Urvashi Tiyagi, Advisor and Former CTO at ResMed, shares her expertise in navigating the complexities of software development for medical devices. She discusses how healthcare leaders grapple with regulatory hurdles while striving for innovation. The conversation touches on the importance of collaboration with regulatory bodies and how AI and wearable technologies are transforming patient interactions. From subscription models to the integration of data and AI, Urvashi highlights the future of healthcare technology and its potential to enhance patient care significantly.
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Quick takeaways
Healthcare leaders must adapt to software-driven business models while navigating complex regulatory landscapes that hinder rapid innovation.
Decoupling medical functionalities from traditional hardware can enhance integration of modern technologies and improve efficiencies in medical device development.
Deep dives
Challenges in Software Monetization
The healthcare sector faces challenges in monetizing software due to its historical focus on hardware in medical devices. In this evolving landscape, companies are integrating advanced technologies such as IoMT connectivity, cloud infrastructure, and AI capabilities into their offerings. However, many organizations struggle to establish a software-driven business model and justify investments in digital capabilities, as traditional revenue streams have primarily stemmed from the sale of hardware. This shift necessitates a reevaluation of financial strategies to lay a foundation for recouping costs through software and digital services.
Regulatory Compliance vs. Innovation Speed
Healthcare leaders encounter significant hurdles in balancing stringent regulatory requirements with the need for rapid innovation. Unlike non-regulated sectors where software updates can be deployed swiftly, the healthcare industry often requires extensive testing and documentation, delaying the launch of new features or products for several weeks or months. This extended approval process poses a barrier to frequent updates or improvements, resulting in fewer opportunities to enhance the user experience and address market needs promptly. As the digital healthcare landscape grows, leaders must strategize ways to streamline compliance while maximizing their innovation potential.
Legacy Architecture and Its Implications
The legacy architecture of medical devices complicates the integration of modern software technologies, as much of the existing code blends medical functionality with general-purpose coding. This coupling necessitates rigorous regulatory testing for both medical and non-medical components, leading to inefficiencies and increased costs. By decoupling medical functionalities from the rest of the software, organizations can mitigate risks associated with regulation and foster faster innovation cycles. Reevaluating capabilities and shifting functionalities from hardware to cloud-based applications can not only reduce costs but also improve patient care by maximizing the efficiency of the technology ecosystem.
Today’s guest is Urvashi Tyagi, Advisor and Former CTO at ResMed. Urvashi joins us on today’s podcast with Emerj Senior Matthew DeMello to discuss the unique challenges healthcare leaders face in driving software development efficiencies for medical devices and customer-facing mobile applications. As the med tech industry strives to balance innovation with regulatory compliance, many companies find themselves navigating complex approval processes that can delay product launches and stifle progress. This episode is sponsored by Pieces. Learn how brands work with Emerj and other Emerj Media options at emerj.com/ad1.
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