Podcasts about medical devices

Artificial intelligence is transforming healthcare, but developing an AI medical device is only part of the challenge. Manufacturers must also navigate certification requirements and maintain safety and performance throughout the entire product lifecycle.In two podcast episodes featuring Sandy Wright and Osman El-Koubani, we explore the journey from certifying LLM-driven medical devices to managing them after CE marking.Certifying LLM-Driven Medical DevicesLarge Language Models such as ChatGPT, Gemini, and Claude introduce new regulatory challenges. Unlike traditional software, these systems raise questions around predictability, validation, traceability, supplier management, and model updates.Topics discussed include:What defines an LLM-driven medical deviceClinical evaluation strategiesDemonstrating clinical benefitUsing commercial AI modelsSupplier controls and external dependenciesSignificant changes and model updatesLife After CE MarkingObtaining CE certification is not the end of the journey.AI medical devices require continuous monitoring once they reach the market.Manufacturers must address:Performance drift in real-world settingsCollection and analysis of real-world dataAI retraining and change managementPredetermined Change Control Plans (PCCPs)Post-Market Surveillance (PMS)Continuous safety and performance evaluationAI Devices Require a Lifecycle ApproachAI systems are dynamic technologies. Success depends not only on achieving certification, but also on maintaining control over performance, updates, and clinical safety throughout the product lifecycle.As regulations continue to evolve, manufacturers must combine robust development practices with proactive post-market monitoring to ensure long-term compliance and patient safety.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.  If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.LinkSandy LinkedIn: https://www.linkedin.com/in/wrightsandy/Osman Linkedin: https://www.linkedin.com/in/osman-kan/Scarlet Linkedin: https://www.linkedin.com/company/scarlet-comply/posts/?feedView=all&viewAsMember=trueSocial Media to followMonir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldeviceInstagram: https://www.instagram.com/easymedicaldeviceThis podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

The following article of the Health industry is: 'How North American Integration Powers Medical Device Production' by Carlos Alejandro  Salazar Gaytán, President, National Association of Healthcare Suppliers (ANAPS) - Medical Expo. 

The Advantage of Rapid Prototyping in Wearable MedTech DevelopmentModern cancer treatments are getting better at targeting specific forms of cancer. However, this improved effectiveness often introduces lethal side effects. Skribe Medical is developing wearable technologies to help oncologists monitor and manage these side effects and ultimately improve cancer survivability.In Episode 45 of the MedTech Speed to Data podcast, Key Tech's Andy Rogers has a conversation with Ryan Neely, Skribe Medical's CEO and co-founder, about the startup's approach to rapid prototyping, clinical trials, and wearable technology.Need to knowCancer treatment can be lethal — The most effective drugs often come with black box warnings of harmful and lethal side effects.600,000 US patients are at risk of cardiotoxicity — Toxic drugs damage the heart, leading to complications like arrhythmia and heart failure.Managing cardiotoxicity can delay cancer treatments — Oncologists must now schedule patients for third-party ECG testing, which takes time and delays treatment.The nitty-grittySkribe Medical is developing a wearable ultrasound sensor that detects cardiotoxicity signals for use in oncology clinics. “We have a patch that can be worn to detect cardiotoxicity and really streamline monitoring of heart health,” Neely says. “Rather than an oncologist sending a patient to get a cardiac ultrasound, which could take weeks, the patch can just be placed above the heart for about five minutes. We record a bunch of different signals, pass them through an AI model, and then we can give them either a thumbs up or a thumbs down.”Neely goes on to explain how the in-clinic wearable approach delivers benefits beyond better patient outcomes. “The first device that we're building is intended to be used in the clinic by a nurse or a medical assistant. By the time the doctor is there, you've got your answer.”Designing a wearable device rather than an implant created several advantages for Skribe Medical during its early development. “In a regulated industry like medical devices,” Neely explains, “it's like a little bit of a chicken and egg where people say, ‘we'd like to see some clinical validation' and you're thinking, ‘Well, I don't have a million dollars to fund that.' In a non-invasive device, any opportunity that you can have to test, even if it's this big, bulky thing, you can get some data.”Skribe Medical's technology can extend to other aspects of oncology, including peripartum cardiomyopathy, a rare form of heart failure arising towards the end of a pregnancy. Long-term, Neely envisions building the longitudinal training data needed for predictive monitoring. “What we'd like to do is be able to say, ‘two weeks from now there might be an issue' so you can do something today that prevents any drop [in injection fraction] at all.”Data that made the difference:Skribe Medical's three founders built first prototype at home. They used their home electronics and 3D printing labs to rapidly prototype the first functional sensors.Rapid wearable development delivered data quickly, first by testing themselves and then through clinical testing.Skribe Medical conducted the first clinical tests at an ECG lab where, with consent, the wearable collected patient data for comparison with the patient's ECG results.Having clinical data so early in the process encouraged investors. Last year's pre-seed round raised $1.6 million from angels and VCs to support the next phase of device development and trials.Listen to Andy's conversation with Neely to hear more about Skribe Medical's journey, development process, and the advantages of wearable medical technology.

In this episode of Medsider Radio, we sat down with Kara Egan, founder and CEO of Teal Health.Teal Health is the company behind the first FDA-authorized at-home cervical cancer screening wand.Before founding Teal, Kara worked in healthcare and software investing at .406 Ventures and Emergence Capital, and held product and marketing roles at Zendesk and Stitch Labs.  In this interview, Kara discusses building support and follow-up into at-home screening, how Teal expanded its comparative clinical study to support broader market adoption, and how healthcare incentives, reimbursement, and institutional trust shape new care models.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device founders and CEOs and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.And if you're ready to level up your medtech game, you should check out Medsider Courses — 8-week masterclasses covering topics like fundraising, M&A and exit planning, design and development, clinical and regulatory strategy, and commercialization.These courses, featuring hard-earned lessons from elite medtech CEOs, can be purchased individually or come free with our All-Access Pass.If you'd rather read than listen, here's a link to the full interview with Kara Egan, which includes a link to ScottBot — an AI version of host Scott Nelson trained on every Medsider interview and playbook. Feel free to ask ScottBot any questions you'd like!KEY MOMENTS FROM THE INTERVIEW(02:49) - Kara's background in health technology investing and software that shaped Teal's consumer-first approach (05:14) - How Teal turned the traditional Pap smear into the first FDA-authorized at-home screening product (07:30) - Turning at-home testing, telehealth, and clinician follow-up into a single care experience (13:48) - Raising Teal's first $1M with mockups and consumer-grade design (22:17) - Teal's comparative study that matched physician-collected screening with 96% sensitivity (23:40) - How asking women what they actually wanted changed Teal's view of the market opportunity (32:05) - “Take off the healthcare hat” — Kara's framework for fundraising, incentives, and commercialization (41:48) - What investors actually care about beyond the company's mission

Highlights from their conversation include: Keith Smith's Journey into Manufacturing and Industrial Engineering (0:49)   Overview of Vonco Products as a Medical Device Contract Manufacturer (1:53)   Single Use Fluid Bags, Horizontal Services, and Turnkey Offering (2:06)   Being “Freaks About Leaks” and the Liqui Lock Guarantee (4:16)   RF Welding vs Heat Seal Welding for Different Polymers (5:39)   The Spark Program and On-Site Rapid Prototyping with Customers (7:03)   Enter Lock Innovation for Enteral Feeding and Customer Adoption (8:21)   Geopolitical Shocks, Iran Conflict, and Plastic Supply Volatility (9:32)   Reshoring, Near Shoring, and Rethinking Global Supply Chains (12:18)   COVID, Panic Buying, and Stockpiling Risk in Medical Devices (14:34)   Automation Priorities, Staffing Challenges, and Failed Experiments (17:01)   Diversification Strategy, Customer Mix, and Supply Chain Resilience (19:28)   Parting Thoughts and Takeaways (20:46)   Dynamo Ventures is a venture firm backing founders upgrading the physical economy. As intelligence moves into critical infrastructure and technology collides with physics, industry is entering a new era of transformation - the industrial renaissance. Born from the dirt and grit of supply chains and shaped by operations, not spreadsheets, Dynamo focuses on the complex realities of building in the real world. We invest in companies transforming infrastructure, manufacturing, logistics, transportation, and the systems that power global commerce. Dynamo works closely with founders who combine ambition with a bias to action, bringing a builder mindset to venture capital through deep operational insight, systematic pressure-testing and hands-on partnership. Our purpose is simple: to back the relentless shaping the industrial renaissance. Learn more at www.dynamo.vc. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

Sponsor Medboard Medboard: https://www.medboard.com/EUROPEEurope Starts Regulating the Regulators - Implementing Regulation (EU) 2026/977: https://eur-lex.europa.eu/eli/reg_impl/2026/977/ojEUDAMED is mandatory - Panic is raising: https://health.ec.europa.eu/medical-devices-eudamed/overview_enGermany: https://www.bfarm.de/SharedDocs/Downloads/DE/Medizinprodukte/DMIDS-anleitung-anzeigepflichtige-mp-ivd.pdf?__blob=publicationFileBelgium: https://www.famhp.be/en/news/eudamed_clarifications_regarding_obligations_from_28_may_2026Portugal: https://www.infarmed.pt/web/infarmed/noticias/-/journal_content/56/15786/13092901AI Medical Devices - Timeline changed for AI ACT: https://www.consilium.europa.eu/en/press/press-releases/2026/05/07/artificial-intelligence-council-and-parliament-agree-to-simplify-and-streamline-rules/Germany guidance: https://www.bundesnetzagentur.de/DE/Fachthemen/Digitales/KI/5_Innovationen/_DL/Roadmap_Pilot.pdf?__blob=publicationFile&v=5Spain new HTA - Royal Decree 415/2026: https://www.boe.es/boe/dias/2026/05/29/pdfs/BOE-A-2026-11587.pdfDenmark on languages - Reminder that there are requirements to follow: https://laegemiddelstyrelsen.dk/en/devices/registration-and-marketing/language-requirement/UKMHRA regulatory advice meetings - Pay and ask what you want: https://www.gov.uk/guidance/medical-devices-ask-for-a-regulatory-advice-meeting-from-the-mhraEasy Medical Device solutionsEasyIFU - electronic Instruction for Use: https://easyifu.comSmarteye - electronic Quality Management System: https://eqms-smarteye.com/Rest of the WorldFDA reinforce Human Factors expectations - This is not nice to have: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-human-factors-information-medical-device-marketing-submissionsSaudi Arabia bundling criteria - More products in a single application: https://www.sfda.gov.sa/sites/default/files/2026-05/MDS-G28.pdfPodcastPodcast Nostalgia - Re-listen latest podcast episodes:Episode 390 - How can a proper intended use save your device with Kanrandeep Badwal: https://podcast.easymedicaldevice.com/390-2/Episode 391 - Feedback after 3 months of the new FDA QMSR is in place with Mathangi Srinivasan: https://podcast.easymedicaldevice.com/391-2/ Easy Medical DeviceConsulting activities (CE marking, Clinical Evaluation, QMS creation…) https://easymedicaldevice.com/services/mdr-ivdr-technical-documentation/BOSS Program: Back Office ServiceseQMS: https://easymedicaldevice.com/smarteye-eqms/EasyIFU: eIFU and Label creation: https://easymedicaldevice.com/easyifu/Authorized Representative in EU, UK and SwitzerlandMarket access all over the world: https://easymedicaldevice.com/services/market-access/Social Media to followMonir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldeviceInstagram: https://www.instagram.com/easymedicaldeviceThis podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

Geschätzte Lesedauer: 11 Minuten Hand aufs Herz: Wenn du in deiner letzten Stellenanzeige „mindestens zehn Jahre Branchenerfahrung" gefordert hast, dann hast du auf eines der schlechtesten Kriterien gesetzt, die die Forschung kennt. Klingt hart? Ist aber so. Wenn du im Vertrieb Vertriebsmitarbeiter einstellen willst, die wirklich performen, musst du dich von ein paar lieb gewonnenen Annahmen verabschieden. Denn die Kriterien, auf die wir im Recruiting am häufigsten filtern, sind nach vier Jahrzehnten Forschung genau die mit der schwächsten Treffsicherheit. In diesem Beitrag zeige ich dir, wie du einen Recruiting-Prozess auf Basis echter Daten aufbaust – kein Bauchgefühl, keine Bro-Science, sondern das, was die Wissenschaft wirklich misst. Du erfährst, welche Auswahl-Werkzeuge funktionieren, warum der laute Verkäufer ein Mythos ist und wie du deine Fehlerquote von rund 40 % auf unter 10 % drückst. Warum die meisten beim Vertriebsmitarbeiter einstellen die falschen Kriterien nutzen Das teure Missverständnis Ich werde immer öfter gefragt: „Chris, schau dir mal unseren Recruiting-Prozess an, wir stellen ständig die Falschen ein." Und fast immer sehe ich dasselbe Muster – es werden die falschen Methoden genutzt. Berufserfahrung, Studienabschluss, ein nettes Gespräch nach Sympathie. Das fühlt sich sicher an, hat aber mit der Vorhersage von Vertriebserfolg wenig zu tun. Warum sich der Irrtum so hartnäckig hält Diese Kriterien wirken plausibel. Niemand wird gefeuert, weil er einen Kandidaten mit zehn Jahren Branchenerfahrung eingestellt hat. Genau deshalb hält sich der Irrtum so hartnäckig. Wer aber wirklich gute Vertriebsmitarbeiter einstellen will, muss aufhören, auf das zu filtern, was sich gut anfühlt – und anfangen, auf das zu setzen, was nachweislich funktioniert. Gutes Vertriebsrecruiting ist keine exakte Wissenschaft, aber es gibt sehr viel belegtes Wissen, das die meisten schlicht übergehen. Vertriebsmitarbeiter einstellen: Was eine Korrelation wirklich aussagt Zwei Beispiele zum Einordnen Damit du die folgenden Zahlen einordnen kannst, ein kurzer Methoden-Check. Wir sprechen von Korrelationen. Eine Korrelation liegt zwischen 0 und 1: Null heißt kein Zusammenhang, eins heißt perfekte Vorhersage. In der Personalauswahl kommst du praktisch nie über 0,60 – und das nur, wenn du die richtigen Methoden klug kombinierst. Die Korrelation zwischen regelmäßiger Aspirin-Einnahme und einem geringeren Herzinfarktrisiko liegt bei rund 0,03 – und rettet trotzdem Millionen Leben. Rauchen und Lungenkrebs hängen mit etwa 0,40 zusammen. Das ist die größte einzelne Risikoursache, die wir kennen. Eine 0,40 klingt also mickrig, ist in Wahrheit aber ein sehr starker Effekt. Die Faustregel-Skala für die Treffsicherheit Praktisch heißt das: Bei einem Wert von 0,40 hast du in einem Team von 20 Leuten statt drei oder vier Fehlbesetzungen nur noch ein oder zwei. Über drei Jahre gerechnet sind das Hunderttausende Euro Unterschied. Als grobe Orientierung gilt: unter 0,10 ist statistisch wertlos, 0,10 bis 0,20 ist schwach, 0,20 bis 0,35 ist praktisch relevant, 0,35 bis 0,50 ist sehr gut für ein einzelnes Werkzeug – und alles über 0,50 erreichst du nur durch Kombination. Vertriebsrecruiting: Welche Auswahl-Werkzeuge funktionieren Seit über 40 Jahren untersucht die Forschung, wie gut einzelne Auswahl-Werkzeuge Berufserfolg vorhersagen. Wenn du dir die Werte ansiehst, ergibt sich eine klare Rangfolge – und sie widerspricht ziemlich genau dem, was im Mittelstand üblich ist. Wer datenbasiert Vertriebsmitarbeiter einstellen will, sollte diese Reihenfolge kennen. Strukturierte Interviews schlagen das Bauchgefühl Strukturierte Interviews – also Gespräche, bei denen du vorher genau festlegst, welche Fragen du stellst und welche Antworten gut oder schlecht sind – kommen auf einen Wert von 0,42. Unstrukturierte Interviews, das, was du typischerweise siehst, liegen nur bei 0,19. Allein die Struktur verdoppelt also die Treffsicherheit deines Interviews. Das muss man sich auf der Zunge zergehen lassen – und kaum jemand macht es. Arbeitsproben liegen bei 0,33, kognitive Leistung bei rund 0,31, Wissens-Tests bei 0,40. Berufsjahre und Abschlüsse sind fast wertlos Und jetzt der unbequeme Teil: Berufsjahre haben einen Wert von 0,09, Ausbildungsjahre von 0,10 – also quasi nutzlos für die Vorhersage von Vertriebserfolg. Handschrift-Gutachten kommen auf 0,02, das ist reines Voodoo. Wenn deine Ausschreibung Berufsjahre fordert und dein Interview unstrukturiert verläuft, setzt du auf zwei Kriterien zwischen 0,09 und 0,19. Das ist statistisch fast Würfeln. Werkzeuge kombinieren: Von 40 % auf unter 10 % Fehleinstellungen Jetzt kommt der spannendste Hebel. Wenn du die richtigen Werkzeuge kombinierst, kannst du die Treffsicherheit nochmal verdoppeln. Wichtig: Du zählst die Werte nicht einfach zusammen. Ein strukturiertes Interview (0,42) plus eine Arbeitsprobe (0,33) ergibt nicht 0,75. Denn jedes Werkzeug erfasst einen anderen Teil der Leistung. Warum sich gute Kombinationen ergänzen Zwei Verfahren, die Verschiedenes messen, ergänzen sich – zwei, die das Gleiche messen, bringen nichts. Ein kognitiver Test plus ein strukturiertes Interview treibt die Treffsicherheit auf etwa 0,63. Für den Vertrieb ist die stärkste Kombination: strukturiertes Interview plus Arbeitsprobe plus geprüfte Past Performance. Damit landest du bei 0,60 bis 0,65. Nimmst du für die Finalisten noch einen Persönlichkeitstest dazu, kommst du fast auf 0,68. Über 0,70 schaffst du selbst mit sechs Werkzeugen kaum – das ist die theoretische Decke. Was das für deine Fehlerquote bedeutet Übersetzt in die Praxis heißt das: Im klassischen Verfahren liegt deine „Luftpumpen-Quote", also das Risiko einer Fehleinstellung, bei rund 42 %. Fast jeder Zweite daneben. Mit der Maximalkombination sinkt sie auf 8 bis 10 %. Du kommst also von einer Fehlerquote von 40 % auf unter 10 %. Darüber muss man eigentlich nicht mehr reden. Kein Prozess liefert 100 % Sicherheit – aber wer die richtigen Werkzeuge kombiniert, ärgert sich nicht über die übrigen 10 %, sondern vermeidet die teuren 30 % dazwischen. Die Überraschung: Der laute Verkäufer ist ein Mythos Ambivertierte gewinnen Speziell für den Vertrieb gibt es einen Befund, der viele überrascht. Es hält sich die Annahme: je extrovertierter, desto besser der Verkäufer. Falsch. Studien zeigen, dass die besonders Extrovertierten nicht besonders gut verkaufen – aber die ganz Introvertierten eben auch nicht. Am erfolgreichsten sind die in der Mitte: die Ambivertierten, die je nach Situation zwischen offensiv und ruhig wählen können. Was wirklich zählt: Achievement Drive Der klassische Dampfplauderer ist also nicht dein Top-Performer. Im Interview gewinnt er trotzdem oft, weil er redegewandt ist – und genau hier liegen viele falsch. Der stärkste Faktor ist nicht Lautstärke, sondern Achievement Drive: das Leistungsstreben, der Wille zu gewinnen. Und das ist oft leise. Past Sales Performance allein hat übrigens einen Wert von rund 0,50 – der stärkste einzelne Faktor überhaupt. Wer das ernst nimmt, wird beim Vertriebsmitarbeiter einstellen nie wieder auf den lautesten Bewerber hereinfallen. Die Asymmetrie der Trainierbarkeit: selektiere DNA, trainiere Skill Was schnell lernbar ist – und was nicht Hier kommt der vielleicht wichtigste Denkfehler, den du vermeiden musst. Ja, im Prinzip kann man alles lernen. Aber der Trainingsertrag ist sehr verschieden. Skills und Wissen – eine SPIN-Selling-Methode, MEDDIC, ein CRM, dein Produktwissen – hat ein cleverer Verkäufer in Wochen bis Monaten drauf. Das ist mir bei der Auswahl deshalb ziemlich egal. Die rationale Strategie beim Vertriebsmitarbeiter einstellen Persönlichkeit dagegen verschiebt sich nur über Jahre. Achievement Drive, Frustrationstoleranz, intellektuelle Neugier – das bringst du jemandem im Onboarding nicht bei. Daraus folgt die einzig rationale Strategie, wenn du Vertriebsmitarbeiter einstellen willst: Selektiere auf das Stabile, trainiere das Veränderbare. Wer das Leistungsstreben nicht mitbringt, lernt es bei dir nicht mehr. Wer das Branchenvokabular nicht kennt, lernt es in drei Monaten. Die zwei häufigsten Fehler beim Vertriebsmitarbeiter einstellen Fehler 1: Der Fachexperte ohne Vertriebs-Ader Beide klassischen Fehler haben dieselbe Wurzel: Risiko meiden statt sauber prüfen. Der erste Fehler ist der Fachexperte ohne Vertriebs-Ader – der Servicetechniker oder Anwendungsingenieur, der zum Verkäufer gemacht wird. Fachlich top zu sein erhöht die Chance, vertrieblich zu performen, schlicht nicht. Nach 20 Jahren in der fachlichen Beratung ist der Komfort in dieser Rolle kein Trainingsthema mehr. Fehler 2: Der Abschluss-Crack ohne Produkt-Interesse Der zweite Fehler ist das Spiegelbild: der abschlussstarke Sales-Crack ohne echtes Interesse am Produkt. Im Gespräch fragt er nur nach Provision, Gebiet und Tools – nie nach der Lösung. Im komplexen, beratungsintensiven Vertrieb wird der nie glaubwürdig als Experte auftreten. Der Branchenkenner fühlt sich sicher, weil seine Etikette stimmt. Der laute Verkäufer fühlt sich sicher, weil er Gespräche gewinnt. Beide sagen wenig über echte Leistung aus. Der Adjacent Industry Hire: die Lösung für den Bewerbermangel Adjazenz schlägt Branchenetikett Was tust du stattdessen? Du holst dir jemanden, der die Grundeigenschaften eines guten Verkäufers schon mitbringt – aus einer verwandten Branche. Das nennt sich Adjacent Industry Hire und ist sogar wissenschaftlich untersucht. Beispiele: ein SaaS-Vertriebler ins ERP-Geschäft, ein Industrieautomatisierer in die Robotik, jemand aus der Spezialchemie in den Bereich Coatings. Worauf es wirklich ankommt Entscheidend ist nicht die Branche selbst, sondern die Nähe von vier Dingen: Buyer-Persona, Sales-Cycle-Länge, Komplexität des Verkaufs und Entscheidungsstruktur. Wer mit ähnlichen Ansprechpartnern, in einem ähnlichen Zyklus und einer vergleichbaren Komplexität gearbeitet hat, bringt 100 % des Skills mit und braucht nur drei Monate für die Domain Fluency. „Zehn Jahre Branchenerfahrung" ist eben kein Eignungskriterium – es ist die Risiko-Versicherung des Recruiters, auf Kosten der Vertriebsleistung. Wann Fachwissen doch vor Sales-DNA geht Der Lackmustest für deine Rolle Damit ich ehrlich bleibe: Es gibt Fälle, in denen das Fachwissen wirklich vorgeht. Das gilt in hochregulierten, hochtechnischen Feldern – Pharma, Medical Devices, Halbleiter, Spezialchemie, Aerospace oder hochregulierte Cybersecurity. Der Lackmustest ist einfach: Hältst du das Erstgespräch ohne tiefes Fachwissen fünf Minuten durch, oder bist du sofort raus? Drei Lösungen für hochtechnische Rollen Nimm die OP-Technik: Wer nicht mitreden kann, wenn der Chirurg zur Sache kommt, bekommt keinen zweiten Termin. In solchen Fällen hast du drei Optionen: den seltenen Hybrid (teuer und schwer zu finden), den klassischen technischen Verkäufer mit Sales-Basis oder ein Tandem aus Verkäufer und Sales Engineer. Die Frage ist nie pauschal Fach oder Skill, sondern: Wie hoch ist die fachliche Hürde ins Erstgespräch dieser konkreten Rolle? So bildest du das richtige Anforderungsprofil Bevor du den ersten Lebenslauf liest, musst du wissen, wonach du suchst. Und zwar nicht aus dem Profil des – vielleicht mittelmäßigen – Vorgängers und nicht aus einer kopierten Stellenanzeige. Die saubere Methode heißt Anforderungsanalyse: Du leitest die Kriterien aus der Leistung deiner echten Top-Performer ab. In fünf Schritten zum richtigen Anforderungsprofil In fünf Schritten zu einem Anforderungsprofil, das wirklich auf Vertriebserfolg setzt – statt den nächsten Klon des Vorgängers zu suchen. Top-Performer analysieren Geh nicht von der Rolle aus, sondern von den Menschen, die heute oben performen. Was haben sie in Werdegang, Arbeitsstil und Persönlichkeit gemeinsam? Interviewe sie zu ihren besten Deals. Die Rolle entlang vier Achsen abklopfen Sales-Cycle-Länge, Komplexität (Einzelentscheider vs. Buying Center), Akquise- vs. Bestandsanteil und Beratungstiefe. Daraus ergibt sich deine Buyer-Persona. Strategisch vorausschauen Wo geht die Rolle in zwei bis drei Jahren hin? Welche Skills werden vom Nice-to-Have zur Pflicht? Definiere nicht die Rolle von gestern. Must-Have von Nice-to-Have trennen Maximal drei bis fünf Must-Haves – und zwar alles, was kaum trainierbar ist: Achievement Drive, Frustrationstoleranz, Neugier, Past Performance. Produktwissen und CRM sind Nice-to-Have. In messbare CV-Signale übersetzen Aus „Achievement Drive" wird „belegte Quoten-Übererfüllung in zwei der letzten drei Jahre". Lege pro Signal einen klaren Schwellenwert fest. Anforderungsprofil ist nicht gleich Stellenbeschreibung Mehr als fünf Anforderungen brauchst du nicht – Studien zeigen, dass Bewerber ohnehin nur rund fünf Kriterien wirklich wahrnehmen. Das Anforderungsprofil ist nicht die Stellenbeschreibung. Die Stellenbeschreibung ist Werbung. Das Anforderungsprofil sagt, was jemand können muss, um in der Rolle erfolgreich zu sein. Zwei verschiedene Dokumente. Was im Lebenslauf wirklich zählt Wenn du Vertriebsmitarbeiter einstellen willst, ist der Lebenslauf kein Vorhersage-Werkzeug. Er ist ein Filter, der die Falschen aussortiert. Lies ihn rückwärts – fang bei der letzten Leistungs-Zahl an. Im CV zählen Zahlen, nicht Adjektive. Harte Signale: worauf du achtest Harte Signale sind: konkrete Quoten-Erreichung in Prozent („120 % der Quote in 2023"), ein Ranking im Team („Top 3 von 40"), bezifferte Deal-Größen und Cycle-Komplexität sowie Beförderungen innerhalb des Unternehmens. Red Flags: was dich stoppen sollte Red Flags sind: „verantwortlich für" statt „erreicht", Worthülsen wie „strategischer Vertriebsansatz" ohne Zahlen und Job-Hopping unter 18 Monaten pro Station ohne erkennbaren Grund. Die unbequeme Wahrheit: In den meisten deutschen Lebensläufen stehen die entscheidenden Zahlen gar nicht. Deshalb filterst du beim CV nur grob vor – und holst die fehlenden Fakten im Telefon-Pre-Screening. Verkäufer ohne Zahlen im CV haben entweder keine, schlechte – oder sie wissen nicht, dass Zahlen das Einzige sind, was im Vertriebs-CV zählt. Vertriebsrecruiting-Prozess: vom CV bis zum Onboarding Kriterien allein nützen nichts ohne Prozess. Wer 80 Lebensläufe planlos liest, sortiert am Ende den Falschen mit dem schönsten Foto rein. Du brauchst einen Trichter: erst Hard-Filter gegen die harten Signale (maximal 90 Sekunden pro CV), dann eine strukturierte Bewertung mit mindestens drei Signalen für die Einladung. Das Telefon-Pre-Screening: der unterschätzte ROI-Hebel Das Telefon-Pre-Screening ist der am stärksten unterschätzte Schritt im ganzen Prozess. In 15 bis 20 Minuten holst du die Zahlen, die im Lebenslauf fehlen: Quoten-Historie prüfen, Wechselgrund, Gehaltsrahmen, eine Frage zum echten Verhalten. Zwanzig Minuten am Telefon ersparen dir zwei Stunden falsch geführte Vor-Ort-Interviews. Und vergiss das Active Sourcing nicht – die richtig guten Verkäufer bewerben sich selten, sie werden gefunden. Ein gesundes Verhältnis sind 50 % Bewerbungseingang und 50 % Active Sourcing. Drei diagnostische Interviewfragen Im eigentlichen Interview haben sich drei Fragen bewährt. Erstens: „Wie würdest du dich in 30 Tagen in unsere Produktwelt einarbeiten?" – das misst Selbststeuerung und Lernstrategie. Zweitens: „Erzähl mir vom letzten Deal, den du selbst akquiriert hast – nicht ausgebaut, nicht betreut." – das trennt den echten Hunter vom Beziehungspfleger. Drittens: „Wie würdest du unser Produkt nach einer Stunde Vorbereitung verkaufen?" – das misst, wie schnell jemand von Produktmerkmal zu Kundennutzen übersetzt, die zentrale Vertriebsfähigkeit. Wichtig: Diese Fragen sind nur valide mit einer vorab festgelegten Bewertungsrubrik. Und geh nie allein ins Interview – idealerweise stellt HR die Fragen, die Führungskraft beobachtet. Die Rolle von HR: vom Briefträger zum methodischen Treiber Was HR wirklich leisten muss Hier sterben die meisten guten Prozesse. HR leitet CVs weiter, dann Funkstille – und der Vertriebsleiter entscheidet wieder aus dem Bauch. Eine starke Personalabteilung ist nicht der Verwalter im Hintergrund, sondern der methodische Treiber des Prozesses. Von HR kommen die Interview-Leitfäden, die Bewertungs-Skalen, die Arbeitsproben und die Test-Werkzeuge – das ganze Handwerk. Geschwindigkeit ist Qualität HR sorgt dafür, dass der Prozess eingehalten wird, dass die Kriterien gemeinsam festgelegt werden und dass die Führungskraft sauber durch den Prozess geführt wird. Dazu gehört auch Geschwindigkeit: Die besten Kandidaten sind laut LinkedIn nur rund zehn Tage aktiv verfügbar, nach 30 Tagen haben sich über 50 % anders entschieden. Geschwindigkeit ist im Recruiting nicht das Gegenteil von Sorgfalt – sie ist deren Ergebnis. Recruiting endet nicht mit dem Vertrag: Onboarding als zweiter Filter Die diagnostische Verlängerung Auch wer sauber Vertriebsmitarbeiter einstellen will, produziert mit dem besten Prozess noch rund 10 % Fehleinstellungen – das lässt sich rechnerisch nicht vermeiden. Genau diese 10 % fängst du im Onboarding ab. Denn 70 bis 80 % der späteren Fehlbesetzungen zeigen ihre Muster schon in den ersten drei Monaten. Klare Entscheidungspunkte nach 30, 60, 90 Tagen Verstehe das Onboarding deshalb nicht in erster Linie als Wissens-Vermittlung, sondern als Verlängerung des Recruitings mit anderen Mitteln: feste Check-ins, klare Frühwarn-Zeichen, klare Entscheidungspunkte nach 30, 60 und 90 Tagen. Wer nach 60 Tagen vor sich hin meckert und nicht vorankommt, wird nach 120 Tagen meistens nicht besser – sondern schlechter. Nutze die Probezeit konsequent als das, was sie ist: deine zweite Chance. Quick Takeaways Branchenjahre und Abschlüsse sind fast wertlos (Wert 0,09–0,10) – sie sind die teuersten falschen Kriterien. Strukturierte Interviews verdoppeln die Treffsicherheit gegenüber unstrukturierten Gesprächen (0,42 vs. 0,19). Die Kombination der richtigen Werkzeuge senkt die Fehlerquote von ~40 % auf unter 10 %. Achievement Drive schlägt Extraversion – der laute Dampfplauderer ist ein Mythos, die Ambivertierten gewinnen. Selektiere auf das Stabile, trainiere das Veränderbare: Persönlichkeit bleibt über Jahre, Skills holst du in Monaten auf. Der Adjacent Industry Hire löst den Bewerbermangel – Nähe von Buyer-Persona, Cycle, Komplexität und Entscheidungsstruktur zählt, nicht das Branchenetikett. Telefon-Pre-Screening und HR als Treiber sind die unterschätztesten Hebel im ganzen Prozess. Fazit: Schluss mit dem Würfeln beim Vertriebsmitarbeiter einstellen Die drei Kernsätze Fassen wir zusammen. Strukturierte Interviews, Arbeitsproben und kognitive Tests sagen Vertriebserfolg drei- bis fünfmal besser voraus als Berufsjahre und unstrukturierte Bewertungen. Achievement Striving und Gewissenhaftigkeit sind die stabilsten Persönlichkeitsmerkmale – allgemeine Extraversion ist es nicht. Und weil Persönlichkeit über Jahre stabil bleibt, Skills aber in Monaten aufholbar sind, setzt du auf das Erste und trainierst das Zweite. Dein nächster Schritt Wer im Vertriebsrecruiting weiter auf Branchenjahre filtert, setzt auf das schlechteste verfügbare Kriterium. Wer auf Sales-Disposition baut und Wissen aufbaut, formt ein Team, das mit dem Markt mitwächst. Das ist eigentlich gar nicht schwer – du musst es nur konsequent machen. Wenn du Vertriebsmitarbeiter einstellen willst, ohne dich auf dein Bauchgefühl zu verlassen, fang heute mit einem Punkt an: Führe das strukturierte Telefon-Pre-Screening ein. Damit halbierst du deine Time-to-Hire und verdoppelst die Qualität deiner Pipeline. Du willst tiefer einsteigen? Schreib mir einfach eine E-Mail an recruiting@vertriebsfunk.de – dann bekommst du von mir die komplette Zusammenfassung dieser Folge und den Bewertungsbogen, den ich in meinen Vertriebsprojekten als Blaupause nutze. Beides schicke ich dir kostenlos zu. Gib alles, dein Christopher Funk. Welche Kriterien sollte ich beim Vertriebsmitarbeiter einstellen wirklich beachten? Setze auf das, was kaum trainierbar ist: Achievement Drive, Frustrationstoleranz, Neugier und geprüfte Past Sales Performance. Branchenjahre und Studienabschluss haben dagegen eine sehr geringe Vorhersagekraft auf Vertriebserfolg. Wie senke ich meine Fehlerquote im Vertriebsrecruiting? Indem du mehrere valide Werkzeuge kombinierst: strukturiertes Interview plus Arbeitsprobe plus geprüfte Past Performance. Das hebt die Treffsicherheit auf 0,60 bis 0,65 und drückt die Quote der Fehleinstellungen von rund 40 % auf unter 10 %. Ist Branchenerfahrung beim Verkäufer einstellen wichtig? Meistens nicht. Branchenerfahrung ist oft nur die Risiko-Versicherung des Recruiters. Wichtiger ist die Nähe von Buyer-Persona, Sales-Cycle, Komplexität und Entscheidungsstruktur. Ausnahmen sind hochregulierte Märkte wie Pharma, Medical Devices oder Aerospace. Worauf achte ich im Lebenslauf eines Vertrieblers? Auf Zahlen statt Adjektive: konkrete Quoten-Erreichung in Prozent, Ranking im Team, bezifferte Deal-Größen und Beförderungen. Red Flags sind „verantwortlich für" statt „erreicht", Worthülsen ohne Zahlen und Job-Hopping unter 18 Monaten. Welche Rolle spielt HR beim Aufbau eines guten Recruiting-Prozesses? HR ist der methodische Treiber, nicht der Briefträger. Die Personalabteilung baut den Prozess, liefert Interview-Leitfäden und Bewertungs-Skalen, sorgt für Geschwindigkeit und führt die Führungskraft sauber durch das Verfahren. Wie sieht es bei dir aus: Filterst du noch nach Branchenjahren – oder setzt du schon auf Sales-DNA? Schreib mir deine Erfahrungen in die Kommentare und teile den Beitrag mit dem Vertriebsleiter, der das gerade dringend lesen sollte.

On this episode of the SPOT Radio podcast, Charlie Webb CPPL speaks with Jeff Devich BSME, MBA about the Sterile Start™ program, together they break down why so many medical device manufacturers struggle with the complexity of the ISO 11607 framework and how gaps in understanding can lead to costly delays, failed validations, and audit findings. They share real world insights, practical strategies, and clear explanations that help teams strengthen their sterile packaging programs and avoid common pitfalls.About Jeff Devich BSME, MBAJeff's background includes serving as Director of Operations for a combination of device contract manufacturers. He has extensive experience in equipment and process validation within the MedTech industry. Jeff applies his mathematic and engineering expertise to for the Sterile Start™ program creating Design of Experiments and characterization reports for Van der Stähl Scientific sealers, helping customers understand how process parameters affect their specific products. Email me: jeffrey.devich@gmail.comLinkedIn: https://www.linkedin.com/in/jeffrey-devich-1b6b2788

In this episode of Medsider Radio, we sat down with Karthik Ganesh, CEO of OnMed.OnMed is the healthcare technology company behind OnMed CareStation, a “Clinic-in-a-Box” designed to expand access to primary and urgent care. Before OnMed, Karthik served as CEO of EmpiRx Health, leading the company through rapid growth and a successful private equity transaction in 2021. Throughout his career, he's held leadership roles at QualCare, CareAllies, and Aetna, and advised healthcare organizations through Deloitte and EY.In this interview, Karthik discusses why hybrid care models still require a human touch, how enterprise healthcare buyers evaluate value propositions differently, why brand and culture should shape execution early, and how operating under constraints can sharpen innovation.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device founders and CEOs and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.And if you're ready to level up your medtech game, you should check out Medsider Courses — 8-week masterclasses covering topics like fundraising, M&A and exit planning, design and development, clinical and regulatory strategy, and commercialization.These courses, featuring hard-earned lessons from elite medtech CEOs, can be purchased individually or come free with our All-Access Pass.If you'd rather read than listen, here's a link to the full interview with Karthik Ganesh, which includes a link to ScottBot — an AI version of host Scott Nelson trained on every Medsider interview and playbook. Feel free to ask ScottBot any questions you'd like!KEY MOMENTS FROM THE INTERVIEW(03:04) - Karthik's obsession with healthcare access, and the “broken doorway” problem behind OnMed (05:51) - How OnMed combines telemedicine and brick-and-mortar care into a “Clinic in a Box” (09:04) - The OnMed metrics that surprised Karthik most, including a 37% patient return rate, and the reasons behind the company's success (09:22) - What OnMed designed differently after realizing that patients approach healthcare with their guard up (15:27) - The pitfalls of B2C healthcare and how OnMed was built as a B2B company by intention (22:01) - How Karthik reshaped OnMed around clarity, structure, and high performers (30:23) - What “brand” actually means to Karthik (39:37) - How OnMed tailored its value proposition for payers, providers, employers, and universities (45:45) - Karthik's fundraising philosophy: constraints keep companies inventive

Tariffs, consolidation, and inflation are transforming medical device manufacturing. Wipfli's Cara Walton discusses how these industry trends are reshaping production processes and what medtech companies can do to stay ahead.

Heart of the Deal: The Insider's Guide to Medical Device Sales Success by Dr. Joseph DeAngelis, Kevin Matthews https://www.amazon.com/-/he/Heart-Deal-Insiders-Medical-Success/dp/B0FJB2R9KM Getheartofthedeal.com What if we told you there’s a sales career where rookies routinely earn more than seasoned lawyers and top performers make more than most doctors? You’d probably think we were selling you a get-rich-quick scheme. But we’re not. We’re talking about medical device sales. Global business consultant Dr. Joseph DeAngelis and medical device marketer Kevin Matthews have teamed up to introduce you to a high-stakes, high-reward world where mastering “Clinical Currency”–the unique blend of medical knowledge, sales savvy, and relationship capital that top performers leverage–will lead to unparalleled success. CV5Heart of the Deal offers the first-of-its-kind playbook for dominating the medical device sales landscape–whether you’re a newcomer looking to break in or a veteran aiming to join the seven-figure earners club.

The FDA's new Quality Management System Regulation (QMSR) officially became effective on February 2nd, 2026, replacing the legacy Quality System Regulation (QSR) framework that had been in place for nearly 30 years.Three months later, the reality is becoming clear for many manufacturers:QMSR is far more than a simple regulatory update.It represents a complete transformation in how the FDA expects companies to manage quality, risk, design controls, manufacturing, supplier oversight, and post-market surveillance.From Siloed Quality to Lifecycle ThinkingUnder the old QSR framework, companies often treated quality activities separately:Design controlsCAPAManufacturingSupplier managementPost-market surveillanceQMSR changes this mindset entirely.FDA now expects manufacturers to demonstrate integrated, risk-based quality management across the entire product lifecycle.This means:Design changes must connect to manufacturing validationSupplier issues must feed into risk managementPost-market surveillance must proactively identify trendsManagement reviews must show real decision-makingWhy Many Companies Were Not ReadyA major misconception across the industry was believing that ISO 13485 certification automatically meant QMSR readiness.But manufacturers are now discovering major gaps:Incomplete Design History Files (DHF)Weak risk integrationPoor documentation traceabilityReactive PMS systemsLimited management review evidenceFDA inspections are already reflecting these expectations.Inspectors are requesting:Internal audit reportsSupplier audit documentationManagement review recordsRisk-based decision evidenceThis level of transparency is new for many organizations.Real-World Challenges Manufacturers Are FacingOne of the biggest pain points is DHF restructuring.Companies with years of design changes are now being forced to reconstruct the logic behind historical decisions and organize fragmented information into a coherent, risk-based structure.Another major shift is Post-Market Surveillance.QMSR pushes manufacturers from reactive complaint handling toward proactive monitoring of known high-risk failure modes using trend analysis, registries, and real-world data.Management review processes are also under greater scrutiny.FDA now expects leadership teams to demonstrate how quality data drives actual strategic decisions.Best Practices for QMSR TransitionManufacturers preparing for QMSR should focus on:1. Cross-functional collaborationBreak down silos between QA, RA, Manufacturing, Design, and Supply Chain.2. Documentation mappingIdentify where critical design logic and risk decisions currently exist.3. Continuous risk managementImplement ongoing cross-functional risk review meetings.4. Stronger internal auditsMove beyond checklist auditing toward analytical risk-focused auditing.5. Meaningful management reviewsUse management review meetings to demonstrate active leadership involvement in quality decisions.Final ThoughtsQMSR is fundamentally changing the FDA's expectations.Companies that adapt early will build stronger systems, improve product quality, and reduce regulatory risk.Companies that delay may face:FDA 483 observationsWarning LettersProduct launch delaysIncreased remediation costsThe transition to QMSR is not simply a compliance project.It is a complete redesign of how medical device companies manage quality.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.  If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.LinkMathangi Srinivasan linkedin: https://www.linkedin.com/in/mathangiks/Social Media to followMonir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldeviceInstagram: https://www.instagram.com/easymedicaldeviceThis podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

In this episode of Medsider Radio, we sat down with Dr. Connie Lehman, founder and CEO of Clairity.Clairity is the first FDA-authorized AI platform that predicts a woman's five-year risk of developing breast cancer using only a routine screening mammogram.A physician scientist with over 300 peer-reviewed publications, Connie is a Professor of Radiology at Harvard Medical School and Breast Imaging Specialist at Massachusetts General Brigham (on leave). She holds an MD and PhD from Yale and was named to Forbes' 50 Over 50 Innovators and TIME 100 World's Most Influential Leaders in Health.In this interview, Connie discusses her experience translating academic research into a commercially viable startup, the massive undertaking of generating clinical evidence when you're creating a new category, and how Clairity is approaching adoption on two fronts: fitting into physician workflows and building access pathways for patients.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device founders and CEOs and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.And if you're ready to level up your medtech game, you should check out Medsider Courses — 8-week masterclasses covering topics like fundraising, M&A and exit planning, design and development, clinical and regulatory strategy, and commercialization.These courses, featuring hard-earned lessons from elite medtech CEOs, can be purchased individually or come free with our All-Access Pass.If you'd rather read than listen, here's a link to the full interview with Connie Lehman, which includes a link to ScottBot — an AI version of host Scott Nelson trained on every Medsider interview and playbook. Feel free to ask ScottBot any questions you'd like!KEY MOMENTS FROM THE INTERVIEW(03:04) - The broken screening paradigm Connie saw in clinic — and the gap that became Clairity (05:09) - How Clairity rolls the clock back from detection to predicting risk in healthy women (07:31) - Why "more data is better" turned out to be wrong and how that shaped Clairity's product scope (21:57) - How physicians can translate grant-generating discipline into building a company (24:56) - What 18 months of pre-sub meetings revealed about navigating a de novo pathway (26:49) - Why Clairity validated its technology in over 250,000 mammograms when FDA required far less (34:43) - How Connie flipped the natural question from "how can doctors offer this?" to "how can women access it?" (43:47) - How relationships, not pitches, drove Clairity's $43M Series B

Send us Fan MailAmelia Howe is a biomedical engineer and R&D project manager whose career spans startups, research labs, and established medical device companies. She currently leads cross-functional development programs at COLTENE, where she coordinates teams across engineering, quality, regulatory, and manufacturing to bring new medical devices from concept to international launch.Amelia's journey into engineering began with a pivotal shift early in her academic career. While studying at The University of Akron, she transitioned from nursing to biomedical engineering after discovering the field through biomechanics research. Working in Dr. Brian Davis's lab, she contributed to innovative research on shear forces and biomechanics, helping analyze how human movement affects pressure and stress on the body.After graduating summa cum laude, Amelia joined Neuronoff, Inc. as its first employee. In the fast-moving startup environment, she wore nearly every hat imaginable—conducting research, developing prototypes, establishing quality systems, and contributing to core patents. She played a key role in the early development of the Injectrode neuromodulation technology while helping build the company's quality management system toward ISO 13485 compliance.Over time, Amelia gravitated toward project leadership, recognizing that even highly talented engineers need structured coordination to ensure complex products make it through development. She moved into project management roles, overseeing multiple technical programs simultaneously and aligning engineering, regulatory, and business teams around clear timelines and milestones.Today, in addition to her role at COLTENE, Amelia is launching Chrysalis Business Consulting, where she provides project management and business development support to medical device startups. With both an engineering background and an MBA from Quantic School of Business and Technology, she brings a rare perspective that blends technical depth with strategic business insight. LINKS:Amelia Howe LinkedIn: https://www.linkedin.com/in/ameliaehowe/Company website: https://www.linkedin.com/company/chrysalis-business-consulting-llc/Aaron Moncur, host Subscribe to the show to get notified so you don't miss new episodes every Friday.The Being An Engineer podcast is brought to you by Pipeline Design & Engineering. Pipeline partners with medical & other device engineering teams who need turnkey equipment like cycle test machines, custom test fixtures, automation equipment, assembly jigs, inspection stations and more. You can find us at www.teampipeline.usWatch the show on YouTube: www.youtube.com/@TeamPipelineus 

Are you frustrated that your clinically sound medical devices aren't gaining traction in healthcare?In this episode, we challenge the notion that clinician agreement equates to adoption. You'll learn that adoption is a complex behavioral change that requires understanding multiple roles and barriers.By listening, you'll discover:The key barriers to adoption and how to address them effectively.The importance of tailoring your evidence story for different audiences.Actionable steps to create a behavior change plan for your medical device.Tune in now to transform your medical device strategy and enhance clinician adoption!Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.

A medical device's intended use is not just a regulatory formality — it is the foundation of the entire product strategy.In this podcast episode, Monir El Azzouzi speaks with Karandeep Badwal about how intended use influences classification, clinical evaluation, risk management, labeling, and ultimately market access.The discussion explores why many companies underestimate the importance of intended use and how poorly written statements can create major downstream regulatory problems. From Software as a Medical Device (SaMD) to AI-driven products, the episode highlights real-world examples where unclear intended use created challenges during certification and compliance activities.The episode also provides practical guidance for manufacturers on:Defining a robust intended use statementAligning intended use with clinical evidence and risk managementAvoiding “labeling tricks” that may trigger regulatory scrutinyBuilding internal collaboration between regulatory, clinical, and product teamsThis is an essential discussion for MedTech startups, QA/RA professionals, and manufacturers navigating MDR, IVDR, FDA, or global regulatory pathways.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.  If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.Linkkarandeepbadwal linkedin: https://www.linkedin.com/in/karandeepbadwal/qra-medical linkedin: https://www.linkedin.com/company/qra-medical/Social Media to followMonir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldeviceInstagram: https://www.instagram.com/easymedicaldeviceThis podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

Are you frustrated that clinically approved medical devices aren't gaining traction in healthcare?This episode dives deep into the gap between evidence and execution, revealing that it's often not the product, but the behavioral changes required for adoption that are overlooked. We challenge the common assumption that education alone will drive change.By listening, you'll discover:The key barriers to the adoption of medical devices in healthcare.How to approach behavior change for successful implementation.Strategies for improving clinician engagement.Tune in to discover how to turn your medical device into a success story in the healthcare market.Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.

In this kickoff episode of Project Medtech's “Five Things You Need To Know” miniseries, Duane Mancini is joined by Sean Thompson to break down the essentials of sterile medical device packaging compliance. Sean shares a practical, startup-friendly roadmap anchored in ISO 11607, starting with defining device inputs that drive packaging design decisions (sensitivities, geometry, sterilization method, scalability). He then walks through the four pillars—Make, Ship, Store, and Usability—covering sealing process validation, distribution simulation testing and feasibility testing, shelf-life strategy via accelerated and real-time aging, and the newer focus on usability and aseptic presentation. The episode highlights how missed packaging steps can create costly timeline and commercialization setbacks.Sean Thompson LinkedInPackaging Compliance Labs WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law and JumpStart Inc.

In this episode of Medsider Radio, we sat down with Antony Odell, co-founder and CEO of Echopoint Medical.Echopoint is a London-based UCL spinout developing iKOr, an optical microcatheter for coronary diagnostics.Antony brings over 30 years of medtech experience across Johnson & Johnson, Fresenius, and Stryker, before transitioning into startups as CEO of Tayside Flow Technologies and Tissue Regenix. He holds a BSc in Physiology and Biochemistry.In this interview, Antony discusses translating academic IP into a commercial device, choosing early clinical sites to balance speed and learning, managing non-dilutive funding as a long-term discipline, and outlines the most important responsibilities of an early-stage medtech CEO.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device founders and CEOs and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.And if you're ready to level up your medtech game, you should check out Medsider Courses — 8-week masterclasses covering topics like fundraising, M&A and exit planning, design and development, clinical and regulatory strategy, and commercialization.These courses, featuring hard-earned lessons from elite medtech CEOs, can be purchased individually or come free with our All-Access Pass.If you'd rather read than listen, here's a link to the full interview with Antony Odell, which includes a link to ScottBot — an AI version of host Scott Nelson trained on every Medsider interview and playbook. Feel free to ask ScottBot any questions you'd like!KEY MOMENTS FROM THE INTERVIEW(03:06) - How Antony's career centered on translating clinical insights into commercial reality (05:54) - What Echopoint's iKOr does, and why 40% of cath lab patients leave without a diagnosis (12:13) - How Echopoint landed its first U.S. clinical site, and what that means for the company (13:48) - What to assess before spinning out an academic idea, and why clinician input is the first real test (20:14) - Why Echopoint chose Barts over typical sites for its first-in-human study (22:58) - How getting too close to one clinical site can lead to dangerous groupthink (30:54) - Why non-dilutive funding belongs on the board agenda permanently (39:54) - How CEOs should manage boards, control information flow, and avoid becoming a “glorified note-taker”

Are you frustrated with stagnant growth despite having an experienced distributor?This episode uncovers the common misconceptions surrounding long-term distributor relationships and highlights how reliance on these partnerships can lead to hidden underperformance. You'll learn why it's essential to reassess your distribution strategy for optimal success.By listening, you'll discover:The key criteria for selecting effective distributors in your marketHow to evaluate if your current distributor is truly the right fitActionable steps to boost underperformance and increase market growthTune in to transform your medical device strategy and unlock growth potential.Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.

Sponsor: Medboardhttps://www.medboard.com/ EuropeEUDAMED: It's Go Time -May 28th 2026 for New Products: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32024R1860&qid=1720686388639 https://health.ec.europa.eu/document/download/04ce2012-97df-4dd0-8a39-d4f6993b9e16_en?filename=md_eudamed_roadmap_en.pdfBrand new Notified Body Rules -Implementation regulation 2026/977https://eur-lex.europa.eu/eli/reg_impl/2026/977/ojhttps://www.medtecheurope.org/resource-library/new-eu-rules-more-business-predictability-and-transparency-in-medtech-conformity-assessment/EU MDR IVDR Simplification Proposal - 2 trackshttps://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2025/1023/COM_COM(2025)1023_EN.pdfEMA Breakthrough Medical Devices Pilot  - Just launchedhttps://www.ema.europa.eu/en/news/new-pilot-support-development-breakthrough-medical-deviceshttps://www.ema.europa.eu/en/documents/presentation/presentation-breakthrough-medical-devices-pilot-information-sessio_en.pdfMIR form update - Update your files or links:https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance/pmsv-reporting-forms_en SwitzerlandSwissdamed device Registration - July 1st is cominghttps://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank/produktregistrierung.htmlSwissmedic's 2026 PMS Focus Campaign - Class Iia, Iib and IIIhttps://www.swissmedic.ch/swissmedic/en/home/medical-devices/market-surveillance-of-medical-devices/schwerpunktaktionen/info-ueberpruefung-dokumentation-zur-ueberwachung-nach-inverkehrbringen.htmlUKMHRA proposes indefinite CE Mark Recognition - Poll is closedhttps://www.gov.uk/government/consultations/medical-devices-regulations-targeted-consultation-on-the-indefinite-recognition-of-ce-marked-devicesNew UK Clinical Trials Framework -Live Since April 28thhttps://www.gov.uk/government/news/launch-of-clinical-trial-reformsNew MHRA fees + Faster Incident Reporting -  Reminder to budget and update procedures.https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market#feeshttps://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements/vigilance-reporting-requirementsMHRA Medical Devices (Amendment) Regulations 2026 - Brand New, Your Input Neededhttps://www.gov.uk/government/news/mhra-invites-views-on-proposed-changes-to-medical-device-regulation EventsMedtech Summit - June 15-16, 2026 in Berlin, Germanyhttps://informaconnect.com/medtech-summitEuropean Medical Device Supplier Excellence Conference - June 9-11th, 2026 - Brussels, Belgiumhttps://medicaldevicesupplierexcellence.com/ InternationalUSA — FDA Launches -  AI Platform HALO and Upgrades Elsa to 4.0https://www.fda.gov/news-events/press-announcements/fda-expands-ai-capabilities-and-completes-data-platform-consolidation Canada: Two changes happening —  Mandatory Digital Submissions + New AI/ML Device Guidancehttps://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/activities/announcements/mandatory-use-regulatory-enrolment-process-notice-to-industry.htmlhttps://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/medical-devices/application-information/guidance-documents/pre-market-guidance-machine-learning-enabled-medical-devices/pre-market-guidance-machine-learning-enabled-medical-devices.pdf PodcastPodcast Nostalgia  Episode 384: AI Medical Devices: What Notified Bodies Really Look for (Camille Petri): https://podcast.easymedicaldevice.com/384-2/Episode 385: The Fake QMS Problem: Why your ISO 13485 System will fail and Audit: https://podcast.easymedicaldevice.com/385-2/Episode 386: Life after CE Marking: Why AI Medical Devices Need Continuous Monitoring (Osman El-Kouban): https://podcast.easymedicaldevice.com/386-2/Episode 387: Master UDI-DI: The New Layer many Medtech Companies don't Understand (Hussam Mostafa):  https://podcast.easymedicaldevice.com/387-2/Episode 388: Certifying LLM-Driven medical devices (Sandy Wright): https://podcast.easymedicaldevice.com/388-2/ Easy Medical DeviceConsulting activities (CE marking, Clinical Evaluation, QMS creation…) https://easymedicaldevice.com/services/mdr-ivdr-technical-documentation/BOSS Program: Back Office ServiceseQMS: https://easymedicaldevice.com/smarteye-eqms/EasyIFU: eIFU and Label creation: https://easymedicaldevice.com/easyifu/Authorized Representative in EU, UK and SwitzerlandMarket access all over the world: https://easymedicaldevice.com/services/market-access/ This podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

Are you struggling to grow your medical device business while juggling the pressures of visibility and adoption?In this episode, we challenge common assumptions about growth strategies in healthcare. Many companies mistakenly believe that chasing patients through marketing is the fastest path to success, but this often leads to stalled growth and missed opportunities.By listening, you'll:Understand why meaningful partnerships outperform visibility in driving adoptionLearn how to assess the true value of your offering and its impact on customer retentionDiscover strategies to recalibrate your growth approach for sustainable successTune in now to uncover the secrets to building a thriving healthcare business by prioritizing value over noise.Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.

In this episode of Medsider Radio, we sat down with Kurt Jacobus, co-founder and CEO of restor3d.restor3d provides patient-specific orthopedic implants using 3D printing and advanced software.Kurt has over two decades of experience in medtech entrepreneurship, including successful exits to Enovis and NuVasive. Prior to his career in medical devices, Kurt was a consultant at McKinsey & Company. He holds a PhD in Mechanical Engineering and is an Adjunct Professor at Georgia Tech. In this interview, Kurt discusses how restor3d used the FDA's 520(b) pathway to generate revenue and regulatory proof simultaneously, why self-regulating beyond FDA requirements makes submissions a competitive barrier, and how to approach investor relationships and board construction with long-term thinking.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device founders and CEOs and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.And if you're ready to level up your medtech game, you should check out Medsider Courses — 8-week masterclasses covering topics like fundraising, M&A and exit planning, design and development, clinical and regulatory strategy, and commercialization.These courses, featuring hard-earned lessons from elite medtech CEOs, can be purchased individually or come free with our All-Access Pass.If you'd rather read than listen, here's a link to the full interview with Kurt Jacobus.KEY MOMENTS FROM THE INTERVIEW(03:21) - How Kurt went from wanting to build race cars to 20 years of orthopedic entrepreneurship (06:03) - How restor3d's patient-specific implants challenge the “8 sizes fit 8 billion people” model (15:36) - Why early-stage companies should “ring the cash register” as soon as possible (17:16) - How a 520(b) pathway helped restor3d generate revenue before full FDA clearance (31:48) - How restor3d treats every FDA submission like a PhD thesis and holds itself to standards beyond what regulators ask for (35:24) - What Kurt learned from restor3d's limited market release (40:03) - How Kurt raised is last$100M+ round, and why fundraising is really a networking game (45:13) - What makes a great board, and how the wrong one can quietly derail a company

In episode 247 of the Transition Drill Podcast, hear the journey of former Navy Corpsman Jason Brooks for veterans and first responders navigating the shift from service to health tech and agentic AI. Jason talks about the power of testing the waters during a career pivot, and what it takes to find your "North Star" after the uniform.Jason grew up in a intrigued by science and academic ambition, but his home life was far from stable. After his parents divorced, he spent his youth bouncing between New York and Pennsylvania, eventually finding himself on the streets and living in friends' homes during high school. Despite the chaos, Jason maintained a laser focus on his dream of becoming a doctor, inspired by his Uncle Walter. A tragic car accident at age 17, where he felt helpless as a friend passed away, solidified his "why" and shifted his focus toward medicine and service.Though he initially resisted the military, Jason eventually joined the Navy as a Corpsman. His time in service was defined by the same curiosity that led him to science as a child. He thrived in the medical field, but like many, he reached a point where he had to decide what came next. His transition wasn't a straight line. He describes a process of "dipping his toes" into various opportunities, moving through a career that eventually shifted from direct patient care to the tech and business side of healthcare.Today, Jason is a leader in the health tech space as the CEO of Innovo AI, proving that the skills learned in the field translate directly to the corporate boardroom. He's now a father of two, balancing his professional accomplishments with a commitment to his family and his roots. From working on seventh generation farms in the Hudson Valley to managing high-level healthcare operations, Jason's story is a testament to seizing the day. He shares how to handle the friction of a tumultuous transition and why you should never be afraid to take a chance on a new direction, even if it feels like starting over.CONNECT WITH THE PODCAST:Instagram: https://www.instagram.com/paulpantani/WEBSITE: https://www.transitiondrillpodcast.comLinkedIn: https://www.linkedin.com/in/paulpantani/SIGN-UP FOR THE NEWSLETTER:https://transitiondrillpodcast.com/home#aboutQUESTIONS OR COMMENTS:paul@transitiondrillpodcast.comSPONSORS:GRND CollectiveGet 15% off your purchaseLink: https://thegrndcollective.com/Promo Code: TRANSITION15Blue Line RoastingGet 10% off your purchaseLink: https://bluelineroasting.comPromocode: Transition10Frontline OpticsGet 10% off your purchaseLink: https://frontlineoptics.comPromocode: Transition10#transitiondrillpodcast #militarytransition #firstresponders

Unique Device Identification (UDI) has become a central element of medical device compliance worldwide.From EUDAMED in Europe to FDA databases in the United States, regulators increasingly rely on accurate UDI data to improve traceability and patient safety.But many manufacturers underestimate one important reality:

In just the past two months, Stryker, Intuitive Surgical, and Medtronic – three of the world's Top 100 Medical Device companies – have faced cyberattacks. Why are medtech companies becoming prime targets for hackers? What makes medical devices so vulnerable? And how is the FDA responding? In this episode of Let's Talk Medtech, Naomi Schwartz, VP of Regulatory Strategy at Medcrypt, breaks down: ✅ The anatomy of recent cyberattacks on leading medtech firms ✅ Why hackers are targeting the medical device industry ✅ What these breaches mean for patient safety and data security ✅ FDA's new cybersecurity requirements and what companies must do now

Have you ever wondered why your medical device fails to gain traction after regulatory approval? You're not alone.In this episode, we explore the critical difference between mere activity and a real commercial strategy. Many MedTech companies mistakenly believe regulatory approval guarantees demand, only to find themselves stalling without solid market plans.By listening, you'll:Learn how to develop a commercial strategy in parallel with regulatory processes.Understand the three key questions to answer before approval to ensure market readiness.Discover why engaging buyers early can facilitate smoother adoption of your medical device.Tune in now to transform your approach to go-to-market strategies and avoid costly missteps!Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.

In this episode of Medsider Radio, we sat down with Alfred Griffin, co-founder and CEO of LightForce.LightForce is the developer of the world's first fully customized 3D-printed bracket system directly personalized for each patient's digital treatment plan.Alfred holds a DMD and PhD in Craniofacial Biology from the Medical University of South Carolina and completed his orthodontic residency at Harvard School of Dental Medicine, where he currently serves as faculty and the Board of Fellows. An ABO-certified practicing orthodontist, he continues to see patients every month while running the company.In this interview, Alfred shares how applying existing technology to an overlooked market can unlock a larger opportunity, how adoption friction is a design problem, and why scaling a new category requires treating operations as a core product investment.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device founders and CEOs and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.And if you're ready to level up your medtech game, you should check out Medsider Courses — 8-week masterclasses covering topics like fundraising, M&A and exit planning, design and development, clinical and regulatory strategy, and commercialization.These courses, featuring hard-earned lessons from elite medtech CEOs, can be purchased individually or come free with our All-Access Pass.If you'd rather read than listen, here's a link to the full interview with Alfred Griffin.KEY MOMENTS FROM THE INTERVIEW(02:43) - How growing up in a family of dentists shaped Alfred's path into orthodontics (07:41) - How LightForce uses digital planning and 3D printing to create fully customized braces (08:48) - Why LightForce isn't a brilliant idea, but an obvious fix for the teen braces market that aligners missed (12:19) - How LightForce is like Google Maps for teeth, eliminating detours and removing inefficiencies (17:30) - How Alfred built LightForce around his clinical strengths and hired for experience to round out the gaps (30:56) - The 3-part secret to LightForce adoption by physicians (36:42) - How Alfred approaches fundraising, matching investors to the company's stage and needs (41:51) - About LightForce's digital factories and why they're the company's core moat

Can you break into Medical Device Sales without a background in sales?In this episode, Vidhi Patel shares the exact roadmap she used to transition from a Biology major and Clinical Researcher to an On-Site Specialist at Stryker, and finally landing her dream role in Breast & Skeletal Health Sales at Hologic.If you've been told you "don't have enough experience" or you've been stuck in a clinical role wanting to pivot to the business side, this interview is for you. Vidhi and I break down the tactical tools—from 30-60-90 Day Plans to the "About Me" PDF—that make a candidate undeniable to hiring managers.In this video, you will learn:Why the "On-Site Specialist" role is the best backdoor into sales.How to use LinkedIn to get noticed by top-tier recruiters.The secret to the "About Me" page that builds instant rapport with surgeons.Why you should let your company pay for your MBA (and why you don't need it to get hired).How to handle the grueling Stryker/Hologic interview process and the Gallup test.TIMESTAMPS:0:00 - Intro: Meet Vidhi Patel2:15 - Why Ohio State? (The OSU Connection)4:10 - From Clinical Research to Stryker On-Site6:45 - The Reality of the OR: Managing 3 Different Shifts9:30 - How LinkedIn and Networking Landed the Interview12:00 - Working with External Recruiters: What You Need to Know14:50 - The 30-60-90 Day Plan: Don't Just Copy/Paste!17:30 - The "About Me" PDF: The Secret Weapon for Rapport21:00 - Soft Skills: Reading the Room vs. Following a Script23:15 - Why Hologic? (A Personal Connection to Breast Cancer)25:30 - National Parks & Work-Life Balance in Med Sales29:00 - MBA vs. Experience: Which one matters more?31:30 - Advice for those stuck: "You just need one YES."Connect with Vidhi Patel:LinkedIn: https://www.linkedin.com/in/vidhipat/

Send us Fan MailRyan Schoonmaker has spent roughly two decades in medical device product development, building a career around solving hard engineering problems in high-stakes environments. Today he is the founder of Tight Line Solutions, where he works with growth-stage product development teams to reduce chaos, improve execution, and build the kind of systems that make technical organizations more efficient and predictable. His messaging consistently emphasizes that innovation is not just about ideas, but about disciplined execution, sound principles, and the ability to lead teams through complexity. Before launching Tight Line Solutions in late 2025, Ryan served as Director of Mechanical Engineering at Beta Bionics. Prior to that, he held senior R&D leadership positions at BD and spent more than seven years at Dexcom, progressing from Staff Mechanical Engineer to Director of Mechanical R&D. His background also includes product development work at Safety Syringes and Helbling Precision Engineering, where he worked on drug delivery systems, insulin-related devices, infusion sets, and other life science technologies. That combination of consulting, hands-on engineering, and executive leadership gives him a rare view across the full arc of product development.One of the most compelling parts of Ryan's story is that his work has touched products with enormous real-world impact. In his own words, helping bring the Dexcom G6 and G7 to market reinforced the lesson that meaningful innovation requires structure, rigor, and strong execution. Public patent records also show his name on multiple Dexcom-related design patents, reflecting direct involvement in device development. He pairs that technical depth with a strong focus on team culture, communication, and breaking large problems into manageable pieces—exactly the kind of perspective that resonates with engineers trying to grow into stronger technical leaders. Ryan also brings a strong academic foundation in mechanical engineering, with a B.S. from the University of Maryland and an M.S. from Tufts University, where his thesis focused on vibrotactile feedback in minimally invasive surgery. That blend of technical depth, medical device experience, and leadership philosophy should make for a rich conversation on product development, risk mitigation, engineering culture, and what it takes to build products that truly matter. LINKS:Guest LinkedIn: https://www.linkedin.com/in/ryan-schoonmaker-59048411/Guest website: https://www.linkedin.com/company/tight-line-solutions/Aaron Moncur, host  Subscribe to the show to get notified so you don't miss new episodes every Friday.The Being An Engineer podcast is brought to you by Pipeline Design & Engineering. Pipeline partners with medical & other device engineering teams who need turnkey equipment like cycle test machines, custom test fixtures, automation equipment, assembly jigs, inspection stations and more. You can find us at www.teampipeline.usWatch the show on YouTube: www.youtube.com/@TeamPipelineus 

Join Ed Parcaut as he sits down with Téa Phillips, inventor and founder of MetaFlex Glove, for an inspiring discussion on creativity, resilience, and the realities of building a mission-driven startup. In this episode, Téa Phillips shares her journey from growing up in a family of tinkerers and makers to developing a Class 1 medical device designed to help people with hand pain and mobility challenges. Together, Ed Parcaut and Téa Phillips dive into: The early inspirations from her inventor father and entrepreneurial grandparents Real-world challenges of launching an innovative medical product How MetaFlex Glove addresses issues like arthritis, carpal tunnel, and sports injuries The ups and downs of entrepreneurship: manufacturing hurdles, FDA regulations, hiring lessons, and fundraising Why building something meaningful is worth every struggle Whether you're an aspiring entrepreneur or interested in the power of purposeful invention, this episode offers practical insights and a dose of motivation. Learn more about MetaFlex Glove at metaflexglove.com and connect with Téa on LinkedIn or Instagram. *Contact Ed Parcaut:** -

The implementation of Unique Device Identification (UDI) has already transformed regulatory compliance in the medical device industry.Now, Europe is introducing an additional layer: Master UDI-DI — adding both structure and complexity to the system.Understanding the UDI StructureTo fully understand Master UDI-DI, it's important to distinguish between the different levels:• UDI-DI → Identifies a specific device• Basic UDI-DI → Groups devices with the same intended purpose and characteristics• Master UDI-DI → Applies to highly individualized devices with specific design parametersThis new layer aims to better manage products with high variability.Why Master UDI-DI Was IntroducedFor certain devices — such as spectacle frames, lenses, and other customizable products — the number of variations can become overwhelming.Master UDI-DI helps:• Reduce the number of identifiers required• Improve traceability• Simplify product grouping• Enhance recall efficiencyKey BenefitsDespite its complexity, Master UDI-DI brings several advantages:✔ Better organization of device data✔ Improved market surveillance✔ Faster identification during recalls✔ Stronger protection against counterfeit productsChallenges for ManufacturersHowever, the implementation is not without challenges:• Increased data requirements• Risk of incorrect UDI assignment• Need for cross-functional coordination• Integration with EUDAMEDAs highlighted in the discussion, errors in UDI can be costly — including recalls and data inconsistencies.Timeline and UrgencyWhile the labeling deadline is set for November 2028, manufacturers should not wait.EUDAMED requirements are already active, and preparation takes time.

Are you letting the fear of failure prevent your medical device from thriving in the market?This episode reveals how the conventional wisdom around failing can actually stifle innovation. Embracing failure is not just an option; it's a necessity for growth in the healthcare sector. By listening, you'll:Learn to view failure as a stepping stone to successUnderstand the role of failure in fostering resilienceDiscover how to encourage your team to innovate without fearTune in to revolutionize your approach to failure and open new paths for success in your medical device journey.Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.

בפרק הזה אני מארחת את איה פטרבורג, שותפה מייסדת בקרן S Capital (יחד עם חיים סדגר). איה היא אישה שהקריירה שלה רצופה בפיבוטים אמיצים – מעריכת דין, דרך הובלת פיתוח עסקי בסטארטאפים, ועד להפיכתה לאחת המשקיעות הבולטות והמוערכות בישראל. השיחה שלנו, שהתחילה על כוס קפה עוד לפני שלחצנו Record, צללה מהר מאוד אל מאחורי הקלעים של קבלת החלטות בעולם ההשקעות, אבל התמקדה בעיקר באדם שמאחורי היזם. דיברנו על הכוח של אינטואיציה, על החשיבות הקריטית של ענווה, ולמה בחירת משקיע היא לפעמים החלטה גורלית יותר מבחירת שותף. מנזיר בודהיסטי למבחן ה"נעים לי": כוחה של אינטואיציה  השיחה שלנו התחילה באחד הסיפורים המרתקים שאיה שיתפה,  אשר החזיר אותנו לגיל 20, לטיול בדהרמסאלה שבהודו. מתוך מאות נזירים, משהו במבט ובאנרגיה משך אותה לגשת דווקא לנזיר אחד ספציפי ולבקש ללמוד ממנו על בודהיזם. לימים התברר שזהו המתורגמן האישי של הדלאי למה וראש הספרייה הלאומית. היכולת הזו "לזהות" אנשים, את הזיק בעיניים ואת הפוטנציאל, מלווה אותה עד היום כשהיא פוגשת יזמים. אנחנו מדברות על "מבחן ה-נעים לי" ועל Fit בין אנשים. איה מחדדת ש"נעים לי" לא אומר לחפש את האדם ה"נחמד" ביותר, אלא לבחון את ההתאמה האמיתית (Fit) לדרך משותפת. זה אומר לשים יד על הבטן ולשאול: האם נעים לי בסיטואציה הזאת מול האדם הזה? האם נצליח להחזיק מרחב משותף ולנהל שיחה מכבדת גם כשיהיו מחלוקות ומורכבויות בהמשך הדרך? היכולת הזו להקשיב לבטן היא קריטית. איה, וגם שותפה חיים סדגר, מאמינים שאינטואיציה אינה מנותקת מדאטה, אלא היא רצפטור שקולט המון נתונים מהסביבה ועוזר לנו להרגיש עם מי נוכל לכבוש את העולם. ענווה ככלי עבודה וחוסן מנטלי ערך בולט שאיה אימצה מהבודהיזם ורלוונטי כל כך לעולמנו הוא ענווה. היא מזכירה ליזמים (וגם למשקיעים!) לא לחטוא בחטא היוהרה. גם כשמגייסים סכום עתק או רושמים הצלחה מסחררת, המציאות יכולה להשתנות ברגע. לכן, כשהיא בוחנת השקעה, היא לא מתאהבת במוצר – הרי הוא כנראה ישתנה. היא מסתכלת על החוסן הנפשי של היזם, על הגמישות המחשבתית שלו, ועל היכולת שלו לעמוד נחוש גם מול "כיתת יורים" של השוק או של משקיעים ותיקים. לשחק במגרש שבו אתם מנצחים: Founder-Market Fit איה מודה בכנות מרעננת: "אני אוהבת לנצח". מתוך התפיסה הזו, היא מייעצת ליזמים לבחור בקפידה את המגרש שבו הם פועלים. היא משתפת סיפור על יזם סדרתי ומוצלח שרצה להקים חברת Medical Device מתוך רצון "לעשות טוב". איה וצוות הקרן שכנעו אותו לוותר על הרעיון, פשוט כי לא היה לו שם Founder-Market Fit. המסר כאן חזק: ההצלחה הכי גדולה מגיעה כשאנחנו מייצרים לעצמנו מגרש שמותאם בדיוק לחוזקות, לניסיון ולייחודיות שלנו, ולא מנסים להתחרות במקומות שלא מדויקים לנו רק כי הם נשמעים נכון. אל תסתנוורו מסיבובי ענק: משקיע זה "חתונה קתולית" בתקופה שבה אנחנו שומעים על סבבי סיד מפלצתיים מקרנות אמריקאיות, איה עושה קצת סדר, במיוחד עבור יזמים בתחילת דרכם. היא מזכירה שלא כל הנוצץ זהב, וקרן ענקית היא לא תמיד השותף הנכון לכל חברה. התובנה הכואבת אך החשובה שלה היא שמשותפים - קשה ככל שזה יהיה -  אפשר להיפרד. אבל ממשקיע – אי אפשר להיפטר. הוא נשאר איתכם ב-Cap Table לכל הדרך. לכן, היא מפצירה ביזמים להשקיע זמן, לעשות רפרנסים ולבחור את המשקיעים שלהם באותה רמת קפדנות שבה בוחרים שותף לחיים. מסר לסיום: לייצר את המציאות של עצמך את תפיסת העולם היזמית שלה, איה שאבה במידה רבה מאביה ז"ל. כילד שאהב לצייר קומיקס, ציוריו נגנבו ופורסמו בעיתון ללא מתן קרדיט. במקום לשקוע בקורבנות או באכזבה, הוא פשוט החליט להקים עיתון משלו כדי שיהיה לו איפה לפרסם את יצירותיו. הסיפור הזה הוא תמצית היזמות והמסע האנושי בעיניה של איה – היכולת לקחת את הקושי, לא לוותר, ולייצר במו ידינו את המציאות ואת המגרש שבו נוכל לצמוח ולהשפיע.

Join Our Medical Device Sales Program: https://click.newtomedicaldevicesales.com/yt-488Ken RealiLinkedin: https://www.linkedin.com/in/kenreali/Reali Family Vineyard: https://www.realifamilyvineyard.com/

Join Our Medical Device Sales Program: https://click.newtomedicaldevicesales.com/yt-488Ken RealiLinkedin: https://www.linkedin.com/in/kenreali/Reali Family Vineyard: https://www.realifamilyvineyard.com/

Are you frustrated by slow adoption rates of your medical device? You're not alone.This episode challenges common assumptions about clinician feedback and market readiness. You'll learn how to dig deeper into feedback to uncover real challenges that hinder adoption.By listening, you'll discover:The true barriers to adoption for your medical deviceThe importance of asking specific questions to gain clarityHow to simplify the introduction of your product for greater clinician acceptanceTune in to discover actionable strategies to enhance your medical device's market presence and adoption rate.Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.

What does it really take to succeed in medical device sales in New York City?In this episode of the Chase MedSearch Podcast, host Jordan Chase sits down with Tyler Nader, a Medical Device Sales Leader and former NYC Territory Rep who built dominant businesses across Manhattan, the Bronx, Brooklyn, and Queens.  New York is different. It's dense. It's political. It's hyper-competitive. And it's home to some of the most prestigious academic hospitals and Level 1 trauma centers in the world — including Columbia, Cornell, Mount Sinai, NYU, Montefiore, and Northwell.Tyler shares what it's really like to:• Sell into Level 1 trauma centers at 22 years old• Navigate hospital politics and institutional hierarchies• Handle logistics in the most demanding healthcare market in America• Launch a new therapy from zero to nearly $2 million in two years• Exceed quota 11 consecutive quarters• Become the #1 rep nationally (and globally)• Build physician trust in elite academic institutions• Compete in a market where “there are 100 of them to one of you”• Transition from top producer to hiring managerHe also talks candidly about imposter syndrome, getting kicked out of ORs (operating rooms), working 365 days straight in trauma, and why New York reps are built differently.This episode is a masterclass for:• Medical device sales reps looking to break into competitive markets• Startup MedTech companies launching new therapies• Hiring managers evaluating territory-building talent• Reps who want to understand how to build true physician credibilityIf you can make it in New York City, you really can make it anywhere.RESOURCES:https://www.linkedin.com/in/tyler-nader-24bba6b1/

Achieving CE marking under the EU MDR is a major milestone for medical device manufacturers. However, for AI-based medical devices, certification is not the end of the journey — it is only the beginning.In this episode, Osman El-Koubani shares insights into the post-market realities of AI as a Medical Device (SaMD) and what manufacturers must do to remain compliant over time.CE Certification Is Not the Finish LineMany companies assume that once their device is certified, the main regulatory burden is over.In reality, Post-Market Surveillance (PMS) becomes critical — especially for AI systems that can evolve or degrade in real-world conditions.Relaxing after certification can lead to:• Loss of control over performance• Undetected risks• Regulatory non-complianceAI in the Real World: Performance DriftAI models often behave differently once exposed to real-world data. This phenomenon, known as performance drift, can reduce accuracy and reliability over time.Manufacturers must implement continuous monitoring strategies, including:• Real-world data (RWD) collection• Performance tracking• Feedback loops for improvementUpdating AI Devices: What Is Allowed?Updating AI systems introduces regulatory complexity.Key questions include:• What qualifies as a significant change?• Does retraining require re-certification?• How should updates be documented and justified?Manufacturers often struggle with these decisions, leading to compliance risks.PCCP: Enabling Controlled EvolutionThe concept of a Predetermined Change Control Plan (PCCP) allows manufacturers to define in advance how an AI system can evolve.While this concept is gaining traction globally, its implementation in Europe is still evolving and requires careful regulatory consideration.Building a Mature AI PMS SystemA robust post-market system for AI devices should include:• Continuous performance monitoring• Risk management integration• Clear documentation of updates• Strong governance of data and modelsWho is Osman El-KoubaniDr Osman El-Koubani is a doctor and clinical researcher. With nearly a decade of experience at the intersection of healthcare, digital innovation, and AI, he has developed and implemented NHS digital solutions and advised multiple software and AI medical device startups. At Scarlet, Osman works as a Clinical Engineer and AI/ML expert, leading clinical evaluation, risk management, and usability for AI-driven medical devices, while also helping SaMD and AIaMD manufacturers navigate certification and maintain compliance through transparent, practical, and safety-focused regulatory processes.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.  If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.LinkScarlet Linkedin: https://www.linkedin.com/company/scarlet-comply/posts/?feedView=all&viewAsMember=trueSocial Media to followMonir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldeviceInstagram: https://www.instagram.com/easymedicaldeviceThis podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

Are you frustrated by the slow uptake of your medical device in export markets?In this episode, we challenge the common belief that distributors are solely responsible for market uptake. You'll learn why the slow adoption of your product is often not about activity, but rather about how demand is generated and responded to.By listening, you'll discover:The true constraints holding back your medical device's successHow to ask the right question about demand generationInsights on how to rethink your export strategy for better resultsTune in to uncover insights that can help you transform your go to market strategy for your medical device.Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.

Are you tired of guessing your way through MedTech exporting decisions?This episode shows why many MedTech companies stumble when they don't have a structured approach to diagnose their issues.By listening, you'll discover:A structured framework for confident decision-making in medtech expansionHow to Identify key constraints that hinder your growth and adoption ratesHow to effectively evaluate feedback without making premature changes Tune in to gain the confidence and structure needed for successful exporting in the medical device field.Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.

Many medical device companies believe they have a compliant Quality Management System (QMS).On paper, everything looks perfect:• Procedures are written• Forms are available• Risk management is documented• CAPA systems are definedBut during an audit, everything falls apart.What Is a “Fake QMS”?A fake QMS is not necessarily incorrect — it is simply not implemented in reality.Employees may not understand it.Processes may not be followed.Evidence may not exist.In short:

In this episode of the Medical Sales Podcast, Samuel sits down with Stéphan Toupin to unpack one of the boldest transitions in medical sales, from a successful pharmaceutical career into the riskier but far more flexible world of medical device distribution and entrepreneurship. Stéphan shares why he willingly took a major pay cut to leave pharma, how freedom mattered more to him than salary, and what it really looked like to build something of his own from the ground up after divorce, major life change, and a move from Canada to the United States. He explains the key differences between pharma and med device, why distribution can offer unlimited upside for the right person, and what people misunderstand about the U.S. medical device market. He also breaks down how his company now helps foreign medical device manufacturers enter the U.S. by supporting everything from strategy and importing to warehousing, distribution, and commercialization. This is a must listen for anyone curious about entrepreneurship in med device, the distributor path, and what it truly takes to bet on yourself. Connect with Stéphan Toupin: LinkedIn Connect with Me: LinkedIn Love the show? Subscribe, rate, review, and share! Here's How »

Are you confident in your distributor's transparency? This episode may change that view.In this episode, we're uncovering a critical mistake in medical device distribution that could leave you vulnerable. Many clinicians mistakenly believe regular chats with distributors are enough for a solid partnership, but that's often not the case.By listening, you'll discover:How transparency impacts your distribution strategyThe essential questions to ask during distributor meetingsActionable tips on creating effective contingency plansTune in now to ensure your medical device distribution isn't a risky gamble.Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.

Are you frustrated by low adoption rates despite enthusiastic feedback from clinicians?This episode dives into the misconception that clinical enthusiasm translates to commercial success. We discuss how understanding your decision-making unit is crucial for effective stakeholder engagement.By listening, you'll discover:How to map out your decision-making unit effectivelyThe true decision-makers who influence adoptionActionable strategies to address objections directlyTune in now to uncover crucial strategies that could save your medical device launch.Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.

Join Our Medical Device Sales Program: https://click.newtomedicaldevicesales.com/yt-477

Join Our Medical Device Sales Program: https://click.newtomedicaldevicesales.com/yt-473