New ISG research says US medtech companies are integrating engineering, quality, and compliance functions to support software-defined devices that evolve after launch.
US medical technology companies are moving away from conventional product development and toward software-defined ecosystems that continue to evolve after launch, according to a new report from 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 US finds that digital investment is increasingly focused on complete product lifecycles rather than isolated technology programs. As connected devices proliferate, engineering, regulatory affairs, quality management, cybersecurity, and post-market operations are becoming interdependent functions that require an integrated digital foundation, according to the report. ISG notes that a single software update can simultaneously affect validation evidence, cybersecurity posture, regulatory documentation, and field performance.
“Medical device transformation is now a lifecycle challenge, not a series of projects,” says Jenn Stein, partner and industry leader, ISG Manufacturing and Health Sciences, in a release. “Companies need data and workflows to be shared across critical disciplines to sustain improvement after launch.”
AI Adoption Advances with Caution
Manufacturers are applying AI and automation across engineering, software development, testing, verification, validation, and technical documentation, the report says. 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 are increasingly influencing purchasing decisions.
ISG says manufacturers are also exploring agentic AI but remain selective about allowing autonomous execution in highly regulated and safety-critical processes.
Embedding Quality and Cybersecurity into Development
Organizations are modernizing quality management systems and strengthening software bill of materials management to harmonize processes, the report finds. Companies are embedding regulatory, risk, and cybersecurity controls directly into development workflows to improve traceability, which supports the federal Quality Management System Regulation and strengthens vulnerability management for software-based devices.
Manufacturers expect quality transformation to enable faster engineering rather than function as a downstream control, according to ISG.
Real-World Data Driving Post-Market Decisions
Manufacturers are implementing remote patient monitoring, predictive maintenance, and complaint intelligence across deployed devices, the report says. The goal is for operational and patient data to generate earlier safety signals that guide engineering decisions and product improvements.
ISG says success is measured through shorter complaint cycles, lower validation effort, fewer quality issues, and greater device uptime.
“Shared data becomes more valuable when it connects field experience with product decisions,” says Rohan Sinha, ISG principal analyst and lead author of the report, in a release. “Service providers can help manufacturers coordinate these functions while maintaining accountability throughout the lifecycle.”
Provider Rankings
The report evaluates 25 providers across three quadrants: digital engineering and product development; regulatory compliance, strategy and quality assurance; and AI and innovation driving post-market enablement.
Accenture, Capgemini, Cognizant, HCLTech, Infosys, LTTS, TCS, and Wipro are named Leaders in all three quadrants. Deloitte is named a Leader in one quadrant. Apexon, Hexaware, and Tech Mahindra are recognized as Rising Stars in one quadrant each.
In the area of customer experience, Persistent Systems is named the global ISG CX Star Performer for 2026 among medical device digital service providers, earning the highest customer satisfaction scores in ISG’s Voice of the Customer survey.
“Medical device transformation is now a lifecycle challenge, not a series of projects,” says Jenn Stein, partner and industry leader, ISG Manufacturing and Health Sciences, in a release. “Companies need data and workflows to be shared across critical disciplines to sustain improvement after launch.”
BINGO!!!
The closing sentence of the paragraph should raise a red flag for anyone reading or hearing it. After recognizing and recovering from my emotional reaction to hearing a series of buzzwords thrown together, I have to ask “What, precisely, are you calling for?”
One thing I cannot discern from the remark is to what degree if any data and workflows are being or should be considered horizontally across companies. The delivery of patient care in technology intensive settings at any one point in time requires using devices from multiple manufacturers simultaneously and often synchronously. When I worked as a clinical engineer, and especially when I served in standards committees, it was obvious to me that manufacturers brought very narrow perspectives, specific to the scope of their products, on what goes on at the bedside.
It seems to me that this can only be exacerbated as devices become increasingly software based and upgrades are developed, or perhaps even evolved, more rapidly.
I offer one suggestion for a topic if discussion and debate among manufacturers, CE/HTM, and caregivers. Should manufacturers be required to make public the risk management files they are required to maintain by existing regulation?
This was a point of major contention between clinical engineers and manufacturers during the period I worked on medical device communications interoperability generally and the 80001 standard in particular almost two decades ago. Manufacturers resolutely refused to share their files, and the handful of CEs involved asked repeatedly how we were supposed to have confidence that we or anyone could assess a system of interacting devices where we were denied access to information concerning potential risks?
Hopefully that concern has been resolved.
24/7 would do its community a service by helping to assess whether it has.
And with that, I end my string of buzzwords.