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 →A History of Innovation at Mayo Clinic: Interview with Mark Wehde
This October, Mark Wehde, Section Head of Technology Development at the Mayo Clinic Division of Engineering, will join us at the American Medical Device Summit in Chicago to talk about how engineers at Mayo Clinic have teamed with physicians for over 100 years to find new ways to better care for their patients. In advance of the summit, we spoke to Mark Wehde about this relationship and the culture of innovation at Mayo Clinic. What does it mean to you to ‘innovate’? For most from my generation, technology has grown up around us. The things we take for granted today were only barely imaginable 30 or 40 years ago. To this day I still find it amazing that I can walk into our lab and make a radio. I can make an ECG monitor. I could make a respiratory monitor. This afternoon. To me, that is one of the singular pleasures of being an engineer – we can make the things we use.
Read More →Norbert Leinfellner On His Passion For Change Management
Norbert Leinfellner has been with Fresenius Medical Care in Concord, California, since 2015. Prior to joining Fresenius, Norbert worked as a Program Manager at other medical device companies in the San Francisco Bay Area, most recently at Carl Zeiss Meditec, Inc. in Dublin, California, for the development of devices in the Carl Zeiss Retina Diagnostics product line. Norbert holds a Ph.D. in Physics from Technical University Graz, Austria. Norbert has a long history of passionately implementing cultural change at companies which are increasingly challenged to deliver value in a rapidly changing market. The cornerstones of such a cultural change include the implementation of effective project management and the transformation to a matrix organization that promotes ownership, transparency and clear roles & responsibilities. Norbert will be speaking about “Organizational Change Management as a Strategic Growth Initiative” at our upcoming 2018 American Medical Device Summit taking place October 23-24, 2018 in Lombard, IL. We spoke with him in advance of the summit to hear more about his passion for change management.
Read More →US Medtech Industry Looking at Ireland as a Resource
While the American medtech industry is thriving, it still must deal with challenges that include higher production costs, finding skilled staff and the ongoing issues innate to a highly regulated sector. Then there are global concerns such as competition, funding and the high cost of research. With Europe and the United States being the key markets, many U.S. medtech firms have located some of their operations in Ireland in order to take advantage of an established, flourishing life sciences sector, strong governmental support and easy access to the lucrative European market. Among the more than 300 companies with Irish facilities are Boston Scientific, Abbott, Vistakon, Medtronic, Teleflex, Stryker, Cook Medical, Zimmer Biomet, DePuy Synthes, Hollister, and BD. The medtech field in Ireland employs more than 32,000 people, which is the highest per capita in Europe. One-quarter of the world’s diabetics — 30 million people — rely on an injectable device manufactured in Ireland, while half of all ventilators used by acute hospitals worldwide are also made there. Meanwhile, three-quarters of global orthopedic knee products were produced in Ireland. There are several important reasons why American medtech companies have been choosing Ireland as their European base of operations, benefiting from Ireland’s manufacturing expertise, R&D facilities, pool of trained workers, data analysis skills, collaboration between companies, financial advantages, and regulatory advantages.
Read More →Ahead of the Curve: Disruptive Technologies in the Medical Device Market
Technia Transcat believes the medical device industry is continually evolving. Disruptive technologies are causing a paradigm shift in the development of new devices, influencing which businesses will enter this segment of Life Sciences, and who they will market their innovative devices to. In addition, what is also critical to the medical device industry is addressing the “Soft Business” disruptive modernizations. Organizations must implement internal processes and organizational behavioral changes in order to sustain a competitive advantage and continue to grow through organic means in an industry challenged with reducing costs associated with risks of regulatory compliance and certification of supply chain solidity. Technia Transcat and Generis have teamed up to create an ebook that explores how technology is changing the medical device industry and how to harness and embrace this technological change. To access the ebook, click here.
Read More →Recent Developments in the Use of Flexible Printed Circuit Boards in Implantable Devices – An Ebook
Over the past 50 years, life expectancy has been steadily increasing. The aging population, therefore, has steadily increased both in number and mean age. There are many neurological and cardiovascular diseases that can be best managed using implantable devices, reducing the need for medications. The key challenges for implantable medical devices are how to support low energy consumption, stable performance, and continued miniaturization. Implantable devices are not new. The pacemaker, as an example, has been around for more than 50 years. The early devices were cumbersome, with short battery life, so when the battery was low, the device had to be removed and replaced, putting a burden not only on the patient but also on medical services and the managed care system. Today these same devices are less than 3% of the size and weigh only a fraction of the former weight. The real revolution in the technology is not the size reduction, but the fact that today’s tiny implantable devices can be wirelessly monitored reducing check-up frequencies. Eltek has teamed up with Generis to create an ebook that looks at the history of implantable devices, the miniaturization of the devices, their wireless communications capabilities and their future. For more information on Eltek and to access the ebook, click here.
Read More →Cognition Ebook: Safety By Design
Cognition’s latest ebook “Safety by Design: Guided compliance for risk reduction in medical device production and commercialization,” explores how to mitigate risk during the device developmental process. The ebook looks at pressing topics such as understanding the challenges that surround the meeting requirements of the FDA and other regulatory bodies, FDA’s position on risk reduction and automatic traceability. When submitting for regulatory approval, companies need to demonstrate that they have used a well-defined, documented design control and risk management process in place, along with evidence that they are following it. Cognition’s Cockpit Platform provides templates that are configurable to meet common standards and regulations. To access the full ebook, click here.
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 →Life Cycle and Durability Testing for Medical Devices
Wineman Technology are specialists in military/aerospace and provide custom systems integration, automated test systems, machinery and controls modernization, and software development. As experts in this field, Wineman Technology has decided to enter the medical device industry and transfer their skills and knowledge into this field. Wineman Technology is uniquely positioned to help life science domain experts with medical device testing, as well as building cutting-edge biomedical system test architectures and database solutions. With their strong background in systems integration, software development, and turn-key test system design, they can deliver advanced equipment more effectively and on a tighter schedule than in-house design resources, or work with your team to augment your current capabilities. Wineman Technologies’ latest ebook explores the most common challenges and mistakes in medical device testing, how to implement device testing with manufacturers while saving time and costs, and how software infrastructure influences the efficacy of medical device testing. Lastly, the ebook shares a case study that shares the results of a universal test system that Wineman Technologies created for Stryker. To access the full ebook, click here.
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