The Human Factor in MedTech Design with Dylan Horvath | Ep. 20

The Med Device Cyber Podcast · with Dylan Horvath · May 31, 2025 In this episode of The Med Device Cyber Podcast, Christian Espinosa interviews Dylan Horvath from Cortex Design about the critical role of human factors engineering and user-centric design in medical device development. Horvath emphasizes the need to integrate human factors from the initial stages of design to ensure commercial success, noting that devices must be not only safe and effective but also desirable and intuitive for users. The discussion highlights the challenges of market adoption and the necessity of considering all stakeholders, from users to buyers and reimbursement decision-makers, in the design process. The conversation also addresses the increasing importance of cybersecurity in FDA submissions, stressing that early integration of security measures is crucial to avoid costly redesigns and delays, especially with the current FDA resource constraints. Horvath shares insights from his company's journey into MedTech, including their participation in the Qualcomm Tricorder XPRIZE, and underscores the value of an organizational culture that embraces experimentation and continuous improvement. The episode offers valuable perspectives for product security teams, regulatory leads, and engineers seeking to navigate the complexities of MedTech design and compliance effectively.

Key Takeaways

• Human factors engineering must be integrated into medical device design from the very beginning to ensure both safety, effectiveness, and commercial success.
• A comprehensive design approach considers not only the end-user but also all stakeholders involved in market acceptance, including purchasers and those involved in reimbursement decisions.
• Early integration of cybersecurity considerations into the design process is crucial to avoid significant costs, delays, and potential redesigns during FDA submissions.
• The current FDA environment, characterized by resource constraints and uncertainty, necessitates highly buttoned-up and complete market submissions, making back-and-forth communication more difficult and costly.
• Organizational culture that values continuous improvement, empathy for the user, and an acceptance of iteration and "failure" as part of the design process is vital for bringing innovative medical devices to market.
• The MedTech industry offers significant opportunities for impact and innovation, driven by demographic shifts and the need to democratize healthcare access, making robust design and security practices more important than ever.
• Design decisions made early in the development lifecycle, such as microcontroller selection, can have profound and costly regulatory and functional ramifications if not carefully considered from a security perspective.

Listen on mdcpodcast.com · Watch on YouTube

Listen to this episode

• Watch on YouTube
• Listen on Apple Podcasts
• Listen on Spotify
• Browse all episodes

---

Want help applying this to your own device program?

Blue Goat Cyber is a specialist medical device cybersecurity firm: 250+ FDA submissions, zero rejections. If anything in this conversation hit close to home, book a 30-minute strategy session - no cost, no obligation.