Cleveland neural engineering workshop 2017: strategic evaluation of neural engineering

Current state

The term “industry” is shorthand for a complex ecosystem of agencies, companies, innovators, investors, regulations, and customers. Navigating the industry can be challenging, even for the most experienced people. The translation process, moving an innovation through each of the stages between the workbench and the patient’s bedside, is time and resource-intensive. Companies may also struggle to meet insurers’ requirements and metrics for reimbursement. This can pose a substantial barrier to entry for smaller or less well-funded companies, often independent of their products’ viability or potential market share.

Large companies often have the institutional knowledge to guide their innovations along but may lack the agility and creativity of smaller start-ups. New companies may struggle to stay funded while scaling the steep learning curve inherent to the industry ecosystem. Academics and clinicians are in particular need—and lack access to—solid, consistent, and current navigational training. Emerging scholars and practitioners in graduate programs also need introductory education on the existence and uses of quality systems in industry.

When programmatic successes happen, as with the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) public-private partnership (Author, 2016), the initiating agencies deserve to receive feedback illustrating what’s working well and outlining opportunities for further expansion or improvements. Productive collaborations can be encouraged through open and multi-directional communication, or they can be stymied by legal and procedural impediments to knowledge sharing among colleagues or peers across the industry.

Key factors

Vision

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.

Goals (2–5 years)

One degree shifts

Current state

The “consumer” refers not only to the patient, but also the caretaker, support network, and advocate community centered around the “end user” of engineered neurotechnology devices. The indications for neural interface technology are expanding rapidly, ranging across conditions such as chronic pain, sleep apnea, movement disorder, amputation, spinal cord injury, and a rapidly growing list of conditions. The consumer requirements for each of these areas may vary widely. Consumers with indications like sleep apnea and chronic pain are generally healthy and lead active lives. They would prefer technology that is ‘invisible,’ not interfering with everyday activities or requiring any user attention. Other consumers with indications such as spinal cord injury or stroke have a much greater functional impairment and will develop a more extended relationship with their neural technology. The collective need and experience of the consumers should inform the decisions and direction of neural technology development.

Neural engineers tend to have a unique and potentially fruitful relationship with users of devices. The users tend to be extraordinarily engaged in the use of their devices, with a direct understanding of the need for the therapy the device provides. Additionally, consumers of these devices tend to care about the use and success of their devices and to use them in real-world, daily life operations. The strength of their engagement and the strong feedback that consumers have the potential to provide means we need to make greater use of consumer feedback at every stage of the process, from innovation to clinical trial design to the regulatory approval process.

Because of the special relationships users have to neural devices, an emerging trend in neurotechnology is the movement from patient information being a collection of anecdotes that are not sufficiently data-driven, to patient information being solicited, collected, and used as scientific data for decision-making purposes at every stage of development of the neural device. Developing stronger pathways for patient input, including patient preference information (PPI) and patient-reported outcomes (PRO), serves all stakeholders. Those pathways serve neural engineers by reducing the cost of evidence gathering and providing more robust evidence throughout the development of devices. Stronger pathways for the incorporation of PPI and PRO serve patients because they result in devices that better meet their needs.

A related trend is the incorporation of Patient-Centered Outcomes Research (PCOR) in the development and implementation phases of neurotechnology devices, which involves asking questions about patients at scale. PCOR considers issues including patient survival and quality of life, barriers to implementation, and availability of the device across various populations, among other factors.

Key factors

Vision

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.

Goals (2 to 5 years)

Current state

The central concern is acquiring funding for promising technologies, which can then be more thoroughly researched, developed, and understood. Securing and allocating resources is not just a matter of math; it is an act of rhetorical persuasion, which helps the medical and engineering communities to both explain and understand what types of technologies are important or worth future investment of time, money, and other resources.

Long-term financial support systems are inconsistent around the world, and therefore collaboration remains a key component among investigators, funders, and industry. The larger goal, supported but not fully addressable by this forum, is the development of a comprehensive funding landscape that cultivates research along the continuum, from initial discovery to consumer-focused translation and onward to sustainable commercial dissemination.

Key factors

Vision

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.

Goals

One degree shifts

Current state

In 2017 for the first time at Cleveland NEW, reimbursement was a standalone theme, separate from the regulatory theme. In 2013 and 2015, discussion in the reimbursement/regulatory group centered on issues of regulation, focusing on increasing communication with and knowledge of the operations of the Food and Drug Administration (FDA).

The increased discussion, concern, and interest among Cleveland NEW workshop participants from 2013 to 2017 regarding reimbursement, and the need to create a separate theme for reimbursement, attest to the volatility in this area and to its significance to neural engineering technology.

The importance of educating ourselves and our community about the Centers from Medicare and Medicaid Services (CMS) reimbursement process can hardly be overstated, because CMS approval is often the determining factor in whether a device reaches commercialization. Innovations that have received approval from other bodies, like the FDA, but are then stymied at the CMS level, virtually guaranteeing that they will not reach commercialization. If translation is the goal of a research effort, understanding the CMS process will guide efforts towards solutions that may reach patients rather than fail at market entry after 10’s to 100’s of millions spent on research.

As one workshop participant noted, the importance of CMS approval to the success of a new neurotechnology means that it would be appropriate to begin to provide prospective neural engineers with information about the CMS process during undergraduate engineering classes. In the 2015 reimbursement/regulatory workshop, participants noted as major challenges a lack of communication with CMS and a lack of knowledge regarding the CMS decision-making process. These conditions still hold in 2017. Participants voiced confusion regarding the written CMS guidelines, which are difficult to understand and follow. Additionally, alongside the rapid changes in technology noted in 2015, possible policy changes in the current environment present uncertainty.

The Affordable Care Act included reimbursement policy changes that impacted CMS and the insurance industry, which follows the example of CMS in determining whether to assign reimbursement codes (Author, 2010). As neural engineers who seek reimbursement codes for new technologies continue to acclimate to these changes, there looms the possibility of an entirely new set of policy changes, should the Affordable Care Act be repealed under the current administration.

Key factors

Participants noted similarities between the current state of communications with CMS and the regulatory environment about the FDA ten years ago. The improved FDA regulation process could provide a blueprint for increased and improved interaction with CMS. Among the lessons learned from the FDA example is our efficacy as a group. When we work and speak on behalf of the field, rather than on behalf of an individual company or technology, our voice is stronger, more unified, and more convincing.

The lack of timeline regarding the reimbursement process can be detrimental to innovation. Participants noted that they were unsure at what point in the process CMS should be brought in. At various points in the discussion, participants asked when, how, and why do we engage CMS, who do we talk to, and how often during the process?

The breadth of those questions suggests both our need and desire for more open lines of communication with CMS. This lack of knowledge likely moves in both directions. To receive the clarity and information we need from CMS, we also need to provide them with clarity and information about our work and its importance.

In addition to communication-related challenges, other challenges presented by the current reimbursement environment include the increasingly high costs associated with generating evidence and the increasing demand for evidence to receive reimbursement approval.

Vision

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.

The reimbursement group addressed underlying questions about how innovative technology can be moved through the CMS process in ways that better serve the technology and the patient. For example, one participant questioned what role the patient plays in driving CMS decisions. PRO and PRI could be better used to in the process, reducing evidence costs, improving outcomes, and increasing the chance of CMS approval.

Another source of cost effective, patient-centered data is the U.S. Veterans Affairs office, given its unique system of health records and clinical trials.

Goals (2 to 5 years)

Build a relationship with CMS

Building a relationship between the neural engineering community and CMS means advocating for ourselves as well as connecting with organizations and individuals who can advocate on behalf of the neural engineering community to CMS.

Relevant organizations might include clinical medical societies like the American Medical Association and patient advocacy groups; relevant individuals might include high-level clinical trial experts and congressional representatives who have significant neuroengineering activity in their districts and/or sit on committees related to healthcare regulation and reimbursement. We need to invite these and other interested parties to understand our challenge and work together with us to solve it. When reaching out to individuals at CMS, we recognize the distinction between the national-level organization and local- and regional-level hospitals and insurance companies with which CMS contracts.

Our efforts will begin at the local and regional levels because this offers an increased ability to connect with individuals already within our networks with an awareness or understanding of the neural engineering community.

Current state

There is a broad and accelerating interest from funders, including the BRAIN Initiative, Innovation Challenge, as well as industry, to produce innovative NE technologies. Established entities like Medtronic, Boston Scientific, and St. Jude/Abbot are starting to see competition in the form of emerging groups such as Neuralink, Kernel, even Facebook and Google.

Innovation is moving towards having neuromodulation transition toward minimally or non-invasive technologies, including recent advancements in non-invasive DBS, transcutaneous spinal stimulation, modulated and focused ultrasound, and optical/magnetic stimulation. There is also a shift towards understanding and developing multi-modal neural devices, which collaborate with biological approaches such as electrical optical activation of stem cells.

Progress since 2015 has started to “close the loop” between recording and stimulation, with advances in brain-controlled muscle, spinal, and deep brain stimulation. Emerging progress in 2017 includes bi-directional interfaces (human trials), BCI decoding and sensory feedback from limbs, as well as prosthetic limb interfaces with motor decode and sensory feedback.

Key factors

Vision

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.

Goals (2 to 5 years)

One degree shifts

Current state

Neural engineering (NE) science has reached new frontiers. It has the potential to help ameliorate chronic diseases such as Tourette’s Syndrome and Parkinson’s Disease, and to be combined with other modalities (such as artificial intelligence) to manage conditions such as obesity, diabetes and heart disease.

In this new research landscape, neuroengineers, clinicians and patients work together to develop neural devices that achieve optimal benefits for patients and caregivers. Patients are no longer merely the hosts or subjects – they are becoming co-scientists in the innovation process. There is an increasing need for clinicians to receive patient feedback and data, and this workshop has identified several key reasons why we need more input from patients. Since clinicians and researchers don’t always know what patients need, it also allows clinical assumptions to be tested and adjusted based on real-world use or patient preference.

Treating neuroscience research patients as co-scientists in their own protocols can have beneficial psychological effects, can result in better therapy compliance, and could contribute to a successful outcome for the patient and the project. However, the NE community must balance the need for patient input with the host of global, cultural and gender-related differences that will affect preferences and feedback.

Financial constraints are an obstacle for the NE clinical community because many of their innovations are highly individualized and not designed to be immediately scalable for commercialization.

The 2017 clinical workgroups reinforced the belief stated in 2015 that in this new era of innovation, physicians and neuroengineers are partners on the “clinical team.” This theme was repeated throughout the sessions. Researchers can feel distanced from the clinical aspects of the protocols, especially what’s working well and what isn’t, and the clinicians feel that a deeper understanding of the engineering aspects will inform their clinical procedures.

To improve understanding of every team member’s capabilities, neural engineers should engage with the medical field they’re trying to impact, and clinicians should spend time with neuroengineers. In addition, both need to spend time with end-users, caregivers, and physical and occupational therapists to better understand the synergies, mechanics, and therapeutic aspects of device/patient interactions. “Opening up” to other collaborators teaches all team members about how they fit, what others contribute, and how important each contribution is.

There is one clinical environment in which neuroengineering challenges are mitigated. The Veteran’s Administration (VA) is a unique key player in the NE community. Its research and services are fully dedicated to injured veterans who have served honorably in the United States military. “The VA takes care of its people – period,” one workgroup member stated. As part of its mandate, the VA must maintain specialized treatment and rehabilitation programs for spinal injuries, blindness, amputations, mental illness, and other serious service-connected health conditions. As a result, many typical barriers to research and treatment, including tight funding limitations, are not present, and VA neuroengineers and clinicians enjoy greater flexibility and support to develop and deploy new technologies. Another benefit of the VA system (and not typical in the public sector) are the variety of ancillary services, training and support provided to caregivers, whom they value as critical ongoing support for their veterans.

Fortunately, the VA also cares about translating successful technologies out to non-VA patients. This makes them a valuable partner and ally for the NE community. The VA is also an anomaly with respect to development costs and budgets, since cost is less important to them than providing optimal patient care. VA researchers also have protected research time – they can investigate a variety of solutions without as much concern for marketability or commercial value.

Key factors

Vision

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.

Goals (2 to 5 years)

One degree shifts

Current state

The regulatory environment in the United States has been changing in a favorable direction since the 2015 workshop. Meeting participants noted recent positive interactions during the pre-submission process, but there remain opportunities to improve communication and to find agreement on the scientific basis for specific regulatory decisions.

Key factors

Vision

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.

Goals (2 to 5 years)

One degree shifts