Smith & Nephew

LAB-TO-PRODUCTION AUTOMATION 

We enable global medical clients to shorten go to market time by implementing a lab-to-floor development plan that eliminates re-validation.  

Challenge:  Within regulated industries, especially medical and pharmaceutical device companies, the R&D and production departments often reside in physical and financial isolation from one another.  These operational silos result in independent workflows and handoffs. The R&D department will develop a new design or process, and then transfer their findings to the operations and manufacturing group who then must develop solutions to meet production and regulatory demands. 

Solution:  Hildurcrest group introduced a new methodology and process development. Bridging the Gap between R&D Labs and the manufacturing floor.  

The R&D center developed bespoke solutions for automating manual processes that dominate traditional device and consumables assembly. The investment in R&D automation resulted in designs that support production volumes.  

Once the R&D team validated the process and protocol, the product design allowed for scalability and eliminated the need to revalidate another solution for manufacturing.  The automation center was simply transferred to operations, and the production facility was able to expedite  IQ/OQ/PQ enabling verified  production only  5 days after R&D validation.  

Results

Our lab to floor approach to delivered an automated benchtop design that saved the organization 20 weeks versus their standard production validation approach.  

This allowed the facility to deliver finished product to the marketplace 4 to 5 months faster and traditional approaches to manufacturing automation.  In this instance, the organization captured nearly 6 million in top line revenue that would have been lost through standard protocol. 

Additionally, the automation solutions replaced many manual processes. This added a layer of quality control and repeatability which elevated the company's claim as a market leader in delivering world-class product.