Accelerate digital transformation with the digital thread

Background image: Med Dev Digital Thread Kalypso

We help companies craft a scalable and actionable strategy to connect the enterprise and transform product innovation with a seamless flow of information across the value chain.

Today there are endless opportunities for medical device and equipment makers to serve more people around the world with increasingly innovative and affordable devices, but to capture these opportunities, companies must address the challenges that impact their ability to effectively innovate and commercialize new products.

Digital technologies and capabilities hold the potential to transform organizations by making it easier to embrace new opportunities and adapt when market challenges arise. Increased connectivity across the value chain is how companies become more agile and resilient, positioning them for long-term gains and increased market share.

While the benefits of digital transformation are clear, navigating the continuously evolving technology landscape and constructing programs that have well prioritized objectives, target robust architectures and plan for effective organizational change is difficult. Many companies struggle to develop scalable and actionable digital transformation strategies.

The digital thread is a seamless flow of data that connects business processes across the value chain. It helps companies address key industry challenges.

  • Shift strategic priorities more easily to address rapidly evolving market expectations such as value-based healthcare, higher levels of technology sophistication, personalized solutions, and home healthcare devices
  • Eliminate silos and data proliferation to accelerate product development and commercialization
  • Accelerate product registrations, submissions and tracking in an ever-evolving global regulatory landscape
  • Proactively find opportunities for top-line growth and cost containment to maintain margins and meet shareholder and pricing pressures
  • Dynamically adapt supply chain operations to address fluctuating demand, supply and production exacerbated by pandemics such as COVID-19
  • Gain greater value from mergers, acquisitions and divestitures

The digital thread delivers measurable business outcomes by transforming the way companies in the medical device industry navigate challenges and discover opportunities to accelerate growth.


  • Improve and save patient lives
  • Gain competitive advantage
  • Increase agility and resilience to market dynamics
  • Attract and retain top talent


  • Faster time to market
    Up to 33% decrease in time to market
    Up to 50% decrease in cycle time change
  • Higher product innovation and development yield
    Up to 80% faster product requirements creation
    Up to 90% decrease in design reviews
  • Higher regulatory compliance rates
    Up to 90% improvement in right-first time quality
    Up to 30% reduction of specification rejections


  • Increased sales from new products
  • Greater cost efficiency in design and manufacturing
    Up to 25% increase in productivity
    Up to 50% decrease in tool and fabrication costs
  • Reduction in operating expenses
    Up to 12% increase in labor efficiency
    Up to 40% decrease in maintenance cost

How We Help Medical Device and Diagnostics Companies Enable the Digital Thread

We develop strategy. We also design, deliver, validate and implement solutions to achieve it.

We have delivered business value and rapid, sustainable results for the world's leading medical device and equipment companies. We achieve this by breaking down complex challenges through prioritized step-wise approaches to demonstrate immediate value.

Our digital thread strategy service seeks to understand your organizations unique aspirations and challenges and helps provide a cohesive roadmap to value leveraging these capabilities. Together, we develop a cohesive, prioritized approach to building out your digital value chain. Our approach scales across all aspects of the product lifecycle and can be broad or focused on specific domains.

Digital Transformation Maturity Assessment

We help you evaluate your current state of digital maturity within and across functions, existing digital transformation and digital thread plans, and how you compare to peers in the industry.

Digital Thread Education

We provide you with a tailored blend of digital subject matter content and value at scale case studies to help you explore the different attributes of enterprise digital transformation and the leading practices for achieving scale.

Digital Thread Vision

We help you craft a compelling digital vision that defines how emerging and disruptive technologies will impact your organization, the problems we’ll solve and the benefits we’ll deliver for your customers.

Proof of Concept Use Case Selection & Implementation

We help you select and develop concrete use cases with a strong link to business value.

Digital Thread Roadmap & Business Plan

We work with you to use success from your initial proof of concept(s) to build a broader case for change and roadmap, and gain executive sponsorship for the next phases.

Implementation and Support

Following the assessment and strategy work, we can support you with the full-scale implementations of solutions across the discover-create-make-sell process spectrum as well as provide managed services for the deployed solutions.

Use Cases

Improve margins by reducing scrap/waste, cost of goods sold (COGS) and operational inefficiencies

Follow a broader strategy to optimize operations by enabling, connecting and enhancing capabilities including:

  • Model Based Enterprise
  • Product Lifecycle Management
  • Factory Emulation
  • Manufacturing Execution System
  • Facility Twin with Augmented Reality
  • Smart Connected Operations and Industry 5.0 Concepts
  • Data Science / Artificial Intelligence

Address audit issues resulting from redundant and inconsistent information in the design history file (DHF)

Consider a strategy that encompasses the enablement or improvement of capabilities including:

  • Systems Engineering
  • Product Lifecyle Management
  • Data Science / Artificial Intelligence

Connect in-market devices and use real-time data to improve product quality

Focus on developing, deploying and fully integrating:

  • Systems Engineering (including requirements, risk and test)
  • Product Lifecycle Management
  • Quality Management System

The Kalypso Difference

Deep Medical Device Industry Experience

We have served over 100 medical device clients in all areas of digital innovation, including 6 of the top 10 medical device companies in the world. We are industry practitioners with a first-hand knowledge of your products, data, process and organization.

Comprehensive Value Chain Capabilities

Our capabilities across the value chain enable a digital thread of information that changes the way our clients discover, create, make and sell new products. We deliver rapid results while building towards a long-range vision.

Open Platform Approach

We build a scalable and actionable strategy, aligning business and operational models through applied expertise in information technology (IT) and operational technology (OT). We take an open architecture approach to digital transformation, enabling clients to utilize best-of-breed solutions to meet their business needs.


We helped a $10B medical device company produce more products, faster, with the digital thread.

Our client sought to develop a digital strategy and program that would improve the quality and performance of their production process and align the organization through integrated data.

By interviewing 40 executives across 14 business units, we aligned and developed a strategy around 4 focus points for the organization: innovation, quality, integration and rationalization of low-value products. With these focus points defined, we built a pragmatic roadmap for digital thread that resulted in incremental value to all business units, avoiding degradation of capability in every instance.

Through a persistent governance process, we helped to transform how the organization collaborated, harmonized and standardized the quality system, including processes, capabilities and tools.

The program was implemented in partnership with Kalypso and delivered 14 integrated capabilities resulting in faster engineering productivity, laying a foundation for model based enterprise. Through this implementation we accelerated the product lifecycle, helping the client deliver more products annually.

The program reduced compliance risk and increased regulatory clarity allowing more sophisticated registration strategies and global revenues. The system has so far been deployed to over 20,000 users globally and 9 business units.

Our work allowed the organization to become an industry leader in their markets.

Together, we enabled:

  • 40 executives across 14 business units to align on a focused strategy
  • 14 integrated capabilities, resulting in faster engineering productivity
  • Reduced compliance risk and increased regulatory clarity
  • Accelerated product lifecycles, to deliver more products annually
  • The foundation for model based enterprise
Background image: Medical Device Case Study
Background image: Kalypso White Overlay

Thought Leaders

Dave Hadfield2023
Director & Global Leader - Medical Device Practice