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Unlock the value of connected health

Accelerate the development of safe, reliable, and intelligent medical solutions

Intelligent medical products and systems are opening the door to a new era of healthcare, connecting patients, doctors, devices and entire healthcare systems. They offer increased agency, mobility, and ultimately – better outcomes.

Today’s technology and data enable:

  • faster, more accurate diagnostics
  • more efficient and effective treatments
  • more convenient, personalized, and less costly patient care

Intelligent medical products and systems make healthcare resources available at home and at doctors’ offices, reserving hospital care for extreme needs only. They improve care,  safety and efficiency through remote and integrated monitoring. And they deliver better outcomes through personalized medicine and improved patient experience.

increased complexity across development, operations, regulatory, and post market support.

The potential is enormous, but the challenges are also significant:

  • Time to market and cost pressures in an increasingly competitive environment
  • Breaking down functional and technological silos for efficient and integrated care
  • Ensuring reliable and secure integration and interoperability in the connected health ecosystem
  • Securing the data critical for patient insights, safety and well-being
  • Managing regulatory compliance when technology evolves at multiple times the speed of regulation
  • Global scaling and sustenance across markets with different local requirements

Succeeding in the complex connected health ecosystem requires deep multidisciplinary expertise combined with extensive regulatory knowledge, certified processes and assets.

We are a recognized global leader in medical devices, connected medical devices, MedTech digital transformation and patient engagement services. With over 35 years of experience in over 30 clinical categories, our medical device expertise includes:

Our full-lifecycle services accelerate the build, launch and operation at scale of intelligent medical products & systems, supported by strong regulatory, quality & compliance capabilities.

From components to complete connected systems

Whether you’re developing complex assemblies, optimizing them, integrating sensors and wearables or engineering complete end-to-end connected medical systems, processing signals, data, images and generating new AI enabled diagnostics or digital biomarkers, we’re here to accompany you on your entire journey. From biocompatible enclosures and electro-mechanical components, power and electronics, embedded software, mobile and web apps, sensors and IoT devices to cloud platforms and distributed systems, integrated and interoperable with new or legacy health IT, we deliver.

Complete lifecycle support

We support R&D from business concept and product strategy through design, development, verification and validation, and product certification. Beyond the engineering lifecycle we also support the business and regulatory strategy and the consequent operational launch, regulatory approval, and lifecycle maintenance including post-market surveillance and quality management support.

Intelligent Medical Products and Systems (IMPS) framework

Our Intelligent Medical Products and Systems (IMPS) framework provides an ideal foundation for Pharma and MedTech companies to build or extend their connected health solutions. It incorporates a set of tools, processes and libraries to significantly accelerate the development of compliant, GxP and SAMD-ready connected health systems. A composable solution with a microservices-based architecture using modular software building blocks, the framework provides curated reusable components, APIs and use-case specific blueprints to efficiently realize fully customizable and scalable digital health products and platform-based solutions.

Focused on interoperability, connectivity and data management, our IMPS framework is developed under certified processes and cybersecurity by design, supporting up to Class III SAMD. As a cloud-agnostic solution (AWS, Azure, Google Cloud compatible) with built-in healthcare interoperability (HL7/ FHIR/ DICOM, etc.), it enables ease of connectivity into the health ecosystem as well as integration with 3rd party systems.  It provides unprecedented flexibility and the ability to maintain full control of your IP, and to manage the evolution of your connected health system.

We can also ease compliance burden with full regulatory support throughout the lifecycle as well as take full responsibility as Legal Manufacturer of SAMD

    Capgemini as your legal manufacturer for SaMD

    Crossing the finish line

    Finding value in intelligent medical products

    Unlock the value of connected health

      Our offers

      We design secure, compliant, and engaging omni-channel digital health solutions (and platforms) that integrate seamlessly into the healthcare ecosystem. Our built-to-grow approach leverages our strong domain expertise coupled with deep regulatory knowledge.

      We combine user insights, new technologies, regulatory rigor, advanced systems engineering, and breakthrough business models to improve health outcomes, create business value, and delight users. E2E medical devices empower healthcare innovators to create, develop, and launch regulated smart products and services.

      From developing the strategy, through audits and deployment, to validation and operations, we help our clients ensure end-to-end privacy and security of data.

      Software-driven transformation across regulated platform & product engineering, engineering & lifecycle processes & transformative business models.
      With our global network of experts and more than 25 dedicated labs, we support the development, testing, certification and sustenance of a wide variety of medical products and systems. Our dedicated toolchains and proprietary frameworks accelerate product development, including:

      • Model Based Systems Engineering and Simulations,
      • our hardward in-the loop and automated test suite;
      • our DevSecOps pipeline.

      We provide best-in-class consulting and managed services combining deep sector know-how, extensive regulatory & compliance expertise – including approaches for rapid deployment – leveraging data & digital technologies to improve performance, quality and regulatory compliance.

      We support clients with regulatory strategy, regulatory documentation, audits, gap analyses and remediation activities and QMS optimization, managed services and operational QA/RA support at scale.

      We are certified to ISO 13485, ISO 27001, ISO 9001, ISO 14001, CMMI DEV/5 CMMI SVC/5 compliant to MRD, IVDR, 21 CFR 820, GDPR, HIPAA, GxP, and ensure conformity to all local regulations and all applicable standards

      What’s next

      Your medical products and system innovations have the potential to bring value to people’s lives. Let’s take them to market – quickly and safely. Contact one of our experts and find out how our capabilities can enhance your R&D.

      Meet our experts

      Abhishek Khandelwal

      Vice President, Engineering and R&D Services, Capgemini Engineering

      Atul Kurani

      Vice President, Head of Medical and IoT business, Capgemini Engineering

      Mark Hersey

      Solution Director & Business Development Lead Life Sciences | Quality, Process, Regulatory, Standards

      Andrew Koubatis

      ER&D Pre-Sales Director

      Suresh Sarojani

      CTO MedTech, Capgemini Engineering