When it comes to quality management, life sciences organizations all face a similar set of challenges derived from both the significant industry competition necessitating improved quality performance and reduced costs, and from ever-tightening regulatory compliance measures. Quality leaders in life sciences need to contend with these pressures while also meeting goals around innovation, and improving efficiency across the product development lifecycle in an industry that is relying more and more on a growing global network of suppliers, contract manufacturers, and other partnerships. The growing network of suppliers in life sciences means that visibility into supplier quality and across the value chain are more important than ever before, as an adverse event could quickly lead to recalls, fines, and irreparable brand damage.
Read More →Proving New Technology Works in Products: The 8-Point Assessment Checklist
Key Tech is often visited by enthusiastic and clever innovators demonstrating a brand new technology, hopeful that it could make it into a product. In this whitepaper, Key Tech explains how they’ve never seen a perfect technology; even the best has its limitations and flaws. At the first meeting with Key Tech, the new technology is usually embodied in a contraption referred to as the “Frankenstein Prototype”. The first task is to tease out the flaws in the new technologies in order to understand what it will take to get rid of them.
Read More →5 Rules of Engagement for Breakout Performance
Whether you work at a small tech startup or a large, established manufacturer, there is an implicit understanding that business success can be easily quantified. Whether you are a CEO or a sales representative, the common wisdom is that there are identifiable numbers that can objectively determine if you are a success or a failure. In a world full of endless layers of nuance and opinion, tangible metrics of business performance are irresistibly attractive. However, there are serious limitations to taking such a binary approach to measuring success. This black and white approach to measuring business success is actually counterproductive, particularly if the goal is to achieve transformative performance improvement.
Read More →The FDA’s New Approach to Digital Health
Recognizing that their traditional approach to moderate and higher-risk, hardware-based medical devices is not well suited for the more rapid and iterative design, development, and validation phases used for software products, the FDA has created a new Digital Health Innovation Action Plan. One important piece of this plan is the “Software Pre-Certification (Pre-Cert) Pilot Program”. This pilot program, which began on September 1, 2017, is a voluntary program that will enable the FDA to develop a tailored approach toward regulating digital health technologies by looking first at the software developer and/or digital health technology developer, rather than the product. The purpose of this is to streamline the regulatory process for companies with a history of developing and testing quality products. Once pre-certified, that developer would be empowered to make software iterations and changes as needed. The nine participants that have been selected for the Software Pre-Cert Pilot Program are Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorous, Roche, Samsung, Tidepool, and Verily. According to the FDA, these participants were chosen as they “represent a wide range of companies and technology in the digital health sector, including small startups and large companies, high- and low-risk medical device software products, medical product manufacturers and software developers.”
Read More →Whitepaper: Smart Quality Management, Industry 4.0 and Quality Management Systems
In order to remain competitive in the rapidly-evolving Industry 4.0 landscape, most companies will be required to make technological changes. In the medical device industry, there are a number of unique considerations this technological change presents. This whitepaper, written by Pilgrim Quality Solutions and produced by Generis, explores the impact Industry 4.0 will have on the medical device industry, and how to make the shift to ‘Quality 4.0’. It explores areas where medical device manufacturers should focus investment; the impact on product validation and regulatory and quality compliance; and how Quality Leaders can embed operational quality into risk processes that are outside of traditional QMS. View the whitepaper to explore: Industry 4.0 – What is Industry 4.0 and What is Driving it – The Smart Factory, Cyberphysical Systems, and the Internet of Things – Effect on Products and Processes Implications for the Medical Device Industry – Focus on Digital Technologies – Data Security – Investing in Change Impact on Validation, Regulatory & Quality Compliance – Validating Smart Products – FDA Guidance – Understanding the Quality Impact of the Smart Factory – Embedding Quality in the Value Chain How to Move Toward Smart Quality Management – The Need for Automated, Operational Quality Risk Management – How Quality Leaders Can Gain Organizational Support for Quality 4.0 Initiatives – Quality 4.0 Investments to Support Industry 4.0 – Strategic Objectives Smart Quality Management, Industry 4.0 and Quality Management Systems
Read More →Averna’s Q&A Ebook: How the Internet of Things is Transforming the Medical Device Industry
The ‘Internet of Things’ is transforming the medical world, allowing more patients to be looked after using real time data. Combining Wi-Fi and Bluetooth capabilities with current technology is allowing for a faster, more resourceful and satisfying experience for both patients and employees. With the Internet of Things(IoT) reinventing the technological landscape so rapidly, companies are struggling to keep up with the latest innovations. Companies must now test the wireless capabilities of all their medical devices to ensure their products feature seamless connectivity. With more tests being conducted and the rise of IoT, competing companies have introduced robots to automate processes in order to reduce costs. Robotic-driven production has become more economical, as robots can perform routine tasks without fatigue at a faster pace. So, how can OEMs in the medical world stay ahead of their competition with all this technological development? One way is to work with a company that excels at Design for Test (DFT) and design for manufacturing (DFM). Companies can also capture and analyze up-to-date test data. For more ways to stay ahead of the competition despite the constant changes in technology and for a deeper understanding of IoT and its impact on the medical device industry, read Averna’s Q&A Ebook here. Averna is a worldwide Test & Quality leader. Their talented team includes hundreds of engineers, system architects, developers, project managers and other professionals, as well as a network of partners such as National Instruments, Keysight Technologies …
Read More →Case Study: 4 Steps to solving Complex Development Projects
Successful companies are constantly fine-tuning existing products and planning new ones. But even the most ambitious businesses can suffer when critical projects get backed up in the pipeline. Management at Chicago-based Rauland-Borg Corporation realized its good intentions were being subverted by the lack of effective project portfolio management (PPM), and decided to do something about it. Check out the full case study to discover the four step approach to solving complex development projects.
Read More →The Myths and Facts of Manufacturing in Mexico
Deciding on the appropriate region for your manufacturing operations is a vital step. Many US manufacturers consider Mexico when deciding on plant locations because of its proximity to US markets, access to resources and skilled labor, as well as the favorable trade agreements. But is Mexico the best decision for your organization? To help manufacturers make an informed decision American Industries developed the eBook below which outlines the benefits, issues, myths and facts about manufacturing in Mexico. Download the eBook below to gather the information you need to make an informed decision on whether Mexican manufacturing is the right decision for you.
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