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Successful sourcing initiative in Asia gives competitive advantage to medical device company
The project was about a multinational medical device manufacturer looking for new OEM manufacturers of urinary hydrophilic catheters in China and India to sell into the United States market.
The specific challenge was to find a supplier that was able to meet the stringent regulatory and legal requirements to enter the US market. As urinary catheters for human use are classified as Class II medical devices by the US FDA, the equipment requires a premarket notification 510 (k) to FDA.
Opportunity
As a strategic initiative to improve the competitive position, the company was looking for a new manufacturer of urinary catheters to add to the list of current suppliers. To ensure creating a long-term sustainable relationship with the supplier, the client asked ARC Consulting to support in finding the most suitable partner in terms of manufacturing capabilities, regulatory support, costs, quality control, location and operational excellence.
Approach
To optimally assist the client, ARC Consulting used a multi-step approach on the project.
- As an initial step, consultants at ARC Consulting started with gathering data using multiple reliable sources of information to identify a pool of potential suppliers.
- Secondly, careful screening of the initial list was performed via desktop research as well as phone and face-to-face interviews, to filter the list further more.
- Thirdly, the aggregated list was further evaluated based on the suppliers past export to the US and/or EU and whether the supplier’s products were already registered in the US market or had a CE mark and ISO certificates.
- Finally, the chosen suppliers for the long list were further examined and studied individually, to be categorized into 3 categories representing the potential as a reliable supplier for the client.
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