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U.S. Medical Device Makers Shift Technology Investments to Complete Product Lifecycles

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  • U.S. medical technology companies are shifting from conventional product development to software-defined ecosystems that evolve continuously after launch.
  • Digital investment is increasingly focused on complete product lifecycles rather than isolated technology programs.
  • Engineering, regulatory affairs, quality management, cybersecurity, & post-market operations are becoming interdependent functions requiring an integrated digital foundation.
  • Enterprises are applying AI & automation to engineering, software development, testing, verification, validation, & technical documentation while evaluating reliability for regulated environments.
  • Manufacturers are exploring agentic AI but remain selective about allowing autonomous execution in highly regulated & safety-critical processes.
  • Organizations are modernizing quality management systems & strengthening software bill of materials management to harmonize processes.
  • Regulatory, risk, & cybersecurity controls are being embedded directly into development workflows to support the federal Quality Management System Regulation.
  • Manufacturers are implementing remote patient monitoring, predictive maintenance, & complaint intelligence to generate earlier safety signals using real-world data.
  • Success metrics include shorter complaint cycles, lower validation effort, fewer quality issues, & greater device uptime.
  • The 2026 ISG Provider Lens report evaluates 25 providers across three quadrants: Digital Engineering & Product Development, Regulatory Compliance, Strategy & Quality Assurance, & AI & Innovation Driving Post-Market Enablement.
  • Accenture, Capgemini, Cognizant, HCLTech, Infosys, LTTS, TCS, & Wipro are named Leaders in all three quadrants.
  • Deloitte is named a Leader in one quadrant.
  • Apexon, Hexaware, & Tech Mahindra are recognized as Rising Stars in one quadrant each.
  • Persistent Systems is named the global ISG CX Star Performer for 2026 among medical device digital service providers.