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.

Medical tubing devices

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.

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.

The initial research yielded a potential pool of 128 companies from China and India that had business relevant to the urinary catheter market.  From this list, 28 were considered to have adequate hydrophilic urinary catheter manufacturing capability. Potential suppliers with prior experience submitting 510 (k) either under their own brand or under their customer’s brand or had products with CE and ISO certificates were identified and selected to make the Supplier Long List and prioritized into 3 groups. The Supplier Long List contained a total of 21 companies with 4 companies classified in Group A (companies already with premarket notification 510 (k)), 3 in Group B (companies which export to the US market under their customer’s 510 (k)), and 14 in Group C (no prior US export business but still with good potential to meet the requirements).

A catalog of the 21 companies was created and delivered to the client with a detailed description of each company; the in-house process capabilities, location, CSR level and relevant pictures.

As the next steps, ARC Consulting proposed to conduct further in-depth evaluations of the suppliers along with requests for quotations, sampling, onsite visits, and any other criteria defined by ARC Consulting and the client. The final step was proposed to be negotiating the terms of the actual supply and signing the contract with the supplier.

  • Provided the client with comprehensive market knowledge and information.
  • A long list of all potential suppliers in China.
  • Assisted in screening and evaluating all potential suppliers according to client’s requirements.
  • Detailed company information and contacts of each supplier.
  • A highly qualified short-list of potential suppliers meeting all the regulatory requirements for exporting to the US market.
  • Support and assistance during the whole process from screening to negotiating with potential suppliers in China.
  • An in-depth market report based on up-to-date material for accurate and fact-based business decisions.

See more about our market entry and sourcing consulting services and our experience in the healthcare and medical products sector.

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