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New Product Development (NPD) Lifecycle | HCL Brochure New product development made simple With capability to support end-to-end NPD lifecycle, knowledge and skill of cross functioning, 1250+ patents filed, investment for in-house state-of-the-art labs, assured design quality and experience in emerging markets devices, get our comprehensive solution to simplify product development and redefine care. HCL’s Services across Product Life Cycle ` Design Transfer ` Equipment Qualification – ` Data Analytics and ` NABL accredited Testing Labs; and IQ/ OQ/ PQ Reporting ` Regulatory Compliance partnerships with certification bodies Launch Support – Documentation ` Manufacturing Process ` Product Maintenance ` D&A Team with AI/ ML Techniques Validation ` CSV Tool database ` Computer System Validation ` CE Marking ` Hardware Testing – Board ` Environmental and EMI/ ` Static & Dynamic Code EMC testing Analysis ` In-house EMI/ EMC, Mechanical and ` Functional Environmental Testing Labs ` System Testing – ` Unit Testing ` Software Testing – Unit ` Electronic Device Automation Testing Verification Functional ` Integration Testing ` Integration Framework (eDAT) & ` Performance ` Software System Testing ` Mobile Test Automation Framework Validation ` Sub-System ` COTS/ Tool Validation (MTAF) ` Tool Qualification ` Mechanical Testing ` HALT ` Automated Testing ` Reliability testing ` Requirements Definition ` Prototyping ` Device Management ` Dedicated CoEs Framework ` System Engineering ` Embedded Software ` Industrial Design, Finite element based Application ` Localization and analysis, Regulatory, Clinical, Usability, ` Architecture Design Development Modularization wireless ` Hardware Design ` Care Continuum Framework ` Device Driver ` Healthcare Enterprise ` Software Design Development Abstraction / ` Medical Mobile Application Design & Management Framework ` Mechanical Design ` OS porting Develop- ` In-house Test Labs ` Business Logic ` Electronic Packaging ` Protocol Driver ment Development ` Reliability Engineering Development ` Interoperability – ` Application Layer API ` Hardware and Software DICOM, HL7, IHE based integration ` BIOS Communication Protocol ` Pre-compliance testing ` Desktop, Client Server ` Security – HIPAA and Web based Solutions ` Feasibility Study ` Concept Visualization ` Usability analysis ` Partnerships and alliances with through sketches leading surgeons and hospitals ` Human Factors ` Embedded GUI Engineering and ` Renderings (2D & 3D) ` PC based Applications Product Cognitive ` Product Interface and Development Concep- ` Analysis Experience Design tualization ` Web Applications ` Design directions for the ` Mock-ups Development new product ` Consumer Immersion ` Custom UI Design ` Product Styling Design ` Partnerships and alliances with ` Contextual Research ` Fieldwork data collation ` Benchmarking leading market research agencies Voice of ` Observation and ` Synthesis & analysis ` CTQ definition Customer Qualitative research ` Feasibility [ 2 ] New Product Development - HCL Experience A Winning Team ` Combining horizontal knowledge of Mechanical, Hardware, Digital, Embedded Software and Regulatory SME’s ` Doctors, PhDs, Masters in relevant domains Ability to support Product Performance & Competitive Benchmarking Studies ` Partnership with SR University, Chennai for Clinical Trials, Wet Lab testing ` Partnership with GLR Lab, Chennai ` Partnership with Johns Hopkins Medicine Imaging Expertise ` Image Processing solution development ` Porting and optimization, Porting to FPGAs and ASICs ` Spatial and Frequency domain processing, Color image processing ` Closed loop Camera control ` Expertise on all major DSPs ` Real time imaging hardware design and development ` Large image processing application development Cross Leveraging Industry Experience $50 MN+ invested in labs ` Strategic Research, Innovation and Design for Experience Lab (STRIDE) for across 10 Industry Industrial Design Verticals at HCL ` 9+ Design Assurance Labs (EMI/ EMC Testing, Radio Frequency lab, Environmental Chambers, DTV Signal generation, Wireless Network Simulation etc.) ` Mechanical Verification and Validation lab, Value Engineering Lab ` Mobile Testing, Smart Mobile Lab ` Customer specific labs Regulatory, Clinical and PEBLES Center of Excellences (COE) ` 400+ biomedical, biotech, biochemistry, microbiology and Engineering experience across all therapeutic areas ` PEBLES (Packaging, Material, Labelling, Sterilization, and biocompatibility) capability ` Former auditors with NB ` Former consultants for Regulatory bodies ` Supporting MDR and IVDR CE compliance for 18+ customers Process Maturity and trained MQMS ` Certified for: ` CMMI Level 5 ` ISO: 13485 ` BS 7799 ` ISO: 27001 [ 3 ] Case Study: NPD Case study for a leading European MedTech company Challenges A leading device manufacturer of Immunoassay and Clinical Chemistry wanted to tap potential for smaller lab requirement. Their leadership decided to go ahead with NPD process with a short time line before competitors tap this potential. HCL Solution ` HCL team showcased a good process and new product development knowledge from the sustenance engagement. The ability to scale up quickly with required skill sets helped in this program. HCL used its extensive experience of managing new product development lifecycle and co-creating 150+ Medical/ IVD Devices in the electro mechanical product design for this immuno-assay analyzer. ` Various center of Excellences within HCL helped to bring necessary flavors of NPD process. Mechatronics, Should costing, Value engineering CoE, Industrial Design team’s functional expertise is used in this program. HCL could help devise new product development strategy and provide services to various functions like Reliability, system level testing, Test fixture development, design verification, thermal engineering, cable routing, fluidics, motion control areas. Value Delivered ` Successfully completed the program with improved the time to market by 3 months [ 4 ] Case Study: Breast Biopsy System, Implantable Pain Relied System and Automated Drug Delivery systems Business Objective Business Objective Business Objective ` Design & Development of ` Develop a Next Gen ` Development of Automated Next Generation Breast Implantable Pain Relief Drug Delivery System Biopsy System System HCL Scope HCL Scope HCL Scope ` Complete Product ` Feasibility, Prototyping and ` System Design and Development involving SW, Product development Subsystem Specification Electrical and Mechanical ` Electrical and S/W for the ` Full Product Development Design pump and hand held unit involving hardware and ` Prototyping and Feasibility ` Complete Electrical and S/W software Analysis for various implementation & verification ` Product verification and modalities ` FMEA, SHA analysis and validation ` Load Characterization using Traceability ` DHF to meet FDA Dynamometer setup ` Validation testing requirements ` Risk Analysis and Design Traceability ` Pre-Compliance testing ` Independent Verification and Validation Value Delivered Value Delivered Value Delivered ` 20% reduction in the overall ` Ultra low power design ` PMA Approval & Product cost of the device and 1/3rd to support 8 years of launch in US & Canada size reduction compared to implantable life with Li-CFx ` Architecture capable of the earlier variant battery absorbing all S/W changes ` 30% reduction in the overall ` 30% reduction in size ` FDA submission ready biopsy cycle time and compared to previous documentation increased sample yield per generation device ` Improved flexibility of the biopsy ` Reduced timeline by 50% product and efficiency of ` Common hardware and ` MRI compatible design. development by utilizing software platforms for Device implanted in 450+ knowledge base different modalities (X-Ray, patients in Europe ` Work as an extended R&D Ultrasound and MRI) team of the customer ` Completely automated cutting across multiple cross biopsy procedure with functional teams vacuum assisted tissue ` Co-authored patent for the sampling technique system architecture of UI and patient monitoring display [ 5 ] BI-103217312770530-EN00IN Hello there! I am an Ideapreneur. I believe that sustainable business outcomes are driven by relationships nurtured through values like trust, transparency and flexibility. I respect the contract, but believe in going beyond through collaboration, applied innovation and new generation partnership models that put your interest above everything else. Right now 137,000 Ideapreneurs are in a Relationship Beyond the Contract™ with 500 customers in 44 countries. How can I help you?.
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