At Flexan, we balance decades of manufacturing expertise grounded by a leadership team that shares more than 120 years of relevant medical device industry experience. From our implementation of capable processes to our focus on DRM (Design for Reliability and Manufacturability), we believe in providing our customers with an environment that fosters innovation and creates pathways for the development of new, ground-breaking clinical therapies and long-term industry sustainability.
From ideation, we help medical device manufacturers who are looking to launch a new product with design for manufacturability collaboration for their silicone and thermoplastic components or devices. From engineering and process design to project management, we provide the solutions and support you need.
Understanding the need for speed in new product development as well as the need to address all regulatory requirements, we provide rapid prototyping and delivery of prototype parts within weeks without sacrificing the quality you demand.
New Product Introduction (NPI)
Our NPI process manages process development, manages project risk and maximizes predictability through a tightly controlled stage-gate process. From concept through commercialization, Flexan NPI is a tailored process that helps us deliver successful product development services on time, and on-budget.
With a technical team of engineers, chemists and technicians who understand the intricacies of medical device manufacturing and the stringent requirements of both the medical device industry and the FDA, we optimize production and savings.
The performance and resiliency of your product relies heavily on the work we do and the components we produce. We validate all of our equipment, facilities, software and processes in order to ensure consistent performance over the life of your product.
Once your product is launched and in production, our operations and sustaining engineering teams will work diligently to ensure the lifecycle of your product is properly managed — including tool maintenance, repair, support for demand changes and incorporation of new technologies.