Key Highlights
- HCLTech is a partner to 5 global major clients in Diabetes care with 10 years of experience
- With focus on patient centricity, we have developed more than 18 devices with more than 27 mobile and web apps in Diabetes care
- Running strong with 400 plus FTEs with 3 dedicated labs/ODCs we are focused on improving Diabetic health by being a strong engineering and Innovation partner
- HCLTech is the preferred engineering partner to 10 of the top 10 medical devices companies and 4 out of Top 5 IVD companies
- 6500+ experienced engineers, dedicated to the Medical devices and diagnostics domain
- Knowledge and successful execution of 200+ devices, ranging from Class I,II, III
- Strong local presence in Europe with 10+ delivery centers
- 20 years of experience in medical devices alone. Several complex mission-critical electro-mechanical/ mechanical products developed from concept to launch
Our Offerings
New product development
With capability to support end-to-end NPD lifecycle, knowledge and skill of cross functioning, get our comprehensive solution to simplify product development and redefine care.
- 1250+ Patents Filed
- Investment for in-house State-of-art Labs
- Assured Design Quality
- Experience in emerging markets devices
Regulatory and quality affairs capabilities
Our Regulatory and Clinical CoEs bring in right domain expertise to provide simple and efficient approach to ensure regulatory and quality compliance.
- Highly experienced 250+ Regulatory Specialists
- Established relationship with Notified Bodies
- Supported remediation of QMS for medical device customers
- Expert Physicians within the Clinical team
Manufacturing engineering services
HCLTech has supported over 28 in Plant transition/movement worldwide for major Medical Device Manufacturers. HCLTech Digitization efforts have enabled Medical Device Customers save over $6MN within the last 3 years. HCLTech has enabled the delivery of over annual saving of $30+ MN to a customer for CIP programs.
- Highly experienced 750+ Manufacturing Engineering professionals
- 60-70% reduction in Time in CNC Tool path programming
- 50% productivity improvement
Sustenance engineering services
HCLTech has co-created 170+ Medical and IVD devices. 85% of the resources work in sustaining legacy products for 9/10 Medical Device firms. Leverage our expertise to increase product life and revenue with higher customer retention.
- Product Feature Changes
- Design to Cost
- Component Engineering
- Product Lifecycle Engineering
- Adverse Event Management
CARE – Foundation for building New Age Healthcare Solutions
HCLTech’s CARE (Connected Assets in Regulated Environment) Platform is a Micro-services architecture featured multi-tenant platform that helps in building a regulated medical class software within a significant reduced time.
Quality Engineering Services
For a medical device customer, HCLTech analyzed the customer complaint handling procedure and worked closely with the PMS team to evaluate the end customer product complaints, verified the Adverse Event Survey, and reviewed to closure.
Mobility Services
HCLTech mobility services include delivering large scale program mobility services through a platform approach. For a diversified Medical Device Manufacturer, complete digital enablement of continuous glucose monitoring solution was launched in 25+ countries.
Electronic Device Automation Testing
HCLTech eDATTM is a modular, scalable, extendable and highly customizable framework for automated testing of electronic devices. The framework solution reduces testing costs, time-to-market, and defect leakage. For a leading healthcare organization, eDATTM framework reduced testing costs by 45% and testing cycle times by 47%.
Digital Engineering Capabilities
HCLTech digital solutions include implementing data processing methods to load data into a Big Data lake, rule-driven inclusion, exclusion and data standardization, and securing channel access. For the world's largest diagnostic company, HCLTech has successfully monetised their biggest database of clinical lab results.
Medical Affairs Center of Excellence
HCLTech Medical Affairs solutions include medical device clinical evaluation reports, PMS services, clinical data management, and clinical trials. Introduction of SAS system avoided manual reconciliation of vendor lab data and the programming of SAS reports to highlight the discrepancies
Smart Manufacturing Services and Credentials
HCLTech has managed to achieve up digital set-up of 50 plants, 60-70% reduction time in CNC tool path programming, over $300mn value savings, and 50% productivity improvement by redesigning workstations and overall unit.
Regulatory CoE Services
HCLTech global regulatory submission strategy includes considering the country-specific agency, the complexity of regulation, process, duration, the similarity of regulations, and acceptance of other country approval.
Key Insights
GUIDANCE FOR EU MDR IMPLEMENTATION
This White Paper focuses on implementation guidance for the following topics such as timeline duration for MDR compliance, Reclassification of medical devices, Updates in the technical documentation, Post market surveillance and vigilance and Conformity assessment.
POST MARKET CLINICAL FOLLOW UP
This Whitepaper focuses on the high-level approach for PMCF activities including details on the impact of the clinical data gained through such PMCF activities for any class of medical devices.
SECURITY FOR IMPLANTABLE MEDICAL DEVICES (IMDS)
This paper discusses the efficacy of the Implantable Medical Devices (IMDs), at the same time it also highlights the possibilities of security attacks on commercially available IMDs. Keeping in mind the challenges and constraints posed by the IMDs, the paper also proposes some viable solutions to address the security threats.
DIGITAL THREAD IN MANUFACTURING
This whitepaper details out digital thread concept and how it can bring together the various systems in a manufacturing ecosystem, across the product lifecycle, to give real-time insights to critical stakeholders. Read on to know the implementation process and business benefits of enabling digital thread for your manufacturing enterprise.
COMPLAINT HANDLING FOR MEDICAL DEVICES
It is seen that even with the well-defined requirements from different regulatory bodies, the number of complaints related observations keep increasing year on year. Implementation of an effective complaint handling process is a challenge for most of the organizations, especially if the products are sold in different geographies. Having a flexible and a dynamic complaint handling process make organizations future-ready and efficient. This in turn can help them sustain their products in the market for a longer duration.
INTEGRATED APPROACH FOR HAZARDOUS SUBSTANCES IN MEDICAL DEVICES REGULATED BY EU
The EU regulations restrict the use of various substances, but the approaches used to phase out hazardous substances are very different. Clearly, the intent of all directives is to control the use and disposal of substances that are hazardous to human health or to the environment. From design to disposal of Medical Devices, these directives impose regulations on an OEM’s products over their entire lifecycle, and impact the OEM’s supply chain, customers, distributors and dealers.
BE FUTURE READY WITH A DIGITAL SUPPLY CHAIN
Learn how HCLTech’s SAP Digital Supply Chain solutions can help enterprises modernize supply chains using powerful new technologies such as RFID, drones, AI and ML, RPA, OCR, and cross-system integrations to materialize the theoretical benefits and make them a reality for businesses.
SMART PACKAGING IN MEDICAL INDUSTRY
Smart packaging is a technologically-driven future in every sector of the packaging industry. Organizations, as well as customers, are inclined towards newer, informative yet user-friendly packs. The report analyzes and gives transparent views about smart packaging in the medical device industry.
Client Success
ENABLING PATIENT CARE THROUGH CONNECTED SOLUTION
HCLTech helped the healthcare conglomerate to focus on unfulfilled needs of patients and consumers on a global scale, creating creative, innovative products and new market categories in their efforts to contribute to the health and well-being of people globally.
HCLTech RECOGNIZED AS A LEADER IN ZINNOV ZONES FOR ENGINEERING R&D SERVICES 2021
HCLTech has strengthened its position as the only Service Provider recognized amongst top 2 players in Overall and Digital Engineering Services segments in the latest Zinnov Zones for ER&D Services 2021 assessment.