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

IF 1.6 The Journal of hand surgery, European volume Pub Date : 2025-06-01 Epub Date: 2025-03-13 DOI:10.1177/17531934251323855
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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从概念到市场:手外科新植入物的开发历程。
本文探讨了开发一种用于手部手术的新型植入物的过程,重点介绍了从概念到市场推出的关键阶段。它概述了监管障碍、财务约束和市场限制所带来的挑战,同时强调坚持不懈、以患者为中心的设计和影响驱动的创新。开发过程包括构思、原型制作、测试以及与学术和工业伙伴的合作。在获取资金、驾驭知识产权和解决严格的法律要求方面提供实用指导。测试方法,包括生物力学和体内研究,讨论以确保安全性和有效性。论文最后提出了初步临床应用、市场推广和长期绩效监测的策略,激励创新者克服障碍坚持下去。证据等级:V。
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