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MEDICAL DEVICES Overview and Challenges

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MEDICAL DEVICES Overview and Challenges MEDICAL DEVICES Overview and Challenges The medical device industry is witnessing transformational changes due to globalization, an uncertain macroeconomic climate, changing regulations and technology advancements. To succeed, we believe device manufactures need to focus on the following: Converging technologies Maintaining an Regulatory compliance Market opportunities and “consumerization” of innovative edge despite without aecting cycle with localized oerings healthcare strained R&D budgets times Manufacturers are looking to The rapid penetration of technology Increased taxation on medical Device development is being emerging markets for growth. in provisioning systems necessitates device manufacturers due to new saddled by compliance and Success will depend heavily on a seismic change in device healthcare regulations in mature regulatory initiatives impacting product oerings built for global development strategies, a sharper markets put additional pressure on development cycles, requiring new markets and localized to meet focus on consumer preferences and the bottom line and already strained investment in lifecycle processes specic regional requirements. This connected care as well as R&D budgets. Device manufacturers needs eective management of new investments in enabling need to rethink their core value and global value chains, consumer technologies such as cloud, mobility, identify opportunities to improve preferences, regulatory and healthcare analytics. R&D productivity environments and business models that are often unfamiliar and complex. External Document © 2018 Infosys Limited External Document © 2018 Infosys Limited Multi-disciplinary capabilities to deliver Sustain your innovation potential even innovative care solutions with strained budgets Infosys combines its expertise in cloud, mobility, Our clients leverage our investments in analytics and device engineering with domain innovation labs, third party compliance, R&D experience in clinical processes, user ergonomics partnerships and advanced engineering and standards to help clients dene and realize expertise that help them ride the technology next generation medical devices. 1 curve with signicantly reduced CAPEX. We Cross-pollinating best practices from product identify and optimize key levers that can be used development programs across industries and to drive sustained cost from the product business situations, we help clients deliver development process using our Value Analysis innovative healthcare solutions from product 2 Value Engineering (VA VE) cost reduction conceptualization to manufacturing. Value methodology. Proposition Design for Globalization Fast-track regulatory compliance 4 With investments in technology, component Infosys’ Compliance & Regulatory engineering and agile processes, Infosys Services and Product Lifecycle provides a more cost eective and ecient 3 Management (PLM) solutions help product development alternative for medical clients reduce the time for regulatory device companies. Our managed product submissions while improving eciency. development approach institutionalizes Infosys oerings are complaint to ISO development of global products that can be 13485, ISO 14971 and ISO 62304 easily localized, easing entry into new markets. It ensuring preparedness for meeting is supported by a broad ecosystem of academia, increasingly stringent & evolving medical experts and laboratories in developed regulatory requirements and safety and as well as emerging markets protocols to rapidly secure RoHS, FDA 510K, PMA, CE approvals. External Document © 2018 Infosys Limited External Document © 2018 Infosys Limited Service Offering We have successfully partnered with our clients through the complete medical device value chain Plan Concept Design Validate Production Support Scientic Innovation Solution &D Concept Design (Mechanical & Electro-Mechanical, / R g Software, Firmware) in r e e Detailed Design (Mechanical & Electro-Mechanical, n i Support for base g n Software, Firmware) E business Design Review and Verication/Validation Variant Design Generation, Value Analysis, Value Engineering g rin tu Digital Manufacturing Support – Design Transfer, c a Creation/Optimizing CNC programs, Gerber les, tool and die design etc. f u n a M Plant Design, Automation and MES Implementation and Support Support to Compliance Management and CAPA atory ul g e Publications and PMA/510 (K) Submission Support R / y t i l Documentation & Compliance as per ISO13485, 21 CFR Part 820., IEC62304, IEC60601 a u Q Risk Management as per ISO14971 ting ke Product Marketing Publications – ar M Digital Asset Management, Web Presence, Next Generation Commerce etc. d n a s e l a S Emerging Technologies (Mobility, Cloud Solutions), Business Process Outsourcing, High Value Consulting, Organizational Change Management, Learning Enablement etc. Infrastructure Engineering and Management – Contact Centre, Hardware, Software, Data Center, Network, Technology Architecture etc. Enterprise Systems including ERP, CRM, PLM, Financial Systems, HR, Legal etc. External Document © 2018 Infosys Limited External Document © 2018 Infosys Limited Representative Successful Engagements A US-based, global leader in cardiac Partnering with a global leader in sleep rhythm management partnered with management solutions Infosys developed Infosys for design, development and a standalone and web based solution for verication of multiple releases of remote patient monitoring along with the software for products to be launched in hardware, rmware and data management various geographies. Infosys helped solution for analysis and reporting, We also the client obtain supplementary PMA, created all design documents and CE approvals besides reducing the verication reports which helped in rapid product cost by 30%. FDA 510K ling and approvals. For a global leader in obstructive sleep apnea home testing, Infosys designed an innovative cloud-based user portal on Salesforce.com to broaden the reach and eciency of the diagnostic solution suite. The portal provided web interfaces with third-party applications to access and analyze patient data immediately upon receipt of the completed test thus reducing the report cycle time by two days. Partnering with a leader in diabetes disease management Infosys developed the For a leader in radiology diabetes data management system used by products, Infosys developed a patients to upload their sugar and web based radiology workow carbohydrate intake for healthcare system that automates the professionals to monitor and provide workow signicantly reducing guidance. The product works on multiple per case time for the radiologist. platforms and was released in multiple languages across geographies with signicantly reduced eort and time. External Document © 2018 Infosys Limited External Document © 2018 Infosys Limited Why Infosys Six of the top 10 device manufacturers come to Infosys for help in creating and implementing the strategies needed to tackle these areas, key to building ?products powered by the latest in medical technology. External Document © 2018 Infosys Limited External Document © 2018 Infosys Limited Gold Standard Medical Devices Process & Quality Managed NPD Ecosystem Standards CoE and Academy Framework • SEI CMMI Level 5 • Advanced • Local Hospitals • HL7 • 8500+ Engineering • ISO 9001-2000 Engineering • Medical Research • DICOM Practice • ISO 13485 Group Laboratories • IEEE 11073 • Medical Devices Centre of • ISO 14971 • NPD as a • Compliance Labs • HDP Excellence • IEC 62304 Managed Service • Technology • IHE Proles (LAW, • Thought Leadership POCs • ISO27001 • Medical Device Alliances IDCO etc) • Competency Academy Development Our clients work with us to take To remain best in class, product The Medical Devices CoE Training in key initiatives and special advantage of world class quality development must be backed by a serves as our “think tank” by topics is coordinated by the CoE with frameworks with processes commitment to relentless innovation. focusing on the latest our Medical Device Academy, an certied at SEI CMMI Level 5, For Infosys, these investments include industry developments and institution dedicated to the education and certication of Infosys employees ISO 9001-2000, ISO 13485, ISO the creation of a managed service for problems with the goal of in a broad range of related regulations 14971, and IEC 62304, ISO27001 developing solutions and new product development, built and technologies. Programs can be levels. These along with our along lean manufacturing principals, proofs-of-concept (PoCs) extended and customized per client knowledge of IHE and related featuring a ready ecosystem of that address them. engagement needs and generally standards such as HL7, DICOM, suppliers, collaborative relationships Standards-related work include a curriculum featuring IEEE 11073, HDP, IHE Proles like with hospitals, clinics and medical includes IHE IDCO and LAW mechanical, software and electronic LAW, IDCO ensure that quality specialists. Our oering features a proles, while PoCs have competency development. frameworks are designed and “design for compliance” build been built for remote vital Representative topics range from the adapted in a way consistent approach that enables swift parameter collection for basics of ECG, to the application and use of implanted devices and remote with the prevailing standards prototype development, even in the blood pressure and weight patient monitoring, pain driving the medical device via smart phones and absence of a complete
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