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.
Read More →De-Risking in the MedTech Industry
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.
Read More →How to Avoid Data Integrity Disasters in Your Manufacturing Network
Lachman Consultants says that pharmaceutical manufacturers can establish a competitive advantage by preventing questions about their product quality data from disrupting current and future revenue. In recent years, data integrity shortcomings identified during GMP inspections have cost firms dearly. In some cases, the financial impact has run into the hundreds of millions of dollars. Despite the risk, many manufacturers do not seek help with data integrity compliance until there is a problem. By then, it may be too late to avoid an impact on profitability. For this reason, Lachman Consultants urges pharmaceutical companies to establish a competitive advantage by taking a proactive approach to data integrity assurance.
Read More →In the Global Life Sciences Market, What You Don’t Know CAN Hurt You
The global life sciences market is witnessing an unprecedented pace of change across pharmaceuticals, medical devices, and biologics. It’s the new normal as trends like big data, the Internet of Things, increasing supply chain complexity and the advance of biosimilars create new opportunities – and challenges – for life sciences companies. As regulators around the globe scramble to stay abreast of these trends, they are making important and often major updates to directives. Quite often these directives are not coordinated between markets, creating a patchwork compliance landscape to be navigated. If you are involved in your company’s quality, regulatory surveillance, compliance, or knowledge management efforts, the following questions are for you: Do you have frequent (i.e. at least monthly) conversations with the regulators in the markets where you manufacture AND sell? Does your company have the expertise to predict and interpret regulatory directives? Do you have reliable methods of disseminating information on the impact of regulatory directives to your clinical operations teams? How does your organization remain aware of and respond to GxP actions, import alerts, or other market actions against other companies in your industry?
Read More →4 Types of Supply Chain Risk and How to Address Them
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”.
Read More →Optimizing Temperature Control for Biopharmaceuticals
This article first appeared in BioPharm International, October 1, Caroline Hroncich Today pharma companies are faced with an ever-changing market that includes increased regulatory challenges, globalization, and heightened competition (1). Biopharma companies are rapidly expanding into emerging markets where there are new opportunities for drug development. Conversely, logistics companies must keep up with the demand, ensuring all storage technology is equipped to retain the safety and efficacy of a drug by the time it reaches the end of its journey. This article by World Courier delves into these relevant industry topics: Common considerations for shipping biopharmaceuticals; Temperature management in extreme climates; Recent advancements; and Looking ahead. Learn more about optimizing temperature control for biopharmaceuticals in the article below!
Read More →Q&A eBook with Advanced Material Solutions: The Importance of Non-destructive Testing in Manufacturing
Competitive forces are driving unheard-of levels of innovation in product design, materials and lean manufacturing processes. A rigorous and proactive approach to risk containment is essential to protect your brand and bottom line. Today’s non-destructive testing field is comprised of several commonly utilized techniques and several others that aren’t as commonly employed. Each technique has its advantages and limitations. No single method is superior, however, AMS’ expertise lies in the team’s ability to identify and deploy the ideal inspection method for each project at the best overall value. Find out more about non-destructive testing, future-proofing best practices, and financial justification in the Q&A eBook with Advanced Material Solutions below! Join us at the American Manufacturing Summit March 28-29, 2017 in Chicago, IL to hear the President of Advanced Material Solutions, Peter Miller, speak on “Future-Proofing Manufacturing Through Non-destructive Testing.”
Read More →Infor CloudSuite Industrial (SyteLine) for Medical Devices
For medical device manufacturers, advancing and maintaining information management solutions that are compliant with an evolving set of FDA regulatory standards is a constant challenge. As you strive to manufacture high-quality medical devices, you need an enterprise resource planning (ERP) solution that can help you minimize compliance risk, as you maintain profitability, drive efficiencies, and streamline all parts of your business. This article will delve into: Upholding GMP quality standards; Maintaining regulatory compliance; Using integrated electronic records; and Meeting regulatory requirements. To find out more about how to reduce compliance risks and meet regulatory requirements, check out the white paper by Copley Consulting Group below:
Read More →How Medical Device Manufacturers Can Optimize Quality, Lower Costs, and Increase Efficiency
Medical device manufacturing has minimal tolerance for error—and quality is of the utmost importance. If your products don’t deliver what you promise, lives can be at stake. At the same time, product returns erode your profit margins, while customer satisfaction can make—or break—your reputation. For companies with unique patented products, meeting demand puts added pressure on every stage of your supply chain. This white paper by the Copley Consulting Group explains how you can make a commitment to lean processes while raising your quality standards, improving efficiency, and driving down costs. It’s important to create efficiencies in your manufacturing processes, but this often involves taking small incremental steps. Find out more about educating your organization about these opportunities, driving down costs, and systematically removing waste and uneven workloads from your manufacturing processes below:
Read More →Top Medical Device Industry Regulations—and Why They Matter
It’s important to keep up with compliance mandates because the US Food and Drug Administration (FDA) keeps a close watch on the medical device industry. If there is an accident involving your devices, it could damage the lives of your patients and the reputation of your company. This article focuses on the most significant FDA quality regulatory programs to be aware of, and tips on how to avoid fines and court action for non-compliance. Read the full article here. For more information about keeping up with regulations, visit The Copley Consulting Group and Infor CloudSuite Industrial for Medical Devices.
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