ATEX, The Reliable and Innovative Supplier
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Device Deployment Cables with Rapid Turnaround
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High Tech Materials and Rapid Response for a New Device
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ATEX, The Reliable and Innovative Supplier
Situation
The customer came to us in the midst of their initial clinical trial. Their original supplier ceased production of a critical implantable textile component with little warning to the customer. Thankfully, the customer was referred to ATEX by a mutual acquaintance who was familiar with our high quality, innovative and responsive engineering and dedication to on-time delivery. The customer reached out to ATEX to provide this much needed textile component and solve their supply chain challenge.
Background
This customer was in a difficult situation, desperately needing implantable material to use in their on-going clinical trial with no source for this textile component. ATEX agreed to step in and immediately convened a development team to support the customer.
Procedure:
ATEX and the customer worked closely to review all existing requirements and further refine them where needed. ATEX collaborated with the customer to develop a replacement component which was then used in a device launched for human use in less than 6 months.
Result:
ATEX became the new textile component supplier to this customer and ensured that the customer’s clinical trial was not paused or delayed. ATEX and the customer worked to make the transition to ATEX seamless. The product was successfully commercialized on time and with a secure and reliable supply chain.
Device Deployment Cables with Rapid Turnaround
Situation
A customer had been sourcing high strength, low creep, low elongation braided cable for their delivery system actuation cable. The customer had clearly defined strength and creep requirements and needed to find a partner who could deliver on those requirements.
Background
A customer came to us who had a delivery system currently on the market. For a next generation improvement, the customer needed to modify the delivery system to improve the user experience and the consistency of the procedure to deploy the transcatheter device.
Procedure:
ATEX developed a material meeting all specified parameters for strength and creep. Once bench testing of the cable in a finished device was completed, the material was determined to be too strong and too stiff, resulting in damage to some internal system components. ATEX and the customer quickly convened dedicated teams and began an aggressive effort to redesign the material to meet new strength and creep requirements while improving functional performance of both the material and delivery system.
Result:
In a very short period of time, a second cable configuration was developed, tested and launched for commercial use. The new configuration was the result of identification of a new raw material and a complete redesign of the braid construction. Success was achieved through substantial collaboration between ATEX and the customer, including multiple team calls each week and frequent on-site visits by both ATEX and customer.
High Tech Materials and Rapid Response for a New Device
Situation
Upon the FDA’s request, a customer was fast-tracking the development of a pediatric heart valve. Their current supplier could not provide material that could meet the stringent demands for elongation and contraction that would be required for both the novel device and procedure.
Background
The FDA had identified that there was an unmet pediatric clinical need that our customer wanted to address. This unmet need was due to low market size making pediatric devices often unavailable or simply smaller versions of adult devices that are not ideal for small yet growing anatomy. This device manufacturer already had a successful adult version of the valve device but knew that a wholly unique product, engineered specifically for a child, was what the market needed.
Procedure:
Upon our customer’s request, we assisted in the development of a custom solution to meet the device requirements. To do so, ATEX deployed a development team to work closely with the customer and gather requirements for the substantial elongation and contraction unique to this pediatric valve. ATEX quickly realized that engineering the perfect solution would also require custom yarn development, component construction and fabrication all at once.
Result:
Development efforts for this project were completed much faster than a typical concept to commercialization timeline would take and was achieved through the work of dedicated teams from customer & ATEX. ATEX and the customer established productive project team calls multiple times per week. The project also included multiple visits to each other’s facilities to further enhance communication and the development to commercialization process. In the end, the customer was able to commercialize a novel product, addressing an unmet clinical need in a relatively short time frame as a result of this intense and productive collaboration.
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