Software-defined products lead manufacturers to rethink product development and post-market operations, ISG Provider Lens^® report says

Medical device manufacturers in Europe are changing how they develop and manage products as software, connected technologies and evolving regulations become more important throughout a device’s life, 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 2026 ISG Provider Lens^® Medical Device Digital Services report for Europe finds manufacturers are becoming more selective about technology investments, prioritizing proven business value, implementation maturity and long-term viability. Before scaling new initiatives, they require measurable results and tested deployment models.

"Traditional divisions between product functions are becoming harder to maintain as medical devices keep evolving after they enter the market," said Sven Geissler, partner, ISG. "Manufacturers need to increase coordination across the product lifecycle without compromising the safeguards required in a regulated industry."

European manufacturers are adapting product development to software-defined devices that require ongoing updates after commercialization, the report says. Rather than simply adding engineering resources, companies are using model-based engineering, automation and AI-assisted software development to improve productivity as products become more complex. They are also adopting standardized digital platforms that bring previously separate engineering environments together and support ongoing product improvements. This marks a shift from one-time development programs toward continuous engineering throughout a device’s useful life.

Regulatory readiness increasingly depends on engineering maturity and digital traceability as well as documentation quality, ISG says. As requirements evolve, European manufacturers are integrating regulatory expertise into product design and adopting digital quality practices to strengthen traceability and consistency. Cybersecurity and AI introduce new compliance challenges, with expanding AI use increasing the need for validation, explainability and human oversight.

Medical device manufacturers in Europe are using post-market data from connected products and remote monitoring to identify potential problems earlier and understand device performance better. Manufacturers are feeding these insights back into product development to guide software updates, design improvements and risk management. Patient engagement is also becoming more important as companies seek ongoing feedback to improve products after they reach the market.

"Medical device companies can no longer treat a product as finished once it reaches the market," said Sneha Jayanth, ISG lead analyst and lead author of the report. "Providers that can support continued improvement while meeting changing requirements will become increasingly important."

The report also explores other trends affecting European medical device companies, including a growing emphasis on sustainability and increasing demand for providers that combine global resources with strong regional expertise.

For more insights into the challenges faced by medical device companies in Europe, plus ISG’s advice for overcoming them, see the ISG Provider Lens Focal Points briefing here.

The report evaluates the capabilities of 30 providers across three quadrants: Digital Engineering and Product Development, Regulatory Compliance, Strategy and Quality Assurance, and AI and Innovation Driving Post-Market Enablement.

The report names Accenture, Capgemini, Cognizant, HCLTech, Infosys, LTTS, TCS and Wipro as Leaders in all three quadrants and Deloitte as a Leader in one quadrant.

In addition, Hexaware is recognized as a Rising Star — a company with a "promising portfolio" and "high future potential" by ISG’s definition — in two quadrants. Tata Elxsi is named as a Rising Star in one quadrant.

In the area of 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, part of the ISG Star of Excellence^™ program, the premier quality recognition for the technology and business services industry.

The 2026 ISG Provider Lens Medical Device Digital Services report for Europe is available to subscribers or for one-time purchase on 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 and research, in-depth knowledge and governance of provider ecosystems, and the expertise of its 1,500 professionals worldwide working together to help clients maximize the value of their technology investments.

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Press Contacts:

Laura Hupprich, ISG

+1 203-517-3132

laura.hupprich@isg-one.com

Philipp Jaensch, ISG

+49 151 730 365 76

philipp.jaensch@isg-one.com