The process of taking an innovative medical device from concept to full-scale production is inherently complex. Challenges can include organizational silos, such as design and manufacturing, which fail to communicate and align at an early stage. This disconnect can cause costly delays and rework. Similarly, research and development groups (R&D) may choose suppliers for a prototype that prove unsuitable for supporting commercial production. Weakness in the area of human factors engineering (HFE) can also derail a device’s development.
Start-up companies typically lack expertise and resources to conduct or oversee the concept-to-commercialization process, while larger organizations may be distracted by the competing demands of other projects. A lack of dedicated manufacturing capability for piloting a new design can also interfere with production of other devices.
Nypro Healthcare provides comprehensive, integrated services for medical devices, including a dedicated facility, specialized competencies, equipment and IT infrastructure.
An end-to-end new product introduction service can cut the average concept-to-commercialization time of 18 to 24 months down to about 12 months. Nypro Healthcare can even provide expertise in regulatory requirements, such as assisting with preparation of the 510K submission to the FDA.
Such services ensure a focused approach and a seamless flow from one phase to the next.
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