Lisa A Ferrara* and Diane Dobrea#
*OrthoKinetic Technologies, USA
# Kapstone Medical, USA
Title: Workshop: Designing and evaluating protective gear and implants for safety and effectiveness
Biography
Biography: Lisa A Ferrara* and Diane Dobrea#
Abstract
Innovation starts with a novel idea that has the potential to evolve into a viable product which can address a specific market need. The criteria for successful product development are multifaceted and involve a multidisciplinary team to ensure that the product behaves in a safe and effective manner. Often, the greatest challenges the team may face are during the early phases of product development. Entry into the product lifecycle of a new technology involves the coordination of multiple resources and experienced experts with diverse backgrounds that can provide guidance on the market need, patent landscape, verification and validation protocols, manufacturing capabilities, potential risks and mitigation. Additionally, there are a number of specific processes outlined in the product life cycle that provide the pathway for successful product development from the early concept stage to final commercialization. Thus, ensuring that a safe product, which functions per its intended use is brought to market, involves many iterative processes throughout the product lifecycle. Therefore, the objective of this workshop will be to provide an overview of product development from early concept to commercialization, which will include a discussion of the potential risks and pitfalls that are commonly faced during the many phases of development.
