
ISG launches research study on digital transformation in medical device industry
Key Takeaways
- ISG's study will produce reports on digital service providers' roles in medical device innovation for the U.S. and Europe, focusing on digital engineering and regulatory compliance.
- The research evaluates providers' capabilities in digital engineering, regulatory compliance, and post-market services, addressing data interoperability and cybersecurity challenges.
Reports will assess providers' capabilities in digital engineering, product development, regulatory compliance, and post-market digital services, with a focus on addressing key challenges such as data interoperability and cybersecurity.
Information Services Group, a global
The study will culminate in two ISG Provider Lens reports—one covering the U.S. market and the other Europe—scheduled for release in November 2025. The reports will assess providers' capabilities in digital engineering, product development, regulatory compliance, and post-market digital services, with a focus on addressing key challenges such as data interoperability and cybersecurity.
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ISG is surveying more than 100 digital transformation providers in the medical device space to analyze their strengths across three core categories:
- Digital Engineering and Product Development: Evaluating providers leveraging technologies like AI, digital twins and edge computing to enhance device design, compliance and speed to market.
- Regulatory Compliance, Strategy and Quality Assurance: Assessing firms that help navigate complex global regulations while ensuring cybersecurity and patient safety.
- Post-Market Digital Enablement: Examining providers offering tools for remote monitoring, device tracking and telehealth integration.
The research aims to guide enterprise buyers in selecting vendors, optimizing partnerships, and evaluating market offerings. It will also support ISG advisors in recommending providers to health care clients navigating digital transformation.
The medical device industry is undergoing a major shift as companies integrate AI, IoT and cloud technologies to enable predictive diagnostics, real-time monitoring, and more dynamic, data-driven business models.
ISG analysts Rohan Sinha and Sneha Jayanth will lead the U.S. and European reports, respectively. Companies not currently included in the study may contact ISG to be considered. Providers and customers can also participate in ISG’s customer experience survey, with respondents receiving a complimentary copy of the final report.
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