June 30, 2017 | June 2017 issue
June 30, 2017 | Dubbed the non-conference, the 4th biennial Cleveland NEW event took place June 21-23, 2017 at the Global Health Innovation Center in Cleveland, OH. More than 80 stakeholders from the neural engineering field participated, including clinicians, funding agencies, industry, researchers, and academics. The event featured two and half days of interactive discussions that endeavored to identify and tackle some of the key challenges and opportunities confronting neural engineering.
The previous event, held in 2015, resulted in the publication of the Neural Engineering Roadmap. This comprehensive guidance document offers a detailed vision of the field through 2035. The document is available on the event website (www.clevelandnew.org) and it is segmented into seven theme areas: funding, reimbursement, regulatory, innovation, translation, clinical practice, and patient-as-consumer. At this year’s workshop, discussions followed along the same lines, with each being led by a theme leader. Using the 2015 Roadmap as a starting point, the 2017 group looked for one degree of change in each area and sought to create goals with short term consensus and actionability. The ultimate aim for attendees was to find a common voice for the neural engineering field to drive initiatives toward common goals.
Digging into each area, theme leaders guided group discussions to get to a point of some concrete actionable efforts. The funding theme was led by Chris Czura of the Feinstein Institute. The vision for this area is a comprehensive funding landscape that sustains research along a continuum from initial discovery to consumer-focused translation through commercial dissemination. The vision calls for some key achievable actions such as reporting unpublishable data or negative clinical trial results on sharable archives. Other goals include efforts to inventory and catalog funding opportunities in the field of neural engineering and the formation of a Neural Engineering LinkedIn group (www.linkedin.com/groups/12051598).
The regulatory and reimbursement theme was segmented into two separate themes. Reflecting on progress since 2015, Cristin Welle of the University of Colorado presented key accomplishments including the FDA Public Workshop on brain-computer interface devices for patients with paralysis and amputation and the NIH Workshop on Standards and Modularity. She also highlighted expedited access, benefit-risk determinations, patient preference initiatives, as well as clinical considerations for IDEs for neurological devices and the 21st Century Act as positive regulation changes in the past two years. On the other hand, the reimbursement outlook has been slow to change for neurological devices. Nonetheless, Dustin Tyler of Case Western Reserve University reported some helpful resources for neural engineering such as the CMS Innovators Guide and chapter 14 of the Medicare Policy Manual for medical devices. Following two days of discussions the working groups came up with steps forward to crowd-source an IDE template for the community, initiate a liaison between federal funding agencies and the FDA, and catalog reimbursement resources and case studies for neurotechnology devices to help guide future development.
The innovation section was co-led by Chet Mortiz of the University of Washington and Kevin Otto from the University of Florida. To kick off their discussion groups, they reported on the trends and progress of technical innovation since 2015. Some prominent funding programs have accelerated the migration of technical discovery science into industry, such as the GSK Innovation Challenge. Open source tools including open Ephys and open optogenetics Wiki were also cited as positive developments. Equally as exciting is technology development in closed loop BCI, bidirectional DBS electrodes, and noninvasive stimulation techniques, including optical, magnetic and ultrasonic stimulation. The deliberations from this group identified three areas for improvement over the next two years; increasing the diversity of collaborations to drive future innovation, building an interactive network of neural engineers, and improving communication with the general public about these technical advances.
The themes of clinical practice and industry translation in neural engineering followed similar pathways. In 2015 there was an identified need for improved communication, best practices, mentoring, and training. Once again in 2017, the need for expanded training opportunities resurfaced but within the context of improved interactions between engineers and clinicians. There needs to be greater awareness of available training opportunities, particularly for quality systems and ICOR programs. These sections also highlighted the need to improve public/private partnerships.
The notion of a patient as a consumer was a discussion point in and of itself but with theme leadership under Dawn Bardot from the Medical Device Innovation Center, the discussions produced four specific needs statements that can help drive patient engagement initiatives in a scientific manner for neural engineering.
Those who participated in these days of lively discussion will stay tuned for the resultant one degree of change—and hopefully more—by the 2019 workshop.
