Comprehensive manufacturing platform for high volume production of medical devices – STI specializes in laser machining and finishing of implants and surgical tools for MIS applications. STI’s contract manufacturing services consistently deliver quality assured products that meet tight specifications.
STI supports companies at different stages of their product life cycle. STI manufactures excellent quality products and delivers them on-time to satisfied customers. Medical device companies, looking for either a primary supplier or a second source supplier, contract STI to manufacture metal components and assemble end-products.
Flexible capacity, ramp-up production and full traceability
Successful market introduction requires effective management of product inventories and the ability to quickly respond to changing market demands. Demand for a certified product for clinical use varies greatly and is difficult to predict. The graph below plots the number of units manufactured as a function of time, highlighting a typical purchase order pattern from early R&D stages onwards.
Initial market penetration requires small quantities used for evaluation by opinion leaders and demonstration in professional symposiums. Positive feedback may significantly increase the demand for the product. Therefore medical device companies stock their products before introducing them into the market. After receiving approval for market distribution, purchase orders normally reflect market demand fluctuations.
The initial stage of market penetration is very sensitive for any company trying to balance its manufacturing expenditures against income from sales.
STI developed the means to respond to changing market demands. The normal mode of operation relies on a single shift of 12 hours per working day. When demand peaks, STI responds by adding shifts. In cases of persistent demand for a particular product, STI may either increase its production capacity or allocate dedicated resources to a particular product or customer. STI’s wide customer base allows flexible resource allocation that benefits all customers.
In addition to the mass production capacity, serial manufacturing necessitates complete lot and batch traceability. Therefore STI maintains all production files for at least seven years or longer depending on the client.
STI offers turnkey projects to medical device companies seeking to outsource all or part of their supply chain. The scope of activities included in a turnkey project may start with raw material and component sourcing, inventory management, manufacturing of the various components, cleanroom product assembly to a final sterile product kit, inventory management of final product and distribution to buyers.
As a certified EN ISO 13485 medical device manufacturer, STI uses its in-house manufacturing capabilities to provide most of the required services. STI assumes full responsibility for any complementary service contracted by it to support the turnkey project.
For further details please view the turnkey scope of services.