Episode 74 · June 18, 2026 · 32m listen · 969 words · ~5 min read

Cancer Drugs Can Damage the Heart - This Startup Wants to Fix It with Ryan Neely - Full Transcript | The Med Device Cyber Podcast

Read the complete, searchable transcript of Episode 74 of The Med Device Cyber Podcast - expert conversations on medical device cybersecurity, FDA premarket and postmarket guidance, SBOM management, threat modeling, and penetration testing.

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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 from this episode

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, aiming to replace burdensome and infrequent ultrasounds.
From 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.
The 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.
Successful 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.
Remote 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.
The 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.

Full episode transcript

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...

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