Concept, Design, Prototype & Validation

Taking leverage of its proven Product Engineering strength, HCL offers solutions to medical device manufacturers at each and every stage of the product lifecycle. HCL partners with the Medical Device manufacturers right from the requirements definition to the end, or in any specific stage of the product lifecycle.

HCL is one of the few vendors in the world providing end-end services in this area there by ensuring increased time to markets for customers.

HCL has exhaustive experience of working with top medical device manufacturers on some of the most complicated and sophisticated medical devices including Blood Glucose Meter, Sterilization System, Disinfection System, Sedation Drug Delivery System, Nerve stimulator, Dialysis Equipment, Infusion System, Blood chemistry Analyzer, Patient Monitoring System, Ablation and Sensing Unit, Diabetes Management Software, Implantable Drug Delivery system, Computer Radiography System, X-Ray cartridge readers, X-Ray Systems, ICD, Breast Biopsy System, Orthopedic implants, Cardiovascular implants Laparoscopic Device and many more.

• Proven systems and processes that assure cost benefits
• Rich portfolio of reusable, modular frameworks ensures shorter time-to-market
• 24 X 7 support on our development services
• Investments in dedicated labs and resources for medical devices customers
• FDA registered design house for end-to end concurrent design and development of medical devices
• Extensive work experience across Class I, II and III medical devices and equipment
• World class processes like Six Sigma, CMMi Level 5, SEI CMM Level 5, PCMM Level 5, ISO 9000, MDD & ISO-13485 and BS 7799
• Flexible Business models like Global Risk Reward Program and Output-based Pricing
• Strategic Partnerships & Alliances with GVK Bio (CRO), Human Factors International and Celestica
• Focused IPs & Frameworks like MQMS(Medical Quality Management System) based on ISO 13485 and ISO 14971, FDA QSR, Client Quality Systems
• Dedicated CoE with strong team of 6500 product engineers specialized in Embedded software, Hardware engineering and verification and Validation

Services Spread

HCL engages with customers from concept/idea generation stage to design and development and New Product Manufacturing and Implementation. We offer specialized services in mechanical Engineering, Medical imaging, Compliance testing, Independent Validation & Verification, Prototype Development and Reliability Analysis.

HCL has executed turnkey development projects for new products as well as provided discrete services for existing products. Our embedded product lifecycle services provide:

Concept/Idea Generation: Market Requirements, User, Market & Technical Research, Feasibility Studies, Concept Directions, Functional Specifications, Feature Benchmarking, Human Factors Consideration, Mock-Ups and Preliminary Proof of Concept

New Product Design & Development: Feasibility study, architecture, modeling & design, development, release management

New Product Adaptation: Re-development & re-engineering, new technology adaptation, performance and reliability improvement, and multiple platform porting services

Product Sustenance: Lifecycle enhancements, defect tracking and fixing, feature enhancements, regression testing, and maintenance release

Independent Verification & Validation: Software Verification, Mechanical Verification, Electrical Verification, Systems Verification, Systems Validation, OTS/COTS/Tools, Particular Std Testing and compliance testing

Engineering Services for Medical Device Manufacturers

Mechanical Engineering

HCL has necessary processes, people, skills, tools and infrastructure to provide high quality mechanical engineering services. HCL's capabilities in providing solutions throughout the product development life cycle from ID Concepts, Detailed Engineering design through CAD Modeling and detailing, to Simulation, Finite Element Analysis, Reliability Engineering, Prototyping, Testing & Certification support, Sustenance engineering and product life cycle support makes it a unique one-stop solutions provider for Engineering Services.

Embedded Engineering

We have expertise in safety-critical embedded systems with more than 2000 person years of cumulative experience in developing small footprint and safety-critical embedded systems. Our embedded engineering practice has more than 1200 professionals, equipped with competencies in a range of programming tools, microprocessors and real-time operating systems.

HCL mitigates pain points for manufacturers and provides a variety of capabilities, including:

• Hardware Engineering Services: Field-programmable gate arrays (FPGA) design, application-specific integrated circuit (ASIC) design and board & system design
• Embedded Software Skills: User interface, embedded graphic user interface (GUI) and man machine interface (MMI), Web applications and custom user interface design
• Medical Device Life Cycle: Product concept, requirements definitions, system architecture, product development/reengineering, testing/ certification, launch & field support and product sustenance & enhancements
• Validation and Verification Services
• Regulatory Compliance: HCL is ISO-13485 certified
• Extensive support during FDA validation

In addition, HCL has expertise in the areas of system engineering (including system architecture design, product risk management and risk of hazardous substances), design services (including identification and analysis) and a state-of-the-art product testing and certification facility.