A Medical Device Plant Journey: From Lean-6 Sigma, through Operational Excellence, to an Industry 4.0 Vision

Wednesday, 28 November 2018 10:10 - 10:45


  • LivaNova is a global medical technology company built on nearly five decades of experience and a relentless commitment to improving the lives of patients around the world. Our advanced technologies and breakthrough treatments provide meaningful solutions for the benefit of patients, healthcare professionals, and healthcare systems. At LivaNova, we understand the importance of bringing both clinical and economic value to our customers. We are an active, market-leading medical technology and services company, offering a diverse product portfolio and global reach. LivaNova is listed on the NASDAQ stock exchange; we are a market leader with a workforce of more than 3,500 employees worldwide. We are headquartered in London (UK) and maintain a presence in more than 100 countries.
  • Mirandola plant has been, since the beginning of the Lean journey in 2010, the first mover and the front head of LivaNova manufacturing sites. In the last 8 years, a solid foundation was built leveraging on Lean principles conjugated with advanced 6 Sigma applications, which merged recently into an integrated Operational Excellence development, together with the other sites in the group.
  • In addition to that, since 2 years Industry 4.0 applications were progressively developed, together with a significant processes automation expansion, exploring new ways on how to envision a fully integrated approach among all the above components
  • Being the manufacturing cycle of Disposable products vertically integrated (from plastic moulding injection to sterilization), the opportunities of implementing Operational Excellence and Industry 4.0 have been wide, based on a very strong validation process (being ourselves in a critical medical device business). Among the most relevant are:
    • Six Sigma implementation in moulding to manage automatic components scrap based only on process parameters control (Zero dimensional control)
    • Real time OEE and deep analytics by means of statistical tools to measure not only specific data by equipment but also trends and line capability
    • Fully automated sterilization and handling process, processing more than 100 pallets/day with parametric release, moving goods with AGV from the assembly lines to sterilization and then Finished Goods warehouse
    • Enhanced automatic and robotized machines developed starting from several Lean principles: takt time, one piece flow, change over reduced from minutes to seconds, full Poka Yoke, TPM, real time traceability by SCADA, drastic reduction of paper for shop floor management
    • Creation of multifunctional teams focused on value streams rather than on processes
    • Electronic paperless Kanban implementation as lean manufacturing strategy used to avoid overproduction and contain inventory stock
    • Driving operational and environmental improvements through better operators involvement
  • New frontiers under test at the moment will complement the existing structure to further develop Industry 4.0 applications
    • Automatic visual inspection in molding, fully replacing the human control with higher accuracy, added with automatic components packaging and handling
    • In-process total quality control (dimensional and aesthetical) and automatic retrofit actions (retroaction) in order to improve process capability
    • Automatic material handling and picking in Finished Goods warehouse through AGV forklifts working 24/7
    • Predictive maintenance and predictive SPC
    • Unconventional heating technologies (radiofrequency, irradiation) in assembling production lines to contain operating costs and reduce environmental impact
    • Replacement of hydraulic driven equipments with electric ones in molding, in order to improve process capability, minimize machines breakdown ,reduce utilities and maintenance costs
    • Implementation of ISO 14001 environmental certification and the OSHAS 18000 to promote environmental, health, safety and sustainable organization à investment to increase eco-sustainability of the site (e.g. On-site trigeneration plant to decrease energy utilities costs, increase power reliability (avoid black-outs, brown outs...) and reduce emissions of air pollutants)

Vittorio Morizio, Vice President, Head of Manufacturing, Cardiac Surgery; Head of Operational Excellence, LivaNova