From concept to market: The development journey of a new implant in hand surgery.

Daniel B Herren
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Abstract

This article explores the journey of developing a new implant for hand surgery, highlighting key stages from concept to market launch. It outlines the challenges posed by regulatory barriers, financial constraints and market limitations, whilst emphasizing perseverance, patient-centred design and impact-driven innovation. The development process involves ideation, prototyping, testing and collaboration with academic and industrial partners. Practical guidance is provided on securing funding, navigating intellectual property and addressing stringent legal requirements. Testing methodologies, including biomechanical and in vivo studies, are discussed to ensure safety and efficacy. The paper concludes with strategies for initial clinical applications, market rollout and long-term performance monitoring, inspiring innovators to persist despite obstacles.Level of Evidence: V.

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