The BioCapture 650 is the best in class ruggedized portable product for air sample collection of Biological and chemical agents.

Design a ruggedized portable product from the ground up incorporating Meso Systems proprietary collection technology.

Stratos collaborated in the definition of system requirements and proactively developed a unique product architecture. This second generation configuration greatly improved the fluidic consumable sub-system, ruggedization, environmental sealing, decontamination, and functional performance. The BioCapture 650 truly enhances the assets of a biohazard first response.

Mechanical Engineering

Design a rugged product that accommodates and activates a disposable collection cartridge that is environmentally sealed from contamination as well as facilitate ease of use and manufacturing objectives.

The enclosure was designed using high impact injected molded plastics with custom elastomeric gaskets and an over molded battery access door to achieve ruggedization and environmental requirements. All external interfaces including the tactile, display, and cartridge actuators were sealed to prevent contamination and promote cleanability. The mechanical architecture of the product was developed to meet manufacturing, assembly, test , and serviceability objectives.

Internal fluidic handling and collection components were combined with an integrated enclosure shell to form a single disposable cartridge. Structural attachments, activation interfaces, air path features, and user access as well as cosmetic elements were carefully partitioned and coordinated within the mechanical team resulting in an integrated consumable strategy that met all functional requirements.

Cost, performance, and innovation trade-offs were constantly evaluated in an effort to optimize the design to best meet functional, consumable, and manufacturing objectives.

Electrical Engineering

Design an electronics package for the BioCapture 650 that meets Mil-Spec durability requirements and incorporates the product’s disposable cartridge command and control, user controls and display interface, and rigorous power management.

The Stratos team architected and specified an electronic system to perform at high speeds within a sealed enclosure that supports the product consumable strategy and performance requirements. The development process included an evaluation of several prototype sub-systems using a Labview testing environment. These subsystems included the cartridge fluidic control and sensing, primary air collection control, and power management system. Close collaboration between the electrical and mechanical teams early in the development cycle, and the use of thermal modeling optimized component layout to meet environmental requirements.

The resulting detailed design required the development of diverse circuitry, software, and electro-mechanical components including high-speed DC and stepper drives, custom motors, feedback control systems, a precision opto-electronic interface, hardware fault detection, a high efficiency power supply, and the user graphical display interfaces.

Industrial Design

Design a portable device for one handed use with critical consideration of the user interface and human factors for a first responder in a threat condition wearing typical protective clothing and using other emergency equipment.

The design process started with a user centric market audit including interviews with firefighters and first responders. A task analysis was developed to fully understand how a potential threat condition is approached and how a first responder acquires samples for testing. As prototypes evolved Stratos conducted human factors evaluations using gloves typically worn with Level A HazMat protective suits to test design assumptions and quantify usability solutions. Graphical and physical user interface scenarios were evaluated for visual, audible, and tactile viability.

The resulting design balanced the product’s 8lb weight for comfortable handle grip during the 5 minute collection cycle and a variety of use positions. The disposable cartridge evolved to enable easy installation and replacement while used in a contaminated environment. The graphical interface incorporated a backlit display orientation and font size for constant visual contact through protective clothing. Visual and audible indicators were also incorporated to quickly indicate operational modes and error conditions. Cosmetic features were all designed to enable ease of cleaning and decontamination as well as communicate the visual language of an emergency threat response device.

Over a half dozen different configurations were explored and evaluated to optimize market acceptance, human factors, ease of use, and environmental functional requirements meeting the user goals of the project.

Software Engineering

Develop a software command and control system that is integrated, robust, and provides a user interface with ease of use in mind.

The software for the system was designed for simultaneous real-time control and synchronization of the sample collection, fluid handling, power management, and user interface. This included multiple motor controls, processing numerous analog optical sensor inputs, s/w closed loop control (PID) of a dynamic system exhibiting significant non-linearity and time lag, integrated system fault detection, and Li-ion battery management.

Software integration was accomplished using a systemic approach that required close collaboration with the electrical, mechanical, industrial design, and optical team members.

Project Management

Under an aggressive project timelines, manage and coordinate the Stratos product development activities of a fully integrated, multi-disciplined design and engineering team as well as facilitate communications between Stratos, the Meso Marketing team, and the Meso R&D team.

Management of the project required clear communication to assure a mutual understanding of expectations betweens all participants throughout the development lifecycle. Proactive coordination of the multidisciplinary Stratos team ensured tight development timelines while maintaining the highest quality of design. The Stratos team’s subject expertise included human factors, usability, industrial design, electronic packaging, electro-mechanical systems, digital and analog electronics, firmware development, bio-compatibility, optics, fluidics, and design for manufacturing.

A detailed requirement specification and development plan were created in an initial Planning phase as the foundation for the program. Development activities over the following eight-month duration also included product architecture, concept development, bench-top critical sub-system testing, detailed design development, and functional prototype testing.

Project management of the program followed Stratos methodology to meet specifications, schedule objectives, and budgetary targets. This methodology incorporates best practice techniques including weekly meetings and status reporting, issue prioritization and resolution, pro-active risk identification and mitigation, and design review and assessment gates.

Bio Engineering

Develop system designs for the BioCapture 650 that meet rigorous biocompatibility, contamination isolation, and cleanability requirements as well as a disposable cartridge that meets collection functional performance goals and optimizes consumable strategy.

The Bioengineering effort closely collaborated with the other Stratos teams as well as Meso’s Research and Development team to carefully consider biochemical compatibility of selected materials, processes, and procured OEM components. Main enclosure materials included plastics and elastomers with properties or surface treatments and textures that would be resistant to contaminate trapping and withstand chemicals for decontamination while maintaining cosmetic quality over use. Disposable cartridge materials needed to withstand irradiation and protect sterile fluids while stored.

The disposable fluidic and collection systems also required tight collaboration between Meso and Stratos to effectively make product performance trade-offs while maximizing the integrity of the proprietary collection methodology. Consideration for seal and vent adhesive interaction with sample collection efficiencies and reagent contamination was closely evaluated. Fluid actuation designs were limited to techniques that preserved viable biological samples collected by air sampler.

The resulting designs maximized collection efficiencies, decreased potential contamination or damage to samples, and ensured designs that best meet decontamination and disposable requirements.

Optical Engineering

Develop a sensor sub-system to meet functional and consumable requirements for optimal performance in a ruggedized environment.

Stratos optical engineering expertise was leveraged to design a novel level detection sensor capable of use over a continuous range. The solution was implemented to minimize disposable cartridge costs and was able to operate at a significant distance from the measurement location. The sensor and associated processing algorithm was able to operate under adverse thermal and ambient light environments, and was resilient to instrument tilt/motion conditions.

This unique design assisted in meeting consumable reagent usage, disposable partition objectives, and rugged performance requirements.