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    Episode 074 · June 18, 2026 · 32m listen

    Cancer Drugs Can Damage the Heart - This Startup Wants to Fix It with Ryan Neely

    Episode Summary

    In this episode of the Med Device Cyber podcast, host Christian Espinosa of Blue Goat Cyber welcomes Ryan Neely, the CEO and Co-founder of Skribe Medical, to discuss the multifaceted challenges of bringing a medical device from concept to commercial success. Ryan shares his extensive background, which began in neuroscience with a Ph.D. from UC Berkeley focusing on brain-computer interfaces and implantable neuroprosthetics. His journey through MedTech includes experience with wireless, ultrasound-powered implants at Iota Biosciences, work in oncology drug discovery, and development of wearable neurotechnology for sleep health. This diverse expertise culminated in the founding of Skribe Medical, a company aimed at revolutionizing heart monitoring for cancer patients. Skribe Medical addresses a critical issue known as cardiotoxicity, where certain effective cancer treatments, like anthracyclines, pose a high risk of damaging the heart. The current standard of care requires patients to undergo frequent, burdensome cardiac ultrasounds, which can lead to significant patient inconvenience and treatment delays for oncologists awaiting results. Ryan introduces Skribe's innovative solution: a small, wearable patch that uses a combination of sensors and an AI model to non-invasively measure Left Ventricular Ejection Fraction (LVEF), a key indicator of heart health. This technology enables oncologists to perform quick, in-clinic spot-checks, facilitating timely treatment decisions and improving the patient experience. The discussion also touches upon the business model, which involves a per-use fee and revenue sharing with clinics, creating a financial incentive for adoption, especially for independent practices that would otherwise refer patients out for imaging. A central argument of the episode is the distinction between regulatory approval and market success. Both speakers forcefully argue that FDA clearance, while a necessary milestone, is often mistakenly seen as the final goal. They describe it as just one gate, with the 'real dragon' being the challenge of commercialization. This includes ensuring the device seamlessly integrates into existing clinical workflows, appealing to payers through a clear reimbursement strategy, and proving its value to both physicians and patients. The conversation also explores the cybersecurity landscape, contrasting the relatively low-risk environment of home use with the high-stakes, 'hostile' nature of hospital networks. They emphasize that any device connected to a hospital network is an immediate target for adversaries, making robust security a paramount concern for patient safety and data integrity.

    Key Takeaways

    • 01FDA clearance is not the finish line for a medical device; the true challenge lies in achieving commercial viability, which includes clinical workflow integration, reimbursement strategies, and market adoption.
    • 02Skribe Medical is developing a wearable patch that uses AI to monitor cancer patients for heart damage (cardiotoxicity) caused by their treatments, aiming to replace burdensome and infrequent ultrasounds.
    • 03From a cybersecurity perspective, a medical device connected to a hospital network is considered to be in a 'hostile environment' as these networks are constant targets for cyberattacks.
    • 04The clinical environment, with its complex, high-stress workflows and numerous interconnected systems, often presents more significant design and security challenges than the home-use environment.
    • 05Successful MedTech innovation requires a deep understanding of the end-to-end process, from clinical need and device development to the business model, payer landscape, and go-to-market strategy.
    • 06Remote patient monitoring (RPM) and new value-based care models are changing the healthcare revenue landscape, creating opportunities for technologies that improve outcomes and efficiency outside of traditional fee-for-service appointments.
    • 07The FDA is becoming more adaptable to new technologies like AI, with programs such as the Predetermined Change Control Program (PCCP) providing a framework for updating machine learning models post-clearance.

    Frequently Asked Questions

    Quick answers drawn from this episode.

    • In this episode of the Med Device Cyber podcast, host Christian Espinosa of Blue Goat Cyber welcomes Ryan Neely, the CEO and Co-founder of Skribe Medical, to discuss the multifaceted challenges of bringing a medical device from concept to commercial success.

    • FDA clearance is not the finish line for a medical device; the true challenge lies in achieving commercial viability, which includes clinical workflow integration, reimbursement strategies, and market adoption. Skribe Medical is developing a wearable patch that uses AI to monitor cancer patients for heart damage (cardiotoxicity) caused by their treatments,...

    • His journey through MedTech includes experience with wireless, ultrasound-powered implants at Iota Biosciences, work in oncology drug discovery, and development of wearable neurotechnology for sleep health. It's most useful for medical device manufacturers, cybersecurity engineers, regulatory affairs professionals, and MedTech founders...

    • FDA clearance is not the finish line for a medical device; the true challenge lies in achieving commercial viability, which includes clinical workflow integration, reimbursement strategies, and market adoption.

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    Pre-fills with: "FDA clearance is not the finish line for a medical device; the true challenge lies in achieving commercial viability, which includes clinical workflow integration, reimbursement strategies, and market adoption."

    From the YouTube description

    Medical device founders spend years thinking about engineering, clinical validation, and FDA clearance. But what happens after you clear the regulatory hurdle? In this episode of the Med Device Cyber Podcast, Christian Espinosa sits down with Ryan Neely, co-founder and CEO of Skribe Medical, to discuss the realities of bringing innovative medical technologies to market. Ryan shares how Skribe Medical is developing a wearable cardiac monitoring platform designed to help cancer patients and oncologists identify signs of treatment-related heart damage more efficiently. The conversation explores the challenges of building AI-powered medical devices, integrating new technologies into existing clinical workflows, and reducing friction for both patients and providers. The discussion also explores one of the most surprising cybersecurity insights of the episode: why hospital networks often present greater risks than home environments for connected medical devices. Ryan and Christian examine how cybersecurity considerations evolve as devices become more connected and why manufacturers must think beyond the device itself when assessing risk. In this episode, we cover: * The growing field of cardio-oncology and cardiac monitoring * Building a battery-free wearable medical device * Why clinical workflow matters as much as technical innovation * Cybersecurity risks in connected healthcare environments * Why hospital networks can create unexpected security challenges * FDA cybersecurity expectations and evolving guidance * Commercialization challenges facing MedTech startups * AI models, continuous improvement, and regulatory frameworks * Why FDA clearance is often just the beginning of the journey Episode Breakdown 00:00 – Introduction 01:53 – The hidden cardiac risks of cancer treatments 02:58 – Scribe Medical's wearable cardiac monitoring platform 03:53 – Future applications beyond oncology 04:45 – Battery-free device design and patient comfort 06:00 – Remote patient monitoring and reimbursement models 09:40 – Cybersecurity risks for connected medical devices 14:06 – Why hospital networks present unique security challenges 16:02 – FDA cybersecurity expectations and evolving regulations 19:03 – Regulatory changes and long MedTech development cycles 21:02 – Commercialization versus FDA approval 24:13 – AI models and the Predetermined Change Control Plan 25:55 – Clinical testing and validation challenges 28:14 – Closing thoughts and key takeaways Find Ryan Neely here on LinkedIn: https://www.linkedin.com/in/ryan-neely-ph-d-14464340/ The Med Device Cyber Podcast is brought to you by Blue Goat Cyber, cybersecurity experts providing essential security solutions for the medical device industry. Learn more by visiting https://bluegoatcyber.com. If you're interested in our services or partnering with us, schedule a Discovery Session: https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session Christian Espinosa is the CEO and founder of Blue Goat Cyber. Christian Espinosa on LinkedIn: https://www.linkedin.com/in/christianespinosa/ Blue Goat Cyber on LinkedIn: https://www.linkedin.com/company/blue-goat-cyber/ Blue Goat Cyber on Instagram: https://www.instagram.com/bluegoatcyber/ Blue Goat Cyber on Facebook: https://www.facebook.com/bluegoatcyber/ Blue Goat Cyber on YouTube: https://www.youtube.com/@BlueGoatCyber/?sub_confirmation=1
    Christian: You could have a product that is great, but if nobody wants to buy it, there's no cost reimbursement, it doesn't fit into a clinical workflow. It doesn't matter you got it cleared by the FDA. Guest: They're not doing any diligence to say whether it's a viable commercial product. And making sure that you understand that piece and how it's going to fit into the workflows and the the payer landscape and the clinical case that really presents the most challenge because you're operating on this hospital network and that's really what you have to think about. Christian: Well I think it's safe to say most people's home networks are not like super secure. Hospital networks are under attack constantly. From a medical device perspective, if you put a medical device on a hospital network, we consider it like a hostile network. Christian: Hi, welcome back to the Med device Cyber Podcast. Today we have a special guest, Ryan Neely with Skribe Medical. Ryan is coming to us, I think you said Mill Valley. Is that right? Ryan: That's right. Christian: That's right north of San Francisco? Ryan: We're just, we're just over the Golden Gate. Christian: Okay. That's a nice area to run. There's a guy I took this course. It was called Chi running, it's like running with Tai Chi principles in mind so your body's aligned. And he was based out of that area. He always had these videos of him running on that mountain or that hill right outside the Golden Gate Bridge. Is that Mill Valley basically? Ryan: Pretty much, yeah. And I've actually read that book so I know exactly what you're talking about. Christian: Oh, okay. Yeah. Yeah, Danny um, Dreyer or something. Yeah. I took a class actually from it. It's good. It's like running like if you lean forward, you run faster because you're going to fall. So, cool. So why don't we uh, why don't you tell us a little bit about your background, Ryan, and what you're up to at Skribe Medical and, and kind of where you are in your Medtech journey and everything else. Ryan: Yeah, for sure. So, um, I come from actually a neuroscience background. I did my PhD at Cal working on brain computer interfaces, uh, you know, implantable neuroprosthetics. That kind of turned into a company where I was the first employee, so that got me my first taste in Medtech. We were doing essentially wireless implants that were powered by ultrasound, uh, company called Iota Biosciences. That, you know, kind of transitioned into a little bit of drug discovery in the oncology space. And then more recently, uh, I was doing some wearable neuro technology in, you know, sleep health to promote um, healthy sleep. And, you know, I kind of put all those things together, uh, with my two co-founders to create Skribe Medical. And what we're doing at Skribe is heart monitoring for cancer care. And just to dig a little deeper into what that means, uh cancer drugs, you know, a lot of them carry a high risk of heart damage. And so many of these drugs like anthracyclines or her2 therapies require patients to come in pretty frequently and get a cardiac ultrasound to make sure that, you know, their heart is in good shape or, you know, to see if they need any kind of intervention. You know, the challenge with that, uh, for a lot of these patients is that first of all it adds a lot of, uh, burden to patients who, you know, already have a lot of appointments. You know, coming in every few months to get these ultrasounds, uh, can be challenging. And for oncologists, you know, they're often waiting for the results of these screens, you know, to be interpreted by a cardiologist so that they know it's safe to continue treatment. And that can add to treatment delays which is obviously problematic. Uh, and so what we've done is created a little wearable device. I have it here, um, I just sticks on right above your heart and it can measure the types of, uh, signals that relate to cardiotoxicity caused by these drugs. And in particular looking at left ventricular ejection fraction, um, using an AI model combined with a number of sensors that we have built into the device, uh, and basically allows oncologists to spot check patients whenever they need to and, you know, get on with treating cancer, uh, without any delays. So that's really kind of the idea behind Skribe. Christian: That's pretty awesome. Is it just used for, or is this your first use case for the cancer drugs uh and the side effects of those to the heart or other... Ryan: it's said that medical device something... Christian: So integrating it into your system, but Ryan: We, we do have kind of a broader roadmap. You know, what we're measuring Christian: something that doesn't alter that flow. You know, you talked about Ryan: is pretty applicable in the case of heart failure. Christian: and clinician... Ryan: You know, a lot of what these patients are experiencing essentially is a accelerated form of heart failure. So the heart failure space, definitely something we could operate in. Uh, and then actually peripartum cardiomyopathy is another condition, so pregnant women are at risk of kind of a similar issue actually where they experience a, a loss in cardiac function and we're looking to detect that as well. So, yeah, I mean I think there are a lot of spaces we want to move into. I think in cardio-oncology, we've really found, uh, a high unmet need where there's just not a lot of great tools for oncologists to measure cardiac function. And so...

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