Peckham P H, Thrope G, Woloszko J, Habasevich R, Scherer M, Kantor C
VA Cleveland FES Center, Cleveland VA Medical Center, OH 44106-3052, USA.
J Rehabil Res Dev. 1996 Apr;33(2):173-83.
Despite long development periods for neuroprosthetic devices, the numbers in clinical use or clinical trials are rising, with an estimated 3,000 systems in use today. As they gain experience with the regulatory approval process, developers are learning to conduct research to best prepare for transfer of technology to industry. The track record of the first motor prosthesis to be approved by the United States Food and Drug Administration contains important lessons for a company planning to undergo the regulatory process. Throughout the development of a neuroprosthesis, the capabilities and preferences of the customers who will use it (physicians, surgeons, therapists, and end-users) should be sought out and used in device design. When a device has reached clinical application, particular attention is needed to maximize both the population who will use it and each individual's degree of use (optimal, partial, reluctant). Identification of person-technology mismatches can help to select training strategies and other interventions that can be applied to ensure a good rehabilitation outcome.
尽管神经假体设备的研发周期很长，但临床使用或临床试验中的数量正在增加，据估计目前有3000套系统在使用。随着开发者在监管审批过程中积累经验，他们正在学习进行研究，以便为技术向产业转移做好最佳准备。美国食品药品监督管理局批准的首个运动假体的记录，为计划经历监管过程的公司提供了重要经验教训。在神经假体的整个研发过程中，应找出将使用该设备的客户（医生、外科医生、治疗师和终端用户）的能力和偏好，并将其用于设备设计。当设备达到临床应用阶段时，需要特别关注如何使使用该设备的人群数量最大化以及每个人的使用程度（最佳、部分、勉强）最大化。识别人员与技术的不匹配情况有助于选择培训策略和其他干预措施，以确保良好的康复效果。
