“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 →The Benefits of Concentricity
“In GD&T, concentricity is a complex tolerance used to establish a tolerance zone for the median points of a cylindrical or spherical part feature. Concentricity is generally reserved for high-precision parts when there is a need to control median points.” – eMachineShop Precision-drilled custom tubing and tubular components are used in medical devices, aerospace applications, nuclearpower plants, industrial manufacturing plants, high temperature furnaces and many other designs. When it comes to tubing and tubular components, concentric, seamless precision tubing is often chosen for its added reliability, rotational stability, strength and increased useful life. Unlike welded tubing, seamless tubing is able to handle high pressure evenly, provides uniform fatigue properties and often reduces the frequency for inspections in high stakes uses. Tube Hollows International specializes in manufacturing highly concentric tube hollows that meet critical design tolerances. The company machines ultra-high concentricity seamless precision tubing in the most challenging alloys, using gun drilling, trepanning, honing and other technologies. I sat down with Tube Hollows to draw from their expertise and gain a greater understanding of the benefits of concentricity. Tube Hollows’ Director of Business Development Alex Miller explained that when engineers define the component part and tubing requirements of complex engineering projects, they often must strike a balance between design specifications, cost, safety, and quality concerns. The concentricity needs of a project can be determined by assessing how the part will function in its end use, whether or not the part will interact with other parts and the environmental factors influencing tolerances for the part. According to Tube Hollows and leading engineering professionals, concentricity in …
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 …
Read More →Point of Care Testing and the Need for Interoperability
Point of Care Testing (POCT) enables rapid diagnostic tests to be performed at or near the site of patient care. This allows for the immediate generation of test results which can then be instantly acted upon, improve decision-making at the time of care and shared with all members of the medical team. POCT devices are used in both a clinical and non-clinical settings. Complex clinical tests such as cardiac or coagulation testing are often conducted within a clinical setting, however, a number of devices are used within mobile units, ambulances etc. POCT devices must therefore plan for device use outside of a clinical setting and must consequently take into account the need for connectivity, portability, longer shelf life of reagents and kits and ensure the device usability. The digitization of medical health records has resulted in a greater need for connectivity among devices and the ability to aggregate data from multiple devices into a single, central system. The aggregation of this data in itself can become a major challenge as providers attempt to aggregate information from multiple devices with proprietary interfaces. Wipro Ltd. advises that POCT1-A2 is the approved standard for point of care device interoperability and recommends that providers adopt a framework-based approach that can help address the challenges of integrating POCT devices by standardizing implementation across devices, leading to ease of maintenance and better ROI for medical device vendors. POCT1-A2 addresses the problems of Point of Care Testing device connectivity and message formats for information …
Read More →Balancing Competing Priorities in Medical Device Manufacturing
Medical device manufacturers must consistently work to balance competing priorities; everything from product development, regulatory compliance and quality to marketing. Managing these priorities in disparate individual silos leads to a lack of efficiency, communication and productivity. As a result, many manufacturers are turning to holistic enterprise operation solutions to streamline their processes from innovation through to the product end of life. Dassault Systèmes Industry Solution Experiences for Life Sciences powered by the 3DEXPERIENCE® platform provide a major leap forward with a Single Source of Truth (SSOT) environment that spans the entire product lifecycle from conceptual design to end of life. These solutions for Life Sciences enhance global collaborative sharing, making compliance and innovation complementary processes that contribute to each other’s and the company’s success. The Dassault Systèmes whitepaper “TRANSFORMING MEDICAL DEVICES WITH SUSTAINABLE INNOVATION”outlines some of the key benefits of this integrated technology for medical device manufacturers: Manage and facilitate innovation without compromising quality and safety through one cohesive platform that allows collaboration of design information and visibility across the product lifecycle from ideation to end of life. Increase patient safety by reducing the number and severity of recalls and field actions Increase business agility by streamlining design collaboration and managing team activities to align project goals and user requirements. Speed compliance processes by integrating regulations into product development (design for compliance) and e-submission. Accelerate time-to-market by streamlining the complete regulatory submission and approval process (dossier assembly, review, submission, tracking, and …
Read More →How Information Technology is Driving Patient Centricity
“The role of IT is vital in driving People/Patient centric solutions. The need for interoperability for home health devices and hospital based information systems will drive the next generation of healthcare IT.” – Phani Bidarahalli, GM & Global Head, Healthcare, WIPRO The current health system spend is not sustainable and as a result there is a growing need for more effective, value adding healthcare services. In recent years healthcare providers have shifted their focus to become more patient and outcome centric in an attempt to achieve the required value for sustainability. Wipro is a multinational Engineering, IT and System integration services company that has been a key partner to some of the largest healthcare organizations and medical device manufacturers in the world. To understand the role that information technology plays in this push for patient-centricity, I sat down with Phani Bidarahalli, GM & Head, Global Practice, WIPRO, to gather some of his opinions and insights. Phani predicts that “the next wave of innovation in healthcare will center around precision diagnosis and measurable clinical outcomes.” Clinicians are already striving to incorporate information produced by medical devices into their decision-making processes, and with the growth of big data we will see more and more “researchers collect and harvest data to identify patterns and develop algorithms to narrow down on disease signatures and develop better clinical pathways.” Cloud based infrastructure is also providing the unique opportunity for healthcare organizations and medical device manufacturers to provide seamless access to data and information …
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