|We should make strides toward fostering a community of trust and partnership that accelerates academic, industry, and government collaboration to propel commercial translation of maturing scientific research and technology.||
• Improve industry education and reduce silo effect among various groups and stakeholders|
• Encourage additional public-private partnerships (PPP) and/or expansion of these.
|There must be opportunities to engage the consumer more directly in the innovation process and to incorporate consumer data. The consumer’s decision-making ability should be strengthened by equipping the consumer with more scientific information, therefore the field must develop ways in which interaction between innovators and assessors of the technology are informed by users of the technology.||
• Write and submit open letters to the editors of a key technology/medical journal of needs statements regarding consumer/patient engagement within the neural engineering field.|
• Host working groups at other neural engineering related conferences.
|The high degree of collaboration necessary to gather funding and other resources should be present in the entire funding pipeline. We should push for more collaborative and interdisciplinary science at NIH and other organizations, including sources of “seed” funding to spur collaborations. Major resource providers such as venture capitalists should receive more education on the technology and its attendant use-cases and points of need, so that our work is understood as more than just a short-term investment or source of revenue. Similar bridges need to be built between pure science and business.||
• Develop and share a comprehensive map of the funding ecosystem.|
• Across the discipline of neural engineering, begin publishing negative or contradictory results in bioRxiv as a resource for other researchers.
|Recast the challenges of the reimbursement process in ways that better serve all stakeholders. Knowledge and understanding of CMS processes can guide us in the development of devices as early as the innovation phase. To develop a stronger and more communicative reimbursement process, we need to ask what we can do for CMS and how CMS can serve us better. We must help CMS better understand the social value of our devices.||
• Make our community aware of CMS.|
• Build a relationship with CMS.
• Fund a fellow at CMS that serves as a bridge between our communities.
|Increase patient agency by developing systems that are sustainable, secure, closed-loop, minimally or non-invasive, and responsive. Neuroengineers can optimize risk and reward by expanding knowledge of the physiological basis for neural disorders and developing a nuanced classification strategy for patient selection. Neuroengineering can both show us and guide us toward the future, and we must innovate cultures of ethics and inclusion within the field and among those who regulate or benefit from its technologies.||
• Create a global neural engineering forum.|
• Increase communications about neural engineering innovations.
• Increase diversity as a means for innovation.
|We envision clinical efficiency in developing and deploying breakthrough solutions that maximize self-agency and balance risk with reward to improve the quality of life for individuals living with diseases or disorders of the nervous system. The goal is to help restore users’ self-agency and participation in their communities of choice through a collaborative, inclusive, multidisciplinary, biobehavioral approach.||
• Improve bi-directional interactions between neural engineers and clinicians.|
• Define views on “augmentation;” a neuroethical framework.
|We envision a seamless integration between funding and regulatory agencies, and two-way communication between these organizations and the NE community, which speaks with one unified voice and is educated in regulatory processes. All stakeholders work together within an expedient, smooth regulatory and reimbursement ecosystem to bring the best neurotechnology products to patients.||
• Develop an IDE template or examples to share within the community.|
• Recommend and identify inter-agency liaisons between federal funding agencies and the FDA.
• Write consensus responses to FDA guidances related to the neural engineering community.
• Write a formal request that NIH support regulatory science requests for application (RFAs).