C3i Accell: Accelerating commercialization of a neural-enabled prosthetic hand system

项目总结 有一大批上肢截肢患者，他们的需求并不是完全的。 被当前的假手技术所满足。我们的工作基于这样一个概念，即假手技术 提供与任务相关的感觉将提高感觉运动任务的熟练程度，从而允许假肢 让用户更广泛地参与就业休闲活动。为了实现这一点，自适应神经网络 系统神经使能假手(ANS-NEPE)系统是我们实验室于#年设计和开发的 与行业和临床合作伙伴合作。该系统使用了无线控制的植入物 神经刺激器和细丝纵向束内电极，根据所得的信号诱发感觉 来自仪表式假手上的传感器。我们有FDA的调查设备豁免权 进行一项人类首例纵向临床试验。第一个受试者已经登记，植入，安装了 系统的外部组件，并已完成了为期2年的植入后随访期。在结束时 关于他参与了这项研究，他选择保留这个系统，现在，在植入三年多后，他 继续在家里和社区使用该系统。在家长赠款中，我们将继续试验以 评估其他受试者的临床安全性和设备功能。审判的主要结果将是 日常使用的神经驱动假手系统的临床可行性论证(大于 一年)，在家里或在工作场所使用无线控制的植入式刺激技术。 虽然该系统的创建和正在进行的临床试验是对该领域的重大贡献， 如果我们不在临床上部署这项技术并将其商业化，临床影响将严重减弱。 在C3i Accell计划的支持下，我们计划解决正在解决的两个关键挑战 在母公司拨款中，将通过将这项技术推向临床部署来增强影响，并 商业化。第一个挑战是开发软件，使临床医生能够对 在临床环境中安全、有效和高效地设置ANS-NEPH系统的刺激设置。我们会 启动临床医生软件的开发，以使用结构化人类对ANS-NEPE系统进行编程 典型用户访谈和样机形成性评价的因素工程方法 为临床医生-用户界面制定一套可靠的与使用相关的要求。第二个挑战是 开发一种商业模式，使我们能够在神经技术和假肢领域有效运营 保护商业生态系统。为此，我们将制定业务框架计划，以实现成功 商业化。这将包括为FDA的监管上市前批准准备战略 以及在关键临床试验期间和商业化后的报销。通过解决这些问题 挑战，我们预计我们可以极大地增加成功商业化的可能性，从而 放大父母拨款和其他联邦支持对这项研究计划的临床影响。

PROJECT SUMMARY There is a large and growing population of individuals with upper-limb amputation whose needs are not fully met by current prosthetic hand technology. Our work is based on the notion that prosthetic hand technology that provides task-related sensations will increase proficiency in sensorimotor tasks and therefore allow prosthesis users to participate in a greater range of employment and leisure activities. To achieve this, the Adaptive Neural Systems neural-enabled prosthetic hand (ANS-NEPH) system was designed and developed by our lab in collaboration with industrial and clinical partners. The system uses a wirelessly-controlled implanted neurostimulator and fine-wire longitudinal intrafascicular electrodes to elicit sensations based on signals derived from sensors in an instrumented prosthetic hand. We have an investigational device exemption from the FDA to conduct a longitudinal first-in-human clinical trial. The first subject has been enrolled, implanted, fitted with the external components of the system, and has completed a 2-year post-implant follow-up period. At the conclusion of his participation in the study, he opted to keep the system and now, more than three years post-implant, he continues to use the system at home and in the community. In the parent grant, we are continuing the trial to evaluate clinical safety and device functionality in additional subjects. The primary outcome of the trial will be a demonstration of clinical feasibility of a neural-enabled prosthetic hand system for daily use (for greater than one year) at home or at the workplace that uses wirelessly-controlled implantable stimulation technology. While creation of the system and the on-going clinical trial constitute significant contributions to the field, the clinical impact will be severely muted if we do not deploy the technology in the clinic and commercialize it. With support from the C3i Accell program, we plan to address two key challenges beyond those being addressed in the parent grant that will enhance the impact by moving this technology towards clinical deployment and commercialization. The first challenge is to develop software that will enable clinicians to program the stimulation settings of the ANS-NEPH system safely, effectively, and efficiently in a clinical setting. We will initiate development of the clinician software to program the ANS-NEPH system by using a structured Human Factors Engineering approach with interviews of representative users and formative evaluations of a mock-up to produce a robust set of use-related requirements for the clinician-user interface. The second challenge is to develop a business model that will enable us to operate effectively in both the neurotechnology and prosthetic limb commercial ecosystems. For this, we will develop plans for a business framework that will enable successful commercialization. This will include preparation of strategies for regulatory pre-market approval by the FDA and for reimbursement during the pivotal clinical trial and after commercialization. By addressing these challenges, we anticipate that we can greatly increase the likelihood of successful commercialization and thereby amplify the clinical impact of the parent grant and other federal support for this research program.