Podcasts about medtech startup

Cardiologist Jim Min watched too many 50-year-olds die with no heart-attack warning. He co-founded Cleerly to automate detailed coronary scans—no invasive procedures, no endless manual work. Yet healthcare's glacial pace, payers, and federal approvals all stand in his way. Hear how he's testing AI across thousands of patients, fighting for universal insurance coverage, and coping with near-burnouts. If you're a founder navigating hyper-regulated markets, Jim's journey is the blueprint.____Why You Should Listen1. Heart Disease Kills More Than All Cancers Combined – The staggering truth behind silent heart attacks (and why most diagnoses come too late).2. Jim's Big Bet on Early Detection – He's using advanced AI to spot “dangerous plaque” long before a patient gets chest pain or drops dead.3. A 10–15 Year Fight to Save Lives – The brutal reality of building a medtech startup in a system that moves slower than any other.4. Surviving a 17-Day Runway – How his mission-focus (and supportive backers) pulled Jim's startup back from the brink.5. Why repeated failure drives game-changing breakthroughs____KeywordsHeart Disease Detection, Medtech Startup, Coronary CT Angiogram, AI in Healthcare, Early Heart Attack Prevention, FDA Approval Process, CPT Code Reimbursement, Plaque Imaging, Cardiovascular Innovation, Clinical Trials____(00:00:00) Embracing Failure & Surviving Dark Days(00:01:56) From Cardiologist to Startup Founder(00:03:07) What Most People Don't Know About Heart Attacks(00:06:39) Using AI & Imaging to Predict Heart Attacks(00:09:19) Why Cleerly Needed to Exist(00:16:34) The Reality of Healthtech(00:20:41) How Cleerly Built its First Product—and Why it Wasn't an MVP(00:28:33) Raising $225M to Prove a Radical Idea(00:33:57) Finding Product-Market Fit & the Fight Worth HavingSend me a message to let me know what you think!

In this episode, Devon Campbell, Founder and Managing Director at Prodct, and Eric O'Dell, Consultant at Project Medtech, join Duane Mancini in a must-listen for bootstrapped Medtech founders! This episode provides a DIY guide to managing your startup's finances without hiring expensive professionals. Learn how to set up bank accounts, choose the right corporate structure, master basic accounting with QuickBooks and spreadsheets, manage your cap table, and navigate taxes. Tune in for actionable advice and build a strong financial foundation for your Medtech venture, even on a limited budget. Devon Campbell LinkedIn⁠ Eric O'Dell LinkedIn ⁠⁠⁠⁠⁠Duane Mancini LinkedIn⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Project Medtech LinkedIn⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Project Medtech Website ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ ⁠⁠⁠⁠Midwest Showcase Registration⁠

In this episode, Kirk Petyo at Talent Factory Recruiting and Duane Mancini discusses his background in recruiting, how startups attract talent, the biggest mistakes companies make in hiring, managing company culture, implementing a successful onboarding process, and so much more. Kirk Petyo LinkedIn Talent Factory Recruiting LinkedIn Talent Factory Website ⁠⁠Duane Mancini LinkedIn⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Project Medtech LinkedIn⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Project Medtech Website ⁠⁠⁠⁠⁠⁠⁠⁠⁠ ⁠Midwest Showcase Registration

In this episode, Charles Allan at MY01 and Duane Mancini discuss his background in the Medtech industry, what MY01 is working on, the Medtech Innovator program, focus on collecting clinical data for commercialization support, fundraising strategies as you advance rounds, the Canadian Medtech ecosystem and so much more.

"Die Beschwerden sind da, und das motiviert dich einfach, die App zu nutzen." Pauline Nöldemann hat aufgrund ihrer persönlichen Erfahrungen mit Nahrungsmittelunverträglichkeit ein Startup gegründet, das genau diese Unverträglichkeiten für die User:innen analysiert und direkt ein passendes Therapie-Angebot bietet - und das Ganze in einer handlichen App. Welchen Beitrag zu einem innovativen Gesundheitswesen kann ein MedTech-Startup mit einer solchen App leisten? Welche positiven Effekte kann eine App auf das Zusammenwirken von Kund:innen und Anbieter:innen, auf die Rentabilität und Kosten, und auf die langfristige Auswertung von Daten haben? Und wie erlebt Pauline ihre Rolle als Frau im Team? Auf diese und viele weitere Faktoren geht Pauline für uns in dieser Episode ein und lässt uns an ihren Erfahrungen und Erkenntnissen teilhaben, welchen Mehrwert eine App für Nahrungsmittelunverträglichkeiten bietet. RESSOURCEN / LINKS: Pauline Nöldemann bei LinkedIn BesserEsser bei LinkedIn BesserEsser im Web Mein LinkedIn Profil für wöchentliche Posts zu Agilität & Innovation Du bist auch eine Frau, die die wirtschaftliche Zukunft gestaltet? Dann lass' uns reden! Buche hier ein Kennenlernen mit mir! DIR GEFÄLLT WAS DU HÖRST? Dann hinterlasse mir bitte eine 5-Sterne-Bewertung auf Apple Podcasts, eine Rezension und abonniere den Podcast. Vielen Dank für deine Unterstützung! Hier bei Apple Podcasts bewerten und abonnieren: https://podcasts.apple.com/de/podcast/femture-wie-frauen-in-die-zukunft-f%C3%BChren-female-leadership/id1571909871 Dieser Podcast wird produziert von der Podcast-Agentur Podcastliebe. Mehr dazu: https://podcastliebe.net

In this episode of Medsider Radio, we sat down for an engaging chat with Ahmed Zobi, founder and CEO of Syntr Health Technologies, which has developed an automated microfat processing system for use in aesthetics and plastic surgery. The FDA-cleared SyntrFuge device allows clinicians to harvest patients' adipose tissue and then reinject it as processed microfat within minutes into the desired area, eliminating the use of fillers. Ahmed has a decade of experience in the medical device industry. He advises and mentors many startups, has been recognized as a Forbes Next 1000 Honoree, and is a guest lecturer at the USC Keck School of Medicine. Ahmed also serves as a board member at various organizations, including the Wound Healing Society and the UCI Center for Innovation and Entrepreneurship.In this interview, Ahmed shares his ideas on the risks and rewards of entrepreneurship, how to operate in a lean fashion, why he puts regulatory clearance above all, and how he managed to be the youngest candidate to receive a phase 1 SBIR grant.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and a curated investor database to help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume V. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Ahmed Zobi.

He scaled his business from 0 to 20 million in under 3 years. Get inspired by the story of Scott Nelson's strategic brilliance and entrepreneurial triumph with Joovv and FastWave Medical, a groundbreaking MedTech startup reshaping the industry landscape. Learn about the strategic decisions, challenges overcome, and pivotal moments that defined Scott's path to success. Harsh and Scott also discuss the challenges and rewards of transitioning from working with large strategic companies to early-stage startups. They emphasize the importance of taking risks, learning from experiences, and being prepared for the ups and downs of entrepreneurship. You're watching Episode 037: Harsh Thakkar (@harshvthakkar) interviews Scott Nelson (@scottnelsonlive), Co-Founder, President, & CEO of FastWave Medical. -----Links: *Fast wave medical *Joovv *If you enjoy this type of content, or would like to watch this episode, subscribe and give us a like on YouTube !-----Show Notes:(0:00) Entrepreneurship, Med-Tech, and startup journey.(2:40) A new medical device for treating complex artery disease.(6:04) Transitioning from corporate to startup life. (9:38) Career advice and growth strategies for startups & entrepreneurs.(13:52) Learning from experience.(18:48) Decision-making, and consumer health trends.(21:10) Perfect is the enemy of good.For more, check out the podcast website - www.lifesciencespod.com

From napkin sketch to sales revenue! Our latest guest has built a completely vertically integrated medical device development company, taking inventor ideas, translating them into products with all the necessary checks and balances, and launching them into their early stage surgical sales force!I am Maureen Shaffer, Host of the Message Engineer for the Medtech Startup show and CEO of message and market advisory, Mingletoe. In this episode, I share my insightful conversation with Jason Scherer, CEO of vertically integrated medical device development company, VitaTek, which takes devices from napkin sketch to sales revenue. Previously, Jason spent 15 years as a top tier, award-winning surgical sales manager. I thoroughly enjoyed talking with Jason about how he applies the focus and speed of sales along with key opinion leader relationships to full medical device development, from sketch to sales.We dive deep into the world of contract device development and discuss how to accelerate medical device and medtech development and reduce time to market.Overall, this episode is full of insightful and thought-provoking discussions about medtech design and development, including the topics below. I highly recommend giving it a listen or watch and joining the conversation online!

„Diese ganzen Normen und Regularien bieten ganz wichtige Tools und Methoden, die helfen können, ein gutes und qualitativ hochwertiges Produkt zu entwickeln.“ Wie können wir sichergehen, dass innovative Geschäftsideen in der MedTech-Branche möglichst vielen Menschen zugutekommen, und nicht im Dschungel der Regulatorien untergehen? Und wie genau bekommen wir die vielen regulatorischen Anforderungen, wie etwa Zertifizerungen oder Copyrights, in den Griff, insbesondere als Startup? Genau hier helfen Acceleratoren dabei, vielversprechende Business-Modelle in dieser speziellen Branche zum Erfolg zu führen. Lea Renz und Dr. Ramona Samba vom 4C Accelerator berichten uns in dieser Folge, warum es gerade in der MedTech-Branche Acceleratoren braucht. Mit ihrer Praxis-Erfahrung und ihrem erprobten Know-how haben sie schon viele frische Unternehmer*innen auf dem Weg zu ihrem eigenen erfolgreichen MedTech-Startup begleitet und standen ihnen in unzähligen Situationen mit Rat und Tat zu Seite. Wie eine solche Teilnahme am 4C Accelerator aussehen kann und auf welche Feinheiten es etwa beim Bewerbungs- und Auswahlprozess ankommt, das erfährst du in dieser Episode. Aber auch, wie zum Beispiel künstliche Intelligenz mit ihrem Disruptionspotenzial inzwischen viele Bereiche der stark regulierten Branche vor neue Herausforderungen stellt, oder welche weiteren Karriereaussichten es für Startups gibt, darum geht es unter anderem heute in dieser FEMture-Folge. RESSOURCEN / LINKS: [4C Accelerator](https://mi-incubator.com/de/4c-accelerator-de/) [Lea Renz bei LinkedIn](https://de.linkedin.com/in/lea-renz) [Dr. Ramona Samba bei LinkedIn](https://de.linkedin.com/in/dr-ramona-samba-bb055068) [Episode 37: Innovation erfolgreich umsetzen - Interview mit CEO Dr. Ramona Samba](https://podcasts.google.com/feed/aHR0cHM6Ly9mZW10dXJlLnBvZGlnZWUuaW8vZmVlZC9tcDM/episode/ZWQyYWZhMjVhY2YxNGM0NjQ5NGM1YTdhOGIxNzlkMWE?sa=X&ved=0CAUQkfYCahcKEwiA-abw-6qEAxUAAAAAHQAAAAAQAQ) [Mein LinkedIn Profil für wöchentliche Posts zu Agilität & Innovation](https://www.linkedin.com/in/nadinzimmermann/) Du bist auch eine Frau, die die wirtschaftliche Zukunft gestaltet? Dann lass' uns reden! [Buche hier ein Kennenlernen mit mir!](https://calendly.com/femture) DIR GEFÄLLT WAS DU HÖRST? Dann hinterlasse mir bitte eine 5-Sterne-Bewertung auf Apple Podcasts, eine Rezension und abonniere den Podcast. Vielen Dank für deine Unterstützung! Hier bei Apple Podcasts bewerten und abonnieren: https://podcasts.apple.com/de/podcast/femture-wie-frauen-in-die-zukunft-f%C3%BChren-female-leadership/id1571909871 Dieser Podcast wird produziert von der Podcast-Agentur Podcastliebe. Mehr dazu: https://podcastliebe.net

In this episode, Eric Horesnyi at Matrix Requirements and Duane Mancini discuss his background as an entrepreneur, quality management systems and the importance of quality as a key pillar for culture, and so much more.

Building any kind of startup is hard. Starting a business in healthcare or medical technology is even more challenging, given the long timelines for product development and all the regulatory requirements companies have to meet. But imagine how much harder it would be to start a company if you were still just a senior in high school! Recently Harry learned about a company called Vytal that's building eye-tracking technology to measure brain health, and he knew he wanted to have the co-founders on the show. Not just because the technology is interesting, but because CEO Rohan Kalahasty and the CTO Sai Mattapali are both 18 years old, and both entering their senior years at Thomas Jefferson High School of Science and Technology in Fairfax County, Virginia. Very few teenagers have ten employees and over a million dollars in seed capital. But that's exactly where Rohan and Sai are right now. Some of the challenges they've faced have been absolutely typical—like how to build a network of partners and how to meet government standards for new medical devices. And others have been a little unusual, like how to get time off from school to meet with investors and how to convince their parents that the business won't take too much time away from their studies. Listen in to hear their whole startup story.For a full transcript of this episode, please visit our episode page at http://www.glorikian.com/podcast Please rate and review The Harry Glorikian Show on Apple Podcasts! Here's how to do that from an iPhone, iPad, or iPod touch:1. Open the Podcasts app on your iPhone, iPad, or Mac. 2. Navigate to The Harry Glorikian Show podcast. You can find it by searching for it or selecting it from your library. Just note that you'll have to go to the series page which shows all the episodes, not just the page for a single episode.3. Scroll down to find the subhead titled "Ratings & Reviews."4. Under one of the highlighted reviews, select "Write a Review."5. Next, select a star rating at the top — you have the option of choosing between one and five stars. 6. Using the text box at the top, write a title for your review. Then, in the lower text box, write your review. Your review can be up to 300 words long.7. Once you've finished, select "Send" or "Save" in the top-right corner. 8. If you've never left a podcast review before, enter a nickname. Your nickname will be displayed next to any reviews you leave from here on out. 9. After selecting a nickname, tap OK. Your review may not be immediately visible.That's it! Thanks so much.

In this episode of Medsider Radio, we sat down with Craig Davis, CEO of NovaScan, a company revolutionizing cancer diagnostics with a low-cost, single-use device capable of real-time cancer detection and stratification.Craig is a strategist, entrepreneur, and leader with a resume boasting a unique blend of business acumen, investment insight, and technical expertise. In this interview, Craig unveils his journey from being a partner at LaSalle Investments to leading the charge in revolutionizing cancer diagnostics. He delves into the myriad of challenges entrepreneurs face, like fostering efficient early-stage development, designing clinical trials for rapid data collection, and mastering the art of fundraising in an ever-evolving financial landscape. Before we jump into the conversation, I wanted to mention a few things:If you're into learning from proven medtech and health tech leaders and want to know when new content and interviews go live, head over to Medsider.com and sign up for our free newsletter. You'll get access to gated articles, and lots of other interesting healthcare content.Second, if you want even more inside info from proven experts, think about a Medsider premium membership. We talk to experienced life science leaders about the nuts and bolts of running a business and bringing products to market.This is your place for valuable knowledge on specific topics like seed funding, prototyping, insurance reimbursement, and positioning a MedTech startup for an exit.In addition to the entire back catalog of Medsider interviews over the past decade, premium members get a copy of every volume of Medsider Mentors at no additional cost. If you're interested, go to medsider.com/subscribe to learn more.

In this episode of the Message Engineer podcast, host Maureen Shaffer, CEO, Mingletoe, shares a deeply helpful how-to-fundraise conversation with growth investor, Lenard Marcus, who specializes in health IT and enterprise software. Lenard Marcus is currently a General Partner with Edison Partners, an award-winning growth investment firm, making it onto GrowthCap's short list of best growth investment firms for the second year in a row. Lenard co-leads Enterprise Software team where he focuses on healthcare IT and cybersecurity and works with Gregg Michaelson on the Healthcare IT team. Lenard also serves on the board of Capital Rx a 2.0 PBM and VirtualHealth, a cloud-based care management platform. Lenard earned his IE degree at Stanford and his MBA at Columbia.

Conflict Zones and Corporate Teams: Insights from former Special Forces Officer, Sal FilardiIn this episode of the Message Engineer podcast, host Maureen Shaffer, CEO, Mingletoe, shares her insightful conversation with former US Army Special Forces officer (Green Beret), Sal Filardi. Sal Filardi is a Communications Consultant, Pinnacle Leadership Coach, and FirstTee Youth Mentor and Golf Coach. Sal is also a proud father & veteran. Sal discusses his work in conflict zones worldwide, and how he draws on that experience to help corporate teams better communicate and work together. This episode offers valuable insights for anyone looking to take their organization to the next level and build a lasting, successful company. Tune in and join us for an informative and engaging conversation. He speaks to us from his home in North Carolina.

In this episode, Ben Holmes at Nanochon and Duane Mancini discuss the University of Virginia biomedical engineering program, the importance of understanding the economics of the problem you are trying to solve, the iCorp program, taking on the PMA pathway as a startup, finding capital as a PMA product, what's next for Nanochon and so much more. Ben Holmes LinkedIn Nanochon Website Project Medtech Website Project Medtech LinkedIn Duane Mancini LinkedIn

A while back, I stumbled onto a story on TechCrunch that caught my attention - an innovative medical startup from Romania, helped doctors from three countries collaborate to treat Ukraine refugee cancer patients – this of course happening after Russian's invasion of Ukraine. That startup was Medicai.Mircea Popa is the founder of Medicai which is a collaborative imaging platform that enables better sharing and communication between patients, doctors and clinics. They currently have 120 customers and are projected to do 1.5M in revenue for 2023. Prior to Medicai, Mircea and a friend co-founded SkinVision, a skin cancer screening app that detects melanoma from images taken on a smartphone.***CONNECTMedicai's website: medicai.io

In this episode, our host Giovanni Lauricella and our guest Amar Sawhney discuss the biggest challenges at a Medtech Startup, challenges in raising capital for Medtech, minimizing risk for your investors, and so much more. Amar Sawhney LinkedIn Incept Website Project Medtech Website Project Medtech LinkedIn Duane Mancini LinkedIn

Nuances of Balance and Feedback with Christine Winoto, Executive Director, UCSF Rosenman Institute and Founding Partner at MedTech Venture Partners! Christine Winoto, Executive Director at UCSF Rosenman Institute and Founding Partner at MedTech Venture Partners joins Maureen Shaffer, CEO, Mingletoe, to chat about medtech, healthtech, and digital health startups. When I engaged Christine to help identify the common pitfalls for startups, she redirected the conversation to talk about how the UCSF Rosenman Institute meets people where they are with what they need. And connects the founders to relevant resources (people mostly) to meet their needs, whereas often times we want to prescribe a one-size-fits-all solution. Christine had such a nuanced and wise approach to offering advice, providing feedback, and choosing what to do next as a founder. She shared why it was important to be cautious of judging as an outsider and why what startups need and what they think they need may be differ. It was a remarkable and enlightening conversation that changed the way I approach feedback and providing guidance. Listen to hear for yourself! Watch to see!

Seth Bogner, CEO, HeartPoint Global joins Maureen Shaffer, CEO, Mingletoe, to chat about how to infuse social purpose and drive investor value in a cardiovascular medical device startup company. Seth also shared his thoughts on how 25 partnerships propel his company forward in challenging situations–from developing innovative and novel cardiac surgical solutions for developing countries to supply chain shortages, how to hire and retain the best global medtech talent across three continents, and why building a strong culture pays market dividends.

In this episode, Peeyush Shrivastava and Duane Mancini discuss the company he founded with his two other middle school friends, dropping out of college together, the rise of magnetocardiography, how they raised money from Mark Cuban, the support from CincyTech, a problem centric approach, and so much more. Peeyush Shrivastava LinkedIn Genetesis Website Project Medtech Website Project Medtech LinkedIn Duane Mancini LinkedIn

Executive SummaryNora is the CEO and co-founder of Berlin-based Medtech Selfapy, a major provider of prescribable digital therapy solutions in Germany. She is the winner of this year's German Startup Award for Female Founder of the Year 2022 and a Forbes 30 under 30. She is a psychologist by training with degrees from York and Cambridge but decided to join startups early on, to later found Selfapy. Self-pay fills the void for patients while they are waiting for psychological treatments, which may take three to six months. After a long journey they now even have a reimbursement certification for German health insurers.Subscribe HereWe are always sharing new resources with you. Find all of our options below. https://linktr.ee/startupradioGerman Startup Awards 2022This interview is in media partnership with the German startup association (Bundesverband Deutscher Startups https://deutschestartups.org/). Their German Startup Awards #GSA22 honor each year outstanding female and male founders and investors in special categories. You can learn more about the winners in our interview and on this website: https://germanstartupawards.de/rueckblick/rueckblick-2022You can also have a look at our history, we also interviewed many winners of the German Startup Awards 2021 already.The FounderOur guest Nora is not only the winner of this year's German Startup Awards for Female Entrepreneur of the Year, but she is also a Forbes 30 under 30. She graduated from the University of York and the University of Cambridge with degrees in Psychology, before joining Rocket Internet. She later became City Head for Foodora in Hamburg and decided one faithful new years day that with this stress level, she could also venture out on her own, with larger rewards. Growing up in a family of psychologists, she decided early on to help people with mental disorders. She co-founded Selfapy in Berlin in 2016.The StartupBerlin-based Selfapy (https://www.selfapy.com/) addresses the issue of wait time for psychological treatments. Due to recent changes in German legislation, they are also available on prescription. The name Selfapy is a combination of self and therapy. The app bridges the wait time before a patient can see a psychologist, which can take up to 6 months. The app not only bridges this time but can also already help patients and lay the groundwork for therapy.Selfapy runs clinical trials, where they could show that they reduce depression symptoms by up to 40% in 3 months.Venture Capital FundingSelfapy has raised 30 M US$ in funding in total. Note that Crunchbase is quite a bit outdated here. They are open to talking to new investors.Selfapy is HiringYou can have a look at our blog post to learn more.Links and Show Notes HERE:https://medium.com/@startuprad_io/medtech-startup-selfapy-offers-psychological-help-without-wait-gsa22-957b2354a05a Topics Discussed in this InterviewIn this interview we are talking about psychology, depression, psychological therapy, psychological help, eating disorders, prescription, apps on prescription, mental health, mental health apps, depression treatment, Berlin, startup, startups, mental health startup, MedTech startup, health care startup, venture capital, university of york, university of CambridgeMentioned in this episode:Learn more www.startupraven.comYounium and TvaritOur Enablers Younium Younium is the subscription management and billing platform for B2B SaaS. Younium brings the transformative infrastructure to manage and grow your business while you focus on the things that matter. https://www.younium.com/ Tvarit Tvarit is an industrial ai startup, that helps companies to reduce rejections by 40%-60% in metal casting, as well

In this episode of Medsider Radio, we sat down with Heather Underwood, CEO of EvoEndo.Heather is a medical device and health technology entrepreneur with a highly interdisciplinary background at the intersection of computer science, global health, human-centered design, education, and international development. In this interview, Heather elaborates on her unique approach to innovation in the medtech arena, how fundraising isn't one-size-fits-all, and why regulatory clearance isn't the end of the road.Before we jump into the conversation, I wanted to mention a few things:If you're into learning from proven medtech and healthtech leaders, and want to know when new content and interviews go live, head over to Medsider.com and sign up for our free newsletter. You'll get access to gated articles, and lots of other interesting healthcare content.Second, if you want even more inside info from proven experts, think about a Medsider premium membership. We talk to experienced healthcare leaders about the nuts and bolts of running a business and bringing products to market.This is your place for valuable knowledge on specific topics like seed funding, prototyping, insurance reimbursement, and positioning a medtech startup for an exit.In addition to the entire back catalog of Medsider interviews over the past decade, premium members get a copy of every volume of Medsider Mentors sent to their door at no additional cost. If you're interested, go to medsider.com/subscribe to learn more.Lastly, here's the link to the full interview with Heather if you'd rather read it instead.

In this episode, Christine Dobbyn interviews medical device industry expert, Duane Mancini, Managing Partner and CEO of Project Medtech. This episode was recorded  live from the Startup Symposium in Houston, Texas at TMC Innovation. Duane discusses the Project Medtech Podcast, medical device startup ecosystem, and the Startup Symposium.Duane ManciniDuane has extensive experience in go-to-market strategy including regulatory & reimbursement, biocompatibility, pre-clinical efficacy testing, and clinical trial design & execution. As a result of Duane's unique background, he has developed a comprehensive understanding of what early-stage start-ups need to do in order to be successful.

In this episode, our host Giovanni Lauricella and our guest Sidney Collin discuss their seed round, raising money before graduating college, the difference between angels and VCs, raising money around a class I medical device, and so much more. Sidney Collin LinkedIn De Oro Devices Website Project Medtech Website Giovanni Lauricella LinkedIn Project Medtech LinkedIn

In this episode of Medsider Radio, we sat down with Cody Simmons, CEO of DermaSensor.Cody spent four years learning about business strategy and analytics at biotechnology giant Genentech before becoming CEO of DermaSensor in 2016, where he leads development and commercialization efforts for the company's novel skin cancer detection tool. In 2018, he was included on the Forbes 30 Under 30 list in healthcare.In this discussion, Cody shares why he thinks companies need to focus on regulatory and reimbursement alignment from the very beginning, the importance of finding ally investors, and how to build trust with potential partners in your network.Before we jump into the conversation, I wanted to mention a few things:If you're into learning from proven medtech and healthtech leaders, and want to know when new content and interviews go live, head over to Medsider.com and sign up for our free newsletter. You'll get access to gated articles, and lots of other interesting healthcare content.Second, if you want even more inside info from proven experts, think about a Medsider premium membership. We talk to experienced healthcare leaders about the nuts and bolts of running a business and bringing products to market.This is your place for valuable knowledge on specific topics like seed funding, prototyping, insurance reimbursement, and positioning a medtech startup for an exit.In addition to the entire back catalog of Medsider interviews over the past decade, premium members get a copy of every volume of Medsider Mentors sent to their door at no additional cost. If you're interested, go to medsider.com/subscribe to learn more.Lastly, here's the link to the full interview with Cody if you'd rather read it instead.

In this episode, our host Giovanni Lauricella and our guest Dave Marver discuss taking a company public, the importance of building a brand, the importance of intellectual property, what are some of the differences and similarities between private and public companies, and so much more. Dave Marver LinkedIn Onward Website Project Medtech Website Giovanni Lauricella LinkedIn Project Medtech LinkedIn

What can simplify the life of a medtech founder and how can they get that much-needed support? Maria Pelipas is a seasoned program manager with innovation experience across biotech strategy consulting, partnership management, startup accelerators, investment funds and innovation agencies. Medtech Actuator has a number of programmes, like their twelve-month accelerator, which is like a mini commercialisation MBA for first-time or early-stage founders.  For this episode, Pete and Maria discuss trends in health tech and medtech over the past few years, raising capital, what medtech founders face today and the process of taking an innovation from research to commercialisation and beyond.   This episode speaks to the life of medtech founders and the struggles they encounter when taking an idea from the research stage and commercialising it. Their mental health is also explored along with possible solutions and advice.  Check out the episode and full show notes here. To see the latest information, news, events and jobs on offer at Medtech Actuator, visit their Talking HealthTech Directory here.  Loving the show?  Leave us a review, and share it with some friends, and let us know how we can improve by completing our podcast listener survey. Keen to take your healthtech to the next level? Become a THT+ Member for access to our online community forum, quarterly summits and more exclusive content.  For more information visit here.

In this episode, our guest Mitch Robbins and Duane Mancini discuss his background in recruiting, the current demand for Medtech talent, the future of remote work, progression of going from fractionalized to full time team members, passive vs. active recruitment, how do you attract top talent as a Medtech startup, how many applicants can companies expect for certain positions, how to de-risk your hiring process, and so much more. Mitch Robbins LinkedIn The Michael Anthony Group Website Duane Mancini LinkedIn Project Medtech LinkedIn Project Medtech Website

In the last podcast episode of the series, MIDI Medical Product Developments CEO, Gregory Montalbano shares his personal insight as related to what an Accelerator or Incubator can and should be doing for its MedTech Startup entrepreneurial members. Greg also outlines the “Five Accelerator Model Types” and reveals each accelerator type's own motivations for establishing programs, investing resources and capital as well as the different metrics MedTech Accelerators use for measuring a start-ups success.

In this episode, Craig and Duane Mancini discuss what his team is currently working on at UpLyft, his first company that he started, his experience with non-dilutive capital in Ohio, his advice on raising capital, how he raised money in his first company, why his company focused on digital marketing and the benefit, and so much more. Craig Misrach LinkedIn UpLyft Website Duane Mancini LinkedIn Project Medtech LinkedIn Project Medtech Website

In this episode, Jon and Duane discuss the issue of clinical data collection in medical device development, the lack of clinical data for products on the market, the need for balance between innovation and safety, why you need to think about clinical data early, why sales and marketing need to have a heavy influence in your clinical data collection, how the MDR is affecting innovation in Europe and more. Jon Bergsteinsson LinkedIn Smart-Trial Website Duane Mancini LinkedIn Project Medtech LinkedIn Project Medtech Websiste

In this episode, Michelle and Duane discuss discuss her focus on startups, when to get a regulatory strategy done, why regulatory strategy is crucial and should be a part of your business plan, why you need to be careful when building your website, when it makes sense to use a stepwise regulatory approach, benefits to a De Novo pathway, could the US move towards MDRish regulations, and more. Michelle Lott LinkedIn LeanRAQA Website Duane Mancini LinkedIn Project Medtech LinkedIn Project Medtech Website

In this episode, Neil and Duane discuss his new company and what they are working on, his background as a practicing physician, why they are a class III medical device, the lack of innovation and funding in women's healthcare, why they weren't afraid of a PMA process with the FDA, first time fundraising as a CEO, and more. Neil Ray LinkedIn Raydiant Oximetry Website Duane Mancini LinkedIn Project Medtech LinkedIn Project Medtech Website

In this episode, Andy and Duane discuss how his journey has prepared him for being a CEO in the Medtech space, what they are working on at Koya Medical, where are they going next, what he has learned in each phase of his career so far, the importance of trust of team, the importance of who you raise capital from and why you should value that over how much you raise, and more. Andy Doraiswamy LinkedIn Koya Medical Website Duane Mancini LinkedIn Project Medtech LinkedIn Project Medtech Website

Nikin discovered his love for electronics at 9, and became the youngest research assistant at India's DoD. He discusses his journey in accelerated learning pathways and founding a medtech startup.“Don't ever be afraid to ask for help or to ask for opportunities. Very few opportunities land in your lap… you have to hustle and create the opportunity.”From piloting projects on anti-train collision and smart homes starting from when he was 9 to attending Northeastern on a full ride scholarship when he was 16, Nikin Tharan describes how he paved his journey through curiosity and a passion for reading/learning.In this episode, we talk:Accelerated learningEntrepreneurshipSocial impactFor anyone interested in generating social impact, this podcast episode provides actionable insights, lessons, and mindsets for future founders and technologists._______________________GuestNikin TharanOn LinkedIn | https://www.linkedin.com/in/ntharan/______________________HostEllen XuOn ITSPmagazine

In this episode, Giovanni and Kelly discuss what he is currently working on at Fisher Wallace Laboratories, why he chose crowd funding as a source of capital for his Medtech start-up, how to crowd fund, what you need to do with the SEC, which platform they used and why they chose it, and more. Kelly Roman LinkedIn Fisher Wallace Laboratories Website Giovanni Lauricella LinkedIn Project Medtech LinkedIn Project Medtech Website

In this episode, Giovanni and Kelly discuss what he is currently working on at Fisher Wallace Laboratories, why he chose crowd funding as a source of capital for his Medtech start-up, how to crowd fund, what you need to do with the SEC, which platform they used and why they chose it, and more. Kelly Roman LinkedIn Fisher Wallace Laboratories Website Giovanni Lauricella LinkedIn Project Medtech LinkedIn Project Medtech Website

In this episode, Giovanni and Ash discuss his journey in the medical device space, being an entrepreneur in Australia, the Medtech scene in Australia and more. Ash Attia LinkedIn Bionic Vision Technologies Website Giovanni Lauricella LinkedIn Project Medtech LinkedIn Project Medtech Website

In this episode, Giovanni and Ash discuss his journey in the medical device space, being an entrepreneur in Australia, the Medtech scene in Australia and more. Ash Attia LinkedIn Bionic Vision Technologies Website Giovanni Lauricella LinkedIn Project Medtech LinkedIn Project Medtech Website

Singapore-based medtech startup N&E Innovations has partnered with Intersnack Group, a leading savory snacks producer in Europe, to create Vi Kang 99, an active compound synthesised from cashew waste. Didi Gan, Founder, N&E Innovations, shares more about the process behind creating this compound and how it has been implemented in their disinfectant products and face masks.  See omnystudio.com/listener for privacy information.

Meetings sind seit jeher gigantische Zeitfresser. Das hat sich in der hybriden Arbeitswelt nicht geändert. Sherpany möchte Unternehmen dabei unterstützen, ihr Meeting-Verhalten zu optimieren und hat daher via Forrester Consulting 266 Führungskräfte (C-Level oder Vice Presidents) von Unternehmen mit mehr als 1000 Mitarbeitenden in Belgien, Deutschland, Frankreich, Italien und Großbritannien zu ihrer Meeting-Kultur befragt. Über die Ergebnisse und daraus ableitende Verbesserungsvorschläge berichtet Tobias Häckermann im Interview. Im zweiten Interview berichtet Stefan Steiner von VentureLab über die zehn neuen Mitglieder der “Schweizer Startup Nationalmannschaft”. Diese wurden im Rahmen des Venture Leaders Programm ausgewählt und im Herbst auf Roadshow nach Boston und Cambridge gehen, um in das amerikanische Medtech-Startup-Ökosystem einzutauchen, internationale Investoren und Branchenführer zu treffen und Zugang zu branchenspezifischem Fachwissen und Netzwerken zu erhalten.Venture Leaders Medtech 2021 wird von Venturelab organisiert und von EPF Lausanne, ETH Zürich, Hansjörg Wyss, Kellerhals Carrard, Paul Scherrer Institut, Swissnex Boston, Universität Zürich, Kanton Waadt und Kanton Zürich unterstützt.

Dr. Rachel Kuperman, MD, CEO and Founder of Eysz, a medtech/AI startup, discusses the company's AI-enabled Epilepsy Management Platform that they are building that uses passive eye movements to detect and track seizures and neurocognitive side effects in order to help get patients on the right medication sooner. She also talks about their equity crowdfunding offering through the Bioverge Portal that enables the epilepsy community the opportunity to receive equity in Eysz in return for investing in the further development of the platform. #Eysz #EpilepticSeizures Neurologist with dual certification in epilepsy and neurology with over 10 years' experience directing the clinical epilepsy and research programs at UCSF Benioff Children's Hospital, Oakland

We meet Dr. Therese Canares today, an extraordinary physician and entrepreneur.  Not only will she tell us about her current practice, but she will also explain how her medical career helped her pivot into a new role as the founder of an innovative AI product. She will demonstrate for listeners what is possible when motivation and great organizational skills come together. Therese is a pediatric emergency physician, an assistant professor at Johns Hopkins School of Medicine and the founder and CEO of CurieDx, a new and exciting concept she is developing. But first, let's learn a little about her background. Therese was raised by a single mother who came to the U.S. from the Philippines. She credits both her mother and an aunt for providing lifelong inspiration.  They taught her a strong work ethic and the importance of achieving good grades.  Her mother, an architect and engineer, and her aunt, a physician, were the influential role models then who made sure she always had the support and guidance she needed. Their influence led her to choose medicine as her first career. Therese was a biology major as an undergrad at Penn State University.  After finishing in 2003, she took a year off before starting med school. She made the decision to defer because her boyfriend, now husband, survived the 9/11 attack on the twin towers in New York City. The time felt too traumatic to her to begin medical school studies, but she found other work to occupy her that was significant and would help her when she was able to return to academics.  Therese went to work in the lab of Dr. Henry Pollack, a pediatric infectious disease specialist.  While there, she assisted with his research.  The work was worthwhile and cemented her commitment to pediatrics. That experience was also helpful for her as she planned to resume her medical school application.   After acceptance at NYU, she spent nearly 10 years in preparation to become a physician.  She is currently at Johns Hopkins where she sees patients, teaches and continues research work.  She and her husband have two children, and as you will hear, she gives her husband much credit for being a true equal partner, and without whom, she would be unable to follow the career path that she has chosen.  So certainly Dr. Canares leads a busy life.  But like many other people doing complicated daily work, she saw possibilities and opportunities others might not recognize or consider. As a pediatrician and parent, this happened to Therese.  She realized there were times as a busy parent her child needed to be diagnosed by her own doctor, but it seemed difficult to get to the doctor's office when the need would arise.  Sometimes it was in the middle of the night.  Sometimes either she or her husband would have to squeeze the time from within their frequently long work schedules. And it seemed most times the needed visit was on very short notice.  Therese began to think about how to help solve this universal problem.  In doing so, she came up with CurieDx. CurieDx is a software platform which offers point of care medical tests from a picture you send from your cell phone.  But how did Therese get from her concept to a functioning website?  Although obviously capable in many ways, tackling the inception of an AI software platform was not something she thought she could successfully do with the skill set she had at the time.  But she felt passionately about her idea, and with the support of her husband, she decided to go back to school for an MBA so she could acquire the knowledge she knew she would need to move forward. You will hear her describe to Amy some of the many hurdles that came her way including gender bias, but in the end, she achieved her degree. She found a variety of benefits in the program, all of which gave her the knowledge and confidence she needed to move forward on her start up company. In her final month before completing the MBA program, she and her team took first prize in the Johns Hopkins Business Plan Competition. The prize has provided some seed money to get her idea going.   She explains her next step is to build the product and test the algorithms. With success there, she'll need to raise more funds. Her ultimate goal is to make her product available to every telehealth company that can use it.  What has she enjoyed about starting her own business? She tells us it's the “start to finish aspect” or closure that is achieved as she sees things through. She also likes the ability to think creatively while bringing organization to the chaos.  All in all, she is happy with her additional yet very busy career. Dr. Therese Canares is a model to follow for those overachievers out there.  She has la ot of irons in the fire and is thriving.  Here are some takeaways from her story today: Early influences are often the most important You are capable of more than you think and your talents can take you in more than one direction Biases are a reality. Choose how to deal with them before you encounter them so you can stay on track Self-care is vital to multitaskers and overlooking it can derail you A supportive partner makes all the difference   Links: Therese (Waltz) Canares, MD | LinkedIn curiedx.com

A few years ago, I had the privilege of sitting down and talking with serial medtech entrepreneur Paul Buckman, who at the time, was CEO of Conventus Orthopedics. Prior to Conventus, Paul held CEO roles at SentreHEART, Pathway Medical Technologies (which sold to Bayer HealthCare), and Devax (which sold to Biosensors International). From 2004 through 2006, Buckman served as President of the Cardiology Division of St. Jude Medical. Before joining St. Jude, he served as Chairman and CEO of ev3, a company that Buckman co-founded and was later acquired by Covidien for $2.5 billion dollars in 2010.Paul has worked in the medical device industry for over 35 years, including 10 years at Scimed Life Systems and Boston Scientific where he held several executive positions before becoming President of the Cardiology Division at Boston Scientific in January of 2000. Buckman received a BA degree in business administration and an MBA degree from Western Michigan University. Here are a few of the things we’re going to learn in this interview with Paul:- Of all the medtech startups that Paul’s been a part of, the two that are closest to his heart.- Two of the many key learnings that Paul recalls during his time helping to build Scimed.- When it comes to product development for medtech startups, why it’s critical to be ruthless about prioritization.See more...

Medtech entrepreneurship is on the rise, and for good reason.  The continual growth that’s seen within the life sciences industry in Orange County has been attracting an increasing number of international investors and VC firms.  Venture capital firms have set their sights on the Southern California life sciences industry, which is displayed by the fact that the amount of VC investment for 2018 was around $7.6 billion for biotech and medical devices.  It's a good time to be involved in the startup scene.  Yet entering the world of medtech startups is complex and rife with unique challenges.  When 90% of startups fail, what does one need to know about the 10% that don't?  What are the best practices to cover blind spots one may have when launching a medtech startup? In this episode of DeviceAlliance’s Medtech Radio, we speak with the Director of LaunchPad & Investor Relations at OCTANe OC, J.C. Ruffalo.  Join us as we discuss how to properly launch your startup medtech company, creating a cohesive business plan, and amplify your capital funding strategy.  Learn insight from over 600 successful LaunchPad Alumni since 2010, and discover why LaunchPad ranks in the top 5 out of over 900 SBDCs in the United States. 

One of the big highlights of Singapore Fintech Festival x SWITCH is a “startup pitching competition” called SLINGSHOT, which has crowned Medtech startup Eko.ai, the winner - beating almost 2,400 others from more than 120 countries. Carolyn Lam, Co-founder, Eko.ai, & Lim Seow Hui, Director, Enterprise Singapore’s Startup Development Division, tell us all what lies in store in future.  

On today's episode of the Global Medical Device Podcast, we're discussing how startup entrepreneurs like you can remove the common regulatory obstacles your business faces and other tips and pointers you can use when developing new medical devices. Our guest today – Mitch Levinson – is the CEO of Cerebrotech Medical, and with over 30 years experience as a startup CEO and executive for companies that have IPO'd like ZELTIQ Aesthetics and Thermage, he knows all about the ins and outs of FDA regulation. His Number One Tip? Mitigating risks as early as possible. We discuss the ways you can reduce your risks and shorten your regulatory audits, and the best way to do that is to pick the right tech. Mitch also says to start early and meet with the FDA board as soon as possible so you know what parameters you need to meet ahead of time. And among these parameters, we also discuss more of Mitch's insider tips, including… Holding early meetings with FDA to set your parameters right away Growing a quality system organically so you aren't struggling through auditing later down the road Finding products that financeable so you can be backed by the investors you need Pursuing clearance in the US and the EU at the same time to speed up your approval process Building the right company culture so you have the most supportive employee team and board to keep your start-up running smooth Seeking FDA approval and mitigating risks go hand-in-hand in this industry. Tune in for Mitch Levinson's insightful tips and tricks so you can start applying his advice to your startup today.

In this episode, Rightley McConnell, VP of Operations at Precision Systems, Inc., covers how to maintain quality and speed when developing medical device software. Rightley and Dan discuss:Challenges to device software development for complex systemsUse of AGILE methodology in a regulated environmentApplicable standards including 21 CFR 820, ISO 13485, ISO 14971How quality can remain central at each development phaseAnd more. Rightley can be reached at rmcconnell@psi-software.com.

After graduating from M.I.T. with a Bachelor of Science in Management Science, Peter Dolch went on to pursue an impressive resume of business endeavors. With more than 25 years of experience in launching and managing technology-based start-ups, he left a mark on NYC before moving north to the suburbs. Peter is an active contributor to the community and the President and co-Founder of Thaumaturgix, Inc. (Tgix) which was twice ranked in the Inc. 500 Fastest Growing Private Companies list. Peter acts as the Managing Partner at Tgix; the CTO of Biospectal SA (a Swiss-based MedTech Startup); the Managing Partner at AEON Foundry, an NYC-based fund investing in and mentoring early-stage startups; is on the Advisory Board of American Diamond Mint, a new way to buy, sell and trade diamond assets; and is a Science Advisory Board member of DietPower. Some of his past achievements include: Founding Board Member of Port Indigo, a mobile solutions company; Founding Board Member of UnChat LLC, an online democracy platform; member of the Board of Advisors of Transclick, a wireless multi-lingual gateway and translation platform; Founding Board Member of CheetahMail, an email marketing company; member of the Board of Advisors to Intellireach Infocrossing, an IT outsourcing company; Board President of his NYC Co-Op. What You Will Learn: Peter Dolch's career of launching and managing startups How to generate revenue with your company's unused resources Challenges of investing in early-stage startups Benefits of investing independently versus venture funds Angel groups and how they work Y Combinator and how accelerators work to help startups reach the next inflection point rapidly Expectations you should set with your investors What makes a company fundable How to connect with Peter Dolch: Website: www.tgix.com LinkedIn: https://www.linkedin.com/in/peterdolch

After graduating from M.I.T. with a Bachelor of Science in Management Science, Peter Dolch went on to pursue an impressive resume of business endeavors. With more than 25 years of experience in launching and managing technology-based start-ups, he left a mark on NYC before moving north to the suburbs. Peter is an active contributor to the community and the President and co-Founder of Thaumaturgix, Inc. (Tgix) which was twice ranked in the Inc. 500 Fastest Growing Private Companies list. Peter acts as the Managing Partner at Tgix; the CTO of Biospectal SA (a Swiss-based MedTech Startup); the Managing Partner at AEON Foundry, an NYC-based fund investing in and mentoring early-stage startups; is on the Advisory Board of American Diamond Mint, a new way to buy, sell and trade diamond assets; and is a Science Advisory Board member of DietPower.Some of his past achievements include: Founding Board Member of Port Indigo, a mobile solutions company; Founding Board Member of UnChat LLC, an online democracy platform; member of the Board of Advisors of Transclick, a wireless multi-lingual gateway and translation platform; Founding Board Member of CheetahMail, an email marketing company; member of the Board of Advisors to Intellireach Infocrossing, an IT outsourcing company; Board President of his NYC Co-Op.What You Will Learn:Peter Dolch’s career of launching and managing startupsHow to generate revenue with your company’s unused resourcesChallenges of investing in early-stage startupsBenefits of investing independently versus venture fundsAngel groups and how they workY Combinator and how accelerators work to help startups reach the next inflection point rapidlyExpectations you should set with your investorsWhat makes a company fundableHow to connect with Peter Dolch:Website: www.tgix.comLinkedIn: https://www.linkedin.com/in/peterdolch See acast.com/privacy for privacy and opt-out information.

In this episode, Seth Goldenberg, VP of Vault Medical Device & Diagnostics at Veeva Systems, cover data flow throughout the product lifecyle and how advanced data management can speed devices along the path to market. Seth and Dan discuss:How data management and access impact the product lifecycleWhat the device industry can learn from pharma's data practicesHow EU MDR is changing the data landscapeWhen in a device company's growth does a cloud system start to make sense?

In Part II of this two-part episode, Adam Dakin, Managing Director of Dreamit Health, covers funding trends in medtech and how to pitch to institutional investors. Adam and Dan discuss:Medtech funding trends and how they've changed in recent yearsInvestor perspectives on medtech vs. digital healthHow to build value to make your startup attractiveTips for success at the pitch table

In this episode, Adam Dakin, Managing Director of Dreamit Health, covers funding trends in medtech and how to pitch to institutional investors. (Part I of II)Adam and Dan discuss:Medtech funding trends and how they've changed in recent yearsInvestor perspectives on medtech vs. digital healthHow to build value to make your startup attractiveTips for success at the pitch table

In this episode, Gregory Bernabeo, Patent Attorney and Partner at FisherBroyles, covers intellectual property ground rules and special topics in the medtech space. Greg and Dan discuss:Why a patent isn't what (exactly) what you thought it wasIs my medtech innovation patentable?Are patents valuable if I can't afford to litigate?Can medtech innovators protect their IP rights and publish their research?What's important when selecting a patent attorney for my medtech project?

In this episode, Matt Maltese, Executive Director of the PA Pediatric Medical Device Consortium and Dan Henrich discuss:Current barrier to pediatric device innovationHow pediatric specialists operate without pediatric devicesRisk/Benefit rationale for small patient populationsCurrent industry and FDA initiatives to bring more devices to market for kids

When considering a new career opportunity we advise individuals to explore “The 4 Pillars” : market, product, leadership and mission. However, all those items require “fuel in the tank” to keep the organization alive….MONEY. On today’s podcast, Joe Mullings interviews David Hochman, Chairman and CEO of Orchestra BioMed. David brings to the table over 20 years of venture capital, entrepreneurial and investment banking experience and his powerful perspective on the future of financing opportunities in MedTech. Listen in as David shares with us an incredibly innovative financing model, where he deploys a currently used model in Biotech / Biopharma that Orchestra BioMed has pivoted for use in the MedTech space.

In this episode, regulatory expert Monica Ferrante, VP of Regulatory and Quality at Aspire Bariatrics, talks regulatory strategy and approvals for new medical devices coming to market.Monica and Dan discuss:FDA risk classifications and how to steer down various regulatory pathwaysHow FDA is changing in recent yearsTrends in regulation--are medical devices under-regulated by FDA?Formal vs. informal pre-submission meetings with FDAHow to go about finding trustworthy regulatory support

In this episode, branding expert Bill Gullan, President of Finch Brands, speaks with Smithwise Marketing Director Daniel Henrich about what branding is and why's it's critical in the world of medtech ventures. Bill and Dan discuss:What branding is, and what it's notHow company identity and go-to-market strategy are reflected in a brandWhen is the right time to worry about branding? Developing market and buyer insightsNaming your product and company

Theranova is an experienced media device developer with a track record creating innovative and practical solutions to large markets. Joe Mullings sat down with the CEOs of two companies that had their start inside Theranova. Joe Urban, CEO of Potrero Medical that recently spun out into their new headquarters and Eric Kriegstein, CEO of Respirix. They discuss the MedTech Startup environment, being a Theranova portfolio company and being a first time CEO.

On this episode, we sit down with Stephen and Anna John, a brother-sister team of medical device developers, working to bring life-saving respiratory therapy to the developing world. Their device, NeoVent, is a low-cost, mechanical solution to deliver two levels of air pressure to infants in respiratory distress without the need for continuous electric power.Stephen and Anna grew up in rural Nepal, where their family worked to meet the medical needs of an undeserved population. Their father, Sunil, is a pediatric cardiologist and continues to split his time between practicing in Kalamazoo, Michigan and Nepal. Sunil is serving as a clinical advisor in the development of NeoVent. They're working to bring NeoVent to market through their company, AIM Tech. You can contact them through their website or by sending an email to stephen.john@aimtechhealth.com."Every year, over one million infants die of severe respiratory illnesses, making it one of the leading causes of under five mortality in the world. 99% of those are in low to middle income countries, which shows you that there are good treatments for these conditions, but they're not reaching most of the world." -Stephen John, CEO, AIM Tech

In this episode, Joe Popowicz, founder of Emergent Clinical Consulting, sits down with Smithwise President Eric Sugalski to talk about clinical evidence strategies surrounding new medtech. They cover pre/postmarket data needs, regulatory pathways, Value Analysis Committees, Significant Risk vs. Nonsignificant Risk, Institutional Review Boards, and more. See more and find contact info for Joe on the Smithwise.com blog.

We're joined this episode by Wamis Singhatat, VP of Product Development and CTO of Active Protective, a medtech company working to bring a really cool new piece of technology to market. Their product is a smart belt that can detect a fall in progress and deploy airbags to cushion the hips of the wearer. You can see a video of the deployment in action on the Smithwise blog. Wamis sat down with Smithwise President Eric Sugalski to discuss their strategies for bringing this product to market.

Welcome to Medtech Mindset, a production of Smithwise. This episode is a great way to tell if this podcast is for you.Eric Sugalski and Dan Henrich sit down to discuss the big picture of bringing a new piece of medical technology to market. We touch on product development and designregulatory pathwaysclinical evidencego-to-market strategyintellectual propertyother themes. In coming episodes, we'll explore these topics in more detail with guests who are experts in these areas and guests who have recently been through the process.

Shiv Shukla started as an undergrad volunteering at an opioid recovery clinic, where he discovered that opioid addictions came from chronic pain. Since then, Shiv has taken on Global Goal #3, Good Health and Well-Being. He developed a technology that addresses pain with non-invasive magnetic pulses. In this episode we cover: How the NeuraLace Medical device works and how it’s different than any other solution tackling chronic pain. Chronic pain affects 1 in 3 Americans and is severely under-treated. The data behind the industry of chronic pain and the opioid epidemic. Global Goal #3.5 A high-level look at the NeuraLace business model and current projects he’s focused on to raise capital.   In this episode, find out how the technology works, and what it's taking for this breakthrough MedTech company to become widely available for impact.

More than a decade ago, AUM Cardiovascular founder Dr. Marie Johnson was a doctoral student when tragedy struck her and her family. Her husband, Rob, passed away suddenly at the age of 41. He had blockages in his coronary arteries including a ruptured plaque in the left anterior descending artery supplying a large part of...[read more]Related StoriesWhy Intersect ENT is an Example of Hope for the Medtech IndustryAre Medical Device Models the Key to Building a Lean Medtech Startup?Substantial and Sustainable – 2 Words That Medtech Companies Should Get Used To

On today's episode of the Global Medical Device Podcast, we’re discussing how startup entrepreneurs like you can remove the common regulatory obstacles your business faces and other tips and pointers you can use when developing new medical devices. Our guest today – Mitch Levinson – is the CEO of Cerebrotech Medical, and with over 30 years experience as a startup CEO and executive for companies that have IPO'd like ZELTIQ Aesthetics and Thermage, he knows all about the ins and outs of FDA regulation. His Number One Tip? Mitigating risks as early as possible. We discuss the ways you can reduce your risks and shorten your regulatory audits, and the best way to do that is to pick the right tech. Mitch also says to start early and meet with the FDA board as soon as possible so you know what parameters you need to meet ahead of time. And among these parameters, we also discuss more of Mitch’s insider tips, including… Holding early meetings with FDA to set your parameters right away Growing a quality system organically so you aren’t struggling through auditing later down the road Finding products that financeable so you can be backed by the investors you need Pursuing clearance in the US and the EU at the same time to speed up your approval process Building the right company culture so you have the most supportive employee team and board to keep your start-up running smooth Seeking FDA approval and mitigating risks go hand-in-hand in this industry. Tune in for Mitch Levinson’s insightful tips and tricks so you can start applying his advice to your startup today.

The lean startup movement has become increasingly popular within the tech community after the release of Eric Ries’ book in 2011. Although I personally believe the lean startup methodology is brilliant, some aspects are difficult to apply to the medtech space. For example, it costs significantly less money to iterate on a software idea in...[read more]Related ArticlesCan Medical Device Companies Increase Sales and Reduce Costs at the Same Time?Substantial and Sustainable – 2 Words That Medtech Companies Should Get Used ToSocial Media Best Practices for Marketing Medical Devices