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

C3i Accell：加速神经假手系统的商业化

• 批准号: 10449736
• 负责人: JAMES J. ABBAS
• 金额: $ 15.38万
• 依托单位: FLORIDA INTERNATIONAL UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-03-01 至 2023-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10449736
• 关键词: Address; Administrative Supplement; Amputation; Amputees; Attention; Businesses; Clinic; Clinical; Clinical Pathways; Clinical Trials; Collaborations; Communities; Computer software; Development; Devices; Documentation; Ecosystem; Electrodes; Electronics; Employment; Engineering; Enrollment; Esthesia; Factor Analysis; Feedback; Foundations; Hand; Home; Human; Implant; Individual; Industrialization; Infrastructure; Interview; Investigation; Leisure Activities; Limb Prosthesis; Medical Device; Modeling; Outcome; Ownership; Pathway interactions; Patients; Persons; Population; Preparation; Process Assessment; Prosthesis; Quality Control; Regulatory Pathway; Reporting; Research Support; Risk Assessment; Safety; Secure; Signal Transduction; Site; Specific qualifier value; Structure; System; Technology; Testing; Third-Party Payer; Translations; Upper Extremity; Validation; Vision; Wireless Technology; Work; Workplace; base; commercialization; cost; design; expectation; first-in-human; follow-up; formative assessment; hazard; innovation; instrument; limb amputation; meetings; neurotechnology; novel; organizational structure; parent grant; primary outcome; programs; prosthesis wearer; prosthetic hand; prototype; relating to nervous system; sensor; software development; success

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.

项目概要 上肢截肢者数量庞大且不断增长，他们的需求没有得到充分满足 目前的假手技术已经满足了这一要求。我们的工作基于这样的理念：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 用户参与更广泛的就业和休闲活动。为了实现这一目标，自适应神经网络 系统神经假手（ANS-NEPH）系统是由我们的实验室设计和开发的 与工业和临床合作伙伴的合作。该系统采用无线控制的植入式 神经刺激器和细线纵向束内电极，根据衍生信号引发感觉 来自仪器化假手中的传感器。我们获得 FDA 的研究设备豁免 进行纵向首次人体临床试验。第一个受试者已被登记、植入、安装 该系统的外部组件，并已完成 2 年的植入后随访期。结论时 在参与这项研究后，他选择保留该系统，现在，植入后三年多，他 继续在家里和社区使用该系统。在家长补助金中，我们正在继续试验 评估其他受试者的临床安全性和设备功能。试验的主要结果将是 证明日常使用的神经假手系统的临床可行性（大于 一年）在家里或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对该领域做出了重大贡献， 如果我们不将该技术部署到临床并将其商业化，那么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 在母基金中，这将通过将该技术推向临床部署来增强影响力， 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、有效且高效地设置 ANS-NEPH 系统的刺激设置。我们将 启动临床医生软件的开发，通过使用结构化的人机界面对 ANS-NEPH 系统进行编程 因素工程方法，包括对代表性用户的访谈以及对模型的形成性评估 为临床医生用户界面制定一组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 肢体商业生态系统。为此，我们将制定业务框架计划，以实现成功 商业化。这将包括制定 FDA 监管上市前批准的策略 以及关键临床试验期间和商业化后的报销。通过解决这些 挑战，我们预计我们可以大大增加成功商业化的可能性，从而 扩大家长补助金和其他联邦对该研究计划的支持的临床影响。