AI-Driven Tools Boost U.S. Medical Device Development

Manufacturers modernize product engineering, post-market monitoring for faster product rollouts, ongoing improvements, ISG Provider Lens^® report says

STAMFORD, Conn.--(BUSINESS WIRE)-- U.S. medical device companies are adopting digital-first and patient-centric operating models to accelerate innovation while meeting rising compliance and cybersecurity requirements, according to a new research report published today by Information Services Group (ISG) (Nasdaq: III), a global AI-centered technology research and advisory firm.

The 2025 ISG Provider Lens^® Medical Device Digital Services report for the U.S. finds enterprises are modernizing their product development and post-market digital enablement processes with connected technologies, data-driven quality assurance and sustainability initiatives. As manufacturers face increasing regulatory scrutiny and cost pressures, they are using advanced digital tools to enhance safety, efficiency and patient outcomes while complying with evolving standards.

“U.S. medical device makers are transforming how they design, validate and monitor products,” said Jenn Stein, ISG partner and life sciences industry lead. “By embedding digital compliance and patient-centric design into their operations, they are enhancing agility and trust.”

Digital engineering is helping enterprises reduce time to market and introduce new features without compromising quality. U.S. manufacturers are integrating AI, digital twins and advanced simulation into design and testing to speed product development, the report says. These tools perform real-time analysis of performance data, predictive diagnostics and virtual validation of prototypes. Digital twins are increasingly used to model not just devices but human systems, which helps to make more personalized care possible.

U.S. companies are adopting digital quality management systems and regulatory intelligence platforms to strengthen compliance and reduce administrative burdens, ISG says. AI is helping to make this possible by streamlining documentation, automating risk-based validation and supporting continuous audit readiness. These systems are becoming essential as firms adapt to new frameworks such as the U.S. Food and Drug Administration’s Quality Management System Regulation (QMSR). By embedding compliance in the design of devices, organizations improve traceability and prevent costly post-market revisions.

A growing focus on patients’ needs is reshaping product strategy, the report says. Manufacturers are investing in intuitive interfaces and accessibility features to enhance device usability, which can improve patients’ adherence to care plans. Advances in post-market surveillance and analytics help companies monitor safety, obtain real-world evidence and formulate product improvements. This data-driven approach lets companies respond proactively to patient and regulatory requirements.

“Enterprises that combine compliance, technology and human-centered design are setting new standards for medical innovation,” said Rohan Sinha, senior manager and principal analyst, ISG Provider Lens Research, and lead author of the report. “Service partners play a key role in enabling these companies to safely and ethically invent the future of medical devices.”

The report also explores other medical device trends in the U.S., including the use of eco-friendly materials for sustainability and secure cloud architectures for data protection.

For more insights into the technology-related challenges faced by medical device enterprises in the U.S., plus ISG’s advice for overcoming them, see the ISG Provider Lens^® Focal Points briefing here.

The 2025 ISG Provider Lens^® Medical Devices report for the U.S. evaluates the capabilities of 20 providers across three quadrants: Digital Engineering and Product Development; Regulatory Compliance, Strategy and Quality Assurance; and Post-market Digital Enablement.

The report names Accenture, Capgemini, Cognizant, HCLTech, Infosys, LTTS, TCS and Wipro as Leaders in three quadrants each. It names Deloitte as a Leader in two quadrants.

In addition, HARMAN, Hexaware and LTIMindtree are recognized as Rising Stars — companies with a “promising portfolio” and “high future potential” by ISG’s definition — in one quadrant each.

Customized versions of the report are available from Hexaware and LTTS.

The 2025 ISG Provider Lens^® Medical Device Digital Services report for the U.S. is available to subscribers or for one-time purchase on this webpage.

About ISG Provider Lens^® Research

The ISG Provider Lens^® Quadrant research series is the only service provider evaluation of its kind to combine empirical, data-driven research and market analysis with the real-world experience and observations of ISG's global advisory team. Enterprises will find a wealth of detailed data and market analysis to help guide their selection of appropriate sourcing partners, while ISG advisors use the reports to validate their own market knowledge and make recommendations to ISG's enterprise clients. The research currently covers providers offering their services globally, across Europe, as well as in the U.S., Canada, Mexico, Brazil, the U.K., France, Benelux, Germany, Switzerland, the Nordics, Australia and Singapore/Malaysia, with additional markets to be added in the future. For more information about ISG Provider Lens research, please visit this webpage.

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 that is now at the forefront of leveraging AI to help organizations achieve operational excellence and faster growth. The firm, founded in 2006, is known for its proprietary market data, in-depth knowledge of provider ecosystems, and the expertise of its 1,600 professionals worldwide working together to help clients maximize the value of their technology investments.

View source version on businesswire.com: https://www.businesswire.com/news/home/20251023023929/en/

Press Contacts:



Laura Hupprich, ISG

+1 203-517-3100

laura.hupprich@isg-one.com



Julianna Sheridan, Matter Communications for ISG

+1 978-518-4520

isg@matternow.com

Source: Information Services Group, Inc.