Industry Spotlight: Data Strategy for Medical Device Manufacturers

Unlocking Innovation and Compliance in a Complex Landscape

Medical device manufacturers are at the forefront of healthcare innovation, delivering life-saving technologies that improve patient outcomes and quality of care. Yet, as the industry evolves, so do its challenges. From post-market surveillance and device connectivity to real-world evidence generation and stringent regulatory requirements, the sector faces mounting pressure to modernize and harness the full potential of its data. Publicis Sapient stands as a trusted partner, helping medical device companies break down data silos, overcome operational inefficiencies, and build unified data strategies that drive innovation, compliance, and customer engagement.

The Unique Data Challenges Facing Medical Device Manufacturers

1. Siloed Data and Fragmented Systems

Medical device organizations often operate with data scattered across product lines, geographies, and legacy systems. This fragmentation makes it difficult to gain a holistic view of device performance, patient outcomes, and operational efficiency. Without a unified data strategy, valuable insights remain locked away, limiting the ability to innovate and respond to market needs.

2. Regulatory Hurdles and Data Privacy

The medical device sector is governed by rigorous regulations such as FDA, GDPR, and HIPAA. Ensuring compliance requires robust data governance, auditable processes, and secure handling of sensitive patient and device data. Navigating these requirements while enabling digital transformation is a delicate balance that demands deep industry expertise.

3. Post-Market Surveillance and Real-World Evidence

Manufacturers must continuously monitor device safety and effectiveness after market launch. This involves aggregating and analyzing data from diverse sources—clinical systems, device telemetry, patient feedback, and more. Generating real-world evidence to support regulatory submissions and product improvements is both a challenge and an opportunity for those with the right data infrastructure.

4. Device Connectivity and Interoperability

The rise of connected medical devices introduces new complexities. Integrating device data with electronic health records, cloud platforms, and analytics tools requires secure, scalable architectures. Ensuring interoperability while maintaining data integrity and privacy is essential for delivering value to providers and patients alike.

5. Operational Inefficiencies

Manual processes, legacy workflows, and lack of automation can slow down everything from product development to regulatory reporting. Streamlining operations through data-driven automation not only reduces costs but also accelerates time-to-market and enhances compliance.

How Publicis Sapient Empowers Medical Device Manufacturers

Unified Data Strategy: Breaking Down Silos

Publicis Sapient partners with medical device companies to develop and execute comprehensive data strategies. By leveraging platforms like Salesforce Data Cloud and advanced integration tools, we help organizations consolidate data from disparate sources, creating a single source of truth. This unified view enables:

Regulatory Compliance by Design

Our approach embeds compliance and privacy into every layer of the data strategy. We help clients establish robust data governance frameworks, automate consent management, and leverage built-in compliance features of leading platforms. This ensures that all data initiatives—whether for post-market surveillance, clinical trials, or customer engagement—meet the highest regulatory standards.

Enabling Real-World Evidence and Post-Market Surveillance

With unified, high-quality data, manufacturers can generate real-world evidence more efficiently. Publicis Sapient’s expertise in data integration and analytics empowers organizations to:

Driving Device Connectivity and Digital Transformation

We design and implement secure, scalable architectures for connected devices, ensuring seamless data flow between devices, cloud platforms, and analytics tools. Our solutions enable real-time monitoring, predictive maintenance, and enhanced patient support—unlocking new business models and value streams.

Operational Efficiency Through Automation

By automating manual workflows and integrating advanced analytics, we help medical device companies reduce operational overhead, accelerate product development, and improve responsiveness to regulatory changes. Our SPEED framework—Strategy, Product, Experience, Engineering, Data & AI—ensures that every transformation is tailored to the unique needs of the sector.

Real-World Impact: Transforming Data into Value

Publicis Sapient’s proven methodologies have delivered measurable outcomes for leading healthcare and life sciences organizations:

Why Publicis Sapient?

With deep expertise in healthcare and life sciences, a track record of successful digital transformations, and a relentless focus on measurable outcomes, Publicis Sapient is uniquely positioned to help medical device manufacturers thrive in a data-driven future. Our collaborative approach brings together cross-functional teams—clinical, IT, compliance, and commercial—to define goals, prioritize opportunities, and deliver actionable roadmaps.
Whether you are seeking to modernize your data infrastructure, enhance regulatory compliance, or unlock new value from connected devices, Publicis Sapient is your partner for sustainable, scalable transformation.
Ready to transform your data strategy and drive the next era of medical device innovation? Connect with Publicis Sapient to start your journey.