After being selected by a medical design firm to help improve a promising new product, Sanmina, a contract manufacturer, was able to redesign its subassemblies, implement alternate components, upgrade an obsolete display and enhance the quality of the plastics and base casting. The contract manufacturer also helped with documentation and FDA approval, and brought the product to market in a relatively short ten months.
The design firm and client had developed an improved way to treat a common ailment, but needed assistance finishing the product and satisfying FDA requirements. The company’s future depended on a successful launch. After looking into several electronics contract manufacturers, the design firm selected Sanmina, a company with 20-years of experience. The electronics contract manufacturer serves the fast growing segments of the global electronics manufacturing services market.
Many people suffer from the particular condition that the new device treats. Although not life-threatening, it significantly impacts their quality of life. The design firm developed the new product to treat the condition more effectively than previous methods. In fact, it is a one-time treatment so it is better than medication and unlike surgery, it required no hospitalization. Laboratory, animal and clinical studies confirmed the effectiveness and safety of the device. The market was large and growing, but the company’s entire success rested on the redesign and manufacturing of the device, and especially the FDA approval.
The two organizations decided to focus on a partial redesign of several sub systems. Critical engineering challenges involved several components, system testing and then the documentation which previously did not meet FDA standards. The CM provided support at all stages, from design through repairs and returns. For example, design-for workshops helped improve production yields and made the design more robust.
In addition, Sanmina improved the design firm’s test protocols and re-designed test fixtures for more complete test coverage and higher product quality. Revised test programs and procedures were guided by field failure data. The improved designs were less expensive and alternate components resulted in a more agile and robust supply chain. Development and validation costs were minimized because of the contract manufacturer’s experience with medical product design, new product introductions and supply chains. The client’s supply chain was simplified because of the vertical integration of several key components.
The final hurtle was clearing FDA requirements. Because of exacting FDA protocols, Sanmina has a separate team of regulatory personnel to assist with meeting agency requirements. The company kept the agency informed of developments. With documentation that met FDA requirements, agency approval came without delays.