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    Episode 47 · November 18, 2025 · 43m listen · 629 words · ~3 min read

    How Market Intelligence Shapes MedTech Growth with Kevin Saem | Ep. 46 - Full Transcript | The Med Device Cyber Podcast

    Read the complete, searchable transcript of Episode 47 of The Med Device Cyber Podcast - expert conversations on medical device cybersecurity, FDA premarket and postmarket guidance, SBOM management, threat modeling, and penetration testing.

    Prefer the listening experience? Open the episode page for the synopsis, key takeaways, topics, and Apple / YouTube listen links.

    Episode summary

    This episode of The Med Device Cyber Podcast features Kevin Saem from Zapirus, who discusses how market intelligence is revolutionizing the MedTech industry. Saem highlights the historical gap in regulatory and sales sophistication between MedTech and other life sciences, traditionally lagging by about five years. He introduces Zapirus, a SaaS platform designed to centralize business development research and automate lead qualification for MedTech service providers through machine learning and AI. The conversation emphasizes the increasing importance of cybersecurity in MedTech, driven by the emergence of connected devices, software as a medical device (SaMD), and large language models. The hosts and Saem discuss how proactively addressing cybersecurity, akin to early human factors engineering, is crucial for mitigating risks, avoiding costly delays in FDA approvals, and attracting investment. They reference notable cases like the Aluminina False Claims Act settlement and a concerning AI therapy incident to underscore the tangible consequences of neglecting robust security measures. The episode concludes by stressing the need for MedTech companies to adopt a proactive, process-driven approach to cybersecurity and market intelligence to ensure sustainable growth and investor confidence in an increasingly competitive and regulated landscape.

    Key takeaways from this episode

    • MedTech has historically lagged behind other life sciences in regulatory and sales sophistication, but market intelligence tools are bridging this gap.
    • Proactive cybersecurity measures are essential for MedTech companies to secure FDA approvals, attract investment, and prevent critical incidents.
    • The increasing complexity of connected devices, SaMD, and AI in MedTech necessitates a 'security-first' approach to product development.
    • Companies need to move beyond word-of-mouth growth by implementing robust commercial strategies and utilizing market intelligence for sustainable scaling.
    • Neglecting cybersecurity can lead to severe consequences, including significant FDA delays, financial penalties, and even patient harm.
    • Adopting a systematic and repeatable process for both cybersecurity and market intelligence is crucial for long-term business success and scalability.

    Full episode transcript

    Hi, welcome back to another episode of the Med Device Cyber Podcast. Today, we have a guest, Kevin from Zapirus, and we're going to be talking a little bit about market intelligence and how it ties into cybersecurity. We're excited to talk about his SaaS platform, which has changed marketing and the industry quite a bit. It’s very forward-thinking because it’s very focused on MedTech. Welcome to the podcast, Kevin, and you're coming to us from right outside Toronto. Is that right today? Yeah, absolutely. Thanks for having me on the podcast. I'm super excited today to spend some time together and have some fun. Awesome. Well, do you want to tell us a little bit about your background in the industry, Kevin, and maybe what the impetus was for Zapirus and how things are going for you today? I came from the research world in the early days, so a technical space, right? My PhD was in chemistry, technically, but translational chemistry. So I was focusing on the application side of things, developing portable diagnostic devices, instrumentation, and nanofabrication. I was in the clean room all the time, doing tissue engineering work as well, which we're starting to see a bunch of new cool companies come out through the innovation of those materials and technologies out of universities. So that was kind of my roots, and then I got super curious about the entrepreneurial side because through that work, I was able to publish some patents and papers and things like that, and wanted to see how you take it beyond that and create a larger impact in the community and the space. That took me into the startup world. I spent some time in France working at a liquid biopsy company there. I was a chief operating officer, raising capital, doing all the fun startup stuff, pitching and begging for VC money and things like that. That was pre-COVID. Post-COVID, I came back to Canada, and shortly after, Zapirus was born out of COVID, and we've been scaling up ever since. And what was the, how did you see the need to start Zapirus? What was the reason you basically built Zapirus? Like, what was the need you felt needed to be filled? Yeah, so at the time, I look at the healthcare space as a whole. We can break it up into pharma, biotech, and then we've got MedTech and consumer healthcare stuff. MedTech, from a regulatory sophistication, sales sophistication, company sophistication, has historically been a minimum of five years behind life sciences like pharma and biotech, from a regulatory standpoint. So, just to be clear, you're saying you feel like the MedTech industry is five years behind pharma for regulatory? A variety of different things. Yes, it starts with the regulatory, and then it bleeds down into the innovations and tools used in the space, sales team structure, and sophistication. Just by the nature of investment into that vertical, you're going to get more polished systems, processes, and companies. At the time, in the biotech space, there were a lot of cool solutions that helped more efficiently and effectively connect businesses together, business-to-business, through market intelligence. There's this transition from going to the library to get information to the internet, right? The Google Age, the Yahoo searching age. So, the information age. What was born out of that were traditional databases, basically digitized curation of information in a platform. Then you saw the emergence of selling contacts, which was such a taboo. There were firms that were just scraping people's contact info in the early days. Think about ZoomInfo in the early days. They were installing crawlers in people's browsers and taking contacts out of people's emails unwarranted. Then regulation caught up, and they said,