Surgical Device Development

For latest version: please go to https://academicentrepreneurship.pubpub.org/pub/ix4cdtm1/release/5 The pre-development phase takes an idea to a concept with a business case for developing the device. Key elements include defining user needs, generating different concepts and their respective regulatory pathway, intellectual protection strategy, reimbursement model and overall commercialization strategy. The development phase is an iterative process that converts the concept into a product that is tested and evaluated through the verification and validation process, and ready for regulatory submission. Design Transfer is a set of procedures that are required to ensure that the device’s design is correctly translated into production specifications and performing a market preference evaluation prior to a full scale product launch. Following product launch, the product enters the post-market activities phase, in which operations are scaled up to reach sales targets, the product is maintained and improved if possible, and strategies for product refresh, product extensions, seeking new markets.