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Security-First Mindset Drives Both Performance and Profits

In manufacturing, medical device, medtech, risk management by Alicia CheungLeave a Comment

Designing with security in mind is proving to be essential for OEMs in the embedded space. But exactly what that means remains a moving target: What’s secure today is not necessarily secure tomorrow. In volatile industry environments where threats are non-stop, OEMs want to secure their devices and systems, but don’t necessarily understand how to maintain protection for the long term. A smart approach features design strategies and standards, but as importantly, is grounded in a security-driven mindset that embraces security implementations and deals proactively with different risks. This kind of vigilance can prevail in many ways: protecting systems, distinguishing OEMs, and driving new opportunities to create long-term profit centers from security services.

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De-Risking in the MedTech Industry

In medical device, medtech, quality, Quality Management System, risk management, Uncategorized by Alicia CheungLeave a Comment

Risk analysis is an essential component of your quality management system. A mandatory task for every new medical device about to hit the market is creating an appropriate Risk Management Plan as required by ISO 14971, the international standard for applying risk management to the design and manufacture of medical devices.

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Reduce Supplier Risk, Reduce Organizational Risk

In compliance, medical device, medtech, quality, regulations by Alicia Cheung1 Comment

Risk is a major focus in most businesses today, regardless of industry. In the past few years, the Life Sciences have seen a steady rise in supply chain issues resulting in lost market caps, recalls, regulatory fines, and other financial impacts valued in the billions of dollars. The Medical Device Industry is no exception to this reality; if the industry wants to improve patient outcomes, then it has to manage risk. According to Pilgrim Quality Solutions, one of the largest sources of organizational risk is dependence on third-party suppliers. Today’s global economy has added complexity to supply chains, and longer supply chains are making it increasingly difficult to manage suppliers, and in many cases, suppliers’ suppliers, thereby increasing overall risk. The plethora of regulatory requirements placed on Medical Device organizations, including the updates to ISO 13485:2016, reflect this new reality.

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4 Types of Supply Chain Risk and How to Address Them

In business, logistics, risk management, supply chain by Cressida Murray2 Comments

As a Corporate Sourcing & Logistics Executive at NBCUniversal, Mark Pierson is responsible for the strategic sourcing of suppliers and the implementation and management of contracts and processes to ensure that NBCUniversal uses efficient and effective logistics and compliance procedures in all of their global operations. These include home entertainment, television and theatrical production and distribution, NBC News, Sports, Olympics, and theme park divisions.  Evidently, NBCUniversal has a tremendously complicated supply chain and one that sources from manufacturing, retail, food services, and more. Risk is inherent in any business, but in a global company with such varied business units, the number of risks to plan for are limitless. Pierson scans the news each morning and uses the VUCA method to classify types of risk and what response they warrant.  This method asks two questions: How much do you know about the situation? How well can you predict the results of your actions? When Pierson came to the American Supply Chain Summit last year, he shared some of his experience and the supply chain and logistical risks he was facing that week alone in his talk on “Seeing the Big Picture: Gaining Visibility Across your Supply Chain”.

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Webinar: How to Turn Your Industrial Energy Program into a Competitive Advantage

In Generis, generis group, manufacturer, manufacturing, manufacturing operations by GenerisLeave a Comment

So where should you focus when developing an energy strategy for your own business? In this session, EnerNOC‘s Managing Director of Industrial Solutions, Jay Zoellner, will walk you through the essentials of a successful energy strategy. You’ll learn: Why energy impacts the bottom-line for industrial enterprises more today than ever before The five critical success factors for every industrial energy strategy A three-step process for assessing, designing, and implementing a successful industrial energy program Sign up for this informative EnerNOC Webinar here today! To learn more about EnerNOC, please join us, as Generis hosts the American Manufacturing Summit and gather further insights on March 28-29, 2017.

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