Webinar
How to Secure and Monetize Medical Devices
Learn how to secure software, meet FDA/EU rules, and drive recurring revenue with automated updates and smart monetization.
Original Air Date: January 1, 2024
Overview
In the fast-evolving world of medical devices, software producers face a unique challenge: how to secure, update, and monetize embedded software while staying compliant with global regulations. In this webinar, Prescribing Success: How to Secure and Monetize Medical Devices, you'll hear directly from Alex Rybak, Senior Director of Product Management, and Vic DeMarines, VP of Product Management for Software Monetization at Revenera.
Together, they unpack the critical role of software in modern medical devices and share actionable strategies for navigating FDA and EU cybersecurity mandates. Learn how to implement secure software update systems, generate and manage SBOMs, and build monetization models that drive recurring revenue.
Discover how leading healthcare organizations are automating entitlement management, reducing operational costs, and improving customer experience. Whether you're just starting your software modernization journey or looking to optimize your existing processes, this session delivers practical insights and proven frameworks. Don’t miss the opportunity to future-proof your software strategy and unlock new revenue streams.
Recap
Key Themes and Takeaways
The Shift to Software-Driven Medical Devices
Medical device manufacturers are transitioning from hardware-centric models to software-driven, subscription-based offerings. This shift introduces new opportunities for recurring revenue, but also demands robust systems for software delivery, entitlement management, and compliance.
Regulatory Compliance: FDA and EU Cybersecurity Mandates
The webinar outlines how both the FDA and EU MDR regulations require manufacturers to manage cybersecurity risks throughout a device’s lifecycle. Speakers emphasized the importance of pre- and post-market requirements, including vulnerability scanning, SBOM generation, and timely patching.
The Role of SBOMs in Security and Transparency
Software Bills of Materials (SBOMs) are essential for understanding what’s inside your applications. The presenters explained how SBOMs help track vulnerabilities, ensure license compliance, and provide transparency to customers and regulators. They also discussed formats like SPDX and CycloneDX.
Managing the Software Supply Chain
With open source usage exploding, the software supply chain has become fragmented and risky. The webinar highlighted the need for automated tools and policies to manage dependencies, track provenance, and mitigate supply chain attacks.
Automating Software Updates for Medical Devices
Automation is key to delivering secure and frequent updates at scale. The speakers shared how one healthcare customer moved from manual DVD-based updates to Kubernetes-powered container deployments, improving both security and operational efficiency.
Monetization Models for Software and Data
Modern medical devices now include monetizable software features and even clinical data. The webinar explored how producers can implement flexible monetization models—subscriptions, pay-per-use, and feature-based licensing—to maximize profitability.
Analytics and Entitlement Management
Using a centralized IoT monetization platform, manufacturers can gain deep insights into software usage, entitlement status, and update success rates. These analytics help reduce revenue leakage, identify upsell opportunities, and improve customer engagement.
Getting Started with Security Frameworks
For organizations early in their security maturity journey, the speakers recommended starting with OpenChain’s ISO standards and engaging with SBOM communities. Building a policy, educating teams, and automating SBOM generation were presented as foundational steps.
Speakers

Alex Rybak
Senior Director of Product Management
Revenera

Vic DeMarines
VP of Product Management for Software Monetization
Revenera

Michael Goff
Principal Product Marketer
Revenera
Frequently Asked Questions
An SBOM is a detailed inventory of all components within a software application, including open source, proprietary, and third-party elements. It helps software producers track vulnerabilities, ensure license compliance, and provide transparency to customers and regulators. SBOMs are critical for managing cybersecurity risk and are increasingly required by global regulations. They also support faster remediation when security issues arise.
To comply with regulations like the FDA’s cybersecurity guidance and the EU’s MDR, producers must manage risk across the entire lifecycle of a medical device. This includes pre-market security testing, SBOM generation, and post-market monitoring for vulnerabilities. Having a documented security framework and update policy is essential. Automation and traceability are key to maintaining compliance efficiently.
Automated software updates reduce manual effort, increase update frequency, and improve security posture. They ensure that only entitled customers receive updates, helping prevent revenue leakage. Automation also enables faster response to vulnerabilities and supports scalability across large device fleets. This is especially valuable in regulated industries like healthcare.
Producers can monetize software through subscription models, pay-per-use, or feature-based licensing. By integrating entitlement management and analytics, they can tailor offerings to customer needs and track usage. This flexibility allows for recurring revenue and better alignment with modern business models. It also simplifies product packaging and reduces SKU complexity.
Analytics provide visibility into software usage, update adoption, and entitlement status. They help identify upsell opportunities, renewal risks, and underutilized features. With centralized data, producers can build predictive models and automate notifications to backend systems. This insight drives smarter business decisions and improves customer engagement.
Start by adopting a security framework and developing a policy for managing open source and third-party code. Use tools to generate SBOMs and improve their depth over time. Engage with industry groups like OpenChain, SPDX, and CycloneDX to stay current with standards. Even basic SBOMs can provide valuable insight and support compliance efforts.
Challenges include update frequency, entitlement verification, and scalability. Manual processes are slow and error-prone, especially when devices are widely distributed. Automation helps overcome these issues by streamlining delivery, ensuring compliance, and reducing operational costs. It also supports business continuity during disruptions like COVID-19.
Revenue leakage occurs when software is delivered to users who aren’t entitled to it. To prevent this, integrate entitlement checks into your update process and automate delivery through a monetization platform. This ensures only authorized users receive updates and helps maintain license compliance. It also protects intellectual property and supports recurring revenue.
Key metrics include update success rates, feature utilization, entitlement status, and customer engagement. Producers should also monitor renewal risk and upsell indicators. These metrics help optimize product offerings, improve customer retention, and identify growth opportunities. Dashboards and KPIs built from centralized data support ongoing performance tracking.
Modern platforms support monetization across software, hardware, and data services. They enable flexible licensing, feature-level control, and usage-based billing. Integration with CRM and order management systems ensures seamless operations. These platforms also provide self-service portals for customers, enhancing transparency and control over software access.
Resources
Online Event
Software Monetization User Group 2025
October 21, 22 & 23 (Tuesday, Wednesday & Thursday)
Whether you’re focused on growing annual recurring revenue, streamlining operations, or turning data into actionable insights, you won’t want to miss User Group this year. Register today to reserve your spot and get notified on the full agenda
Report
Software Monetization Models and Strategies 2026 Outlook
Revenera’s latest research report on trends around AI monetization, usage-based pricing, and customer retention challenges. Keep reading to see how your business compares.
Webinar
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Wednesday, November 19
In this session, Paul Bland, Senior Director of Technical Product Management for Revenera, and Philip Daus, Partner at Simon-Kucher, will share actionable ideas to counter rising costs, protect profitability, and adapt your pricing for the AI era
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See how Revenera's Software Monetization platform can help you take products to market fast, unlock the value of your IP and accelerate revenue growth.