September 2020 issue
September 30, 2020 | While the Mid-scale Research Infrastructure Workshop may have a long name, its impact was nothing short of impressive. Unlike most of the conferences and workshops these days, this one was designed to be 100 percent online since it was first imagined. Led by Shadi Dayeh of the University of California, San Diego, the National Science Foundation-funded event was meant to examine current state of the art in neuromodulation technologies, future directions of neural implant research, and to highlight the needs of the clinical and patient communities involved in the development of such technologies.
Over the course of the two-day event, which took place earlier this month, there were approximately 600 attendees from more than 140 companies, agencies, or institutions, and presentations from 34 of the field’s leading researchers, supporters, and patient participants.
The NSF’s Mid-scale Research Infrastructure program seeks to bridge the gap between academic research and development of implantable bioelectronic devices for clinical translation. Dayeh’s vision is to turn the content of the meeting into a compelling application for support for a National Neurotechnology Alliance at UC San Diego in order to expedite innovations from bench to bedside. Aims included identifying gaps in infrastructure that can address national clinical needs and involving patients benefiting from these devices.
To satisfy the aims of the conference, speakers representing industry, academia, and start-ups were asked to address the most pressing needs and potential hurdles in both current access models for GMP and future, ideal conditions.
The conference was launched with testimonials from two research participants with implanted devices. Ian Burkhart has worked with Battelle and Ohio State University to address spinal cord injury. His BCI has allowed him to regain motor control with single-digit dexterity and improved motor control. Burkhart underscored the importance of providing more options toward an independent life for people living with SCI.
Kelly Owens, a second patient participant, received an implanted cervical vagus nerve stimulator three years ago. The VNS was meant to address Owens’ debilitating inflammatory arthritis and Crohn’s disease. Within two months of implantation, Owens was deemed to be in clinical remission for both conditions. Owens stressed three areas of critical focus to address the obstacles of greater patient access to life-saving technologies: changing the toolkit for clinicians, educating physicians with options to treat diseases with devices as opposed to biologics or complex surgeries; expanding funding for clinical trials to allow travel and time off work compensation so that more study subjects can participate; and amending regulations and policies concerning clinical trials to allow patients to self-select their risk tolerance.
Unlike most conferences, the outcome of this event is perhaps at least as important as the event itself. Dayeh and his team will draft a proposal to the NSF’s MSRI program in support of an academic-based GMP facility. The hope is that such a facility will find ways to make it easier and cheaper for researchers to undertake the regulatory process and help realize high impact devices within the patient population. “To know is a privilege, but to benefit from this research is currently a luxury and should be a right to all patients who are suffering from these diseases.”
The program featured clinical perspectives on the needs of neuromodulation devices with input from professors Eddie Chang of UCSF, Ahmed Raslan of Oregon Health and Science University, and Sharona Ben-Haim of UCSD. They were followed by a segment focusing on insights from clinicians and engineers within the start-up realm where insights from Manfred Franke, Nicholas Opie, Cameron McIntyre, and Ben Pless were shared.
Tim Denison, Royal Academy of Engineering Chair in Emerging Technology at Oxford University, provided the keynote address. “Building Communities for Transitioning Platforms from Products to Ecosystems” opened with a clear call to expand access to technology to underserved populations. Denison highlighted a case in which a child with dystonia received a deep brain stimulator; children are often underserved due to their unique and changing needs.
He went on to describe how innovation can help address the growing healthcare cost crisis. He highlighted the advances in biomedical device technologies and their respective approvals via the FDA contrasting their growth to the decline in new drug interventions for the same period. Denison suggested that cooperation as opposed to a winner-take-all model would rapidly propel the field forward. He explained that clinical translation depends on technology and economics. A common platform that could support multiple compatible technologies as well as templates and best practices to standardize neurotechnology device production and manufacturing appears to be a logical solution to advance R&D. Denison closed with a call for all researchers to commit to being good stewards for patients and to make meaningful, ethics-driven contributions toward solving clinical problems.
The first day of the program concluded with presentations from the FDA, DARPA, and industry leaders who shared their perspectives on GMP practices. Tim Marjenin, Eric Van Gieson, Courtney Lane, and Erika Ross represented myriad voices on the topic.
The second day of the conference opened with an update on progress and needs in brain neuromodulation devices. Speakers included Vanessa Tolosa, Dan Rizzuto, Martin Scheuttler, and Marom Bikson.
Tolosa and others noted that having access to a cleanroom and other shared facilities where clinicians and researchers can work in close proximity can generate unparalleled creativity. A campus-based GMP infrastructure would increase access while reducing costs, but it could, however, make compliance and certification more difficult with multiple users from differing institutions and with differing training.
To close her talk, Tolosa agreed that a neurotech ecosystem would benefit a diverse and dispersed community. She continued to point out that a working device is insufficient—devices must also meet quality standards and standardized methods and controls for production are needed.
Also on the second day were presentations from Riki Banerjee, Stéphanie Lacour, Susan Harkema, and Rosana Esteller. While the panel was notable for being solely comprised of women, their presentations exquisitely captured the progress and needs in spinal cord neuromodulation devices. With equal voices between industry and academia, the panel reported on the successes elsewhere of varied consortia. Lacour noted that EPFL’s consortium is taking steps to fill quality control needs through public/private partnerships and that there are many steps to be taken and milestones to be achieved between laboratory and clinical trial including scaling, manufacturing reproducibility, system compatibility, stability, and reliability.
Michael Wolfson, program director, division of discovery science and technology with the NIH, presented the agency’s blueprint for a medtech program. The program assimilates 14 NIH institutes and centers to address grand challenges in the field, including the development of new biomedical devices.
The final session of the conference included Victor Pikov, Loren Rieth, and Robert Rennaker. Together, they presented a comprehensive overview of progress and needs in peripheral nerve stimulation devices. Of note, the cohort emphasized that contract manufacturing organizations need to address the driving forces, including market pull, technology push, leadership team, and VC, as significant motivators to be recognized.
Another unique component of the agenda were the summaries provided after each session. Dayeh and his team solicited and documented feedback, questions, and answers from the audience and presenters. This knowledge capture was instrumental in ensuring buy-in from a wide variety of stakeholders in real time.
