Advertise on podcast: The Med Device Cyber Podcast

AI is becoming more capable, more autonomous and more accessible. What does that mean for medical device cybersecurity? Liam Dowd joins Christian Espinosa to discuss the changing security landscape, from continuous SBOM monitoring and vulnerable hospital environments to the growing role of AI on both sides of the cybersecurity equation. They explore how AI could make attackers faster while also giving defenders better tools, why excessive agency may become one of the technology’s biggest security risks, and where AI could genuinely improve healthcare. In This Episode: * 01:01 Why continuous SBOM monitoring matters * 02:55 Why hospital networks should be treated as unsafe * 05:05 Hacking into a surgical device in seconds * 06:49 How AI is changing offensive cybersecurity * 09:20 Using AI defensively * 10:03 The AI cybersecurity arms race * 16:17 The danger of excessive AI agency * 21:36 Why AI still needs human oversight * 23:48 Where AI could improve healthcare * 27:46 AI hallucinations and autonomous systems * 32:53 Liam’s view of where AI is heading Connect with Liam Dowd: https://www.linkedin.com/in/liam-j-dowd/ 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: https://bluegoatcyber.com Schedule a Discovery Session: https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session 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

What makes medical device penetration testing different from traditional cybersecurity? Christian Espinosa is joined by Blue Goat Cyber penetration tester Parker Daudt to explore what ethical hacking looks like when the device being tested can directly affect patient safety. Parker explains how penetration testing pushes beyond vulnerability scanning to uncover the real impact of an exploit, why outdated threat models can leave important attack surfaces untested, and why even something as simple as a CD drive can become a meaningful entry point. They also discuss hospital environments, exploitability, the risks created by large-scale device deployment and why medical device security has to be considered through the lens of the patient, not just the technology. In This Episode: * 01:30 Moving from traditional cybersecurity to patient safety * 05:57 Working with manufacturers on real-world risk * 09:25 Vulnerability scanning versus penetration testing * 11:55 Unexpected medical device attack surfaces * 14:26 Why penetration testing depends on the threat model * 17:38 Why hospitals should be treated as hostile environments * 20:08 Exploitability versus probability * 22:45 Why medical device cyber risk has real-world consequences * 24:50 How one compromised device can create a foothold * 26:16 Is hacking really like the movies? * 29:21 Parker’s biggest takeaway for manufacturers Connect with Parker Daudt: https://www.linkedin.com/in/parkerdaudt/ 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: https://bluegoatcyber.com Schedule a Discovery Session: https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session 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

Medical device cybersecurity is still surrounded by some persistent misconceptions. In this solo episode, Christian Espinosa breaks down seven of the most common misunderstandings he continues to hear across MedTech, from what actually makes a device “cyber” to why cybersecurity cannot be treated as a final-stage compliance task. He also explains why medical device cybersecurity is fundamentally different from traditional IT security, and why getting these basics wrong can create problems long before a product reaches the market. In this episode: 00:07 What actually makes a medical device “cyber”? 02:12 Why medical device cybersecurity is about patient safety 05:21 Why cybersecurity cannot be a point-in-time exercise 06:27 Exploitability versus probability 08:30 Why pre-market clearance is not the finish line 10:43 Why software developers are not cybersecurity experts 11:47 Why traditional cybersecurity is different from medical device cybersecurity 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 about Blue Goat Cyber: https://bluegoatcyber.com Schedule a Discovery Session: https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session 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

What if a medical device could prevent an attacker from exploiting a vulnerability, even before a patch becomes available? Joe Saunders, CEO and co-founder of RunSafe Security, joins Christian Espinosa to explore a different approach to protecting the software inside medical devices and other critical infrastructure. Joe goes through how RunSafe's technology changes the way software functions load into memory, making certain exploits ineffective without introducing the performance demands typically associated with additional security software. But the implications extend beyond stopping an attack. For medical device manufacturers, vulnerability management can create significant development, testing, and regulatory challenges. Could preventing exploitation at runtime also reduce the burden of patching and help companies get products to market faster? The conversation explores the economics of cybersecurity, the threat of compromised software updates, and why increasingly capable attackers are forcing manufacturers to rethink how they protect devices already deployed in the field. In This Episode: 02:44 Protecting critical infrastructure and medical devices 05:25 Why traditional runtime security creates challenges 07:25 How RunSafe protects software without a running agent 11:05 Understanding memory-based exploits 20:59 The cost of constant patching and recertification 25:54 Reducing exploitation risk from 12,000 potential gadgets to zero 28:16 Cybersecurity and faster medical device approvals 30:45 Threats to critical infrastructure 36:24 The danger of compromised medical device updates 38:43 Why AI is accelerating the cybersecurity challenge 40:10 Building security into software from the beginning Connect on Linkedin with Joe Saunders: https://www.linkedin.com/in/joesaunders/ Learn more about RunSafe Security: https://runsafesecurity.com 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

What if the biggest problem in skin cancer diagnosis is not finding suspicious lesions, but what happens after we find them? Stefan Mazy joins Christian Espinosa to discuss the personal experience that led him to explore a different approach to skin cancer testing after his mother underwent extensive surgery for an aggressive basal cell carcinoma. Stefan explains how his team is developing a microneedle patch designed to collect cellular tissue without a traditional surgical biopsy, and why he believes the current diagnostic pathway is struggling to scale as skin cancer awareness and testing increase. The conversation also explores the role of AI in identifying suspicious lesions, the trade-off between sensitivity and specificity, and why detecting more abnormalities could increase pressure on an already strained clinical pathway. Christian and Stefan also discuss cybersecurity in medical technology, manufacturing risks, brain-computer interfaces and why connected devices require founders to think beyond the device itself. In This Episode: * 03:33 Stefan’s mother’s skin cancer diagnosis * 08:14 Why he began searching for an alternative to biopsy * 10:08 The scale of unnecessary skin biopsies * 12:37 How the microneedle patch works * 15:13 Why uncertainty creates a diagnostic bottleneck * 23:44 Can AI reliably identify skin cancer? * 28:07 The problem with false positives * 31:50 Cybersecurity, brain-computer interfaces and future risk * 35:20 Stefan’s key takeaway on technology and healthcare Check out Stefan Mazy and DermaR here: https://www.linkedin.com/in/stefanmazy/ 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

Why can a MedTech company have promising technology, a strong team and investor interest, yet still lose momentum when it matters most? Ryan Roghaar joins Christian Espinosa to examine the commercialization gaps that can quietly weaken a medical device company long before the technology itself becomes the problem. Ryan explains why companies often move through fundraising, regulatory strategy, sales and market entry in the wrong sequence, and why inconsistencies between a pitch deck, website, evidence and buyer messaging can immediately create doubt. The conversation explores what happens when claims outpace evidence, why MedTech companies struggle to define exactly who they are selling to, and how cybersecurity and AI are adding entirely new layers of risk to commercialization. In This Episode:07:43 Why Ryan moved into MedTech 10:32 Moving from marketing agency to MedTech consultancy 11:32 Why devices fail outside the technology itself 12:41 Does MedTech commercialization follow a sequence? 16:08 The evidence gap inside MedTech companies 17:10 How investors pressure-test startups 19:55 When a company tells four different stories 23:36 Can cybersecurity become a commercial differentiator? 24:11 Why medical device hacking feels different 27:24 Cybersecurity risks from MRIs to brain implants 32:21 The three biggest commercialization gaps Ryan is seeing 35:57 Why unclear buyers dilute your message 39:08 The pressure to take the wrong customer 42:47 Ryan’s three key takeaways for MedTech companies Check out Ryan Roghaar’s LinkedIn here: https://www.linkedin.com/in/ryanroghaar/ 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*

What happens when AI starts screening job candidates who are also using AI to get through the screening process? In this episode of the Med Device Cyber Podcast, Christian Espinosa speaks with Darwin Shurig, founder of Top Talent Accelerant, about why recruiting in MedTech is becoming increasingly difficult and what companies can do to avoid costly hiring mistakes. Darwin explores why traditional “post and pray” recruitment is breaking down, how strong candidates can be screened out while weaker candidates use AI to get through the process, and why some highly specialized roles in AI, machine learning and cybersecurity are remaining open for months. The conversation also looks at the enormous cost of getting talent decisions wrong, why the best candidates often are not actively applying for jobs, and how showing candidates the real culture and expectations of a company can help create better alignment before an interview ever takes place. Darwin also shares the personal journey behind his book, The Modern-Day Job, and how major changes in his business and personal life led him to reconsider success, purpose and the importance of the people we choose to work with. In This Episode:01:13 Darwin’s journey from critical care to MedTech recruiting 04:38 Why recruiting has become such a crowded industry 06:55 The cost of getting the hiring process wrong 09:00 How AI is changing candidate screening 10:11 Why specialized MedTech roles can stay open for months 11:26 Why traditional hiring processes need to change 12:31 Creating a better candidate experience 13:48 The $9 billion impact associated with warning letters 14:49 Why the best candidates are not applying to your job posts 15:53 When AI starts interviewing AI 16:45 Remote hiring, geography and compensation 18:58 The story behind The Modern-Day Job 36:51 Why values and alignment matter when choosing people 40:33 Building teams around shared values and culture Check out Darwin Shurig’s LinkedIn here: https://www.linkedin.com/in/darwin-shurig 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

Why do so many promising MedTech companies fail even when the technology is strong, the funding is there and the product is compliant? In this episode of the Med Device Cyber Podcast, Christian Espinosa speaks with Amel Havkic, founder of EvoMed Consulting, about the hidden barriers that prevent medical technologies from achieving real clinical adoption. Amel explains why clinical adoption is often treated too late, how workflow friction can derail an otherwise strong product and why the founder’s greatest strength can sometimes become the company’s biggest strategic blind spot. The conversation also explores the KOL trap, the cost of forcing behavior change inside already overstretched clinical environments and why cybersecurity, reimbursement, usability and implementation cannot be treated as separate problems. In This Episode 01:08 Amel Havkic and VivoMed Consulting02:41 Why 75% of MedTech companies fail04:43 Clinical adoption, fundability and founder blind spots07:23 Why one solution must satisfy many stakeholders09:42 Economic viability and implementation friction12:37 The hidden cost of changing clinical behaviour15:43 The KOL trap and why pilots can mislead18:46 Alarm fatigue and real-world clinical environments20:46 Christian’s introduction to medical-device cybersecurity23:04 Why cybersecurity deficiencies derail submissions27:49 Building the right team around a MedTech founder32:38 Authenticity, intuition and choosing the right partners37:17 Why being human may become a superpower in the age of AI Check out Amel Havkic’s LinkedIn here. 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

AI is moving quickly, but medical devices cannot afford to treat every new model like an ordinary software update. In this episode of the Med Device Cyber Podcast, Christian Espinosa speaks with Tyler Harmon, CEO and co-founder of IASO Automated Medical Systems, about the risks and responsibilities surrounding AI as a medical device. Tyler explains why consumer tools such as ChatGPT and Claude should not be treated as clinical diagnostic systems, even when a doctor remains involved in the final decision. He also explores why a human in the loop does not automatically make an AI system safe when the underlying model was never designed or cleared for that medical use. The conversation examines how predetermined change control plans can support safer AI updates, why developers must understand the difference between frontier models and AI harnesses, and what can go wrong when a medical-device company builds on top of a third-party model. In This Episode 00:48 Tyler Harmon and IASO Automated Medical Systems03:34 What qualifies as AI as a medical device?04:44 Predetermined change control plans06:08 When should an AI medical device be updated?09:00 Why medical AI is not new11:32 Why medical AI still needs human oversight17:40 Doctors using ChatGPT to interpret X-rays20:09 Frontier models and AI harnesses24:16 The challenge of developing proprietary AI29:21 Why medical AI can take years to reach the market34:28 Using consumer LLMs outside their intended licence39:25 Licensing third-party AI for medical-device use40:41 Final lessons for medical-AI developers Check out Tyler Harmon’s LinkedIn here: https://www.linkedin.com/in/tyler-h-938bbb43/ 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

A strong résumé may get someone an interview, but technical ability alone does not determine whether they will succeed within an organization. In this episode of the Med Device Cyber Podcast, Christian Espinosa speaks with Samantha Silk, CEO of Apex Pro Placement, about recruitment, emotional intelligence, and the challenge of identifying the right people for highly technical roles. Samantha explains why an unfilled critical position can cost an organization thousands of dollars every day, when using a specialist recruiter makes financial sense, and why job descriptions often fail to reflect what the company actually needs. She discusses the importance of listening to hiring managers, setting realistic expectations and evaluating candidates beyond the qualifications listed on paper. The conversation explores why highly intelligent professionals sometimes struggle to explain complex ideas, how poor communication can limit careers and why emotional intelligence plays such an important role in leadership, investment and team performance. Christian and Samantha examine gut instinct in hiring, the risks of overriding warning signs, the growing volume of AI-generated recruitment noise and why human judgment remains essential when someone’s livelihood or a company’s future is at stake. In This Episode 00:57 Samantha’s path from cybersecurity recruiting to life sciences04:07 When using an external recruiter makes sense05:39 How an open critical role can cost up to $5,000 per day09:41 Why effective hiring starts with listening to the client11:57 Why most job descriptions fail to describe the real role13:34 Emotional intelligence in recruitment and leadership18:53 Why technical experts must communicate in simple language21:24 Investor pressure and unethical recruitment practices26:25 Using intuition and gut instinct when hiring32:03 How constant screen use affects attention and connection37:22 AI-generated résumés, recruitment noise and human oversight39:58 What rock climbing teaches us about trust in cybersecurity42:36 Final lessons on communication, EQ and technical careers45:04 Christian’s vision for AI agents running a company46:41 Why social engineering succeeds against hospitals47:20 How AI is making phishing more personalized48:21 Why AI is changing every part of business49:25 Final lessons on curiosity, assumptions and friction Check out Samantha Silk’s LinkedIn here - https://www.linkedin.com/in/samanthawein/ 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

Productivity means making meaningful progress on the work that matters most. Yet many organizations remain trapped in repetitive tasks, unclear priorities, unnecessary meetings and systems that rely too heavily on individual employees saving the day. In this episode of the Med Device Cyber Podcast, Christian Espinosa is joined by Sarah Ohanesian and Jeff Gibbard, co-founders of Super Productive, to explore how teams can reduce friction, improve communication and build working environments that support different kinds of brains. Sarah and Jeff share practical strategies organizations can implement immediately, including creating a universal system for capturing work, automating processes that have been repeated three times and building personal user guides that explain how individual team members communicate, focus and perform at their best. The conversation examines the hidden problems created by workplace “heroes,” employees who repeatedly step in to solve crises but may prevent the organization from building repeatable systems. Sarah explains why identity, recognition and job security can make delegation difficult, while Jeff discusses how psychological safety and curiosity can create more productive conversations. The episode explores neurodiversity in the workplace, the limitations of labels and why employees should be able to explain what they need without disclosing a diagnosis. During a special mic-swap segment, Sarah and Jeff question Christian about AI, social engineering and the changing future of cybersecurity. In This Episode: 00:52 What Super Productive does02:24 The difference between being busy and being productive03:39 Why focusing on one task creates momentum04:33 Defining productivity as meaningful progress05:13 Identifying the work that moves the needle06:44 Jeff’s Hyperfocus task-scoring system08:08 Creating a universal inbox for capturing work08:47 Why anything repeated three times should be automated09:07 Building a user guide for every team member10:44 The productivity problem created by workplace heroes11:41 Why some leaders struggle to delegate13:47 Creating psychological safety through curiosity17:16 Why productivity depends on communication19:30 Using personal instruction manuals to improve teamwork24:35 What neurodivergence means25:21 Why different brains require different working environments26:06 Neurodiversity versus neurodivergence28:06 Why “normal” depends on the environment30:47 Neurodivergence in cybersecurity and MedTech31:26 Can emotional intelligence and social skills be learned? Learn more about Sarah Ohanesian, Jeff Gibbard and Super Productive at: https://getsuperproductive.com/ 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

What if a blind person could use a pair of glasses where information is transmitted wirelessly to an implant in the visual cortex, allowing them to perceive shapes, movement, and elements of their surroundings? In this episode of the Med Device Cyber Podcast, Christian Espinosa speaks with Frederik Ceyssens, CEO and co-founder of ReVision Implant, about the development of a visual prosthesis designed to restore useful vision by stimulating the brain directly. Frederik explores why his team chose to bypass the eyes and optic nerve, how flexible electrode arrays can stimulate thousands of points within the visual cortex, and what researchers have learned through long-term animal studies. The conversation also explores the cybersecurity risks surrounding neurotechnology. An attacker could potentially interfere with wireless communication, alter the device’s algorithm, or increase stimulation to unsafe levels. The implant may also remain inside a patient for decades, creating difficult questions about encryption, software updates, and technologies that may become obsolete during the device’s lifetime. In This Episode: 00:38 Frederik’s background in neural implant research02:31 Why ReVision Implant targets the visual cortex instead of the eye04:26 Developing flexible brain electrodes through long-term testing06:48 Raising €4 million to advance the technology07:42 Preparing for the first proof of concept with a human volunteer09:24 How the glasses and brain implant work together11:04 What vision through the implant may look like12:33 Why colour and depth perception remain difficult16:16 The cybersecurity implications of a visual prosthesis17:43 How an attacker could manipulate the device20:25 The hardest parts of developing neurotechnology22:42 How the implant was tested using monkeys26:12 Designing an implant that can last 15 to 25 years28:28 Why today’s encryption may not remain secure for decades30:16 Why replacing the implant would require months of rehabilitation34:51 How close the technology is to science fiction36:07 The next steps towards testing with blind volunteers Find Frederik Ceyssens on Linkedin: https://www.linkedin.com/in/frederikceyssens/ Find ReVision Implant at: https://revisionimplant.com 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

Bringing an innovative medical device to market takes far more than a great idea. It requires regulatory strategy, cybersecurity, quality systems, and commercial planning from the very beginning. In this episode of the Med Device Cyber Podcast, Christian Espinosa is joined by Helen Souris, CEO of CardiHab and Board Member of the Medical Technology Association of Australia (MTAA), to discuss why so many promising digital health companies struggle when they leave the startup phase and enter the realities of regulation. Helen shares her experience leading a digital therapeutics company, raising investment in Australia, navigating software as a medical device regulations and helping startups avoid costly mistakes that can delay or even derail commercial success. The conversation explores why cybersecurity is becoming a deciding factor in procurement, how founders should think about regulatory strategy before writing a single line of code, why quality management systems cannot be bolted on later, and the real-world consequences of ignoring compliance until it's too late. Whether you're building a medical device, digital therapeutic, AI healthcare platform or connected medical technology, this episode offers practical advice for creating products that are secure, compliant and built to scale. In This Episode: 00:57 Helen's journey from pharma to digital therapeutics04:33 The realities of raising MedTech investment in Australia09:06 Why choosing the right investor matters13:22 Why many digital health startups misunderstand regulation15:21 Why cybersecurity comes up in every customer conversation16:15 Why founders still leave cybersecurity until the end16:53 Building regulation, quality and cybersecurity from Day One18:31 The $93 million company forced to pull its product21:09 Explaining medical devices through the user journey22:50 The stadium hacking analogy that changes perspectives25:13 Why wearables need a medical lens26:57 The fake Wi-Fi demonstration everyone should remember28:20 Why rebuilding is always more expensive than building properly29:30 Christian's biggest takeaways Find Helen Souris here on LinkedIn: https://www.linkedin.com/in/helen-souris/ 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/

For years, cybersecurity has been viewed as an IT responsibility. Today's threat landscape demands something very different. In this episode of the Med Device Cyber Podcast, Christian Espinosa is joined by Melissa Aarskaug, a cybersecurity executive with extensive experience protecting highly regulated industries, including banking and casino gaming. Melissa shares lessons from an industry where operations run 24 hours a day, every day of the year, and where even a few minutes of downtime can have enormous financial consequences. The conversation explores why attackers increasingly target regulated industries, how cyber resilience differs from compliance, and why cybersecurity has evolved into a leadership issue rather than simply an IT function. Melissa explains why organisations should focus less on preventing every possible attack and more on ensuring the business can continue operating when incidents occur. Christian and Melissa also discuss how medical device manufacturers can learn from the gaming industry's approach to resilience, the growing role of AI in both cyber defence and cybercrime, why cybersecurity should be integrated into quality management systems, and how leadership teams can better prioritise cyber risk across their organisations. Whether you're a MedTech founder, cybersecurity professional, healthcare leader, or product developer, this episode offers practical insights into building more resilient organisations in an increasingly connected world. Episode Breakdown 00:00 Introduction01:09 Lessons from protecting the gaming industry01:58 Why attackers target regulated industries05:22 Cybersecurity is about pressure, not industries06:07 Compliance versus cyber resilience08:08 Medical devices and connected ecosystems12:29 The famous fish tank cyberattack15:03 FDA expectations versus hospital expectations16:04 AI, cyber maturity and the future of security17:25 Four priorities every leader should focus on21:24 Why penetration tests often fail to create change24:38 FDA compliance and designing security from the beginning26:48 Cyber insurance isn't a silver bullet32:21 Cybersecurity is becoming part of quality33:26 Why cybersecurity is moving beyond IT37:42 Final thoughts and key takeaways Find Melissa Aarskaug here on LinkedIn: https://www.linkedin.com/in/melissa-aarskaug/ 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

Cancer treatment is already difficult enough without adding more hospital visits, more testing, and more delays. Yet many cancer therapies carry a significant risk of damaging the heart, forcing patients to undergo regular cardiac screening throughout their treatment journey. What if clinicians could monitor cardiac function with a simple wearable patch instead? In this episode of the Med Device Cyber Podcast, Christian Espinosa sits down with Ryan Neely, co-founder and CEO of Skribe Medical. Ryan shares his journey from neuroscience research and implantable neuroprosthetics to building a company focused on improving cardiac monitoring for cancer patients. The discussion explores the growing field of cardio-oncology and the challenges patients face when cancer treatment depends on frequent cardiac assessments. Ryan explains how Skribe Medical's wearable monitoring platform aims to reduce treatment delays while improving patient convenience through a battery-free, AI-powered patch designed to measure cardiac function. The conversation also takes a deep dive into cybersecurity considerations for connected medical devices. Ryan and Christian discuss common misconceptions about cybersecurity risk, why hospital networks often present greater challenges than home environments, and how device manufacturers should think about security as products evolve from standalone systems to connected healthcare technologies. Finally, the episode explores commercialization, reimbursement models, FDA engagement, and the reality that regulatory clearance is often just one milestone in a much longer journey toward successful adoption. Whether you're a MedTech founder, healthcare innovator, cybersecurity professional, or clinician, this episode offers valuable insights into the intersection of patient care, connected devices, and healthcare innovation. Episode Breakdown 00:00 – Introduction01:53 – The hidden cardiac risks of cancer treatments02:58 – Skribe Medical's wearable cardiac monitoring platform03:53 – Future applications beyond oncology04:45 – Battery-free device design and patient comfort06:00 – Remote patient monitoring and reimbursement models09:40 – Cybersecurity risks for connected medical devices14:06 – Why hospital networks present unique security challenges16:02 – FDA cybersecurity expectations and evolving regulations19:03 – Regulatory changes and long MedTech development cycles21:02 – Commercialization versus FDA approval24:13 – AI models and the Predetermined Change Control Plan25:55 – The realities of clinical testing and device validation28:14 – Final takeaways and lessons learned 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