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Case Study: Defining the Digital Roadmap for Operational Excellence in MedTech

How we helped Shockwave Medical develop a value-based strategy to drive innovation, productivity and quality at scale

Shockwave Medical, a Johnson & Johnson MedTech portfolio company, is at the forefront of innovation in cardiovascular disease care, with its minimally invasive intravascular lithotripsy (IVL) technology improving the lives of over 300,000 patients every year.

The market for cardiovascular treatments is currently growing at a high double-digit rate annually.

To keep pace, Shockwave needed to scale its operations efficiently while maintaining the highest quality and compliance standards across global markets.

Growth at this scale introduced challenges, such as fragmented digital systems, regulatory complexities and the need for operational agility. To remain a market leader, Shockwave required a structured digital transformation strategy—one that enabled rapid innovation, seamless collaboration and compliance at scale.

Real Results

  • $55M in projected ROI over four years through implementation of four high-impact digital solutions

  • Enhanced quality control through digital oversight, resulting in reduced recall risks and streamlined audit processes

  • Increased productivity across teams through optimized performance without additional headcount requirements

  • Digital foundation established for future autonomous operations and AI-powered insights

Video: Accelerating Value Creation from Digital Manufacturing Initiatives

To meet their growth and product release targets, Shockwave leadership prioritized a digital transformation strategy aligned with four key business pillars —

  • Scale Enablement – growing at or above market rate
  • Innovation Velocity – committed to launching 2 new products every year
  • Productivity – empowering employees and fostering seamless collaboration
  • Quality and Compliance – streamlining compliance with the right tools and data

Our Approach

To drive transformation, Kalypso leveraged its proven Digital Value Accelerator (DVA) methodology to develop a strategic roadmap aligning technology investments with Shockwave’s business priorities.

In the first phase of the project, Kalypso conducted an eight-week DVA to develop a digital transformation plan based on Shockwave’s current technology infrastructure, challenges and business objectives. This work was carried out through 40+ SME and leadership interviews, in-depth site assessments and an analysis of Shockwave’s existing technology ecosystem.

During the initial phase, Kalypso delivered:

  • A prioritized digital roadmap – A clear, phased approach to investment
  • Defined high-value use cases – Ensuring alignment with business objectives
  • Implementation blueprint – A step-by-step plan for execution
  • Projected $55M in ROI – Business case for four digital solutions over four years

With this foundation, we moved into the next phase: designing and implementing the most impactful solutions.

In this second phase, Kalypso focused on two critical enablers of digital transformation: Product Lifecycle Management (PLM) and Manufacturing Execution Systems (MES). These solutions would serve as the backbone for scaling innovation, quality and compliance.

A Quick Primer on Intravascular Lithotripsy

  • Heart disease remains one of the leading causes of death worldwide.
  • Over the past 30 years, cardiovascular disease rates have surged by 60%, placing millions at risk.
  • IVL technology uses acoustic shockwaves to safely break up calcified plaque, restoring blood flow and reducing the risk of severe cardiovascular events.
  • Shockwave Medical’s IVL system is revolutionizing treatment, offering a minimally invasive alternative to traditional interventions. IVL can prevent more serious health outcomes and improve qualify of life for patients.


By capturing design, integration and adoption activities, Shockwave now has a clear path to transform their operations to better serve patients and providers.

With a scalable digital foundation, the company is positioned to accelerate innovation, enhance quality and expand access to its life-saving technology worldwide.