Journal of Biomimetics Biomaterials and Tissue Engineering
Open Access

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 life-cycle 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 life-cycle. 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.

Biography

Lisa Ferrara is currently the Owner and President of OrthoKinetic Technologies LLC, and OrthoKinetic Testing Technologies, LLC, a medical device consulting and certified test facility that provide a turn-key approach for medical device evaluation. Academically, she was on staff for the Departments of Neurosurgery and Orthopedic Surgery respectively, at The Cleveland Clinic Foundation (CCF) in Ohio, where she founded the Spine Research Laboratory and served as the director from 1999 until 2003. During her 25 years of academic research, she has authored more than 50 technical publications, 25 book chapters, has been granted two patents, and given over 50 invited presentations on novel technologies, biomaterials, nanotechnology and nanomedicine, musculoskeletal and spinal biomechanics, surgical stabilization techniques and medical devices. She also serves on numerous scientific advisory boards and was the recent recipient of the Healthcare Entrepreneur of the Year Award for Coastal North Carolina, was highlighted as an industry expert in medical device testing and analysis, and was named Woman of the Year in 2015 by the National Association of Professional Women.