U.S. Medical Device Makers Shift Technology Investments Across the Product Lifecycle
U.S. medical technology companies are moving beyond traditional product development models and increasingly investing in software-defined ecosystems designed to evolve throughout the entire product lifecycle, according to a new research report from Information Services Group (ISG) (Nasdaq: III), 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 medical device manufacturers are shifting digital investments away from isolated technology initiatives and toward integrated capabilities that span engineering, regulatory affairs, quality management, cybersecurity and post-market operations.
As medical devices become increasingly connected and software-driven, these functions are becoming more interdependent. A software update, for example, can have implications for validation evidence, cybersecurity requirements, regulatory documentation and the performance of devices already deployed in the field. ISG says manufacturers therefore need a digital foundation that connects information, workflows and decision-making across the complete product lifecycle.
Moving from Individual Projects to Lifecycle Transformation
“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.”
The shift toward lifecycle-oriented transformation reflects the growing complexity of medical technology. Manufacturers are seeking ways to maintain continuous improvement after products reach the market while ensuring that changes remain compliant, traceable and secure.
Rather than treating engineering, quality, regulatory and cybersecurity as separate functions, organizations are increasingly integrating these disciplines into common digital workflows. This approach can help manufacturers respond more effectively to product changes, emerging risks and information gathered from devices in real-world environments.
AI and Automation Move Into Regulated Workflows
Artificial intelligence and automation are becoming increasingly important across medical device operations. Companies are applying these technologies to engineering, software development, testing, verification, validation and technical documentation.
As AI adoption progresses beyond experimentation and proof-of-concept initiatives, manufacturers are evaluating whether AI-enabled workflows are sufficiently reliable for highly regulated environments. Factors such as explainability, data governance, human oversight and change control are becoming increasingly important considerations when organizations evaluate AI technologies and service providers.
Manufacturers are also exploring agentic AI, although adoption remains selective. ISG says companies are cautious about permitting autonomous AI execution within processes that are highly regulated or safety-critical. Instead, organizations are focusing on use cases where AI can enhance productivity and decision-making while maintaining appropriate human accountability and controls.
Integrating Quality, Regulatory and Cybersecurity
Medical device manufacturers are also modernizing quality management systems and improving software bill of materials management to create greater consistency across development and operational processes.
Organizations are increasingly embedding regulatory, risk and cybersecurity controls directly into engineering and product-development workflows. This approach can improve traceability while helping companies respond to requirements associated with the federal Quality Management System Regulation and strengthen vulnerability management for software-based medical devices.
ISG says manufacturers increasingly view quality transformation not simply as a downstream compliance function, but as an enabler of faster engineering and product development. By integrating quality and compliance requirements earlier in the lifecycle, companies can reduce rework and improve visibility into potential risks before products reach the market.
Using Real-World Data to Improve Products
The growing connectivity of medical devices is also creating new opportunities to use data from deployed products to support continuous improvement.
Manufacturers are implementing capabilities such as remote patient monitoring, predictive maintenance and complaint intelligence to gather operational and patient information from devices in the field. The objective is to identify potential safety signals earlier and use those insights to inform engineering, regulatory and quality decisions.
Real-world data can also strengthen the evidence available to teams responsible for product improvement and lifecycle management. By connecting field experience with product development processes, manufacturers can gain a clearer understanding of how devices perform in real-world settings.
According to ISG, organizations are increasingly measuring the success of these initiatives through outcomes such as shorter complaint-resolution cycles, reduced validation effort, fewer quality issues and improved device uptime.
Connecting Field Experience With Product Decisions
“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 highlights the growing integration of companion applications and remote monitoring capabilities into medical devices. These technologies are expanding the digital ecosystem surrounding connected products and creating additional opportunities for manufacturers to deliver services, gather insights and maintain ongoing relationships with users.
Evaluating Medical Device Digital Service Providers
The 2026 ISG Provider Lens® Medical Device Digital Services report evaluates 25 providers across three quadrants:
- Digital Engineering and Product Development
- Regulatory Compliance, Strategy and Quality Assurance
- AI and Innovation Driving Post-Market Enablement
ISG recognizes Accenture, Capgemini, Cognizant, HCLTech, Infosys, LTTS, TCS and Wipro as Leaders in all three quadrants. Deloitte is named a Leader in one quadrant.
The report also recognizes Apexon, Hexaware and Tech Mahindra as Rising Stars in one quadrant each. Under ISG’s definition, Rising Stars are companies with a promising portfolio and high future potential.
These evaluations provide medical device enterprises with insights into the capabilities of technology and business service providers supporting digital transformation across the product lifecycle.
Persistent Systems Recognized for Customer Experience
In customer experience, Persistent Systems is named the global ISG CX Star Performer for 2026 among medical device digital service providers.
Persistent Systems earned the highest customer satisfaction scores in ISG’s Voice of the Customer survey, which forms part of the ISG Star of Excellence™ program, a quality recognition program for the technology and business services industry.
The recognition highlights the growing importance of customer experience alongside technical capabilities as medical device companies select service providers to support long-term digital transformation initiatives.
Accessing the Full Research
For additional insights into the challenges facing medical device enterprises in the U.S., as well as ISG’s recommendations for addressing those challenges, the ISG Provider Lens Focal Points briefing provides further analysis.
A customized version of the report is also available from Zimetrics. The full 2026 ISG Provider Lens Medical Device Digital Services report for the U.S. is available to subscribers or for one-time purchase.
About ISG
ISG (Nasdaq: III) is a global AI-centered technology research and advisory firm. A trusted partner to more than 900 clients, including 75 of the world’s top 100 enterprises, ISG is a long-time leader in technology and business services and is now at the forefront of leveraging AI to help organizations achieve operational excellence and faster growth.
Founded in 2006, ISG is known for its proprietary market data and research, in-depth knowledge and governance of provider ecosystems, and the expertise of its approximately 1,500 professionals worldwide. Together, ISG’s teams help clients maximize the value of their technology investments and navigate an increasingly complex digital landscape.
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