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 →The Emerging Challenges for Medical Device Manufacturers: An Interview with Maetrics
Maetrics is a global, full service life sciences consultancy firm that has worked with 4 of the top 5 medical device companies, 8 of the 10 top pharmaceutical companies and 6 of the top 10 biomanufacturing companies. Given Maetrics’ breadth of experience and expertise, I wanted to sit down with Edward Tomlinson, Managing Director of Maetrics, to hear his opinions on the challenges that medical device manufacturers and the industry as a whole will face in the years ahead. So Edward, how would you say the medical device industry is progressing as a whole? By any financial method of analysis the industry is doing very well. It is growing faster than pharmaceuticals, there continues to be a robust series of mergers/acquisitions and as the global population both grows and ages there is an ongoing upturn in the addressable market for their products. Adoption of technologies such as mobile or e-Health and 3, or 4-D printing promises many new avenues of treatment. However not everything is all roses. The regulatory agencies around the world are increasing their level of oversight in all areas from product development and approval through manufacturing, sales and marketing practices and post launch patient safety monitoring. Further, the revenue and margin from product sales is increasingly dependent on patient outcomes. In order to protect their market position companies need to not only improve their financial performance to avoid becoming a takeover target but must also up their game in product development, compliance and safety …
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