Specification Developer
What is a specification developer?
A specification developer is responsible for defining the specifications and requirements for a medical device but does not handle the actual manufacturing of the device. Instead, they typically engage a contract manufacturer to produce the device according to their specifications. The role of a specification developer involves creating detailed product specifications, which include design, materials, and performance criteria, and ensuring that the device meets regulatory standards.
The specification developer’s responsibilities include obtaining necessary regulatory approvals from agencies such as the FDA, which may involve securing a pre-market application (PMA) or 510(k) clearance depending on the device’s classification. They must also establish and maintain a quality management system to comply with FDA regulations and register with the FDA through establishment registration.
Why might someone choose to be a specification developer?
Opting to be a specification developer allows an individual or company to focus on the conceptual and strategic aspects of medical device development, such as innovation, marketing, and sales, while outsourcing the manufacturing to specialized facilities. This approach eliminates the need to invest in and manage manufacturing infrastructure, enabling the specification developer to leverage their expertise in product development and market positioning. It provides a strategic advantage by allowing them to concentrate on product design and business growth while relying on established manufacturers for production.