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Rapid Manufacturing of Personalized Braces and Splints for Musculoskeletal Injury

Description:

OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Military Operational Medicine

 

OBJECTIVE: This topic is intended for technology proven ready to move directly into Phase II and is accepting Direct to Phase II proposals only. To develop a manufacturing framework to rapidly produce personalized, human-usable braces and splints with no-to-minimal manual intervention. The solution can accelerate musculoskeletal injury recovery, reduce the need for medical evacuation, and facilitate Warfighter readiness, while mitigating the impact on logistics and storage limitations in military environments and medical treatment facilities.

 

DESCRIPTION: The DoD lacks the capability to rapidly manufacture rehabilitation devices and equipment in areas where space and/or storage requirements are minimal.  Musculoskeletal injuries (MSKIs) are the largest burden of injury for the U.S. military [1]; with 85% of service members medically evacuated following an MSKI not returning to theater [2]. Rehabilitative braces and splints are commonly used to manage and rehabilitate MSKIs. Braces and splints provide partial rigidity to protect and stabilize an injury, while still allowing some movement where needed. Current off-the-shelf braces and splints come in various sizes and designs for different body parts, sides, and injuries. The quantity potentially needed presents a significant challenge for adequately stocking these items where, when, and for whom they are needed. Currently, specific braces are manufactured, selected, transported, and stored, based on anticipation of how many of each type of brace will be required. This is of particular concern in military environments, particularly deployed and maritime care settings, where space may be limited, and the need exists to improve the medical readiness of someone with minor injuries. There is currently no role of care requirements; however, this technology is envisioned in a Role of Care 2/en route care setting.

 

Additive manufacturing can reduce the logistical burden of transporting and storing an array of medical supplies. Currently, applications of 3D printed technology are growing in popularity within medicine [3], with applications in orthopedics being used for personalized implants and customized prostheses [4]. As 3D printing advances, it may provide innovative solutions, such as becoming a more personalized and accessible option than off the shelf bracing/splinting [4]. The desired end stage product/system will be able to rapidly manufacture personalized braces and splints onsite and on-demand for MSKI to accelerate recovery, reduce the need for medical evacuation, and facilitate Warfighter readiness. Desired products contain both flexible and semi-rigid elements, depending on the nature of the injury.  Moreover, the ideal solution should have the potential to provide an array of bracing/splinting products across various MSKIs to promote Warfighter return to duty.

 

PHASE I: This topic is intended for technology proven ready to move directly into Phase II. Therefore, the offeror must be able to demonstrate and provide documentation to substantiate that the scientific and technical merit and feasibility described in Phase I has been met and describes the potential commercial applications. Documentation should include all relevant information including, but not limited to technical reports, test data, prototype designs/models, and performance goals/results. 

Completed Phase I efforts should demonstrate research and development towards a rapid fabrication solution for personalized bracing or splinting technology that requires minimal manual intervention.  Feasible and practical solutions have the potential to combine the rigidity of personalized 3D-printed elements with flexible textiles, garments, or similar materials.  Completed efforts should additionally demonstrate research and development towards a solution that can be customized based on user anthropometrics for braces/splints to be worn for lower and/or upper extremity musculoskeletal injuries. The fabrication framework is expected to minimize the logistical footprint and be used within a setting with access to power.

 

PHASE II: Design and develop the practical implementation of the system that incorporates the previously completed Phase I methodology toward a technology that can rapidly, and optimally generate personalized braces or splints with minimal manual intervention. Product development can be an innovation of existing technologies. Semi-rigid elements combined with textiles or soft materials and fastening or securing materials make up the key design elements.  Designs should be capable of personalization to user size and anthropometrics, injury location, right/left side.  They should also be capable of personalization based on requirements for mobility (e.g. semi-flexible to semi-rigid). Input requirements (manual measurements, scans, etc.) are not pre-defined. Testing and implementation should be relevant to Warfighters who have sustained an upper and/or lower extremity MSKI. The framework/system begins with a scan or computer-based inputs and the output is the final brace/splint.  The user inputting the data or scans may be a clinician. The end recipient is the injured patient. The test-case for the output of this Phase II will be a single ankle brace/splint and hand/wrist brace/splint as a proof of concept, with a request for a physical prototype. The Phase II development should focus on a clinician interface for personalization inputs and the rapid-manufactured, personalized bracing/splinting solution outputs for human-usable production. Technical specifications should focus on a framework that can fit (dimension and weight-wise) on a table/desk and are expected to produce a product in an operational environment. Material selection considerations for environmental exposure during hot and cold weather operations should be considered.  Frameworks that have the potential to interface with additive manufacturing systems that are multi-purpose are desirable. Systems can expect to be supplied by a standard 120V/60Hz outlet. The offeror shall articulate the regulatory strategy and provide a clear plan on how FDA clearance will be obtained.

 

PHASE III DUAL USE APPLICATIONS: The goal of this phase is to secure an FDA approved device and demonstrate effectiveness and usability for the military and civilian end-user. Finalization and validation of the prototype and terminal system involves producing comfortable, durable, and easily applied braces/splints that adhere to similar biomechanical outcomes as off-the-shelf models. The target market should be the commercial market for sustainability. The final commercialized product will likely integrate into a clinical practice setting, account for coding/billing requirements, complete cost/benefit analyses, identify training/education requirements (if needed), and account for socialization/broader outreach.  Expected dual use of the end-product may extend to the needs of civilians and individuals post-military, such as orthopedic and VA rehabilitation facilities, urgent care centers with limited overhead, remote care settings, mobile care units, sports medicine, and other physical medicine situations. Thus, procurement by the government is likely post-commercialization by industry.

 

MSKIs are an immense burden in global healthcare and present a significant challenge to military readiness; therefore, innovative technology that has the potential to provide a rapid, personalized brace/splint to accelerate recovery and shorten the period in which a Warfighter can return to duty is desirable.

 

REFERENCES:

  1. U.S. Army. 2020 Health of the Force Report. (https://phc.amedd.army.mil/PHC%20Resource%20Library/2020-hof-report.pdf)
  2. Malloy et al. 2020, Mil Med. Musculoskeletal Injuries and the United States Army Readiness Part I: Overview of Injuries and their Strategic Impact. (https://academic.oup.com/milmed/article/185/9-10/e1461/5805225?login=false)
  3. Duan X, Wang, B, Yang L, Kadakia AR. Biomed Res Int. Applications of 3D Printing Technology in Orthopedic Treatment. (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8378991/pdf/BMRI2021-9892456.pdf)
  4. Skelley NW, Smith MJ, Ma R, Cook JL, J Am Acad Orthop Surg. Three-dimensional Printing Technology in Orthopaedics. (https://journals.lww.com/jaaos/abstract/2019/12150/three_dimensional_printing_technology_in.3.aspx)

 

KEYWORDS: Rehabilitation, Brace, Injury, Musculoskeletal, Individualized Medicine; Additive manufacturing

 

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