AU Class
AU Class
class - AU

Product Development—Sunny, with a Chance of (Soul-Crushing) Regulation

Share this class
Search for keywords in videos, presentation slides and handouts:


    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