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 →Quality Management in the Board Room
Building the Executive Business Case for EQMS According to Pilgrim, quality leaders today are facing new challenges and opportunities presented by changing global markets, disruptive technologies, new regulations, and social media. Their quality management maturity has not increased quickly enough to keep pace, largely due to chronic underinvestment. When done right, quality extends throughout the enterprise and provides unique value across all functions. However, quality is stuck in a catch-22. It must break out of the silo to achieve its potential value, but the lack of perceived value reduces support from other leaders and top executives. Support from top executives plays a crucial role in the long-term effectiveness of quality. Three elements that quality needs to thrive: Top-down support Executive voice Sustained resources
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 →eBook: Realistic Simulation for Medical Device Developers
Today, medical device developers use realistic simulation solutions from SIMULIA to accelerate the overall product innovation process, reduce development costs, and improve patient safety and product quality. This Q&A eBook with Dassault Systèmes explores realistic simulation and its massive potential to dramatically transform healthcare. Included is a video where Dr. Steve Levine, of Dassault Systèmes, discusses 3D Design and Collaborative Platforms to Support Digital Health at Generis’ American Medical Device Summit 2016. Check out the eBook and the video below!
Read More →SMTC Presentation: Driving Product Optimization Through Early Stage Supplier Engagement
Exploring Design for Excellence (DFX) Brian Morrison, from SMTC, took his wealth of knowledge and understanding as the Director of Value Engineering & Technology and presented crucial industry information at the American Medical Device Summit 2016. Take a look at Morrison’s insightful presentation from the Summit that explores Design for Excellence (DFX) Product Optimization, focusing on these core concepts: What is DFX? DFX Benefits Value Equation Product Design Review Ability to Impact Product Value Early Supplier Involvement (ESI) Impact of Design Decisions Applying DFX to Product Development To view the full presentation, click here. About SMTC SMTC is a mid-size provider of end-to-end electronics manufacturing services (EMS) including PCBA production, systems integration and comprehensive testing services, enclosure fabrication, as well as product design, sustaining engineering, and supply chain management services.
Read More →Maetrics: The ROI of Good Quality & Compliance
On October 5th, 2016 at the American Medical Device Summit in Chicago, Generis welcomed Maetrics to the speaker panel on Day One. Ed Roach, the Managing Director of Maetrics, focused his presentation on four main objectives being: Ideas on how to quantify the costs of quality for investment justification Understanding indirect or potential costs of quality and compliance including Examining FDA’s recent and future approach to Medical Devices The Potential Impacts of FDA’s approach to Medical Devices Understand the Benefits of a Proactive Quality System Benchmarking – Good Investments in Quality and Compliance To view the full presentation online, click here. Panel Speaker: Ed Roach, Managing Director of Maetrics Ed Roach brings nearly 20 years of experience in the life sciences industry to the panel while adding his wealth of knowledge on Quality Systems and Quality Assurance, Validation, Corrective and Preventive Actions (CAPS), Root Cause Investigation, Change Management, and 483/Warning Letter Remediation to the American Medical Device Summit. Generis is thrilled that Maetrics will be returning to Chicago for the American Medical Device Summit on October 4th and 5th in 2017. For more information on Generis or our American Medical Device Summit taking place in 2017, please, don’t hesitate to contact us today.
Read More →The Implications of a Changing Healthcare Environment
An Interview with Siemens Healthcare Diagnostics’ Dr. James Donnelly. The medical device industry has achieved significant growth over recent years, with the industry expected to generate $365 billion in sales by the end of 2015, and $460 billion by 2018 (information sourced from TÜV SÜD). The initial and continued success of a medical device is dependent on the value it brings to the delivery of healthcare, where there is a need to reduce waste in an evolving regulatory and reimbursement climate. Prior to his speaking engagement at the upcoming American Medical Device Summit 2015 in Chicago next week, we had the opportunity to sit down with James Donnelly ,Ph.D., Chief Scientific Officer, Global VP, Medical, Scientific & Statistical Affairs, Siemens Healthcare Diagnostics to gather his perspective on the medical device industry in the U.S., and understand how changes to the healthcare system will influence the industry moving forward. Donnelly has been with Siemens for more than eight years, beginning as Global Vice President of Medical, Clinical and Statistical Affairs. He is passionate about integrating customer input, quality, and innovation into the design of products. He also believes the customer must be an active partner in product lifecycle management and that innovation without purpose will not consistently add value to the healthcare system. Jim, how would you describe the current healthcare environment in the U.S. for medical devices? The current healthcare spend is not sustainable. We spend too much on healthcare delivery without the expected return in value. The healthcare system and its stakeholders are all experiencing significant …
Read More →Speaker eBook: Q&A with the Speakers at the American Medical Device Summit 2015
There is less than one month to the American Medical Device Summit 2015! With the event on the horizon, we took a moment to gather some of our key speakers and asked them to share their insights and opinions on the current state and future outlook of medical devices in the U.S. We posed the following questions: 1. How would you describe the current landscape for medical devices in America? 2. What are some of the biggest challenges that companies are facing when bringing medical devices to market? 3. How can these challenges be overcome? 4. When it comes to medical device inception, development or commercialization, what is the one piece of advice you wish that someone had given you? CLICK HERE to view the Speaker eBook
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