HCL's Medical Device Practice
Challenges
The entire healthcare industry is undergoing a transformation and medical device manufacturers need to be extremely proactive to take advantage of the new technology trends in their favor.
To gain competitive advantage in today's scenario it is imperative that medical device manufacturers must:
- Innovate – develop new products or new versions of exiting products
- Swiftly - shorten product development cycles
- Cost-effectively - produce at minimal cost and with low R&D expenditure
- Efficiently - meet all quality norms & regulatory compliance
Several challenges confront medical device companies. Some of them are listed below:
| Key Factors | Industry Drivers |
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To combat these challenges a vast majority of medical device companies (80 per cent as per the EDM survey) have started outsourcing their device development process. They recognize that there is no point doing something that someone else can do better, faster or at a lesser cost. The outsourcing formula seems to be working too.
Quality JourneyAt HCL, we understand the mission-critical nature of medical devices and follow stringent quality norms in all our design and development processes. We have been continuously moving up in the quality ladder across verticals and today, we are acknowledged as the leaders in Embedded Systems Engineering and product development work. Going forward, we remain committed to keep ourselves abreast with the latest quality norms, cutting across geographies.
Service Offerings
HCL is a recognized leader in the medical device design and development space, providing fast and cost effective end-to-end solutions across a variety of Class 1, 2 and 3 devices, across embedded, hardware, software, manufacturing, regulatory compliance, product risk management, etc. Our end-to-end solutions include providing clients with:
- Design & Development
- Logistic Management
- Quality Assurance
We offer solutions to medical device manufacturers at each and every stage of the product lifecycle. Being an organization with significant Product Engineering strength, we can participate right from the requirements definition to the end, or in any specific stage of the product lifecycle.
Worldwide, we are one of the few vendors to offer end-to-end services for medical devices. Our partnership with Celestica enables us to deliver end-to-end solutions in the Medical Devices area adding further value to our clients. Therefore, a combination of world-class experience, customer-centric processes and best practices, allows us to deliver high-quality solutions to our clients "on time ... in budget".
HCL Differentiators
We offer medical device manufacturers
- 1500+ person years of medical device development experience
- One-stop shop for disease and therapy specific solutions: HCL's extensive expertise in disease and therapy areas enables us to develop disease-specific solutions swiftly
- First Indian Offshore player to be ISO 13485 certified
- Capabilities & Implementation Experience across all Classes of Devices (Class I, II & III)
- Execution excellence and IP security
- Expedience: HCL's experienced engineers design devices keeping quick approvals in mind
- Resource flexibility: Outsourcing design, validation, and manufacturing needs to HCL frees the clients' own resources
- Superior solutions: HCL has made extensive investment in dedicated labs and resources. We also work with the latesttechnologies
- Memberships: Premier forums like AdvaMED & DIA
- Medical Quality Management System (MQMS) certified as per ISO 13485-2003 as well as ISO 14971 risk management standards
- Expedience: HCL's experienced engineers design devices keeping quick approvals in mind
Medical QMS
HCL has a unique and robust medical QMS developed through years of experience and learning.
A snapshot of it is as follows:
