Modern medical device companies are embracing research-driven digitalization to consolidate IT portfolios, enhance business efficiency, and minimize operational costs. With development centers in over 30 countries, we are positioned to deliver end-to-end engineering and R&D services that can transform the medical devices landscape.
We have spearheaded global tech initiatives by developing a gamut of critical hardware products. With 30 years of relevant domain experience, we have emerged as a global innovation and R&D Partner. Harnessing our proven product engineering capabilities, we offer layered solutions for medical device manufacturers applicable at every stage of the product lifecycle.
We are strategic partners to 7 out of the top 10 medical devices OEMs. Our strategy, implementation, and product support expertise across the medical devices’ R&D value chain helps deliver CTMS (Clinical Trial Management Services). Additionally, we ensure:
- End-to-end customer engagement: idea generation, product design, manufacturing, and implementation
- Improved user experiences by effective collaboration with medical devices companies
- Holistic view of study performance with valuable insights and data visualization via rHorizon, our risk-based monitoring tool
- Successful adoption of a flexible and risk-based monitoring approach throughout clinical trials via a highly configurable engine and a comprehensive rules database
- Optimized analytical cycle time, resource allocation, workload monitoring, and data accuracy with Lab Informatics
- Bolstered productivity and reduced duplication efforts
We have extensive work experience across Class I, II, and III medical devices and equipment, following world class processes like Six Sigma, CMMi Level 5, SEI CMM Level 5, PCMM Level 5, ISO 9000, MDD & ISO-13485, and BS 7799.
We have successfully developed over 100 medical devices in the last 15 years, including class II and class III equipment.
New Product Development
New Product Development
HCLTech leverages deep understanding of the product engineering domain to architect innovative solutions for medical devices OEMs – streamlining every stage of the product lifecycle. Our engagements with customers span several key stages – concept/idea generation, design and development, new product manufacturing, and finally, deployment. HCLTech follows world class process standards like Six Sigma, CMMi Level 5, SEI CMM Level 5, PCMM Level 5, ISO 9000, MDD & ISO-13485 and BS 7799. Our development models are powered by extensive experience in designing Class I, II, and III medical devices and equipment.
Clinical research organizations (CROs) have been introducing innovative technologies and infrastructure upgrades for clinical trials. HCLTech has extensive experience in strategy, implementation, and product support of medical devices across the R&D value chain. We offer Clinical Trial Management Services (CTMS), an all-encompassing solution that helps medical device companies improve user experiences.
HCLTech’s Clinical Data Management solution helps generate, accumulate, and analyze high-quality clinical trial data – compatible with a range of applications and database systems. HCLTech also offers Data Analysis – collecting data during trial execution, for analysis (powered by lists, tables, and figures) to determine the safety and efficacy parameters of the drug.
With increasing market competition and tech evolution, medical companies are compelled to maximize operation efficiency across processes.
HCLTech’s rHorizon is a risk-based visibility tool – to simplify site monitoring which constitutes 45% of the annual clinical trials spend. It enables holistic performance views and cleans valuable data insights/visualization, helping onsite clinical research associates (CRAs) focus on critical clinical trial processes.
The solution is powered by analytics that regulates the frequency of monitoring visits on the basis of site performance.
Medical companies are embracing automation to consolidate IT profiles, increase operational efficiency, and reduce business costs. HCLTech’s data automation framework optimizes analytical cycle timelines, resource allocation, workload monitoring, and data accuracy.
The solution encompasses multiple processes:
- Laboratory technology infrastructure setup
- Business intelligence
- Laboratory informatics strategy
- Data migration and warehousing
- Lab informatics implementation
- Laboratory process improvement
HCLTech’s Lab Informatics solution suite comprises Data Migration Integrating and Reporting (DMIR) Solution for voluminous data management/visualization and Lab Information Management System (LabIMS), a one-stop shop for master data processing.