What does digital transformation mean for you?
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There is huge potential value in using IoT for servicing products in the field. Companies can improve customer satisfaction and control service costs by leveraging remote service and monitoring, and understanding how products actually perform in field settings. But there are unique challenges for medical device companies with a connected service vision, including connectivity into devices that are used in life-critical procedures like human surgery. Learn how Medtronic, the world’s largest medical device manufacturer, used the ThingWorx platform to establish smart, connected medical devices and transform their Field Service organization to a Remote Service organization, driving substantial economic benefit and operational improvement.

More and more companies are transforming into model-based enterprises (MBE), using tools and processes of digital product creation (DPC). These transformations are comprehensive, with implications to strategy, business processes, data and people. In this session, Stryker and Kalypso will share technical guidance on leading practices for data creation and management as companies prepare for MBE and DPC, typical barriers and success factors for achieving business benefits, and specific organizational change recommendations.

Fresenius Medical Care is recognized as a global leader in renal care and dialysis systems development with operations in 130 countries. But sometimes, even market leaders need to change. Competitive forces demand that they harmonize global product development business processes and consolidate product development, manufacturing, quality, and regulatory systems into an integrated global system that leverages a common PDM platform. This session will cover how Fresenius leverages industry-leading practices and solutions, along with a cloud-based infrastructure, to overcome obstacles, transform their organization, and drive adoption around the globe.

The FDA Case for Quality (CfQ) provides guidance on how to shift from compliance-centric to product-centric outcome based innovation business models. This new strategy relies heavily on digital transformation and harmonization of cross-functional activities that contribute to the safety and efficacy of each device. Once implemented, regulatory imperatives like EU MDR, UDI, and EUDAMED become more easily managed and a competitive differentiator as regulatory information management (RIM), product BOM’s, documents, changes, non-conformances, complaints and CAPA’s are part of one integral system. In this session, leading medical device manufacturers will present how they are implementing proactive regulatory and quality business strategies within their businesses, milestones to date, and lessons learned along the way. As moderator, Kalypso will showcase industry best practices and leading methodologies.

Johnson & Johnson is leveraging Product Lifecycle Intelligence (PLI), an evolution of PLM to mine operational insights from their product development data that has accumulated within their PLM environments and integrated business systems. Enabled by ThingWorx Analytics and machine learning techniques, PLI is helping them predict the impact of product development decisions on key business performance metrics like demand, cycle time, cost, quality, regulatory compliance, manufacturability and supply chain efficiency. This session will share practical tips and leading practices from PLI users within J&J who have committed to using a data-driven approach to solving product development challenges. Join us to learn how you can establish competitive advantage and improve business performance with PLI technology.

The medical device industry is facing a wave of regulatory challenges, including EU MDR, GDPR, and Single Audit Program (MDSAP). The EU MDR 2020 deadline for the first wave of devices is rapidly approaching, and companies are moving from planning to action. Learn how life sciences leaders are rising to the challenge in this panel discussion. Panelists will explore a range of approaches for tackling common compliance challenges and highlight similarities and differences across companies.