DAF26BZ02-DV009 — Rapid Evaluation of Low Back and Neck Impairment to Advance Readiness
Award Maximum: $2,000,000 Period of Performance: 24 months Phase Type: Direct-to-Phase-II (D2P2)
OBJECTIVE: Develop a quantitative evidence-based tool for rapidly assessing low back and neck impairment that end-users in both operational and clinical environments can use to improve readiness through the prevention, treatment, and management of spine disorders.
DESCRIPTION: Low Back and Neck pain are the costliest and most disabling health conditions in the world and are a pervasive and persistent challenge across the U.S. Armed Forces. Spine disorders affect up to 19.5% of military service members annually and represent the leading cause of disability discharge, medical evacuation, and limited duty days (over 25 million each year), severely undermining operational readiness.
In the Air Force, operationally critical service members such as pilots, air crew, pararescue jumpers, security forces, and maintenance personnel who are exposed to highly repetitive and often, highly physical loading are especially vulnerable. Due to the often chronic and debilitating nature of low back and neck pain, prevalence of these health conditions in veterans is in excess of 40% and is strongly linked with depression, long-term disability, compromised quality of life, and increased opioid usage.
The etiology of neck and back pain, disorders, and injuries is complex and multifactorial, driven by physical, psychological, and social (biopsychosocial) determinants that shape risk of onset, progression, and recovery. These biopsychosocial interactions produce heterogeneous clinical presentations, complicating prevention, diagnosis, and management. Additionally, risk factors that uniquely impact military service members such as combat training under heavy loads, prolonged and frequent use of head-mounted gear and body armor, extended static postures, high G-force exposure, poor equipment ergonomics, whole-body vibration, extreme psychosocial stress, sleep deprivation, as well as cultural norms and advancement incentives that can hinder reporting. This combination of factors can create a perfect storm for complex, disabling, and long-lasting (chronic) low back and neck disorders.
Given the complex nature of these disorders, the current best practice of relying on subjective, self-reported pain and function to guide decisions is insufficient. To better prevent low back and neck pain and intervene early when these disorders are most manageable, medical and operational support teams need objective, reliable, and actionable spine health metrics to help inform training, injury prevention, and clinical treatment decision making. Since the commercial marketplace currently lacks solutions in this space, this topic aims to help develop and transition to market a system that empowers service members in both operational and medical units to rapidly assess multiple biopsychosocial elements of low back and neck impairment including an objective assessment of functional impairment. Development of such a solution that can be deployed at scale will be critical to help decrease the economic and operational burden of low back and neck pain on the USAF and DoW and ultimately improve operational readiness, mission performance, and patient outcomes.
PHASE I: As this is a Direct-to-Phase-II (D2P2) topic, no Phase I awards will be made as a result of this topic. To qualify for this D2P2 topic, the Air Force expects the applicant(s) to demonstrate feasibility by means of a prior "Phase I-type" effort that does not constitute work undertaken as part of a prior or ongoing SBIR/STTR funding agreement. Prior research supporting the feasibility demonstration should have been conducted in the past five years. Reports which provide data, clearly present the analysis done, and provide evidence of scholarly impact will be strongly preferred. Research which has been done with military decision-makers, especially those involved in making difficult decisions like those faced in combat, mass casualty, and triage events, will be strongly preferred. Applicants should already have a defensible framework and methodology to apply that has been tested based on their previous research.
PHASE II: The Phase II effort will focus on the development, maturation, and validation of a quantitative evidence-based software and hardware device for rapidly assessing low back and neck impairment. The objective is to advance the prototype from the Phase I equivalent work of feasibility (TRL 3), which should have established the scientific basis for the solution through prior human subjects testing, to a production-ready prototype (TRL 6+). As part of this Phase II effort the solution should be capability-tested (product evaluation) in a relevant military environment and be positioned to submit for FDA regulatory clearance.
Technical Goals and Functional Requirements:
Rapid Evaluation: Deliver a software and hardware solution that can quantitatively evaluate low back and neck impairment, including sensor-based data collection and automated processing, in 5-10 minutes.
Easy-to-Use: The solution must walk users and warfighters through data collection protocols and be easy to operate even for non-expert or minimally qualified medical personnel.
Evidence-Based Functional Metrics: Metrics produced by the solution must quantify spine function or impairment, be normalized relative to large reference populations to provide context, and be scientifically validated in the literature.
Biopsychosocial Approach: In addition to spine function metrics, the solution must incorporate other biopsychosocial metrics from self-reported questionnaires or other sources to enable a more holistic approach to low back and neck pain prevention and care.
Change Over Time: The solution must be able to monitor changes in function over time relative to prevention or treatment interventions to enable users to evaluate impact.
Actionable Reports: The solution must provide intuitive, visual, and actionable data reports that highlight key risk factors or deficits so users can quickly make decisions.
Interoperability: The solution must be compatible with and be able to operate within existing Air Force IT infrastructure (computing devices, networks, etc.).
Online / Offline: The solution must be cloud capable to allow future scalability, but also must support offline data collection for situations where networks are not available or not secure.
Cybersecurity: The solution must adopt an architecture that will support future HIPAA-compliant Electronic Health Record (EHR) integration and meet IL-5 requirements, but also support a de-identified evaluation mode where users do not have to include sensitive information to test patients. This will increase chances of successful transition since it will decrease early security barriers to adoption, but also will enable future seamless EHR integration to improve user experience and impact.
Operating Parameters and Use Cases: The solution must be portable (no larger than a small briefcase) and operable for USAF Medical Groups, at hospitals, in training centers (e.g. USAF Academy), and Forward Operating Bases (FOBs).
Testing Requirements and Validation Approach: Solution must demonstrate kinematic measurement accuracy > 95% relative to a gold-standard optical motion capture system, must be able to differentiate patients and asymptomatic controls with > 80% accuracy, and must demonstrate excellent intra-rater and inter-rater reliability (ICC > .8). Solution must successfully meet customer needs during a product evaluation in a representative military testing environment. By the end of Phase II, the production-equivalent solution must be Verified and Validated (V&V) under an FDA-compliant Quality Management System (QMS) and positioned for submission to FDA for regulatory clearance.
Deliverables: Prototype software and hardware solution delivered to customer for product evaluation testing. Test reports documenting accuracy, reliability, and performance metrics. FDA communications and evidence of FDA-compliant Verification and Validation (V&V) results. Technical documentation, knowledge center, and training tools for end-users. Transition plan for scaling deployment across Air Force and DoW.
Expected Outcomes: The Phase II effort will culminate in an operationally viable prototype that is positioned to submit for FDA regulatory approval, seek DoW security and IT approvals, establish an Authority to Operate (ATO), and scale-up manufacturing so it can be transitioned into wide-scale use in Phase III. Ultimately, this novel solution will allow users to rapidly assess low back and neck impairment in both operational and clinical environments to improve readiness through evidence-based spine disorder prevention, treatment, and management.
PHASE III DUAL USE APPLICATIONS: The expected Phase III effort will transition the Phase II solution into an operationally deployed capability across Air Force Medical Groups. At Phase III entry, the technology is projected to be at TRL 6+, having been demonstrated in a relevant environment with validated performance.
Military Applications: Although the topic-sponsoring organization has plans to evaluate and apply the solution at the 354th Medical Group, this capability would benefit all USAF and DoW Medical Groups at clinics, hospitals, training centers (e.g. USAF Academy), and Forward Operating Bases (FOBs).
Readiness: Solution will extend capabilities to Deployable Combat Wings (DCWs), Integrated Operational Support (IOS) programs, as well as broader DHA clinical facilities. Accomplishing this will increase the Warfighter operational readiness through rapid assessment that will facilitate evidence-based prevention and treatment. This will allow minimally qualified medical personnel to conduct rapid assessments as a force multiplier (e.g., technicians) and provide a game-changing solution from both an assessment and intervention perspective. Because it will be deployable by less qualified medical personnel, it also will decrease clinic wait times and increase access to care. This combined with getting the right patient the right treatment at the right time will help decrease low back and neck pain chronicity (which, on average, will involve symptoms for > 7.5 years), thus leading to significant healthcare cost reductions.
Commercial Applications: Since low back and neck pain are also the leading cause of disability and most expensive health care expenditure (more than diabetes, heart disease, and cancer) in civilian populations, this technology will yield similar benefits to civilian medical care and injury prevention organizations and patients.
Transition Plan: Phase III will focus on operational deployment at 354th Medical Group, supported by non-SBIR funds from Wing/Squadron Innovation budgets, as well as broad expansion into other AF, Navy, and Army medical groups who have already also expressed interest in this proposed solution. Government approvals will include cybersecurity certification under the Risk Management Framework (RMF), Authority to Operate (ATO) within AFNET, and software integration approvals. Additional DAF customer opportunities include Air Force Medical Services (AFMS).