SBIR-STTR Award

The Lancet recently published a 3-part series calling attention to the global epidemic of LBP and the need for innovative new solutions. LBP is a leading cause of physical disability (experienced by 60-85% of adults) and missed work (>100 million days per year in the U.S. alone), and results in costs >$100B per year in the U.S. alone. The physical demands (e.g., leaning and lifting) of nursing and other professions (e.g. logistics and manufacturing) are at particularly high risk of developing LBP. This often leads to physical disability, healthcare costs and missed work. There are currently no solutions for this job that are effective, affordable, and practical. This project is focused on a game-changing new technology: a spring-powered exosuit - called mechanized clothing (MC) - that blends the assistive benefits of exoskeletons with the form-factor and comfort of daily clothing to reduce LBP and injury risks. MC provides a low-profile way to offload low back muscles during leaning or lifting tasks. MC is poised to be the first and only wearable device that can effectively reduce stress on the lower back, and safely and affordably integrate into the workflow of nurses and other occupations that involve repetitive lifting and leaning. Long-term, MC is expected to: (a) fit under daily clothing and into everyday life, (b) augment biomechanics to reduce low back loading, and (c) reduce incidence of LBP and injury and (d) reduce associated costs. The investigators interviewed over 100 end users, revealing that current assistive devices are unable to effectively integrate into daily working environments. The objective of this SBIR project is to demonstrate commercial and technical feasibility of MC by addressing a key challenge that no other exoskeleton has overcome: integration, i.e., demonstrating that workers can be assisted without interfering with their daily workflow. To accomplish this, the investigators propose the following aims: 1) redesign the actuation system to be lower profile while maintaining battery life, enabling in-field testing and ensuring there are no protruding components that could get caught on the work environment; 2) perform reliability and fatigue tests on the MC clutch, and then refine clutch design as needed to ensure reliability and robustness for real-world testing; and 3) demonstrate feasibility of device integration into a real-world environment by testing nurses and material handlers wearing the MC prototype and assessing the degree to which it can assist without hindering their workflow (e.g., without degrading range of motion or interfering with sitting down). If MC surpasses Phase I success metrics related to workplace integration, the investigators plan to submit a Phase II proposal to further develop MC toward a commercially viable product. 1

Public Health Relevance Statement:
Project Narrative Low back pain is a leading cause of physical disability, and associated costs due to healthcare and missed work are estimated to exceed $100B per year. The objective of this SBIR project is to demonstrate technical and commercial feasibility of mechanized clothing, an innovative spring-powered exosuit designed to reduce the prevalence of low back pain in nurses and other workers at high risk of back pain due to the physical demands of their jobs e.g., (leaning, lifting). By blending the assistive benefits of exoskeletons with the form- factor and comfort of daily clothing, mechanized clothing is poised to be the first and only wearable device that can effectively reduce stress on the lower back, and safely and affordably integrate into the workflow of nurses and other physically demanding occupations. 1

Project Terms:
No Project Terms available.

Low back pain is a leading cause of disability worldwide and is a frequent cause of missed work, costing billions of dollars per year in medical expenses and lost productivity. Much of this pain is due to overuse injuries, which result from repetitive musculoskeletal forces that cause microdamage to accumulate faster than tissues can heal. Healthcare workers are at high risk of back overuse injuries due to frequent bending and lifting: For nurses and operating room staff, there is a 50-70% annual and 80-95% lifetime prevalence of back pain/injury. Back pain and injury fuel the opioid crisis and can be career-ending, but there are currently no solutions available that are practical, effective, affordable and acceptable to most healthcare workers. Exoskeletons (including soft exosuits) are an emerging technology that shows promise in reducing overuse injury risks in industrial applications. This includes the HeroWear Apex exosuit, which was commercialized in 2020 and is now used in >100 worksites in >10 countries. This 3-lb. exosuit has been proven to reduce back muscle forces by 15-40% (without motors or batteries), and the assistance that it provides can be turned on/off as needed. Multiple studies confirm that healthcare workers are highly interested in exoskeletons that relieve physical strain. However, during its development efforts HeroWear has learned that the majority of healthcare workers need the capabilities of an exosuit in a device that 1) fits comfortably under medical scrubs (for safety and aesthetic reasons), and 2) assists in their most common back-straining tasks (bending 10-30°). The successful Phase I feasibility work resulted in 1) an under-clothing switch, 2) a robust on/off mechanism (i.e., clutch), and 3) confirmation that the Phase I device does not restrict movement. The primary remaining research and development challenges for Phase II are prompted by the fact that all commercial exoskeletons are outerwear (or middle-wear - e.g., worn over a shirt but under a safety vest), and that most are rigid and bulky. Recent research publications and HeroWear interviews confirm that the visibility of exoskeletons over clothing is the main reason healthcare workers do not use them. To address this key unmet need for healthcare workers who are at risk for back pain/injury, HeroWear is seeking SBIR Phase II support to continue developing a novel endosuit designed to 1) be worn comfortably under medical scrubs, 2) support mild bending postures, and 3) provide the same mode-switching (on/off) function that has been key to adoption of industrial exosuits, in order to meet the specific needs of healthcare workers. Phase II work will be focused on final prototype design, fabrication, and real-world validation studies. Phase II results will provide the key data needed to engage Phase III participation by private-sector investors, partners, and customers- enabling commercialization of endosuit technology that will greatly improve the health and well-being of millions of healthcare workers. Public Health Relevance Statement Low back pain is a leading cause of disability worldwide and a frequent cause of missed work, costing billions of dollars per year in medical expenses and lost productivity. Healthcare workers (e.g., nurses, physicians) are at high risk of low back pain and overuse injuries due to frequent bending and lifting, and there are currently no solutions available that are practical, effective, affordable and acceptable to most healthcare workers. To address this key unmet need for healthcare workers who are at risk for back pain/injury, HeroWear is seeking SBIR Phase II support to continue developing a novel endosuit designed to 1) be worn comfortably under medical scrubs, 2) support mild bending postures, and 3) provide the same mode-switching (on/off) function that has been key to adoption of industrial exosuits, in order to meet the specific needs of healthcare workers.

Project Terms:
No Project Terms available.