The client is a multi-billion global medical device and pharmaceutical company, with broad portfolios in injectables, infusion therapy, and medication management solutions.
The global infusion market is growing and ever changing with introduction of newer and improved devices incorporated with enhanced safety features, miniaturization, and innovation. It is pegged to be a $5.5-billion industry by 2017. As these are widely used and are Class II medical devices, Food and Drug Administration (FDA) has moved in to establish additional pre-market requirements to address any problems.
Rapid business growth, increasing pressure from competition, innovations in design, and adherence to FDA requirements were some of the reasons the client took a voluntary step to re-engineer their existing infusion pump. The client wanted a cost-effective partner to take this product and transform the R&D to react to the changing market needs and support them for documentation of 510(k) pre-market notification.This re-engineered product would carry all the features of the parent product with innovative additional features.
Wipro set up a development center with over 60 people to completely re-engineer the product in all aspects like electrical, mechanical, software, regulatory and testing.The center is a state-of-the-art facility, the largest in the world outside of the US, and with capabilities to work across various product categories. Critical to Quality (CTQ) parameters were used to decompose broad customer requirements into more easily quantified requirements.All challenges were resolved to meet CTQs and satisfy the customer.
The Wipro team ascertained unidentified problems, completed design in 4 months and prototype in just 6 months. Component analysis, engineering design, adapting existing software to new hardware, testing with complete verification and validation were done to ensure that they are compliant with all the regulations and safety norms.
- Cost optimized by 40% compared to the parent product
- Product was made compelling and efficient by reduction in dimensions by 30%, decrease in volume of pump by 6 times and increase in speed of processing by 2 times
- Trust and confidence from client to complete the project in 18 months but was extended owing to regulatory guidelines and to add more features
- Form factor reduction of 15%
- Improved patient outcomes through higher accuracy
- Faster time to market- design and development