Cost Containment and Flexible Medical Device Manufacturing Services Success Story

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RenalGuard Solutions, Inc. is a privately held medical device OEM focused on innovative technologies for the cardiac and vascular markets. Their lead product, RenalGuard, is a medical device designed to protect patients from contrast dyes used in medical imaging procedures that can be toxic to kidneys. Clinical investigations have demonstrated that RenalGuard is effective for the prevention of contrast-induced acute kidney injury (CI-AKI) in at-risk patients.

RenalGuard is CE-marked and sold in Europe, as well as other countries around the world. Currently, the product is limited in the US for investigational use only while they seek FDA approval for US distribution.

Challenge: Cost Containment and Flexibility

RenalGuard needed a medical device manufacture that could manage their export-only production in a cost effective manner and then scale production following FDA approval. Clinical studies are expensive to run, so it was crucial that Cogmedix could provide cost-effective manufacturing services that supported market penetration outside the US while RenalGuard performed simultaneous domestic clinical trials.

Prior to outsourcing medical device manufacturing to Cogmedix, RenalGuard divested a number of other technologies to focus solely on RenalGuard. As a result of shifting focus solely to RenalGuard, reducing overhead and physical footprint was a top priority.

Solution: FDA-Compliant Manufacturing and A Plan for the Future

Combined with the unpredictable volume of orders for their product and the expenses of shipping only outside of the US, the company was motivated to minimize costs. Cogmedix was willing to work with RenalGuard prior to and during the FDA clinical trial period with the expectation that, once approval came, production volumes would grow significantly. Additional cost reductions were achieved by leveraging a unique relationship with Columbia Tech, a fellow subsidiary of Coghlin Companies, to source PCBAs for device production

These savings could all be reinvested into the product, including its promotion outside the US and the pursuit of FDA clearance to allow penetration of the US market. With help from Cogmedix, RenalGuard has established an avenue to manufacturing their product in compliance with FDA regulations. When their volumes increase, Cogmedix will be ready to support that growth.

Implementation: A Relationship with Room to Grow

Turnkey medical device manufacturing services provided for RenalGuard include: supply chain management, change management, quality assurance, manufacturing, and packaging. Unlike other manufacturing companies, which typically have a minimum threshold for production, Cogmedix is open to small or variable volume operations with innovative companies of all sizes. Cogmedix values not only the production quantity, but also the positive impact a medical device can potentially have for patients and the medical community as a whole.

The Caring Associates at Cogmedix set themselves apart by truly understanding what a long-term relationship means. Short-term challenges are not daunting when a team maintains focus on developing a lasting relationship with OEM clients. A strong system of competency-based cross-training ensures that the Caring Associates at Cogmedix provide excellent coverage to customers both large and small. It also gives them the flexibility of a well-trained staff that can move from one program to another with ease.

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RenalGuard Solutions

Learn why this medical device OEM turned to Cogmedix for cost containment and flexible, turnkey medical device manufacturing services.

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