CEO Jennifer Stelmakh. Born from her real life frustrations with medical solutions and interventions, Jennifer created CozeeCoo, a thoughtfully designed surgical recovery vest that keeps little arms safe and healing cozy while finally replacing stiff elbow restraints. Jennifer shares how the energy and collaboration at ACPA fuel her passion for innovation and community impact. Tune in as she reveals new CozeeCoo updates, what she's learned on her entrepreneurial journey, and why the annual meeting remains critical to transforming support for cleft families everywhere. Links and Resources: Patreon Subscription Tiers for Exclusive Content Our Forever Smiles Merch Store NC Cleft Mom FB Group Our Forever Smiles FB Group ______________________________________________________________________________ Today's sponsor is sienna dawn media Integrated Marketing Agency sienna dawn media is more than just a marketing agency—they are your partners in progress. Their mission is simple — to alleviate marketing bandwidth, allowing creative business owners to focus on what they set out to do: create. sienna dawn media empowers creatives to thrive without the burden of managing their own social media and marketing campaigns. So, if you're ready to set sail toward new horizons, let sienna dawn media chart the course and steer your business toward success. Visit siennadawnmedia.com.
Healthcare organizations are prone to the same weaknesses that any other office or manufacturing site may have. Sonu Shankar, Chief Product Officer at Phosphorus Cybersecurity, explains how the devices you might not suspect might be the ones to bring down your organization if they're not secured. That includes the printer used to print patient wristbands.
When we think of medical devices and how they're built, 3D printing isn't necessarily the first thing that comes to mind. But Boston Micro Fabrication is at the cutting edge of an exciting development in how life-saving devices are prototyped and created. With the news that the FDA is pivoting away from animal testing towards 3D organoids, and with the growing need to produce miniature, intricate and high-quality devices at speed, BMF's nanometer-precise microArch 3D printing technology is opening the door to new possibilities - allowing the rapid production of equipment like stents, endoscopes, and even needles. A BMF-built catheter recently featured in a nature.com scientific report, delivering 183x higher drug concentrations for liver cancer treatment than would otherwise have been possible.We were thrilled to talk to the CEO of BMF, John Kawola, about the company's exciting work. Qualio website:https://www.qualio.com/ Previous episodes:https://www.qualio.com/from-lab-to-launch-podcast Apply to be on the show:https://forms.gle/uUH2YtCFxJHrVGeL8 Music by keldez
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.com/podcastTired of hearing it's “impossible” to break in at six figures? Jacob shares the truth behind high-paying entry roles in medical device sales and why most reps are giving you bad advice. If you're aiming for a $100K+ starting salary, this episode gives you the mindset, strategy, and real-world insight to make it happen—no fluff, no excuses.00:00 - Start01:05 - When It's OK To Get Hired Under 100K04:15 - Do Your Research12:56 - Be Strategic16:27 - Expand The Expectations18:45 - Overall Advice
Dean's Chat hosts, Drs. Jensen and Richey, welcome Dr. Laura Brinker to the podcast! Laura Brinker, DPM, was previously a Vice President of Clinical Affairs at Paragon 28, where she drove innovation in foot and ankle surgical solutions. She now has a consulting firm to address advancements of medical devices, regulatory compliance, and clinical trials. With a background in Mechanical Engineering from Purdue and a DPM from Temple University, she completed her residency at the University of Louisville/Jewish Hospital. Dr. Brinker has combined private practice experience, clinical research, and engineering expertise to advance podiatric surgery and medical device development. Enjoy this entrepreneurial discussion with a young leader in our profession!
Want To Learn How To Grow Your Territory?? If so → https://www.newtomedicaldevicesales.com/podcastAlready in med device sales but stuck below six figures or feeling like you've plateaued? In this episode, Jacob challenges the industry norms and lays out exactly how reps are landing roles at $100K, $130K, even $160K+ from day one. Whether you're in an associate role or already closing deals, this is your blueprint to move up faster, earn more, and position yourself for high-leverage opportunities.00:00 - Start01:06 - When It's OK To Get Hired Under 100K04:16 - Do Your Research12:20 - Be Strategic15:51 - Expand The Expectations18:09 - Overall Advice
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Howard Rosen, co-Founder and CEO of Evident Vascular, a company developing an AI-powered intravascular ultrasound (IVUS) platform to improve vascular imaging and intervention. Before co-founding Evident, Howard held senior leadership roles at Intact Vascular and Vesper Medical, guiding both companies through successful acquisitions by Philips. He also served in executive roles at Haemonetics and BG Medicine, and spent over two decades at Boston Scientific, where he held a range of leadership positions across the peripheral and cardiovascular franchises.In this interview, Howard shares why launching right — not fast — is the key to success in medtech. He breaks down how Evident built early momentum by investing in deep market validation, engaging KOLs as true collaborators, and resisting scope creep at every turn. Howard also unpacks the company's deliberate regulatory strategy, using early FDA engagement as a tool to de-risk development. On the fundraising front, he explains why board composition matters more than valuation, and why strategic acquirers respond best to credibility, not cold outreach.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 Howard Rosen.
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.com/podcastWhat's the real difference between people who break into medical device sales at $60K and those who land $160K jobs straight out the gate? In this episode, Jacob unpacks what separates average from elite. From mindset to coachability to who you're listening to. If you're tired of feeling stuck or settling for less, this episode is your wake-up call.00:00 - Start01:33 - What Is Average03:48 - Develop A Healthy Circle Of People06:42 - Being Coachable09:50 - Invest In Yourself11:38 - Don't Do It All Alone14:29 - Average Thoughts vs Top Performer Thoughts
In this episode of the Medical Sales Podcast, Samuel Adeyinka sits down with Gina Torres, a nurse-turned-medical device sales professional at Johnson & Johnson, to unpack what it really takes to thrive in one of the most competitive fields in healthcare: peripheral vascular and coronary sales. Gina shares her inspiring journey from working multiple nursing jobs to consolidating her career into one life-changing role in medical device sales. She reveals how she broke into the industry, why she chose Shockwave's groundbreaking intravascular lithotripsy technology, and what makes the clinical specialist role such a powerful entry point for both clinicians and driven non-clinicians. From balancing 5 a.m. case starts to late-night procedures, Gina gives a behind-the-scenes look at the unpredictable but rewarding life of a vascular rep. She also breaks down the income potential, the skills that truly separate top performers, and why grit, empathy, and the ability to “get comfortable being uncomfortable” matter more than a clinical background. Whether you're a nurse considering the leap, a bachelor's graduate wondering if you can compete, or an aspiring sales rep curious about cardiovascular devices, this conversation delivers raw insights, career strategies, and real talk about success in medical sales. 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!
A medical sales rep blows the whistle on an alleged kickback scheme where he says a company bribed staff at a Veterans Affairs hospital to buy unnecessary medical devices at taxpayer expense, and use them in medically unnecessary procedures on veterans. The company and doctors dispute the allegations and deny any wrongdoing.Order Sharyl's new bestselling book: “Follow the $cience.” Subscribe to my two podcasts: “The Sharyl Attkisson Podcast” and “Full Measure After Hours.” Leave a review, subscribe and share with your friends! Support independent journalism by visiting the new Sharyl Attkisson store.See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.
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