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 →An Agile Alternative to Document-Centric Methods for Requirements Management
The American Medical Device Summit is less than one month away! The summit will draw on the knowledge of over 40 industry leaders to explore the challenges and opportunities in product development, quality management, speed to commercialization, and regulatory harmonization. One of the companies helping developers tackle the challenges in product development and compliance is Jama Software. Jama Software has developed a more agile alternative to document-centric methods for requirements management, creating the optimal environment for defining problem statements, validating cross-functional input and ensuring that what is delivered at each phase of is what was intended. Check out the Demo Video below to find out how on-boarding this software can help developers navigate complex development cycles and build great products by: Removing the overhead of requirements reviews. Shortening the time between milestones. Mitigating risk and maintaining traceability evidence. Visualizing connections between regulations, requirements and test cases. for a more in-depth look at the software, try the software yourself by signing up for the Jama Software Free Trial!
Read More →eBook: Medical Device Development Best Practices
With the American Medical Device Summit quickly approaching, we took the time to sit down with one of our industry partners, Stratos Product Development, to gather their thoughts on the biggest medical device development challenges and the best practices to overcome them. Check out the Stratos eBook to explore : Complications arising from a lack of proper documentation, and how to overcome them. Strategies to speed the product development process while effectively managing costs. Tactics to make product launches more predictable. Regulatory considerations that need to be factored into the medical device development process in the U.S. The benefits of outsourcing innovation. eBook, Medical Device Development Best Practices 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 →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 →Deliver Enhanced Efficiency in Aerospace Manufacturing
Aerospace manufacturers are emphasizing the need to incorporate high performance, lightweight materials into their manufacturing processes in an effort to improve efficiency, prolong product life through durability and decrease costs. In today’s post we will look at one of the innovations entering the market that has the potential to change the way aerospace manufacturers integrate composites and use aerogels. Blueshift International Materials is a new player in the aerospace arena that has recently brought to market a unique product, AeroZero®, a 100 percent-polymer aerogel that is both lightweight and easily incorporated into composites. The high performance material combines the physical and toughness properties of plastic films with the insulation properties of aerogels to create a strong yet lightweight, thin, clean and flexible insulator. “The emphasis on the lightweighting of products has sparked a growing need for composite materials such as AeroZero due to their low density nature and high thermal insulating properties.” Explains Garrett Poe, Executive Vice President, Blueshift. As the 2015 winner of the JEC Innovation Awards in the Raw Materials category, AeroZero has already garnered attention and demonstrated its ability to be easily incorporate into composites. “Existing aerogels are made from particulate silica, which inhibits their adoption in composite structures,” explains Garrett, “Blueshift AeroZero was designed to be a highly capable core material that is extremely easy to incorporate into composites, meeting the needs of a variety of industries while seamlessly overcoming this significant obstacle organizations face with other aerogel solutions.” AeroZero’s value …
Read More →Reduce Product Costs Using The Should Costing Method
“Should Costing provides the basis for continuous cost reduction and waste elimination. Should Costing also provides the ability to formulate the best economies of scale from a cost view point, which can be used to leverage a ‘best price’ in the negotiation process.” – Geometric Limited Should Costing is a systematic process that enables cost reduction from the conceptualization stage through the product life-cycle. Maintaining competitiveness within the aerospace industry is highly dependent on an organization’s ability to reduce product costs and delivery cycle times. However, the industry as a whole continues to face challenges in managing product costs from the inception stage through the very long life-cycle of its products. Aerospace organizations produce complex products that source between 50-70% of their components from suppliers. To eliminate significant costs prior to production, organizations must first identify the major cost drivers of components that are designed, manufactured and procured. Identifying these cost drivers can aid in supplier selection, effective negotiation and advanced segmentation. I sat down with Ken Sutphin, Head of Mechanical Engineering Practices at Geometric Ltd., to explore the benefits that their customers have seen in adopting the Should Costing method. According to Ken, clients that have utilized Geometric’s proprietary productivity tools for Should Costing have enabled: An improved ability to launch new products at target costs. Processes with integrated tools that are almost 2X faster than conventional process with better repeatability and accuracy. Complete recognition and understanding of component …
Read More →The Barriers to Cost Optimization: Manufacturing
Geometric Limited is a specialist in the domain of engineering solutions, services and technologies. I turned to Geometric earlier this week to draw from their expertise and gain a greater understanding of the processes and benefits of cost optimization for manufacturers. I learned that cost optimization is often thought of as a cost reduction exercise, however established products have inherent costs “built-in” to the product. Manufacturers with established products must focus on post-production expenses and work to reduce material costs and manufacturing expenses, while most of the cost structure for the product is already set because of the product specifications and decisions that were made during the development stage. The experts at Geometric advise that by pursuing cost optimization initiatives during the product development stage “companies can create significant cost optimization through better understanding and evaluation of cost drivers across the entire product realization value chain”. There are, however, five potential barriers to achieving full cost optimization during development and these may arise due to the inherent nature of the product development stage. In this weeks infographic we explore these barriers as the first part of our ‘Cost Optimization Series.’
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 …
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