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In this episode of the Medical Sales Podcast, Samuel sits down with endoscopy leader and author Jon Alwinson to break down what makes GI and ASC sales one of the most predictable, high-impact spaces in medical devices while unpacking Jon's journey from failed entrepreneur to Stryker associate, rookie-of-the-year rep, and now ASC leader at Boston Scientific. Jon shares the systems that drive top-tier performance—true pre-call planning, zoning a territory with precision, and running each week with a focused attack list—while also exposing the pitfalls that hold reps back, from fear and negative self-talk to time-wasting habits and hiding in comfortable accounts. Samuel and Jon dive deep into identity, mindset, and mentorship, exploring how the best reps stay confident, stay disciplined, and stay out of their own heads. If you want a tactical, honest look at what it takes to thrive in medical sales and lead with excellence, this episode delivers it. Connect with Jon Alwinson: LinkedIn Connect with Me: LinkedIn Love the show? Subscribe, rate, review, and share! Here's How »
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Colby Holtshouse, President and CEO of May Health.May Health is developing a minimally invasive ovarian ablation therapy designed to restore ovulation in women with polycystic ovary syndrome (PCOS) and PCOS-related infertility.Before May Health, Colby served as Global Medtech Commercial Lead at Organon, overseeing the worldwide launch of the Jada System following Organon's acquisition of Alydia Health, where she held roles including COO, Interim CEO, and VP of Marketing. She has also held leadership positions at Pelvalon, AccessClosure, Medtronic, and Guidant.In this discussion, Colby shares why early clinical evidence should be built in focused layers rather than oversized, all-at-once trials. She explains how a small, deliberate early launch can reveal the workflow nuances and real-world expectations no study ever captures. And she outlines why founders should define the raise first — and how clarity, preparation, and a deep understanding of strategic partners can dramatically accelerate the fundraising process.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Colby Holtshouse.
Recently I sat down with two true pioneers of the medical device industry — Gregory L. Peel and David “Dino” Harris Jr. — to talk about the book that's already inspiring the next generation of MedTech talent.Greg's new book, The Pivot Point, captures the stories of 16 African-American trailblazers who built careers in an industry almost no one knew existed when they started. Their stories of grit, door-knocking, resilience, and career pivots are pure gold for anyone in (or trying to break into) medical device sales.In this episode we talk about:• How pioneers navigated being the first in a territory• Why most people still don't know this industry exists• The Mayo Stand test — the real scoreboard for reps• The “door-knock theory” and why rejection is a skill• Why you must build multiple income streams• How a single career pivot can change an entire life trajectoryWhether you're a junior rep, a veteran leader, a transitioning athlete or veteran, or someone trying to break into medical sales — this conversation is a roadmap.RESOURCES
Der "Head of Legal Digital & IT" bei ROCHE berichtet, wie ein Konzern * mit der EU-Digitalregulierung umgeht, * wie er auf Augenhöhe bleibt, * auf was es bei der Implementierung ankommt und * welche Kritik und welche Hoffnung an bezüglich dieser Vorgaben hat. Christian Johner beleuchtet die gleichen Fragestellungen aus der Brille von jemanden, der Einblick in viele andere Unternehmen hat.
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.com/youtube-podIf you're new to my channel, my name is Jacob McLaughlin. I'm the founder of New to Medical Device Sales, an exclusive training program designed to help people break into the competitive field of medical device sales. Our average person lands a six-figure role in just 8.5 weeks, earning $105,502 annually. With thousands of success stories from candidates with all kinds of backgrounds, our program equips you with the tools to succeed in this industry.4 years ago I moved out to Arizona not knowing anyone and had $1200 to my name.I came to this exact spot to journal and share how excited I was to be starting my journey in life.Last night I took time to reflect over the past 4 years. It's truly amazing how you can change your life in such a small amount of time.My take aways:1. Go after your dream because even if it doesn't workout like you thought it would, it will bring your right where you're suppose to be.2. Believe in yourself. Nobody is going to believe in you as much as you will, know that good things will happen.3. Change is inevitable. Change is going to happen so you can either accept it and keep moving forward or not.Please bet on yourself and go after your dreams because your life can be better than you ever thought it could be if you do
Diversity in healthcare devices complicates segmentation, security controls, and zero-trust approaches. New certifications aim to help. Bob Lyle, CRO of Medcrypt, identifies how layered defenses, rigorous cybersecurity requirements for new devices, continuous monitoring, and dark-web credential surveillance can reduce risk.
Can you imagine a world in which a wearable device, like a smartwatch, could move your fingers to strum the guitar or play the drums? That kind of technology is part of the innovative research coming out of the Human-Computer Integration Lab at the University of Chicago, led by renowned computer scientist Pedro Lopes. His lab is developing a new generation of gadgets that use haptics (or tactile sensations like the buzz of your smartphone) to move your body, replicate your sense of smell and even make you feel things.In this episode, Lopes explores the potential of wearable devices to transform our future as well as brain-computer interfaces that are being developed by companies like Elon Musk's Neuralink that directly into the body. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.
In this week's episode of Parallax, Dr Ankur Kalra welcomes Dr Courtney Maxey-Jones, Director of the Coronary Care Unit at Upstate University Hospital and a cardiac anesthesiologist intensivist by training. Dr Maxey-Jones co-founded and serves as Chief Operations Officer of GOMED, a not-for-profit organization transforming how we think about medical device waste and global healthcare equity. Dr Maxey-Jones shares the origin story of GOMED - born from witnessing the staggering waste generated in cardiac operating rooms, where expensive single-use devices are discarded due to expiration dates or changing surgeon preferences. Together with her partners, cardiac surgeon Dr Farhan Nadeem and physician assistant Connor Wasilnak, they recognized an extraordinary opportunity to make use of these waste items. Dr Kalra and Dr Maxey-Jones examine the ethical complexities of equipment reuse, the critical unmet needs for EP devices and cath lab equipment internationally, and GOMED's innovative partnership with Syracuse University biomedical engineering students to develop low-resource autoclaves. This episode reveals how observation of systemic waste evolved into a sustainable model for global cardiovascular care equity. Questions and comments can be sent to "podcast@radcliffe-group.com" and may be answered by Ankur in the next episode. Host: @AnkurKalraMD and produced by: @RadcliffeCardio Parallax is Ranked in the Top 100 Health Science Podcasts (#48) by Million Podcasts.
Today we're excited to welcome Navin Dewagan, the CEO of Boston-based Digital Health Solutions.Digital Health Solutions acts as the innovation partner for medical device and healthcare firms. Navin and his team help healthcare solution providers accelerate their medical products to market by leveraging years of domain expertise in IoT and cloud development, cybersecurity, mobile development and embedded software development for healthcare applications. Digital Health Solutions offers end-to-end software product expertise, from ideation to design & development, re-engineering, testing and verification & validation. Plus, with a range of services that's close to our heart at Qualio, the team offers comprehensive quality and compliance support to help customers meet the complex regulatory demands of standards like IEC 62304, ISO 13485 and ISO 14971. Qualio website:https://www.qualio.com/ Previous episodes:https://www.qualio.com/from-lab-to-launch-podcast Apply to be on the show:https://forms.gle/uUH2YtCFxJHrVGeL8 Music by keldez
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.com/youtube-podIf you're new to my channel, my name is Jacob McLaughlin. I'm the founder of New to Medical Device Sales, an exclusive training program designed to help people break into the competitive field of medical device sales. Our average person lands a six-figure role in just 8.5 weeks, earning $105,502 annually. With thousands of success stories from candidates with all kinds of backgrounds, our program equips you with the tools to succeed in this industry.4 years ago I moved out to Arizona not knowing anyone and had $1200 to my name.I came to this exact spot to journal and share how excited I was to be starting my journey in life.Last night I took time to reflect over the past 4 years. It's truly amazing how you can change your life in such a small amount of time.My take aways:1. Go after your dream because even if it doesn't workout like you thought it would, it will bring your right where you're suppose to be.2. Believe in yourself. Nobody is going to believe in you as much as you will, know that good things will happen.3. Change is inevitable. Change is going to happen so you can either accept it and keep moving forward or not.Please bet on yourself and go after your dreams because your life can be better than you ever thought it could be if you do
Wendy Mackenzie Pease, President of Rapport International, interviews Alain Tranchemontagne, CEO of Alleviate, whose 30+ years in medical devices spans start-ups to Fortune 50 organizations. He has led teams across 5 continents, has held commercial and general management positions, and brings significant global experience in the areas of product and market development. He shares practical, battle-tested ways to enter new markets, build culturally diverse sales engines, and lead with data (and humility) across continents. You'll learn how to: Build global demand the right way: Identify and activate credible KOLs, hire a local “anchor” leader, measure activity early, and make fast keep/replace decisions—while respecting culture and language on the ground. Run a 90-day turnaround playbook: Weeks 0–12 = listen widely (patients, clinicians, data), co-create objectives with the team, then double down on what works using “data density” (lots of signals to see real patterns). Go international without missteps: Sequence markets, map regulations and evidence needs, prioritize IP/trademarks, and treat translation as a regulated, technical task for pros—because “good enough” localization will bite you.
Former top medical device rep, Andrew Norden, joins Jordan to reveal the financial pitfalls most reps don't see coming — from job-change 401(k) rollovers to employer-stock risk, emergency funds, insurance gaps, and planning for retirement in a volatile industry. After 20 years in medical device and now a wealth advisor, Andrew offers practical, real-world guidance to help reps protect their income, build security, and create a long-term financial plan they can trust.RESOURCES
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Kaitlin Maier, co-founder and CEO of Reia. Reia has developed a self-managed pessary — a collapsible device that empowers women to treat pelvic organ prolapse comfortably and independently. A mechanical engineering graduate of Dartmouth, Kaitlin previously worked at Sherpa Technology Group, developing patent strategies for leading life science and technology firms. In this conversation, Kaitlin shares how she and her co-founders turned a student project into an FDA-cleared product using resource constraints as a design advantage. She explains how to turn FDA feedback into forward momentum, why running an NIH-funded randomized controlled trial (RCT) strengthened both credibility and confidence, and how non-dilutive funding can buy the time and control founders need to build on their own terms.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Kaitlin Maier.
Antoine Pivron, Vice President of Health Solutions in the B2B division at Withings, highlights the clinical-grade connected devices that are changing the remote patient monitoring market. The equipment and AI-enhanced tools are designed to focus on personalized patient engagement and retention, ultimately leading to improved health outcomes. The data made available identifies trends over time, allowing for intervention when necessary, and is presented in a form that emphasizes prevention rather than reaction. Antoine explains, "We are very well known for our connected devices, especially the weight scales. So we were the first company back in 2009 to develop a connected weight scale, and now we are the leader in this field, mainly in Europe and in the US. So I think we might have the broadest ecosystem of connected devices to be honest, on the market. So we have weight scales, but we also have blood pressure monitors, activity trackers with smart watches. We also have urine analyzers that we're going to launch next week, actually. We really do have a huge range of products that can be used at home to remotely monitor patients." "They're actually analyzing the trends over weeks, months, and they have an intervention when there is something that is not going in the right direction. So it's more about managing alerts if needed. For instance, in chronic heart failure, most remote patient monitoring programs, doctors manage alerts only. And for obesity care, it might be like coaches or nutritionists having a one-time a week or a one-time a month video call with the patient, and they're just managing the trends. So it's not about being in constant alert, it's about having more data to help them make the right decision." #Withings #DigitalHealth #RemoteMonitoring #ConnectedDevices #MedTech withings.com Download the transcript here
Antoine Pivron, Vice President of Health Solutions in the B2B division at Withings, highlights the clinical-grade connected devices that are changing the remote patient monitoring market. The equipment and AI-enhanced tools are designed to focus on personalized patient engagement and retention, ultimately leading to improved health outcomes. The data made available identifies trends over time, allowing for intervention when necessary, and is presented in a form that emphasizes prevention rather than reaction. Antoine explains, "We are very well known for our connected devices, especially the weight scales. So we were the first company back in 2009 to develop a connected weight scale, and now we are the leader in this field, mainly in Europe and in the US. So I think we might have the broadest ecosystem of connected devices to be honest, on the market. So we have weight scales, but we also have blood pressure monitors, activity trackers with smart watches. We also have urine analyzers that we're going to launch next week, actually. We really do have a huge range of products that can be used at home to remotely monitor patients." "They're actually analyzing the trends over weeks, months, and they have an intervention when there is something that is not going in the right direction. So it's more about managing alerts if needed. For instance, in chronic heart failure, most remote patient monitoring programs, doctors manage alerts only. And for obesity care, it might be like coaches or nutritionists having a one-time a week or a one-time a month video call with the patient, and they're just managing the trends. So it's not about being in constant alert, it's about having more data to help them make the right decision." #Withings #DigitalHealth #RemoteMonitoring #ConnectedDevices #MedTech withings.com Listen to the podcast here
Garrett Schumacher is Business Unit Director of Product Security at Velentium Medical and the co-founder and CTO of GeneInfoSec. Garrett discusses his journey from medical student to cybersecurity expert and educator, dedicating his career to securing medical devices. He shares insights on the intersection of cybersecurity and healthcare, highlighting the challenges of protecting genetic data. Garrett gives honest advice about navigating cybersecurity and data privacy concerns, how to be a good leader, and what medtech startups should consider as they design and develop their devices. Guest links: https://velentiummedical.com/ | https://www.geneinfosec.com/ Charity supported: Save the Children Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com. PRODUCTION CREDITS Host & Editor: Lindsey Dinneen Producer: Velentium Medical EPISODE TRANSCRIPT Episode 068 - Garrett Schumacher [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello and welcome back to another episode of the Leading Difference Podcast. I'm your host, Lindsey, and today I am excited to introduce you to my guest, Garrett Schumacher. Garrett is the Business Unit Director of Product Security at Velentium Medical, where he has led the cybersecurity efforts on 200 plus medical device products and systems. He is the co-founder and CTO of GeneInfoSec, a startup focused on securing the world's most valuable and private data, our genetic information. In his work, Garrett has trained engineers, developers, manufacturers, healthcare delivery organizations, and laboratories across the globe in cybersecurity, and is an active member of several related industry working groups. He also teaches secure product development and medical device cybersecurity at the graduate level for the University of Colorado Boulder's Department of Computer Science as an adjunct professor in the little bit of time left in his days, Garrett is either rock climbing or spending time with family. Thank you so much for being here, Garrett. I'm so excited to speak with you today. [00:01:48] Garrett Schumacher: Yeah. Thank you for having me. [00:01:49] Lindsey Dinneen: Of course. Well, I'd love, if you wouldn't mind, by starting out and sharing a little bit about yourself and your background and what led you to medtech. [00:01:59] Garrett Schumacher: Yeah. So I guess my background, I mean, it started as I always thought I was gonna be a doctor. I did my undergrad in physiology, thought I was gonna do med school, the whole nine yards. And towards the end of my, let's say junior year, just started being like, "I don't think this is what I want to do." I always had a fascination with tech. I was really involved with a lot of the tech groups on campus at the University of Colorado Boulder, early days of Hack CU, one of the largest collegiate hackathons. And I really regretted not doing a computer science degree, but I was three quarters of the way done. So sometimes you just gotta finish it up, right? Get the degree, find out what's next. After that I went and did a master's in genetics. I wasn't sure exactly what I wanted to do either yet, but hey, a master's degree is not a bad thing to do if you're unsure. And actually I was in a PhD program and dropped out early with a master's. Different story. But yeah. And then I started I helped the University of Colorado Boulder start their cybersecurity programs. So it was getting into the cyber world. I did a, I guess it was a bootcamp, at the University of Denver in cybersecurity. And so that all culminated in me always focusing on healthcare and cybersecurity together. And then COVID happened and that made the world change for a lot of people. And basically I was looking for a new job and I found Velentium, and I think that's where it really spoke to me, where I could do my love of medical and human health with cybersecurity and technology development. And so yeah, I think that's really how I got into it. I had been doing projects related to that before, but Velentium's where it really culminated and I found a place that let me do all the things I love, not just one or the other. [00:03:39] Lindsey Dinneen: That's awesome and such a wonderful gift. So can you share a little bit about what you do now and sort of your growth trajectory even throughout Velentium 'cause I know you've had quite an interesting and exciting career through the company as well. [00:03:56] Garrett Schumacher: Yeah. Yeah. So I started out as a cybersecurity engineer, and just started helping internal projects, external projects with groups that were seeking FDA approval on a medical device and trying to navigate these kind of new cybersecurity requirements. That's where it started. And even since then I've been, so I teach a class at the University of Colorado Boulder on Medical Device Cybersecurity. We're going into our sixth year of that, seventh semester, starting here in the fall. And I also co-founded a startup in the genetic information security space. So, and we can talk about that later. And so I, yeah, talk about what I do. It's all of those things and, it's not, doesn't happen in 40 hours, I promise you that. But after working as a cyber engineer for about a year, I think I got promoted to like Senior Staff Cybersecurity Engineer. Then probably three years ago, I took over more of an operational leadership role within the unit, the team, where I was doing project management and overseeing the other engineers and still doing engineering work. Definitely decided project management is not for the faint of heart and apparently my heart's very faint. It's not for me. So anyways, and then fast forward to just here in like January, February, Velentium made some really awesome changes. They rebranded as Velentium Medical to make sure everyone knew we do medical. And then they created four business units so that they could really say, "Look, we have different core areas of our business. Each of them have their own different operational needs and what have you." So, I was promoted into Business Unit Director of Product Security. And so now we're a business unit. We're a business within a business trying to better serve our clients and implement the processes we need for our small scope of work compared to a large contract development and manufacturing organization. So just that's been my growth goal so far is, come in as an engineer, work my way up to the leadership roles while also still loving to be an educator and and still having my own startup space in the biotech side of the house. [00:05:58] Lindsey Dinneen: Yeah. Excellent. Well, first of all, congratulations on all of that. That is very exciting and it's really fun to see that growth and that development. And I'm also so curious now, can we talk a little bit about your startup? So first of all, let's talk about that and then I wanna talk about the crossover between the two, if that's okay. So. [00:06:16] Garrett Schumacher: Absolutely. Yeah. So, well the name is GeneInfoSec, so it's just short for genetic information security. We're not trying to hide anything there. We focus on protecting the world's most sensitive data. At least that's our opinion is genetic information affects you. And the data you have today is not gonna be any different, for the most part, from the data that you have in, 10, 20, 40 years. But then even beyond that it's partially your children's data, your grandchildren, great-grandchildren, and then even on the, in the inverse, all the way up to your great-great-grandparents, right? You share some, to an extent, some genetic makeup with them. And so it's this really interesting space where networked privacy is-- it's a very different form of networked privacy. It's not just that I upload a photo to LinkedIn and now I could be implicating someone else that's in the photo. It's, I share my info, and I'm also sharing info that belongs to my cousins in, in, in a sense. And so if you think of the Golden State Killer case in California, that was a really interesting one where the federal authorities had genetic information or samples from a cold case in the eighties. And they sequenced that. They uploaded it to a third party, an open public genetic database, and said, "Hey, here's my data. Who am I related to?" And through that they were able to triangulate like, "Okay here it is. This is the guy that did it" many years later. So, there's a case where it's, there could be positives. We want to use it to find that kind of information and protect people. But at the same time, that brings up a lot of privacy implications. And then you can go all the way to the extreme, the sci-fi of designer bio weapons, maybe tailored to certain persons or ethnicities or groups of people. So during grad school, a couple guys and I, we founded this startup, and that's what we focus on through a technology that really our founder, Dr. Sterling Sawaya, he invented, called molecular encryption. It's a way of encrypting molecules before we generate data from them so that the generated genetic data is already, quote unquote encrypted, or at least protected in some manner. So, so that's what we do. And yeah, I guess why we do it a bit. [00:08:27] Lindsey Dinneen: Yeah. Wow. So, okay, so that brings up a really interesting question. I can guess the answer to this, but is there any safe way to-- this is a funny way to put it-- but recreationally to test your genetic data in the sense of the way that a lot of us would think about it in terms of, "Oh, I'd really love to learn more about my ancestors and things like that." But there are so many security concerns, like you've pointed out. So is there any quote unquote, safe way to do so at this time? [00:08:58] Garrett Schumacher: You know that-- it's a great question. There's been a lot of things going on in the news recently, like with, I'm sure people have heard of 23 & Me, and how they went bankrupt and now a company called Regeneron is buying them and all their assets for a lot of money, but not that much compared to what 23 & Me was worth a few years ago. So that brings up a lot of issues, right? 23 & Me still owns a lot of samples, like maybe around 10 million samples. And the sequencing they've been doing is very small. So if your genome's a whole book, they've been kind of flipping through the pages and picking specific letters, and that's the data they have. So that's not the most sensitive, it's not the full story. But if you have the samples, you can always generate the full book someday. And as that cost of full human genome sequencing decreases rapidly, someone's probably gonna want to do that someday. So, okay, so back to your question though, is there a safe way? What I would say is that I, I don't tell people not to do it. I would say if you have health reasons, concerns, and your doctor suggests a genetic test, a lot of those tests are also that similar, picking a few letters, a few known letters and trying to just read that for a very specific purpose. If your doctor and you come to the agreement that you should do that, you should just do that. However, I do not promote, and even to my family members, I highly don't recommend, using these services. I used to really love who's that group out of Utah? Ancestry.com. They used to be a great group. They were trying to sequence the world's DNA for understanding basically the family tree of everyone. Because anyways, they have interest in understanding who's related to who and how that relates to their religion. So they used to do it for internal purposes, keep it on pretty tight, secure. Well then, they sold to a venture capital group. So, it's really tough to say that there's these groups that there's a good place out there to do it. There are some companies that have security or privacy focused DNA sequencing services. But it's really odd, like you have to set up a cryptocurrency account, pay with cryptocurrency, set up a PO box so that you're not like actually shipping to and from your home. And then ultimately the price of it and how they're getting it to be cost effective is China's doing the sequencing. So you do all those privacy measures and your sample gets sent off to another country. And the FBI has disclosed that they know that when certain countries like that are doing the sequencing, whether you want them to do a little tiny test, like a COVID test or whatever it is, they're sequencing the whole thing. They're keeping the data. This is known, disclosed, not conjecture. So, yeah, so sorry-- long-winded answer of saying, I'm interested too, I wanna learn about this. I've got family members that have done it. But right now I recommend just thinking very carefully and critically about whether the immediate fun of it is worth the potential long-term impacts, and maybe if you're someone that's security or privacy conscious, maybe wait a few years because there are some things on the horizon that will make this a lot better. [00:12:02] Lindsey Dinneen: All right! Thank you for the honest answer. I really appreciate it. So, okay, I wanna go back to your work with Velentium specifically and talk about-- you've gotten to work with so many different clients over the years and you've seen so many different variations on a theme. And I'm curious, what are some of the common mistakes or pitfalls you might see a younger startup make when they are perhaps first designing their device, and cybersecurity is maybe not quite top of mind. So what are some of the things that you see that are challenges we can overcome? [00:12:41] Garrett Schumacher: Yeah I think one of the biggest challenges is that a lot of people aren't maybe aware yet of the scrutiny and the requirements that the FDA-- and not just FDA, but the European union's medical device regulations and the bodies over there that review submissions. And any, if you look across the board, pretty much almost every regulatory market has, very much in the last couple years, placed a lot of scrutiny on cybersecurity. So a lot of companies, especially smaller ones starting out in the space, may not be aware of this. And so then oftentimes they'll find out too late, they'll submit. They'll get feedback back, "Oh no, we have 90 days to respond and we didn't do cyber. We gotta do cyber now." And they don't know how to spell it yet, which is a joke. But there's that. And then there's also, or they'll get in just late at the game, "Hey, we're submitting in a month or three" and "Oh, we gotta do this thing retroactively." And so then therefore, we haven't been able to support someone through the full process, at the proper time, doing the right design things to inform the design during the design, not after. So I think that's probably the biggest mistake is not seeking that external support early and often. And if you're getting that, it shouldn't just be someone that can help you navigate the regulatory space. It shouldn't be someone that can just do the pen testing for you at the end. Really I think in that context, you need a partner that can do everything end to end. So that's what we've really tried to make our processes and our services geared towards is being that partner. And whether you have the bandwidth and you will do a lot of the documentation and work, but you just need someone to guide you, consult you, give you the materials to do so, or if you are truly looking for, no, we need to augment our own team and have you do a lot more of the work for us. That's great. We can do that. So, so that's, I think, the biggest challenge. And I think that the answer is just getting the right partner early and working with them often throughout that entire development, not at the end. [00:14:37] Lindsey Dinneen: Yeah, absolutely. And I really appreciate that perspective. I think that there's a lot more awareness, it seems like even in the industry that, "Oh, cybersecurity is a thing now." But as you said, getting to partner with somebody who does know the ins and outs from the start and can really help guide you through is really critical. Now you do quite a bit of speaking and presenting. You're obviously still teaching a college class and all of those wonderful things. I'm curious how that has played into your career as well, and is that something that you will always want to do? You've got this educator side of you as well. [00:15:13] Garrett Schumacher: Yeah, I mean, I love it. I actually taught at a high school for one year between my master's program and my undergraduate, decided that that's not for me, but that teaching at those higher levels where people are really wanting to be in the room. So now I teach at the graduate level, half of the students will be older than me. And now everybody wants to be there and we can have very mature conversations and they even can challenge me with some really great questions that I'm not ready for, right? And I think the best way to learn is to teach. Absolutely. That's, yeah. I think a lot of people have said that. I completely agree. So I plan to always do that. I mean, I love, even with our internal engineers and external clients, like the idea of helping people understand something and humanizing it for 'em. That's really my big flag I'm waving right now is humanizing it. We don't have to use alphabet soups and crazy language. We can make it easy to understand and we can humanize it for the masses. So that's really what I'm trying to do, one of my big pushes. And so I don't foresee myself ever going away from that, I even do a lot of international training on the cyber biosecurity space where I go to all these countries and these biosafety laboratories and help biologists understand cybersecurity as a fundamental practice and how they can improve their personal security, their professional security. And to me that's the most rewarding thing. [00:16:36] Lindsey Dinneen: Yeah. Oh my goodness. That's so cool. Thank you for sharing about that. So, as you are looking towards the future in the industry itself, but also I suppose your own career, what are some things that you're excited about? What are some trends that you see as being positive? I know that, recently, it's been a little bit challenging-- as a nice word-- for a lot of medical device companies and they're a little worried about funding and those kinds of things, and so, that's maybe a trend that's a little not as fun, but what are the things that are empowering and exciting to you as we move forward? [00:17:13] Garrett Schumacher: So not to make it about artificial intelligence or machine learning, 'cause everybody does. It's definitely, its hype curve. But that is actually one of the things that I think I'm most excited about, but also most scared about. We've seen a lot of companies with layoffs because they believe this artificial intelligence enables them to be more efficient and therefore they can do more with fewer people. And that saves money. And I understand that. I think that one of my big pushes right now is trying to help people understand that AI, at least right now, it's not taking over human jobs-- that it can instead augment, improve how we do those jobs. But people have to be ready for it. So even in, in my own space, like, making sure that our team and our people are ready for that. Because if you aren't getting into that space, if you aren't with the curve, then you're gonna fall behind. And yes, you could be replaced in that sense that someone has done it and so now they're doing it better than you. And so if you're not using these tools, these resources to, to improve your efficiency and to just maximize your capability-- like for example, my team, maybe I don't need to hire a person. Maybe we can build out things that enable us to, with the same amount of people, to better serve more clientele. So that's what I'm really trying to navigate. But it is scary thinking about that future and am I even gonna be ready and technically savvy enough to navigate that new future in the next year, in the next five, 10 years. And especially as someone who I've always had this, this goal of maybe someday, and I'm getting talked out of it very quickly, but maybe like being a Chief Information Security Officer at a large company or a Chief Product Security Officer, something like that. And yeah, quickly, I'm-- "Eh, we'll see." But it's those kind of things that, if we can navigate them correctly, may maybe that is something in my future. So that's, I think, one of my big fears and also passion projects right now. And then also, same on that funding vein-- with my startup, we're experiencing that as well. And we actually, we had a lot of funding potential pre COVID. And then even though our technology-- like in some ways COVID brought the need for our technology to the forefront of people's minds-- it also killed a lot of funding opportunity. And so yeah, I mean, navigating that space of how do you get funding and then does it come from venture capital backed or equity, private equity, and I've seen those worlds. I even advise startups. So I mean, that is also probably one of the biggest challenges I'm facing currently as well. [00:19:41] Lindsey Dinneen: Yeah. Yeah. It's gonna be really interesting to see how things evolve, and it's been fascinating to read the news and see even the headlines where it's like, the FDA is using AI to review submissions and all sorts of things, and you really do wonder how we'll move forward and time will tell, I suppose. [00:20:01] Garrett Schumacher: Yeah. [00:20:02] Lindsey Dinneen: So you have stepped into quite a number of leadership roles fairly young in your career, if you don't mind me just saying so, and so I'm curious how you have navigated that growth for yourself. First of all, do you feel like you were a natural leader or were those skills things you developed along the way? And secondly, what advice might you have for younger leaders? [00:20:27] Garrett Schumacher: Great questions. Yeah, definitely nothing is natural about it. I think for anyone, I mean, it's nothing that you just do and you're just like, "Yep, I'm a leader. That's easy." So it definitely something, just like all aspects of work and maturity, is you have to work on it. But I think how I got there was-- and someone told me a couple tips early in my career, I suppose-- and it was a couple are: find a mentor, and as the mentee you have to put in the effort. If you set up meetings and they're not there, whatever, like they're busy, and you are asking them to give their time for you. So, find mentors and then be a good mentee, meet up with them. I had several people that were critical in my early career. One was Bunky Davis and she was amazing. She was no longer with us, but her and I grabbed coffee every single month. She had navigated biotech startups for like 50 years, was also just a phenomenal cyclist, Olympian, like just amazing. And we'd meet up every month for coffee without missing. And we did that for several years. And, and I had another mentor from the University of Colorado Boulder, Lloyd Thrall, who came from the Department of Defense, and just a spectacular, stellar guy, and we would go meet up all the time. And so learning from these people I think I saw-- well, there's that. And then everybody has their bosses and their horror stories from work, whether that's a high school job or professional later on. And so you see the ways that people can be, you don't want to be. And so that, that makes it easy. But without having those mentors, yeah, I don't know if I would've exposed myself to the good ways, right, and the better ways, and be challenged. So that was really critical was finding a good mentor and then being a good mentee. And then I think the other thing is interacting with people and just listening, active listening. So going to the professional shows and meeting people, listening to them, reading a lot of great books out there on how to be a leader, and you don't take all that exactly word for word, but there are golden little nuggets that you can just pick up out of all those things. So, no, definitely something that I have actively worked on and still am trying to work on. And then I'm constantly trying to listen and being that, have that open door policy for my people too. Because if I hire really smart people, I want them to do the thinking and therefore I need to listen. [00:22:44] Lindsey Dinneen: There you go. I love it. All right, so. You've had a really interesting and exciting career so far, and you're obviously very passionate about medtech and cybersecurity and biotech and all those things, and I'm wondering if along the way there are any moments that really stand out to you as affirming, "Wow, I am in the right place at the right time." [00:23:09] Garrett Schumacher: Yeah. Yeah. One was we had a really special project where and I won't give any names away, but basically my stepmother has an implant inside of her and it's it's not life sustaining, but it's one that you want working just so that your body's working normally, and so that you're not, not embarrassed. You can go into public spaces and be a normal person, right? And whether it's pain management, incontinence, those kind of things. So she had this implant and it was, she had one that came from the leading provider of that at the time. And it, the battery life, right, is supposed to last like 10 or 15 years, and it seemed like pretty much seven or eight was all she was getting out of it. And after decades of having far more surgeries than she needed, all the way up to the very last device she got in her-- it failed within the first year, I think-- so it was like, okay, time to pivot. And we found this new company and they've become a huge leader in the space, recently acquired by another one of the big leaders in medtech in general. And we were hired to do the security work for that project. And the only reason that I actually found out-- because my stepmother was literally like in the process of getting this new device inside of her-- I was at that client's facility doing a pen testing and security testing engagement and some consulting and just visiting them. And I FaceTimed my family in the break room and there was a sign behind me and they're like, "Oh my gosh. We're literally, we just got that implanted in your stepmother like, a couple weeks ago. It's working great. She's so happy with it. It's smaller, it works better, all these things." And it's like, "Wow." So I got to lead the security effort and what they're actually doing is adding remote programming capabilities so a doctor can, over the phone, be improving that therapy for you. But that leads to a lot of cybersecurity implications, right? That kind of connectivity. And so I gotta lead the security work on that for something that is in a near and dear, your family member. And it's those kind of things where it's not, you're not just helping patients. It's, I'm helping someone that I care very deeply about. And it hits home differently when it's not just, "Oh, I want this device to be secure. I want them to get FDA clearance. I want whatever." It's, "No, I need now, I need for my own family member for it to be the best." And it's not that project got special scrutiny from us-- we bring that to every project-- but it helps to have the actual experience of one of those projects. [00:25:33] Lindsey Dinneen: Yeah. And to have that real-- well, you were mentioning it-- not just patients that I kept thinking, "Yeah. Not just patients, people," and the idea of it's sometimes probably necessary honestly, to have a little bit of separation from a clinical point of, "I'm helping all of these patients, and that's a really good thing." But then if you could take a step back and go, "And these patients are human beings that rely on what I'm doing for safety and for security and for this lifesaving, life enhancing device." That's-- what a gift to get to experience something like that. [00:26:04] Garrett Schumacher: It is, it's especially like, if you work in the diabetes-- we've had several projects with insulin pumps-- and insulin's a drug that is, highly toxic if given in the wrong dosage. 99% of the world population would die if it's in the wrong dosage if it's too high. And the only reason the other 1% exist is 'cause they're insulin intolerant. They just, they don't respond to insulin and that's why they have their own type of diabetic issues. And I've got several cousins, a brother-in-law, that also use that stuff every day, rely on those kind of technologies. So, yeah, just it's a little bit more special when it's when you get to do that. But we try to do that for everyone. We try to think of everyone's that person that we're trying to help. [00:26:42] Lindsey Dinneen: Yeah, absolutely. All right. Well, this has been so great, but pivoting the conversation a little bit, just for fun. Imagine that you were to be offered a million dollars to teach a masterclass on anything you want. What would you choose to teach and why? [00:26:59] Garrett Schumacher: Ooh. Well, yeah, first of all, a million dollars for-- I feel like I, I'd have to go with something like that I know deeply, very deeply on. But okay, if I wanna have some fun here, I would say rock climbing, because rock climbing is my other big passion. It's the one thing that takes me away from a computer screen typically. And so if you're paying me a million dollars to teach rock climbing, A, these people really wanna learn how to be good rock climbers, so they're gonna be very engaged. And B, that's going to mean that I can go now actually make money on something that has only ever been a passion for me. So, that would be fun. That would be awesome. [00:27:33] Lindsey Dinneen: Awesome. [00:27:33] Garrett Schumacher: If you're offering, Lindsey, I'll accept. [00:27:35] Lindsey Dinneen: Okay, deal, right? Yeah. I'm gonna have to earn my first million first, and then I'll let you know. [00:27:40] Garrett Schumacher: I'll wait. [00:27:41] Lindsey Dinneen: Okay, fair? Fair enough. What got you into rock climbing? [00:27:45] Garrett Schumacher: Oh man. Well, so my mother was, I grew up in like a small farming town in the northeast corner of Colorado. There's not a mountain for, until you get to Denver area, right? In the summers, she worked at the local college, and in the summers she ran the ropes course and they had a giant rock wall. So, I mean, as a 10-year-old, I'm just hanging out there. I didn't know that there was routes or certain ways or techniques. I just, who can get up the fastest, right? But that was always fun. That was my summers. I always, and I was, shoot, I was always told I was a monkey. I was always on stuff climbing something. I've had my share of injuries from it, trust me. And then in college, it just was natural. I went to CU Boulder, as I've probably already said, and a lot of outdoor climbing opportunities. A lot of, they, they built a new gym there inside the school. And so that then it became this thing where, oh, I can actually-- as you move away from high school sports, basketball and American football and those things, you miss that. You can miss some competitiveness and some team-based things. So now I had another active thing that I could-- and I, again, I wasn't so formal in technique or things like that-- so now I could work with people, socialize and work on that technique in something that I was able to do at that level, instead of, I'm not gonna go beat myself up playing football again. So, yeah, I think that's where it came from. And then it's just been my big hobby ever since. And I mean, now I have a bunch of friends down in Austin, Texas, and we go on a big climbing trip once a year, and I see them once a year. It's fun. So it's like expanded my friend group and it keeps me sane. [00:29:14] Lindsey Dinneen: Huh. Excellent. Yes. That's wonderful. All right. How do you wish to be remembered after you leave this world? [00:29:22] Garrett Schumacher: Oh, that's a good one. How do you humbly answer that? When part of the answer I would wanna say is humble, but that's something I always try to work on, is I just wanna be a good guy. I want people to remember that, he was kind, considerate-- would do something at the drop of a hat for you without expecting anything in return-- just kind, generous. And I think a family guy would be a big one. My, my friends and family first and foremost. And maybe second to that, hardworking. Yeah. [00:29:46] Lindsey Dinneen: Yeah. I love that. All right. And final question. What is one thing that makes you smile every time you see or think about it? [00:29:55] Garrett Schumacher: Oh, my wife. I wake up to her every day and that's she's the best part about everything. So yeah, she's my favorite person, and I'm lucky enough to, when I'm not traveling, wake up next to her and see her at night, and that's the best part. [00:30:08] Lindsey Dinneen: Yeah, absolutely. What a wonderful thing. Well, this has been a fantastic conversation, Garrett. I'm so thankful for your time today. Thank you for sharing some of your stories, some of your advice. And I just honestly wish you the most continued success as you work to change lives for a better world. [00:30:26] Garrett Schumacher: Thank you. Thank you, Lindsey, for having me. This was my first podcast ever. So it went great. Yeah, it was fine. [00:30:32] Lindsey Dinneen: Awesome. You rocked it. Good job. That's wonderful. All right, well, celebrating that and celebrating all your future successes to come. We are so honored to be making a donation on your behalf as a thank you for your time today to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational, and safe environment. So thank you so much for choosing that charity to support, and thank you so much for being here and thank you for doing what you do. [00:31:05] Garrett Schumacher: Thank you. [00:31:07] Lindsey Dinneen: Excellent, and thank you also to our listeners for tuning in, and if you're feeling as inspired as I am, I'd love it if you'd share this episode with a colleague or two and we'll catch you next time. [00:31:19] Dan Purvis: The Leading Difference is brought to you by Velentium Medical. Velentium Medical is a full service CDMO, serving medtech clients worldwide to securely design, manufacture, and test class two and class three medical devices. Velentium Medical's four units include research and development-- pairing electronic and mechanical design, embedded firmware, mobile app development, and cloud systems with the human factor studies and systems engineering necessary to streamline medical device regulatory approval; contract manufacturing-- building medical products at the prototype, clinical, and commercial levels in the US, as well as in low cost regions in 1345 certified and FDA registered Class VII clean rooms; cybersecurity-- generating the 12 cybersecurity design artifacts required for FDA submission; and automated test systems, assuring that every device produced is exactly the same as the device that was approved. Visit VelentiumMedical.com to explore how we can work together to change lives for a better world.
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Somer Baburek, CEO and co-founder of Hera Biotech. Hera is developing AI-driven tissue diagnostics for conditions that disproportionately affect women, including endometriosis and cervical cancer.Before launching Hera, Somer spent nearly a decade in venture capital, where she evaluated early-stage medtech startups and learned what separates the survivors from the rest.In this conversation, Somer explains how Hera designed global clinical pathways that balance cost and credibility, why boutique CROs can outperform big names, and how a pre-commercial startup completed three strategic acquisitions using equity and brand trust rather than cash.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Somer Baburek.
MedBoard EU Joint clinical assessment procedure - EU 2025/2086 regulation for reimbursement in the EU: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202502086 Team-NB position paper on Companion diagnostics - Significant changes rules: https://www.team-nb.org/wp-content/uploads/2025/10/Team-NB-PositionPaper-IVDR-Significant-changes-V2.pdf MDR and IVDR put at risk transplantation - Donor Screening and SoHo preparation: https://www.edqm.eu/documents/52006/162284/PA-PH-TO%20%2824%29%2018%20%E2%80%93%20Risks%20to%20safety%20and%20quality%20in%20donor%20screening%20and%20SoHO%20preparations%20due%20to%20poor%20implementation%20of%20the%20MDR%20and%20IVDR%20%E2%80%93%20CD-P-TO%20Position%20paper%20%E2%80%93%20October%202025.pdf/51d5efb2-4611-13ad-76a0-b5710b371248 Dedicated proportionate regulatory pathway for Niche fields Article 5(5.g) requirements to the highest risk categories (Health institutions to create documentation for the products) Update of MDCG guidance on In-house devices to better reflect the operational reality. Off-label use and RUO are not falling on Article 5.5 so grey zone. Team-NB proposal for MDR & IVDR - 5 topics on the agenda: https://www.team-nb.org/nbs-views-on-mdr-and-ivdr-review-process/ Early dialogue: Use of this to talk to Notified Bodies Article 61.10 & WET: Update for more clarity. Narrow the scope. Digitalisation: Machine readable documents, AI to support simulations to reduce Animal testing. Coding for MD and IVD Designation and recertification: For Notified Bodies Breakthrough: Coordinated pathway with challenge to generate Clinical Data. Notified Bodies Count - S New comers for MDR and IVDR: SGS Fimko oy (IVDR 19): https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/notifications/1016921 ICIM S.P.A. (MDR 51) : https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/notifications?organizationRefeCd=EPOS_43747&filter=notificationStatusId:1 Notice (MDR): https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/notifications/1020121 Standards New Harmonized Standards - Clothing and sterilisers: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202502078 Biocompatibility ISO TS 23485: https://www.linkedin.com/posts/melazzouzi_iso13485-iso-medicaldevice-activity-7393773266689228801-d7LM?utm_source=share&utm_medium=member_desktop&rcm=ACoAAABZ07ABDocaBMTLJo8bsl8V3bgNSBIiZuI UK Reliance with US FDA - Harmonization is ongoing: https://www.gov.uk/government/news/patients-to-benefit-as-uk-and-us-regulators-forge-new-collaboration-on-medical-technologies-and-ai Service eIFU with free access -Test it and let us know : https://Easyifu.com eQMS for a structured Quality Management System - Get your demo: https://eqms-smarteye.com/ Magazine eMagazine . EMD Mag Free- Are Notified Bodies still the right model: https://easymedicaldevice.com/emd-mag/ ROW US FDA: Pre-RFD -:Combination product: https://www.fda.gov/media/189466/download US FDA: QMSR guidelines -: How to create a QMS: https://www.fda.gov/media/189345/download PODCAST Podcast review - What happened in October 2025 Episode 357 - Highlights from La Rentrée du DM 2025: https://podcast.easymedicaldevice.com/357-2/ Episode 358 - Clinical Evidence under EU MDR - Why so many dossier fail (And how to fix it): https://podcast.easymedicaldevice.com/358-2/ Episode 359 - Real World Evidence - How to use it right for FDA and EU: https://podcast.easymedicaldevice.com/359-2/ Episode 360: US Government Shutdown - What FDA can still be doing? Rob Packard: https://podcast.easymedicaldevice.com/360-2/ Episode 361 - Automatisation of your QA RA Job with AI - Hatem Rabeh: https://podcast.easymedicaldevice.com/361-2/
In this episode of Advanced Manufacturing Now, Steve Plumb, editor-in-chief of SME Media, is joined by Amy Bryson, Cary Gitter, and new team member Rachel Thomas to dive into the highlights of the November issue of Manufacturing Engineering & Technology.
Welcome The Allegendly Podcast, the history podcast where truth and trickery go head-to-head! Each episode, our hosts are handed 5 historical "facts", but here's the twist: not all of them are real. Using sharp memory, deductive reasoning, and a healthy dose of skepticism, they must separate the verified from the fabricated.This week's theme: Antique Medical Devices and Procedures. From leech therapy to electrified corsets, we're diving into the bizarre, brilliant, and sometimes terrifying world of old-school medicine. Which treatments were actually used, and which are just historical hearsay?Can you spot the imposters before the hosts do?Tune in, test your knowledge, and prepare to be amazed (and maybe a little horrified).Subscribe for weekly episodes and join the hunt for historical truth!#HistoryPodcast #FactOrFiction #AntiqueMedicine #MedicalHistory #PodcastChallenge
This episode features Steven Martin, Chief Technology Officer at TRIMEDX, who shares how health systems can move beyond AI hype to achieve measurable results in medical device management. He discusses the importance of quick ROI, strong governance, and responsible innovation to optimize operations, reduce risk, and align technology with each organization's unique care philosophy.This episode is sponsored by TRIMEDX.
US Government Shutdown – What the FDA Can Still Be Doing? When the U.S. government experiences a shutdown, the consequences ripple across every industry — but for medical device manufacturers, the uncertainty can be alarming. In this article, Regulatory Expert Rob Packard explores what happens to the U.S. Food and Drug Administration (FDA) during a shutdown, and how it affects global manufacturers. You'll learn: Which FDA activities continue, and which are suspended How submissions like 510(k), PMA, and De Novo are impacted What happens to clinical trials, recalls, and ongoing investigations Whether this situation has happened before and how long it could last How companies can prepare and what contingency actions to take
In this episode of Let's Combinate: Drugs + Devices, host Subhi Saadeh welcomes Mark Kramer, the founding director of FDA's Office of Combination Products (OCP). Mark takes us on a deep dive into the history of how combination products have been regulated in the U.S., starting with the Safe Medical Devices Act of 1990 and how the process evolved into the formation of OCP in 2002.We explore questions such as: What challenges did industry and the FDA face in the early days of combination products? How did the “Request for Designation” process come about, and how is regulatory identity determined? What is the “Primary Mode of Action” (PMOA) rule and why does it matter? How do user fees, cross-center coordination, and post-market regulations shape how combination products get to market and are monitored? Mark also highlights current regulatory gapssuch as cross-labeling and site registration issues that continue to impact developers.Whether you're working in med-tech, pharma, or regulatory affairs, this episode offers historical perspective, technical insights, and strategic take-aways for navigating the combination-product space. Tune in for a candid conversation with one of the leading figures in this field.Timestamps:00:00 Introduction & Guest Welcome00:35 Historical Background of Combination Products03:05 Creation of Office of Combination Products (OCP)04:29 Early Challenges and Developments04:54 MDUFA, PDUFA, User Fee Programs & Legislative Impact14:24 Defining Primary Mode of Action (PMOA)18:35 OCP's Role & Responsibilities26:49 Industry Adoption & Challenges38:48 Regulatory Gaps & Future Directions46:00 Conclusion & Contact InformationContact & Resources:Connect with Mark Kramer on LinkedIn or via email at Mark.Kramer@greenleafhealth.comMark Kramer is Principal of the Medical Devices & Combination Products regulatory practice at Eliquent Life Sciences (formerly Greenleaf Health). He has more than 35 years experience at FDA and in regulated industry. At FDA, he established and directed the Office of Combination Products and was a scientific reviewer and later supervisor of the premarket review of devices in a variety of medical discipline areas. Following his FDA career, he served as Regulatory Affairs Executive and Chief Regulatory Strategist at GE Healthcare and then as an independent regulatory consultant for over 10 years before joining Greenleaf. Mark served as a board member of the Regulatory Affairs Professionals Society (RAPS) and in 2021, he was awarded the RAPS Founders Award, the profession's highest honor, recognizing exemplary regulatory professionals who have shaped regulatory policy and practice and have made a positive impact on the profession.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.
Sai Ranjith is a quality engineer with over eight years of experience in the medical device industry. He specializes in regulatory compliance, risk management, and product lifestyle quality. In addition to his technical work, Sai has a Six Sigma green belt and is a certified ISO 13485:2016 Medical Device Auditor. He actively contributes to the quality community through ASQ, serving as the program chair for the Granite State Chapter and an active member of the ASQ Quality Management Division. Sponsored by: MAESTRO: The first all-digital, fully connected CMM built for the future.
In-utero procedures can yield better long-term outcomes for the baby. However, fetal surgery relies on instruments developed for other disciplines. An early-stage startup in Maryland is developing in-utero instruments to improve outcomes for both fetus and mother.Fetal Therapy Technologies CEO Selena Shirkin joins Key Tech's Andy Rogers for Episode 42 of the MedTech Speed to Data podcast to discuss startup innovation in fetal surgery.Need to knowFetal surgeries carry risks — In addition to uterine damage complicating future pregnancies, 40% of surgeries have a risk of preterm birth.Few specialized tools are used — In the field's forty-year history, the FDA has only approved the Karl Storz Fetoscope for use in fetal surgeries.Off-label device use is widespread — Equipment borrowed from adjacent fields like laparoscopy and neurosurgery weren't indicated for use in the uterus.The nitty-grittyShirkin and Chief Technology Officer Eric McAlexander founded Fetal Therapy Technologies as students in Johns Hopkins University's biomedical engineering graduate program. While shadowing surgeons, they saw how off-label instruments complicated procedures.“I watched a surgeon using a grasper and suture,” Shirkin recalled. “The suture was falling out of the grasper because they didn't fit. It took time in the surgery to make sure that didn't occur.”Observations like these led the team to wonder why the field lacked optimized tools. “As biomedical engineers,” Shirkin says, “we asked ourselves what if we created those purpose-built instruments that actually make these procedures safer?”They quickly ran into the commercial limits of a market as small as fetal surgery. With only one device FDA-approved for in-uterine procedures, surgeons have no choice but to use devices off-label. So Fetal Therapy Technologies is flipping the script by leveraging the broader applications of an instrument designed for fetal surgeries.“In a way, our company solves two problems at once,” Shirkin says. “A company that creates a fetal innovation [that] also raises a much broader market of general microsurgery.”Their first product is a uterine port. “Similar to laparoscopic surgeries,” Shirkin explains, “that involves inserting a port through the abdomen into the uterus. [The new] port is designed to leverage the elastic properties of the uterine environment to make entry safer than the current clinical standard.”For broader commercialization, they aim to demonstrate equivalence to predicate devices and qualify as a 510(k) Class II device following benchtop and animal studies. Approval for fetal surgeries is a longer journey, but the company can build on its data before entering human trials.Data that made the difference:Shirkin offered insights for other students considering an entrepreneurial future in MedTech.Leverage university resources. “We work incredibly closely with the Johns Hopkins Center for Fetal Therapy,” Shirkin says. We've also gotten opportunities from Johns Hopkins Technology Ventures.”Build a network of advisors. “We are supported by a very broad variety of clinical, technical, and business mentors across the Johns Hopkins ecosystem and beyond.”Tap into local funding sources. “There's a lot of collegiate business plan competitions that we've been very successful [raising] non-dilutive funds that way. There are also state-level grants. We just received a Baltimore Innovation Initiative grant.”
Podcast: The Industrial Security Podcast (LS 35 · TOP 3% what is this?)Episode: Medical Device Cybersecurity Is Tricky [The Industrial Security Podcast]Pub date: 2025-10-28Get Podcast Transcript →powered by Listen411 - fast audio-to-text and summarizationYes the device has to be safe to use on patients, and yes it has to produce its results reliably, but patient / data confidentiality is also really important. Naomi Schwartz of Medcrypt joins us to explore the multi-faceted world of medical device cybersecurity - from MRI's to blood sugar testers.The podcast and artwork embedded on this page are from PI Media, which is the property of its owner and not affiliated with or endorsed by Listen Notes, Inc.
Yes the device has to be safe to use on patients, and yes it has to produce its results reliably, but patient / data confidentiality is also really important. Naomi Schwartz of Medcrypt joins us to explore the multi-faceted world of medical device cybersecurity - from MRI's to blood sugar testers.
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Tim Gleeson, CEO of BRIJ Medical, a company rethinking one of the oldest procedures in medicine — surgical wound closure.BRIJ's Brijjit Force Modulating Tissue Bridge is a small, non-invasive clip designed to redistribute tension across incisions, helping wounds heal with fewer complications and smaller scars.An accomplished entrepreneur and investor, Tim also founded and led Novasyte Health through its acquisition by IQVIA and later launched VIDANT Capital. A former Medtronic executive, Tim brings global experience and a lifelong passion for building impactful medtech ventures.In this interview, Tim shares why the biggest opportunities often hide in “boring” markets, how focusing on physician champions and patient psychology drives commercial traction, and why the best fundraisers plan for twice the time and four times the cost.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Tim Gleeson.
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.com/youtube-podIf you're new to my channel, my name is Jacob McLaughlin. I'm the founder of New to Medical Device Sales, an exclusive training program designed to help people break into the competitive field of medical device sales. Our average person lands a six-figure role in just 8.5 weeks, earning $105,502 annually. With thousands of success stories from candidates with all kinds of backgrounds, our program equips you with the tools to succeed in this industry.4 years ago I moved out to Arizona not knowing anyone and had $1200 to my name.I came to this exact spot to journal and share how excited I was to be starting my journey in life.Last night I took time to reflect over the past 4 years. It's truly amazing how you can change your life in such a small amount of time.My take aways:1. Go after your dream because even if it doesn't workout like you thought it would, it will bring your right where you're suppose to be.2. Believe in yourself. Nobody is going to believe in you as much as you will, know that good things will happen.3. Change is inevitable. Change is going to happen so you can either accept it and keep moving forward or not.Please bet on yourself and go after your dreams because your life can be better than you ever thought it could be if you do
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Kate Dilligan, CEO of Cooler Heads.Cooler Heads is a commercial-stage company addressing a problem affecting many chemotherapy patients undergoing treatment for solid tumors: hair loss and the loss of privacy that comes with it. The company's FDA-cleared medical device, Amma, makes scalp cooling accessible by fitting into infusion center workflows rather than disrupting them.Kate brings an unconventional background to medtech — from political fundraising to developing classified software for the U.S. government. As a solo female founder who had never worked in hardware, she started Cooler Heads in 2018 after her own experience with breast cancer. By mid-2025, the company had raised $11 million in Series A funding and placed devices across 27 states, with most accounts having never offered scalp cooling before.In this interview, Kate shares how to design for health system adoption by solving workflow problems first, why saying “no” to scope creep protects your first-generation product, and how political fundraising tactics translate directly to building investor relationships in medtech.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Kate Dilligan.
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.com/youtube-podIf you're new to my channel, my name is Jacob McLaughlin. I'm the founder of New to Medical Device Sales, an exclusive training program designed to help people break into the competitive field of medical device sales. Our average person lands a six-figure role in just 8.5 weeks, earning $105,502 annually. With thousands of success stories from candidates with all kinds of backgrounds, our program equips you with the tools to succeed in this industry.4 years ago I moved out to Arizona not knowing anyone and had $1200 to my name.I came to this exact spot to journal and share how excited I was to be starting my journey in life.Last night I took time to reflect over the past 4 years. It's truly amazing how you can change your life in such a small amount of time.My take aways:1. Go after your dream because even if it doesn't workout like you thought it would, it will bring your right where you're suppose to be.2. Believe in yourself. Nobody is going to believe in you as much as you will, know that good things will happen.3. Change is inevitable. Change is going to happen so you can either accept it and keep moving forward or not.Please bet on yourself and go after your dreams because your life can be better than you ever thought it could be if you do
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Young Juhn, CEO of Wellysis.Wellysis is the Samsung spinout behind S-Patch, a lightweight wearable that enables long-term ECG monitoring without the discomfort of established cardiac monitoring devices.Young has spent more than two decades bridging hospital and home-based care — from his early career at Johnson & Johnson, to more than a decade at Kaiser Permanente, to leading healthcare innovation at Samsung before spinning out Wellysis in 2019.In this interview, Young shares why patient interviews should shape product design, how regulatory clearance is just the starting point for global commercialization, and why building a medical foundation before branching into consumer markets is critical for lasting adoption.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Young Juhn.
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.com/youtube-podIf you're new to my channel, my name is Jacob McLaughlin. I'm the founder of New to Medical Device Sales, an exclusive training program designed to help people break into the competitive field of medical device sales. Our average person lands a six-figure role in just 8.5 weeks, earning $105,502 annually. With thousands of success stories from candidates with all kinds of backgrounds, our program equips you with the tools to succeed in this industry.4 years ago I moved out to Arizona not knowing anyone and had $1200 to my name.I came to this exact spot to journal and share how excited I was to be starting my journey in life.Last night I took time to reflect over the past 4 years. It's truly amazing how you can change your life in such a small amount of time.My take aways:1. Go after your dream because even if it doesn't workout like you thought it would, it will bring your right where you're suppose to be.2. Believe in yourself. Nobody is going to believe in you as much as you will, know that good things will happen.3. Change is inevitable. Change is going to happen so you can either accept it and keep moving forward or not.Please bet on yourself and go after your dreams because your life can be better than you ever thought it could be if you do
The barriers to market entry for medical devices -- everything from hearing aids to MRI machines -- here and abroad are significant. Some researchers suggest that more than 95 percent of proposed medical device innovations fail to launch. Host Llewellyn King and Co-host Adam Clayton Powell III talk to Alex Gorrie, founder and CEO of London-based Dromeda.ai.
Send us a textMedicaid covers nearly 90 million Americans, but coverage doesn't always equal health.What if the real driver of outcomes isn't the doctor's office or an app, but the communityitself?In this episode of CareTalk Executive Features, WiderCircle co-founder and CEO Darin Buxbaum joins David Williams to share how peer-led circles and community engagement are improving health outcomes, boosting member trust, and delivering value for health plans.
Intricon specializes in designing, molding, and assembling some of the smallest and smartest components in the medical device industry. Our guest, Jay Tavakolian, Operations Program Director at Intricon, shares insights into the precision, scalability, and innovation behind building micro medical devices that serve critical applications in surgical navigation, wearables, diagnostics, and therapeutic technologies. The conversation dives into the opportunities and challenges of working at the micro scale—from molding and tooling to advanced automation and 3D manufacturing techniques. Discover how Intricon enhances production capacity while minimizing risk, ensuring that every device meets the highest medical standards.Sponsored By:
This episode tackles the often-overlooked but critical topic of medical device reimbursement. Host Etienne Nichols speaks with Haley King, co-founder and CEO of Paxos Health, about why this process is just as vital as FDA approval for a device's commercial success. They explore the journey a medical device takes, highlighting the distinction between FDA approval and securing reimbursement from payers.Haley explains the three key pillars of reimbursement: coding, coverage, and payment. She delves into the complexities of CPT codes and the significant difference between a temporary Category 3 code and the gold-standard Category 1. The discussion also covers the immense challenges medical device companies face, including the lengthy timeline—sometimes years—to secure payer coverage, which can be a make-or-break factor for startups. The conversation wraps up with a look at how artificial intelligence is beginning to streamline the cumbersome, manual process of patient access and appeals.Key Timestamps1:45 - The initial challenge of making coverage match medical need.3:30 - The three-part reimbursement pathway: coding, coverage, and payment.5:50 - Navigating CPT codes and the difference between Category 1 and Category 3.10:15 - Common challenges for medical device companies seeking payer coverage.13:20 - The multi-year timeline to achieve Medicare coverage for innovative devices.15:00 - Advice for regulatory and quality professionals on speeding up reimbursement.20:10 - How AI is currently being used in patient access and reimbursement.24:45 - Debating the accuracy of AI and its role in replacing human expertise.Quotes"A lot of times patients are not going to be able to pay out of pocket for expensive medical treatments, and a lot of times providers are not going to be able to write off those treatments on their side. So somebody needs to pay for this. And that's usually the health insurance companies..." — Haley King"I think that for this sort of a use case [AI], you're always going to want some human in the loop... AI has the potential to be super, super powerful in this space, but I think you're always going to want to have human experts involved." — Haley KingTakeawaysIntegrate reimbursement strategy early: Unlike FDA approval, which focuses on safety and efficacy, payers also demand evidence of a device's clinical and economic value. Medical device companies, particularly startups, should integrate reimbursement planning into their pitch decks and product development timelines from the outset.Recognize the two-step process: FDA approval is not a golden ticket to reimbursement. Companies must understand the subsequent and often lengthy process of securing coding, coverage, and payment from payers like CMS and private insurance companies, which can take several years.Enhance clinical trials for payers: Regulatory and quality professionals can speed up the reimbursement process by designing clinical trials that not only meet FDA requirements but also generate robust data to prove a device's clinical and economic value. This may involve including additional endpoints to justify the cost.Harness AI for efficiency, not replacement: AI is a powerful tool for automating the tedious parts of reimbursement, such as sifting through patient records and payer policies. However, it should be viewed as a way to enhance, not replace, the work of human experts who can handle complex edge cases and appeals.Be aware of coding complexities: The distinction...
In this conversation, I talk with Jason Scherer, the CEO and founder of VitaTek, to learn about the innovative approach his company takes in the medical device manufacturing industry. He shares insights on the challenges faced with bringing medical devices to market, the importance of technology in reducing healthcare costs, and the experiences of innovators in the field. The discussion also touches on the future of robotic surgery and AI, as well as the investment risks associated with medical device development. We hope you enjoy the show! Godspeed. ~ James 00:00 Introduction to Vita Tech Group 02:22 The Stages of Medical Device Manufacturing 05:14 Challenges in Medical Device Development 08:21 Innovative Solutions in Medical Device Production 11:01 The Impact of Technology on Healthcare Costs 13:58 Future of Robotic Surgery and AI 16:31 Navigating the Medical Device Market 18:54 The Role of Innovators in Medical Devices 21:45 Investment and Risk in Medical Device Development 24:25 Conclusion and Future Outlook
Jacques the Party Scientist is Bringing Joy to the WorldJacques The Party Scientist ditched his career in pharmacology to, among other things, develop the Joy Bootcamp, the first joy-based leadership retreat. We chatted about his corporate life in Medical Devices (something we have in common), his transition to self-employment, and the ways in which he uses speaking to spread his message of joy.To learn more about the Party Scientist and Jacques, visit https://thepartyscientist.com/__TEACH THE GEEK (http://teachthegeek.com) Prefer video? Visit http://youtube.teachthegeek.comGet Public Speaking Tips for STEM Professionals at http://teachthegeek.com/tips
Medboard Europe TToo much Incomplete Tech File - Let's explain to you how to do it: https://www.team-nb.org/wp-content/uploads/2025/09/Team-NB-PositionPaper-BPG-IVDR-V2-20250903.pdf 2025/1920 on Master UDI-DI - Not only lenses but also Spectacle frames and Ready-to-wear: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202501920 Borderline manual Update - New products included: https://health.ec.europa.eu/document/download/71a87df8-5ca1-4555-b453-b65bdf8de909_en?filename=md_borderline_manual_en.pdf red blood cell additive solutions containing adenine dual action cream with menthol and capsaicin Lactose tablets for vaginal use microabrasion dental stain removers medical examination table covers Mobile sterile air system EU asks your feedback on EU MDR and IVDR - Enjoy reading some 100 feedbacks: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14808-Medical-devices-and-in-vitro-diagnostics-targeted-revision-of-EU-rules_en Switzerland Swissdamed Technical Documentation - XML upload: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank/swissdamed-informationen/swissdamed-technical-documents.html Business Rules Swissdamed: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw630_40_002e_pu_swissdamed_business_rules.pdf.download.pdf/BW630_40_002e_PU_swissdamed_Business_Rules.pdf UK UK PMS guidance for Report - Template available: https://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements/requirements-of-the-manufacturers-pms-system PMSR Template: https://www.gov.uk/government/publications/medical-devices-standardised-format-for-the-post-market-surveillance-report Magazine Issue 1: Sept/Oct 2025 - Next one will come November 2025: https://easymedicaldevice.com/emd-mag/ Events Medtech Conf events - Be listed on the MAP: https://medtechconf.com/events-map-2/ EasyIFU Free trial for eIFU with EASYIFU - Compliant EU 2025/1234: https://easyifu.com ROW US FDA Computer System Assurance - SOP offered on the show notes: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/computer-software-assurance-production-and-quality-system-software-0 Malaysia affiliate member of MDSAP - What does it change?: https://portal.mda.gov.my/index.php/announcement/1636-malaysia-is-now-mdsap-medical-device-single-audit-program-mdsap-member Australia Essential Principles Checklist Update -: Update the templates V1.2: https://www.tga.gov.au/resources/resource/checklists/essential-principles-checklist Egypt guidance to import your devices - Medical Devices, Accessories, IVD: All type of devices: https://edaegypt.gov.eg/media/lafopofx/1-regulatory-guideline-of-issuance-of-import-approvals-of-all-types-of-medical-devices_gd.pdf Medical Equipment and Accessories: https://edaegypt.gov.eg/media/fltnd1qc/4-regulatory-guideline-of-issuing-import-approvals-for-medical-equipment-and-their-accessories_gd.pdf IVD: https://edaegypt.gov.eg/media/e2rf4qg5/2-regulatory-guideline-of-the-procedures-and-rules-of-obtaining-import-approvals-for-iaboratory-and-diagnostic-equipment-gd.pdf Podcast Episode 353: Cybersecurity in Medical Devices: What QA/RA must do Today: https://podcast.easymedicaldevice.com/353-2/ Episode 354: From Surgeon to CEO: Building Neurogyn AG: https://podcast.easymedicaldevice.com/354-2/ Episode 355: Postmarket Surveillance for SaMD and AI: https://podcast.easymedicaldevice.com/355-2/ Easy Medical Device Service Support for Consulting (QA RA projects) Support for Authorized Representative and Market Access Integration to an eQMS Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Josh Vose, CEO of Tulavi Therapeutics.Tulavi is advancing hydrogel-based implants like the allay Hydrogel Cap, which is designed to optimize nerve injury recovery and reduce the risk of neuroma formation.Josh is a physician, engineer, and entrepreneur with more than 20 years of experience in medical devices. He has held leadership roles at Medtronic following its acquisition of PEAK Surgical and drove growth at startups including SIA Health, which he led through commercialization and acquisition by Integra LifeSciences.In this interview, Josh shares why defining the clinical problem with absolute clarity is the foundation of medtech success, and how leaning into the harder regulatory path can create lasting moats.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Josh Vose.
In this episode, host Etienne Nichols sits down with Jose Bohorquez and Mohamad Foustok from CyberMed to dissect the complex world of Software as a Medical Device (SaMD) and cybersecurity. They emphasize that SaMD is first and foremost a medical device and should be treated as such from the very beginning of the development process. The conversation highlights the most common mistakes companies make, like treating security as an afterthought and jumping straight into coding without a solid architectural plan.Mohamad Foustok introduces the concept of "zero trust" and the critical importance of designing for security across the entire product lifecycle, from initial concept to post-market surveillance. The discussion clarifies that cybersecurity is not limited to network-connected devices but applies to any medical device with a software function, regardless of its connectivity. They also touch on the historical context of FDA guidance, noting a significant shift in recent years that has raised the regulatory bar and put a greater emphasis on robust cybersecurity documentation.The guests provide actionable advice for MedTech professionals, stressing the value of a balanced approach that integrates security and functionality from day one. They explain that a well-thought-out process, though seemingly slower at the outset, ultimately saves time and resources by preventing costly and time-consuming redesigns later on. This episode serves as a vital guide for anyone looking to build a secure and compliant medical device in today's evolving regulatory landscape.Key Timestamps[01:50] Common pitfalls in developing SaMD, including overlooking regulatory guidance like IEC 62304.[03:20] The critical mistake of treating cybersecurity as an afterthought in product development.[05:00] Who cybersecurity applies to beyond software, including patients, manufacturers, and supply chains.[06:30] The FDA's stance on cybersecurity for any device with a software function, even if not network-connected.[08:00] A discussion on "reasonable assurance of cybersecurity" and what it means for manufacturers.[10:00] The "zero trust" principle and why you should never assume a network is secure.[14:00] How hospitals and other stakeholders are demanding more rigorous cybersecurity standards.[15:40] The ideal process for a "security-first" development lifecycle.[21:00] Why rushing development without a proper architecture can lead to significant delays and cost overruns.[23:00] A brief history of FDA's cybersecurity guidance and the major shift in 2023.Quotes"Software as a medical device ultimately is a medical device, and so you want to be developing it from the get-go with that mindset." — Jose Bohorquez"Security can't be an afterthought. You have to consider security at the inception of your approach to a product." — Mohamed FustokTakeawaysA "Security-First" Mindset is Essential: Integrate cybersecurity from the initial architectural phase of your project. This proactive approach saves significant time and money by avoiding costly redesigns and delays later in the development process or after an FDA submission.Cybersecurity is for All Software-Driven Devices: Don't assume that only cloud-connected devices need cybersecurity documentation. The FDA requires documentation for any device with a software function, including embedded systems and programmable logic, even if it's not connected to a network.Regulatory Compliance is a Process, Not a...
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.comToday we have the pleasure of having Mr. James Watkins who went from being an Associate Sales Rep all the way a former Vice President at Medtronic. He goes into his journey on how he was able to break in and the journey it took to make it to VP
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.comToday we have the pleasure of having Mr. James Watkins who went from being an Associate Sales Rep all the way a former Vice President at Medtronic. He goes into his journey on how he was able to break in and the journey it took to make it to VP
In this episode of the Medical Sales Podcast, Samuel Adeyinka sits down with Kat Hurd, medical device sales coach and former Fortune 500 leader with 15 years of experience. From athletic training to rep of the year, to VP-level leadership and now founder of her own coaching business, Kat's journey is proof that you don't need a biology degree to thrive—you need grit, process, and the right mindset. Kat shares the pivotal moment that led her to leave corporate leadership and launch her coaching business, why so many reps fail without a clear sales process, and the three biggest gaps she sees holding reps back: lack of process, lack of ownership, and inconsistent follow-through. She also unpacks the truth about work ethic, limiting beliefs, and how managers can spot red flags before making a bad hire. Whether you're trying to break into med device, hit President's Club, or grow into leadership, this episode is packed with real-world strategies from someone who's been a top rep, a respected leader, and now a coach guiding the next generation of sales professionals. Connect with Kat Hurd: LinkedIn Connect with Me: LinkedIn Love the show? Subscribe, rate, review, and share! Here's How » Want to connect with past guests and access exclusive Q&As? Join our EYS Skool Community today!
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Ahmed Elmouelhi, CEO of TRiCares. TRiCares is developing Topaz, the first purpose-built transcatheter tricuspid valve replacement system — a technology designed specifically for the right side of the heart, where complex anatomy has made durable solutions elusive.Ahmed is a 20-year medtech veteran with leadership experience across electrophysiology, men's health, neuromodulation, and structural heart. Before joining TRiCares, he helped build multiple businesses at AtriCure and held key roles at Medtronic during the early days of TAVR. He also serves as Chairman of the American Heart Association in Minnesota.In this interview, Ahmed shares why adoption — not added complexity — is the ultimate measure of medtech innovation, how a small group of physician champions can accelerate clinical studies faster than internal resources alone, and why treating your board like collaborators in the “sandbox” leads to stronger partnerships and better outcomes.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Ahmed Elmouelhi.
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.com/podcastToday we get to learn from Cade Cook who broke into Medical Device Sales right out of college with a distributorship! Today he goes over the difference of working at a distributorship and a Large Medical Device CompanyHe also shares why he pursued Medical Device Sales over nursing and how he has been able to change his life because of it
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.com/youtube-podIf you're new to my channel, my name is Jacob McLaughlin. I'm the founder of New to Medical Device Sales, an exclusive training program designed to help people break into the competitive field of medical device sales. Our average person lands a six-figure role in just 8.5 weeks, earning $105,502 annually. With thousands of success stories from candidates with all kinds of backgrounds, our program equips you with the tools to succeed in this industry.4 years ago I moved out to Arizona not knowing anyone and had $1200 to my name.I came to this exact spot to journal and share how excited I was to be starting my journey in life.Last night I took time to reflect over the past 4 years. It's truly amazing how you can change your life in such a small amount of time.My take aways:1. Go after your dream because even if it doesn't workout like you thought it would, it will bring your right where you're suppose to be.2. Believe in yourself. Nobody is going to believe in you as much as you will, know that good things will happen.3. Change is inevitable. Change is going to happen so you can either accept it and keep moving forward or not.Please bet on yourself and go after your dreams because your life can be better than you ever thought it could be if you do
Do you want to get into Medical Device Sales?? If so → https://www.newtomedicaldevicesales.com/podcastGot the opportunity to sit down with Dr. Brian Blackwood and discuss what he looks for in his reps. Dr. Brian Blackwood is a board-certified orthopedic expert who specializes in joint replacement of the hip and knee, including Mako SmartRobotics™ joint replacement. With extensive training in the latest joint replacement and revision techniques, Dr. Blackwood is dedicated to providing the advanced orthopedic care his patients need to get back to an active lifestyle.In addition to being Boulder's first fellowship-trained hip and knee replacement specialist, Dr. Blackwood is a nationally renowned robotic-assisted total joint surgeon. By specializing in this minimally invasive technique, he is able to reduce pain, restore mobility, and promote a quick return to normal activities for patients suffering from joint pain. Dr. Blackwood is also a certified national educator for robotic-arm assisted surgery and has trained hundreds of other providers in this technique.
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