U.S. medical device makers embrace digital-first models to meet compliance and patient needs, report says

U.S. medical device companies are increasingly adopting digital-first and patient-centric business models to accelerate innovation while navigating growing compliance and cybersecurity demands, according to a new report from Information Services Group, a global technology research and advisory firm.

The 2025 ISG Provider Lens Medical Device Digital Services report highlights the ongoing transformation in how medical device manufacturers design, validate, and monitor their products. By integrating digital compliance and patient-focused design, these companies are enhancing their operational agility and building greater trust with both regulators and consumers.

Jenn Stein, ISG partner and life sciences industry lead, noted that U.S. medical device makers are shifting their strategies to embed digital solutions into their operations. “By embedding digital compliance and patient-centric design into their operations, they are enhancing agility and trust,” she said.

The report reveals that manufacturers are modernizing product development and post-market processes with advanced technologies such as AI, connected devices, and data-driven quality assurance systems. These innovations are crucial as manufacturers contend with increasing regulatory scrutiny, cost pressures, and rising patient expectations.

Digital engineering is playing a key role in helping companies reduce time-to-market for new products without sacrificing quality, according to the report. U.S. manufacturers are integrating technologies like digital twins, AI, and advanced simulations into design and testing phases. These tools allow for real-time performance analysis, predictive diagnostics, and virtual prototype validation. Notably, digital twins are now being used not only for devices but also to model human systems, facilitating more personalized care.

AI is also central to the efforts to strengthen regulatory compliance. Many manufacturers are adopting digital quality management systems and regulatory intelligence platforms to ease the administrative burden of meeting evolving standards such as the U.S. Food and Drug Administration’s (FDA) Quality Management System Regulation (QMSR). These systems streamline documentation, automate risk-based validation, and support continuous audit readiness, helping companies stay ahead of changing regulatory frameworks.

The focus on patient needs is another emerging trend reshaping product strategy, the report states. Manufacturers are investing in user-friendly interfaces and accessibility features to improve device usability, which can enhance patient adherence to prescribed care plans. Additionally, advances in post-market surveillance and analytics are enabling manufacturers to gather real-world evidence, monitor safety, and drive continuous product improvements.

“Enterprises that combine compliance, technology, and human-centered design are setting new standards for medical innovation,” said Rohan Sinha, senior manager and principal analyst at ISG, 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 trends within the U.S. medical device sector, such as the growing use of eco-friendly materials for sustainability and the adoption of secure cloud architectures to protect patient and device data.

As the industry continues to evolve, U.S. medical device makers are positioning themselves at the forefront of innovation by embracing digital-first strategies that enhance product quality, safety, and patient outcomes while meeting rising compliance and cybersecurity standards.