dMedical device manufacturers are facing increasing challenges in the development, production and commercialization of their devices. To offset rising costs, evolving regulations and increased pressure to speed time to market, manufacturers are streamlining their processes and implementing strategies that drive operational efficiency. Dassault Systemes has generated an informative white paper to help medical device developers drive innovation and improve operational efficiency by creating processes that incorporate quality, engineering, and regulations. Download the “Beyond Compliance” whitepaper to learn how to Connect the Dots Between Quality, Engineering, and Regulatory to Increase Innovation and Improve Operational Efficiency. To hear more from Dessault Systemes, Join the discussion at the American Medical Device Summit 2016 taking place in Chicago on Oct 5th – 6th, 2016.
Read More →Infographic: 5 Mistakes That Can Derail Your Medical Device Development
Medical device developers have a series of hurdles they need to navigate in order to successfully bring their device to market. In today’s infographic, we explore the top five mistakes that can derail the medical device development process and consequently speed to commercialization. Check out the Infographic: 5 Mistakes That Can Derail Your Medical Device Development For more insights into medical device development, commercialization and manufacturing, join Stratos at the American Medical Device Summit 2016 taking place in Chicago on October 5th – 6th, 2016.
Read More →Medical Device Infographic: The Recall Impact
In today’s post we draw on the expertise and insights of EngiSystems to examine the growing impact of recalls in the medical device industry. The infographic below illustrates the increase in medical device recalls over the past decade and outlines some of the major challenges that have lead to this increase. Infographic: The Recall Impact For more medical device insight. join EngiSystems at the American Medical Device Summit 2016 taking place in Chicago on October 5th – 6th, 2016.
Read More →eBook: Traceability Optimization for Medical Device Developers
Regulatory bodies such as the FDA require medical device manufacturers to document and track huge amounts of information to ensure device safety and demonstrate that safety in the event of an audit. Given the volume and complexity of information to be tracked, many medical device developers struggle with traceability. We sat down with Seapine Software to better understand the challenges medical device developers face, and how they can be overcome. Check out the Traceability Optimization eBook below! eBook, Traceability Optimization for Medical Device Developers
Read More →The User Experience for Mobile Medical Apps
“When granting regulatory approvals for medical devices, both IEC 62366 and the FDA have emphasized the importance of applying human factors and user-centered design activities to the development process to ensure medical device safety and improve usability. The development of mobile medical apps is no exception.” – Stratos Mobile medical apps are becoming widely used as at-home health monitoring and management tools. A key element of an app’s success is its usability and a user friendly design. Stratos, a trusted resource for science and technology innovators since 1987, has generated the eBook below that outlines the five key steps to ensure a seamless user experience for medical mobile applications. User Centered Design a Must for Mobile Medical Applications Don’t forget to join Stratos at the American Medical Device Summit 2016 taking place on October 5th – 6th in Chicago!
Read More →Best Practices for Medical Device Development
Medical device developers must take into account numerous safety, quality and risk factors to ensure the durability and safety of their devices. Developers must also adhere to strict risk management processes and life cycle requirements that may vary regionally. Our friends at Seapine Software have generated the whitepaper below to help developers navigate this shifting terrain and understand the best practices for exposing risk throughout the product development life cycle. Exposing Risk Throughout Your Product Development Lifecycle Hear more from Seapine Software by joining the discussion at the American Medical Device Summit 2016!
Read More →Finding the Balance: Compliance, Product Development & Quality Management
Manufacturers are always looking for ways to speed their time to market and reduce production costs without compromising quality. Those who operate in highly regulated industries also have to ensure that their processes remain compliant with regional regulations. It can be challenging for manufacturers within these industries to find ways to improve both the product and the development process without compromising compliance. To help manufacturers navigate this terrain Seapine Software has released the whitepaper below. The whitepaper addresses strategies to achieve efficiency goals by balancing three functional areas: regulatory, development and quality management.
Read More →Why You Should Create a Collaborative Culture in the Pre-Development Stage
The medical device industry has seen substantial growth in past years and the need for innovative, value-driven devices is rising. The sustainability of the current healthcare system, however, is dependent on minimizing spend and maximizing resources to ensure that for each dollar spent, there is some improvement to the health and quality of life of the individual. In order to achieve the necessary value and quality in the design of new devices, more and more manufacturers are striving to develop a collaborative culture in which the needs of the patient and those of the end user, such as the nurse, physician or other care giver, are taken into account during the pre-development stage. James Donnelly, Ph.D., Chief Scientific Officer, Global VP, Medical, Scientific & Statistical Affairs, Siemens Healthcare Diagnostics says “it’s not just how the patient benefits from a product, procedure, or test result—it’s everybody in between us and the patient that also need to be considered. It’s how the device and its functions will fit into their workflow and how it will add value to their system. You can build the best product in the world, but if they can’t use it in a way that is efficient and cost effective for them, it will fail.” “Device manufacturers need to look now and act fast to understand whether or not, in this changing environment, they are still creating products that represent today’s definition of state-of-the-art while anticipating what is needed in the future,” Donnelly says. “By bringing the patient and user perspective …
Read More →Medical Device NPI: From Design to Market in 10 Months
The new product introduction (NPI) process for medical devices is often arduous, with manufacturers needing to balance device specifications with the shifting requirements of the healthcare system and FDA. The NPI process involves evaluating not only the device, but also its design history, production parameters and the tools and methods that affect its performance in clinical use. Medical device manufacturers are subject to increasing regulatory scrutiny, ambiguity surrounding reimbursement levels and the need to produce substantially differentiated clinical offerings. The increasing pressure of this evolving environment has elevated the need to bring new devices to market as fast as possible (without sacrificing quality, compliance or design). The turmoil of this changing environment has led a number of organizations to turn to the expertise of companies like Sanmina to ensure the successful introduction of a new medical device. Sanmina is a leading electronics contract manufacturer serving the fastest-growing segments of the global Electronics Manufacturing Services (EMS) market; providing end-to-end design, manufacturing and logistics solutions, delivering superior quality and support. I recently came across this case-study and wanted to share it as an example of how medical device NPI can be fast-tracked through the use of an EMS company like Sanmina. The case study outlines how Sanmina helped the device go from design to market in only 10 months.
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 …
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