U.S. Medical Device Makers Shift Technology Investments to Complete Product Lifecycles – ISG – October 23, 2026

U.S. medical technology companies are shifting from conventional product development toward the creation of software-defined ecosystems that evolve continuously after launch, according to a new research report published today by Information Services Group (ISG), a global AI-centered technology research and advisory firm.

The 2026 ISG Provider Lens Medical Device Digital Services report for the U.S. finds that digital investment is increasingly focused on complete product lifecycles rather than isolated technology programs. As devices become more connected, engineering, regulatory affairs, quality management, cybersecurity and post-market operations are becoming interdependent functions that require an integrated digital foundation. A software update can simultaneously affect validation evidence, cybersecurity posture, regulatory documentation and field performance, ISG says.

Jenn Stein

“Medical device transformation is now a lifecycle challenge, not a series of projects,” said Jenn Stein, partner and industry leader, ISG Manufacturing and Health Sciences. “Companies need data and workflows to be shared across critical disciplines to sustain improvement after launch.”

Enterprises are applying AI and automation to engineering, software development, testing, verification, validation and technical documentation. As AI adoption moves beyond proofs of concept, companies are evaluating whether AI-enabled workflows are reliable enough for regulated environments. Explainability, data governance, human oversight and change control increasingly influence purchasing decisions. Manufacturers are also exploring agentic AI but remain selective about allowing autonomous execution in highly regulated and safety-critical processes.

Organizations are also modernizing quality management systems and strengthening software bill of materials management to harmonize processes. They are embedding regulatory, risk and cybersecurity controls directly into development workflows to improve traceability. This approach enables companies to support the federal Quality Management System Regulation and strengthen vulnerability management for software-based devices. They expect quality transformation to enable faster engineering instead of creating a downstream control function.

Manufacturers are implementing remote patient monitoring, predictive maintenance and complaint intelligence across deployed devices. They want operational and patient data to generate earlier safety signals to guide engineering decisions and product improvements. Real-world data can strengthen evidence that engineering, regulatory and quality teams can use for continuous improvement. Success is measured through shorter complaint cycles, lower validation effort, fewer quality issues and greater device uptime, ISG says.

“Shared data becomes more valuable when it connects field experience with product decisions,” said Rohan Sinha, ISG principal analyst and lead author of the report. “Service providers can help manufacturers coordinate these functions while maintaining accountability throughout the lifecycle.”

The report also explores other trends in the U.S. digital device market, including the increasing integration of companion applications and remote monitoring into devices.

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