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 →Innovating within Constraints: What Med Device Designers and Manufacturers in Developed Markets Can Learn from Emerging Markets
This is an excerpt from an interview Generis Group did with Palani Palaniappan, EVP, Innovation & Development at Terumo BCT in advance of the 2017 American Medical Device Summit, where Palani spoke on “The Democratization of Healthcare Technologies”. Read the full interview here. “Often when we create products for the developed world, we think about value for money: creating value to charge a high premium. In the developing world, we should not be thinking about high premiums. We need to think about value for many: it is a high volume business where prices and profit margins are low. We need to be thrifty in product development and innovate within these constraints. Constraints feed creativity. In developing markets we are challenged to ensure we create an affordable product. But developed markets also face price constraints—more and more so. Western markets are becoming saturated. Affordability and accessibility of healthcare is a challenge worldwide in every market. We’ve heard this many times now—it’s become the common sentiment of the populist way of thinking: “Healthcare is too expensive. Drug prices are being controlled. Device prices are being controlled.” And it’s true! Against the backdrop of people living longer and population growth, it is not sustainable to continue serving developed markets with high-premium products. In India and several other emerging economies, there is extreme price control on medical devices, those classified as “essential medical devices.” For instance, the cost of a stent has been forced …
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 →Global Regulatory Intelligence: Evaluating the Developments to the EU MDR
Is your company prepared for the new EU MDR? Michael Santalucia, Vice President of Global Regulatory Affairs for Terumo BCT, is responsible for managing the global regulatory affairs function regarding the development and execution of product submission strategies for the company’s medical devices, regulatory compliance requirements, and industry advocacy. As medical device companies face large regulatory challenges to comply with the new European Union Medical Device Regulation (EU MDR), we sat down with Michael Santalucia to learn how Regulatory Affairs organizations are evolving along with global regulations, what Terumo BCT has been doing to comply with EU MDR, and how members of the medical device industry can stay informed. “The EU MDR is arguably the most important legislation to affect our industry in the last two decades. Because of the impact this will have for any firm with CE marked devices, it is essential to have someone in the organization that can provide the company with advice and guidance to the requirements that have been established and those that are yet to evolve.”
Read More →Case Study: Cyient Uses Predictive Analytics to Predict Failures in Ultra Low Temperature Freezers
Client Problem Cyient‘s client, a leading laboratory equipment manufacturing company, collects data from their Ultra Low Temperature (ULT) freezers deployed across the globe using multiple sensors. They faced challenges in managing this massive data and could therefore barely use it to identify critical failures in the freezers so that immediate maintenance action could be taken. In spite of their huge effort, maintenance was always reactive in nature and the company failed to keep the system up all the time. While the data collected from freezers gave indications of past failures and potential issues, often the delay in extracting these issues from the data resulted in increased gravity of failures. The company thus contended with greater maintenance effort and cost. The client targeted early detection of issues and the ability to predict critical failures in advance to significantly improve the reliability of these equipment and customer satisfaction.
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 →How to Build Your Quality Nirvana: Q&A with Kari Miller of Pilgrim QMS
Quality management is an integral factor in the development, approval, and commercialization of medical devices. With the American Medical Device Summit approaching, we took a moment to sit down with one of the summit presenters, Kari Miller, Vice President of Regulatory and Product Management at Pilgrim Quality Solutions, to gather her insights on the challenges and opportunities in quality management and explore some best practices to create a Quality Nirvana. As Vice President of Regulatory and Product Management, Kari Miller is responsible for driving strategic product direction and delivery of industry best practice solutions to Pilgrim’s customer base. Working with customers, industry analysts, and regulators, as well as Pilgrim’s Development, Professional Services, and Support groups, Kari and her team are responsible for translating market and industry trends, along with customer and regulatory requirements, into industry-leading enterprise quality management solutions that meet the needs of the heavily regulated Life Sciences market. Additionally, Kari leads the development of user documentation and solution presentations. Working with Pilgrim’s Customer Product Advisory Board, Kari is responsible for the company’s product roadmap, product partner relationships, and overall product direction.
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 →Women in Leadership: Raina Dauria, Johnson & Johnson
In the lead up to the American Medical Device Summit, we are highlighting some of the incredible women of the medical device industry through our Women in Leadership series. First up is Raina Dauria, VP, Worldwide Regulatory Affairs, Cardiovascular & Specialty Solutions Business, at Johnson & Johnson. In October, Raina will speak at the American Medical Device Summit on “Developing a Culture that Values Regulatory Leadership.” We spoke with Raina in advance of the summit to learn how Johnson & Johnson fosters a culture of leadership and how she has developed as a leader in her own career.
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