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Miniaturized, on-body delivery system of medical countermeasures for military operations

Description:

TECHNOLOGY AREA(S): Bio Medical 

OBJECTIVE: To provide an on-body, accurate, fast and reliable delivery system capability to administer medical countermeasures (MCM) in the event of exposure to chemical threats. Capabilities sought are intended for use in far-forward deployed settings and must be effective and suitable to automatically deliver accurate doses of MCM upon identification, detection or signs of a chemical, biological, radiological or nuclear (CBRN) exposure. 

DESCRIPTION: The U.S. Department of Defense (DoD) develops and fields medical countermeasures to treat adverse symptoms following an exposure to CBRN agents. The preferred method to administer therapeutics to fast acting agents, (e.g., nerve agents, opioids) is via autoinjector by self-administration or buddy-aid at the point-of-exposure. The idea of pairing an on-body delivery system with a physiological monitor for automatic delivery of life-saving medications is a novel solution to quickly deliver medications to personnel conducting military operations. The concept is similar to how insulin pumps are paired to glucose monitors [1, 2]. During military operations, the capability of an on-body delivery system to rapidly deliver an accurate dose of a MCM via the push of a button, remotely, or automatic delivery informed by a physiological monitor, could be lifesaving. This topic seeks to identify and develop a mechanized on-body injection delivery system to rapidly and accurately administer a medical countermeasure following exposure to a CBRN agent. Ideal medical countermeasure delivery systems for self- and buddy-aid are: 1) robust and reliable, 2) compact and lightweight, 3) simple to operate, and 4) suitable for use across a wide range of temperature and operational environmental conditions. The on-body drug delivery system is envisioned be applied by either the individual or trained medical personnel, and should be comfortably worn by Service Members under uniforms or protective ensembles. Activation of drug administration could be by manual, remote, timer or physiological monitor/sensor trigger. The combination product consisting of the pharmaceutical and the on-body delivery system will require Food and Drug Administration (FDA) approval/licensure. Successful completion of all three phases will support small business valuation by confirming technical merit that invites further investment. This award mechanism will bridge the gap between laboratory-scale innovation and entry into a recognized FDA regulatory pathway leading to commercialization. 

PHASE I: Design and develop the subsystems for the on-body delivery system. Objectives of this phase are: 1) design platform/brassboard device subsystems, 2) conduct preliminary feasibility testing of subsystems, and 3) down-select brassboard subsystem designs. Initiate design and characterization of key aspects of the brassboard delivery platform, which may include selection of on-body location, how the platform is adhered to the selected site, how drug is to be delivered (e.g., single needle cannula, microneedles [3, 4, 5]), and overall design/housing considerations to support an on-body application. Feasibility testing of initial designs and subsystems could include mechanical and fluid simulation and/or testing that would support compact dimensions of the on-body delivery system. 

PHASE II: Assemble subsystems into a prototype delivery system and continue to refine and optimize functionality. The assessment of the prototype delivery system should include accuracy and reliability of dose and volume delivery, and suitability of the on-body site location. Considerations for how the device will be manufactured consistent with FDA guidelines and amenable to industry best practices (e.g., cGMP and ISO13485:2016) should be documented. This phase of work will not include any animal or human testing. 

PHASE III: In this phase, additional changes resulting from customer feedback will be incorporated into the design. A detailed regulatory strategy and package will be developed for submission to the FDA for clearance of the on-body delivery system or approval/licensure of the on-body delivery device/drug combination product. Ultimately, the on-body delivery system could be combined with a wearable physiological monitor or environmental sensor for safe, rapid administration of MCMs, by manual or automatic activation. A compact, easy to use and robust on-body delivery platform could be used to deliver injectable pharmaceutical compounds to benefit civilian markets, such as diabetes care, pain management, and large-molecule drug delivery. This platform could be utilized by medical professionals, law enforcement agents and first responders. For example, law enforcement agents could attach an on-body delivery device containing naloxone, which would automatically inject the drug in the event of exposure to a synthetic opioid, or could be triggered to inject manually or by a fellow officer. 

REFERENCES: 

1: Fabrico Medical. Advanced Assembly of Wearable Patch Pumps for Insulin Therapy. Medical Design Technology. May 28, 2014. https://www.mdtmag.com/article/2014/05/advanced-assembly-wearable-patch-pumps-insulin-therapy. Accessed Jan 11, 2018.

2:  Patch Insulin Pumps. Diabetes Mall. http://www.diabetesnet.com/diabetes-technology/insulin-pumps/patch-pumps. Accessed Jan 8, 2018.

3:  Ita K. Transdermal delivery of drugs with microneedles - Potential and challenges. Pharmaceutics. 2015

4:  7: 90-105.

5:  Bariya SH, Gohel MC, Mehta TA Sharma OP. Microneedles: an emerging transdermal drug delivery system. 2012

6:  64: 11-29.

7:  Kwon KM, Lim S, Choi S, Kim D, Jin H, Jee G, Hong K, Kim JY. Microneedles: quick and easy delivery methods of vaccines. Clinical and Experimental vaccine Research. 2017

8:  6:156-159.

KEYWORDS: On-body, Delivery System, Medical, Countermeasures, CBRN, Auto-injector, Wearable Medical Device 

CONTACT(S): 

Renae Malek 

(301) 619-8426 

renae.l.malek.civ@mail.mil 

Anthony Macaluso 

(301) 619-2016 

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