The global healthcare scenario is rapidly transforming. Customers in the medical devices industries face a multitude of challenges, including:
- Time to market
- Increasing Product Development costs
- Adapting products for specific geographies
- Managing product costs for emerging markets
- Managing costs for product lifecycle management and sustenance
- Modernizing legacy equipment
Tech Mahindra’s Medical Devices engineering practice is a partner of choice for global industry majors. We develop next generation products and technologies through strong domain capabilities in end to end medical product development solutions and sustenance Engineering Support. As a part of our future ready solutions, we offer a range of connected engineering solutions for the healthcare industry across real time remote patient monitoring systems, emergency response systems, etc.
Our solutions help transform healthcare delivery and drive down the insurance and medical costs. Our vision is to improve the safety and optimize the cost of healthcare. Apart from our strict adherence to all industry standards and regulations, we help our customers to:
- Meet product cost targets and optimize development costs by working with you from product design and development to product verification and validation
- Solve product sustenance challenges through comprehensive product value analysis, value engineering, product localization, customization programs and product reengineering
- Simplify product regulatory compliance challenges through our proven expertise in meeting product regulatory compliance support for various geographies
- End-to-end support from Concept Generation, Design, Design Validation, Testing, prototyping till certification
- Strategic alliance ecosystem with global partners for complete design to manufacturing ownership
- Global program delivery models through near shore and offshore development centers
- Flexible business and engagement models such as Risk Reward sharing and output based pricing
Tech Mahindra has specialized skills in offering innovative technology solutions to the medical equipment industry. We adopt stringent process controls and conform to standards and regulatory practices to ensure quicker time to market and enable compliance.
- Expertise in Critical Care, Diagnostics, Imaging, In-Vitro Diagnostics, Mobility and Remote Monitoring devices
- Mature processes meeting the requirements of ISO 13485:2003, ISO 9001:2008, ISO/IEC 27001, ISO 14971, IEC 62304 and 21 CFR Part 820 (QSR) standards.
- Expertise in embedded hardware, software and mechanical design for medical devices
- In-house labs for product verification and validation
- Software process meeting CMMi v1.2 Level 5
- Matured CAPA process integrated with product development framework
Tech Mahindra is one of the leading engineering technology solution providers with the expertise to cater to a wide spectrum of customers in the Medical Devices industry. We have been providing engineering services and solutions to leading medical equipment and medical device manufacturers globally for several years. We offer solutions across:
- Monitoring and diagnostics
- Radiology devices
- Respiratory devices
- Medical informatics
- Therapeutic devices
- In-vitro devices
Our range of services includes:
- Embedded hardware design and development
- Application development
- Firmware development
- Mechanical design and design validation
- Quality Assurance and Regulatory Support
Monitoring and Diagnostics
- End-to-end design and development of multi parameter patient monitors, ECG machines and home care devices
- Design of parameter modules like 3/5/12L ECG, IBP, and SpO2 etc.
- Design and development of devices for interoperability such as HL7, Continua
- Complete software development for diagnostic ultrasound system
- Acquisition, processing and display systems for various imagers
- Consoles, panels, remotes and dash-boards for various imaging system like CT, MRI etc.
- Device inter-operability solutions (DICOM/HL7)
- End-to-end design and development of OT and ICU Ventilators
- Design and development of Anesthesia Delivery Systems
- Design and development of CPAP and BIPAP devices
- Remote monitoring solutions for ICU, OT and Ambulatory usage
- Cloud based infrastructure development for patient data management
- Medical Data Management solutions such as HIS, PACS, PHR, EHR
- Design of gateways and data aggregators
- End-to-end design and development of single channel and multi-channel infusion pumps
- Design of syringe pumps
- Design and development of electro surgical devices
- Application development for bio- chemistry analyzers
- System hardware design and development
Electronic Hardware Development
- Conceptualization of the product
- Gathering requirement specifications
- Product hardware platform design
- DSP, ASIC and FPGA based designs
- Analog front end design
- Physiological parameter module design
- Physiological patient simulator design
- Component engineering
- Compliance/Conformance testing as per customer requirements
- Prototype development and support
Tech Mahindra designs and delivers best in class applications to suit your business requirements. In addition to application development, our dedicated teams work constantly to explore and develop new ways to reuse and optimize existing assets, extending their life and functionality.
- Medical device application development on Linux, Windows, Android and iOS
- Rich user interface development using QT, WPF, Silverlight
- Vast experience in using development kits Android SDK, Eclipse, iOS SDK, Xcode and Visual Studio
- Expertise in application development in Java, C++, Objective C and .Net
- Expertise in communication technologies like Bluetooth classic, BLE, Wi-Fi, Zigbee etc
- Expertise in design and development of device gateways confirming to interoperability standards like Continua, HL7, IHE and DICOM
- Expertise in interface engines like Mirth Connect, Rhapsody, HL7 connect and Interface ware (Iguana)
- Expertise in cloud based solution development using Google cloud engine, Amazon web services, Windows azure
- Remote platform independent patient management applications and cloud based hybrid application development using HTML5
- Expertise in development of cloud based EHR, EMR and PHR applications
- Expertise in healthcare mobility devices in home care and critical environment
- In house UX designers with hands on experience in medical product user interface design
- Matured software development life cycle process complying to IEC 62304
Tech Mahindra has vast experience in BSP customization, porting various embedded operating systems to target boards and device driver development that will help you accelerate development and reducing development time and effort while providing error free solutions. Our engineers have experience in performance optimization for various platforms and operating systems and choose the best development platform for specific architectures. Our well-proven porting methodology will substantially reduce the porting time and development cost for accelerated time-to-market.
Tech Mahindra has flexibility in developing stand-alone solutions for customers or working as part of larger system development based on customer needs. Our embedded team has extensive experience in real-time system development and device driver development for peripherals including UART, Ethernet, PCI, USB and custom FPGAs.
- BSP/HAL support for Embedded Linux, µClinux, RT Linux, Windows CE, Windows Embedded Compact 7 and VxWorks operating systems
- BSP porting on ARM, PowerPC processor boards, x86 / IA-32 processor boards, MIPS processor boards
- Boot loader development for ARM, PowerPC processor boards, x86 / IA-32 processor boards, MIPS processor boards
- Development of custom device drivers for Linux, Windows CE, Windows Embedded Compact 7 and VxWorks operating systems
- Validate the BSP using extensive test suites developed for the target board
- Firmware development on 8 / 16 / 32 micro controller based designs
- Algorithm development on DSP and non DSP micro controllers
- Compiler and controller migration
- RTOS, scheduler based custom software development
- Modular and upgradeable firmware development
- Implementation and communication protocol stack development
- Develop test suites for board integrity tests and debugging
- Compliance to medical safety standards
- Third party design review and onsite consulting
We have proven expertise in industrial design and engineering design for a wide range of medical devices including wearable medical devices like Holter, Pulse Oximeter and temperature monitor etc., anesthesia delivery systems, in-vitro diagnostic equipment, mobility assistance devices, respiratory care devices, ultrasound scanners, infusion pumps, endoscopes and MRI, CT and oncology equipment. Our industrial and engineering design capabilities include:
- Understanding user requirements and studying existing products
- Creating conceptual designs
- Gathering functional requirements and constraints of the product through discussions with user community
- Developing high level designs considering form and functionality
- Generating 3D models and create 2D manufacturing drawings
- Developing detailed design, factoring inter component dependencies, manufacturing and assembly constraints, material selection, etc.
- System interconnection design
- Cable and harness design
- Conducting engineering analysis of the design and iterate on the high-level design till functional requirements are met
We also provide a range of engineering analysis services:
- Finite Element Analysis
- Stress analysis
- Structural analysis
- Computational Fluid Dynamics Analysis
- Tolerance Stack up analysis
- Design for manufacturability
- Design for serviceability
Our engineers are well versed in Value Engineering. We provide a range of Value Engineering services that will significantly reduce your product development and material costs:
- Technical data collection
- Commercial data collection
- Product tear down and value analysis
- Product Should Costing
- Functional analysis
- Idea generation
- Idea evaluation
- Function cost worth analysis
- Reverse engineering
- Re engineering
Quality Assurance and Regulatory Affairs
The demand for medical devices from global markets is a challenge for manufacturers. Ensuring safety and regulatory compliance are the biggest challenges for medical device manufacturers in delivering products efficiently. Products must meet global standard requirements as well.
Independent Verification and Validation
Quality and safety are non-negotiable for medical equipment. Assurance of software quality has become a challenging process for enterprises because of increasing technological complexities, software sourcing challenges, compliance requirements and security issues. Therefore, end to end testing is needed to obtain high quality outcomes. Our Verification and Validation (V & V) services can address testing issues by employing an end-to-end testing lifecycle offering, addressing process, people and tools. Our V & V services can increase productivity, enhance delivery confidence and reduce time-to-market and deliver cost effective regression cycles. We have in-house automation testing laboratory for testing of Class II, Class III medical devices for performance testing and functional testing.
- Independent Verification and Validation activities are complying with requirements of ISO 13485, ISO/IEC 62304, ISO/IEC 14971 and FDA GPSV
- System/sub system software verification
- Electronic hardware verification
- Functional, regression testing and integration testing
- Performance testing
- Product reliability testing
- Product design validation
- Usability testing
- Interoperability testing for medical devices - Continua, HL7 and DICOM etc.
- User acceptance testing
- Compliance testing
- Manufacturing process validation
- Requirements management and traceability matrix
- Test plan, test design, test case development and execution
- Defect tracking management
We have a team of regulatory compliance experts with expertise in global regulatory requirements, including ISO 13485, 21 CFR Part 820, IEC 62304, ISO 14971, and FDA 21 CFR Part 11 etc. We have developed a structured Global Compliance Framework that helps our customer meet regulatory compliance requirements.
- Regulatory compliance for medical devices with a well-structured methodology
- Implementation of privacy and security requirements
- Pre-market submissions assistance – FDA510(K), PMA, MDD and SFDA
- Pre-compliance testing and Gap analysis for IEC60601-1 3rd Ed for new and legacy models and certification through ecosystem partners like TUV, Intertek, UL etc.
- Compliance/pre-compliance to Medical Device collateral and standards like IEC 60601-1-2, 60601-2-27, etc.
- Regulatory advice from product concept to commercialization
- Complete ownership in testing of new or re-engineered devices for regulatory compliance
- HIPAA compliance services
- Risk Management (ISO 14971:2007) consulting
- Detail study and implementation of Risk Management
- Regular updates on regulatory requirements
Medical device manufacturers who want to distribute their products in multiple geographies are subjected to a variety of Quality System regulations with their own unique set of requirements. We help you comply with FDA Quality System Regulation (FDA QSR) and ISO 13485:2003. In addition, we provide training, assistance in implementation and a final audit in preparation for all inspections.
- Implementation of Quality Management System (FDA QSR / ISO 13485)
- Risk Management consulting as per ISO 14971:2007
- Gap Analysis with regard to Quality Management System
- Post marketing surveillance like CAPA, post market risk management, complaint management, failure analysis, etc.
- Audits and assessment services, including
- Quality Management System Audits / Mock Inspections
- Supplier Audits
- Safety certifications through notified bodies like UL, TUV, CSA
Manufacturing Process Validation
Process validation is an essential part of Medical Devices engineering. There are multiple regulations like FDA QSR 820.75 and ISO 13485 7.5.2 that all manufacturing facilities must comply with. Non-compliance with these requirements may lead to FDA 483 or non-conformities. We can help you validate the medical device manufacturing process meeting 21CFR 820 /ISO 13485 requirements.
- Identification requirements for validation
- Validation planning: Validation Master Plan (VMP)
- Validation protocols: IQ, OQ and PQ
- Validation tools and techniques
- Monitoring and control
- Validation Gap Analysis
Tech Mahindra is a leader in developing next generation solutions for the global Medical Devices and Healthcare industry. While the global healthcare system is under a lot of stress from an increasing number of chronic conditions and a lack of specialist care, we are leveraging future ready technology to innovate and create transformative healthcare solutions. Our innovative, connected healthcare solutions are designed to improve healthcare delivery and take care outside the hospital walls.
Tech Mahindra’s Connected Care solutions are designed to extend and simplify preventive care, post discharge care, chronic care and clinical trials.
- Remote PICU
- ICU – On The Glass
- Wearable Multi Parameter Monitor
- Tele Health
Read here for more information about our Connected Care solutions and services.
- Multi-Parameter Patient Monitor Development: End-to-end product development of Multi-Para Patient Monitor with ECG, Respiration, Temperature, NIBP, SPO2, IBP, ICO, NICO and CO2. Performed all requirement gathering, architecture finalisation, hardware design, software development, product Verification and Validation and product dossier preparation for the regulatory submission.
- Remote Patient Monitoring Solution: Successfully developed a wearable multi parameter monitoring solution that provides the flexibility of monitoring on the move. Solution consisted of remote viewers for viewing patient vitals and posture information using Android, Windows, iOS devices from any remote location through a cloud based solution. Wearable monitor had flexible connectivity options (WiFi/BLE/3G) and developed in 3 variants considering the requirements of remote home care as well as critical care needs. Features a hot Key for SOS and Event Marking.
- Consultancy in Compliance to IEC 60601-1 3rd Edition: Successfully completed IEC 60601-1 3rd edition certification for an electro surgical unit that was already certified for IEC 60601-1 2nd edition. Certification involved gap analysis, design reviews, deployment of FMEA/FTA, providing inputs for labels and user manuals, pre-compliance testing and certification through 3rd party etc.
- Quality Management System Remediation: A US based device manufacturer had received multiple 483s from FDA for one of their imaging products after inspection. The Tech Mahindra QARA team worked with the customer for fixing gaps related to the Quality Management System and the entire FDA certified product DHF files. Activities involved were gap analysis of QMS, ownership of design control/CAPA processes, remediation for 5 DHFs and complaint investigations.
- Ambulance Concept to Implementation: Successfully conceptualized and developed a next generation ambulance with the latest technology and improved vehicle engineering to enable ‘Reach and Care’ operations of the Emergency Management and Research Institute. The team worked on freezing product technical specifications comprising performance, safety and regulatory requirements, ambulance interior design, designing and integrating advanced vehicle tracking and management solutions and vehicle selection. Launched over 700 ambulances within six months.
Transform your business by improving patient care management, lowering product design investments and achieving faster time to market with world class Medical Device Engineering Solutions & Services uniquely tailored to suit your business needs. For more information, email us or contact us here.