Description
Product development is plagued with government regulation. If a product is intended to improve the quality of lives, or at least do no harm, then its market is probably regulated by dozens to hundreds of government organizations. We see this pattern play out in markets for medical devices, industrial equipment, vehicles, food, consumer products, and anything that might be touched by children. Product data management is a key enabler of efficient development processes, in general. This session will illustrate the challenges that have been addressed at Ascensia, a worldwide market-leading innovator in diabetes care. In the midst of organizational changes, Ascensia has deployed Fusion Lifecycle software to manage its product changes among a dizzying array of regulations and market expectations. This session will tell the story of the decisions, setbacks, and successes along the firm’s journey. Anyone concerned with managing external market requirements will appreciate this discussion.
Key Learnings
- Discover the role of regulation on product design decisions
- Learn about the common themes and goals of regulation, with specific examples from the US Food and Drug Administration (FDA)
- Learn how to minimize costs of regulatory compliance
- Discover the story of Ascensia’s success with Fusion Lifecycle
Speakers_few
- SCStephanie ChrismanStephanie is a PLM Analyst in Engineering Services at Ascensia Diabetes Care. She spent 20 years in marine and metal fabrication which included welding, scheduling, estimating and eventually IT, as well as more than 10 years as a SolidWorks designer. While working with SolidWorks, she developed department standards and procedures and built a framework of design tables that cut modeling/detailing time for in-house product by half. Stephanie was the engineering lead in moving a paper EC process to Infor Visual and led the project to reimplement Visual alongside a DB upgrade from SQLBase to SQLServer. Ascensia implemented Fusion Lifecycle in August 2017 for EC and is expanding its use to Quality and project scoping and scheduling.
Rodney CoffeyRodney Coffey is the Razorleaf Business Development Manager for PLM services focused on Autodesk. He is an experienced product lifecycle management consultant and has spent the last decade of his career leading teams and implementing PDM & PLM systems for manufacturing clients. He has extensive PLM product experience with the leading PDM, PLM, and business system integration tools in the industry. He works closely with the Razorleaf services team and Razorleaf partners to provide customers with value-added services to streamline their business processes and transform their business.
Fred SmithFred Smith is a Texas-based product development specialist, who has spent 25+ years romping around the aerospace, medical device, energy, and software industries. He is currently a Solution Architect at Autodesk. Fred holds graduate degrees in computer science and electrical engineering from Washington University in St. Louis. In his spare time, Fred is a reader, data scientist, and maker/hobbyist.
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