A scientist in a lab coat and gloves examines a vial near a Beckman Coulter Life Sciences Cytoflex flow cytometry analyzer, with data from algorithm development displayed on a computer screen in a modern laboratory setting.
Key Innovation By fusing optical science with data engineering, we gave a mature instrument platform the analytical flexibility to outpace dedicated software rivals.
Beckman Coulter logo featuring a stylized circular design next to the company name in bold, uppercase letters.

Flow Cytometer Data Analysis

Client

Beckman Coulter Life Sciences

Overview

The CytoFLEX platform from Beckman Coulter Life Sciences is a market-leading flow cytometry platform designed to provide high sensitivity, strong resolution, and flexible configuration options across a wide range of applications. Built to support advanced sample analysis and regulatory workflows, the platform integrates CytExpert acquisition and analysis software and supports features such as multi-color detection and high-throughput processing.

To expand the platform’s analytical capabilities and strengthen its competitive position against third-party software solutions, Beckman Coulter Life Sciences partnered with Triple Ring to develop advanced data analysis algorithms supporting new high-value customer use cases.

Challenge

A key driver of the CytoFLEX platform’s longstanding market success is its sophisticated data analysis software suite, which allows users to predict unknown properties of their test samples. At project initiation, Triple Ring was tasked with designing algorithms to expand the number of high-value customer use cases from two to ten.

Beckman Coulter Life Sciences sought to capture market value held by third-party solutions while maintaining performance, flexibility, and speed of development across multiple technical disciplines.

Solution

Triple Ring applied cross-disciplinary expertise in optics, simulation, and system design to improve performance and manufacturability.

Key technical efforts included:

  • Optimizing optical subsystem design to improve signal sensitivity
  • Developing analytical models to predict system performance across configurations
  • Supporting integration of acquisition and analysis software workflows
  • Refining system architecture to improve manufacturability and yield
Three white and blue laboratory analyzers of varying sizes are arranged in a row on a plain background. The devices have a modern design with a hexagonal dot pattern on the front panels.

Outcome

The expanded analytics capabilities enabled Beckman Coulter Life Sciences to flexibly support multiple high-value customer use cases, strengthening the competitive position of the CytoFLEX platform and enabling future growth.

The collaboration produced valuable intellectual property and enhanced software capabilities that positioned the platform to capture market share previously held by third-party solutions.

Triple Ring Talent

The Story Behind the Collaboration

At Triple Ring, we draw on a deep bench of expertise across diverse disciplines matched to each innovation challenge. For this project, our team blended deep optics knowledge with advanced algorithm development, data science, and software engineering — expanding the CytoFLEX platform’s analytical capabilities from two to ten high-value customer use cases and capturing market share previously held by third-party solutions.

Daniel and Hailey collaborated with many talented colleagues across Triple Ring and Beckman Coulter on this project.

Meet our team
A portrait of Daniel Badali, a smiling man with glasses and a beard against a gray background.

Daniel Badali, PhD

Optics & Applied Physics

Dr. Daniel Badali brings deep expertise in advanced algorithms, optics, and radiation physics. His work bridges software and hardware, enabling complex simulation, imaging, and sterilization technologies that help turn sophisticated concepts into reliable medical solutions.

A portrait of Hailey Gryka, a woman with glasses and long curly hair smiling against a gray background.

Hailey Gryka

Bioinstrumentation & Data Science

Hailey Gryka brings expertise at the intersection of bioinstrumentation and data science. Her work spans device design, data processing, and system validation, helping teams move seamlessly from early concepts to manufacturable, reliable solutions.

An older woman with long gray hair holds a small medical device to her chest, standing against a plain gray background.
Key Innovation By utilizing a computational breakthrough, we turned a pocket-sized device into a tool capable of synthesizing clinical-grade cardiac diagnostics.
White "HeartBeam" logo with a stylized heart and wireless signal icon forming the letter "B" on a light gray background, capturing the spirit of innovative wearable medical device design.

Cable-Free Synthesized ECG

Client

HeartBeam

Overview

HeartBeam collaborated with Triple Ring to develop an innovative telehealth solution designed to transform the detection and monitoring of cardiac conditions. The goal was to create a compact, portable cardiac monitoring device capable of collecting ECG signals in three dimensions and synthesizing them into a clinically meaningful 12-lead ECG.

The resulting platform supports remote cardiac monitoring by enabling physicians to access real-time data outside traditional clinical settings, expanding access to cardiac diagnostics and improving patient care workflows.

Challenge

HeartBeam sought to develop a personal, cable-free, and easy-to-use cardiac monitoring solution for both in-clinic and at-home use. The objective was to create a credit card-sized ECG recording device that leverages vectorcardiography (VECG) and integrates with cloud-based software to deliver critical patient data to physicians in real time.

Achieving this required coordinating multidisciplinary device development while meeting regulatory requirements and supporting rapid product development timelines.

Solution

HeartBeam partnered with Triple Ring to execute a comprehensive, five-phase expedited device development program spanning early R&D, industrial design, product development, manufacturing readiness, and regulatory preparation.

Triple Ring applied expertise in wearable medical device design and system integration to develop the cable-free ECG device and supporting ecosystem. The program included device builds for design verification and validation, packaging development, and manufacturing technology transfer to support scalable production.

Key development activities included:

  • Designing compact wearable hardware capable of capturing three-dimensional ECG signals
  • Integrating smartphone-based communication to transmit data securely
  • Developing cloud-connected workflows that enabled remote physician access
  • Supporting regulatory preparation for FDA 510(k) submission and validation
A hand holds a small rectangular medical device labeled "Heart Beam" against a plain white background.

Outcome

The HeartBeam–Triple Ring collaboration produced a personal, cable-free synthesized 12-lead ECG solution that enables patients to record cardiac data at home. The device integrates with a smartphone application that communicates with the HeartBeam Cloud, where synthesized ECG data is compared with baseline records and made available to physicians remotely.

This multidisciplinary and fast-paced program resulted in a successful 510(k) submission to the U.S. Food and Drug Administration (FDA) and regulatory clearance in 2024 for the hardware that leverages vectorcardiography and collects 3D ECG data. The synthesized 12-lead ECG algorithm remains pending FDA clearance.

The completed system enables physicians to remotely monitor cardiac conditions and guide patient care outside traditional healthcare facilities, supporting new models of telehealth-enabled cardiac diagnostics.

Triple Ring Talent

The Story Behind the Innovation

At Triple Ring, we draw on a deep bench of expertise across diverse disciplines matched to each innovation challenge. For this project, our team applied expertise in wearable medical device design, system integration, and regulatory strategy to deliver a cable-free, credit card-sized ECG device — from early R&D through successful FDA 510(k) clearance in 2024.

Walt and Kevin collaborated with many talented colleagues across Triple Ring and HeartBeam on this project.

Meet our team
A portrait of of Walt Cecka, a smiling man with short hair wearing a plaid shirt against a blurred background.

Walt Cecka

Medical Device Design & Translational Medicine

Walt Cecka brings decades of experience translating novel medical technologies into first-to-market products. He works closely with innovators to shape early concepts into structured development programs that advance patient care across a wide range of clinical applications.

A portrait of Kevin Dunk, a smiling man with short brown hair wearing a collared, button-up shirt.

Kevin Dunk

Mechanical & Aerospace Engineering

Kevin Dunk brings expertise in mechanical engineering and multidisciplinary product development across the full device lifecycle. His work supports teams from early prototypes through verification and manufacturing, helping ensure systems are reliable, scalable, and ready for real-world use.

A person holding a Hound Labs device displaying a "pass" result for a cannabis breathalyzer test.
Key Innovation By combining microfluidic lab-on-a-chip technology and portable breath capture hardware, we brought clinical-grade THC detection out of the laboratory and into the hands of law enforcement and employers.
Hound Labs logo featuring a stylized dog head in a circle next to the company name in bold capital letters, as highlighted in Triple Ring Technologies' case study on our technical product development of Hound Labs' cannabis breathalyzer system.

Cannabis Breathalyzer System

Client

Hound Labs

Overview

Hound Labs engaged Triple Ring to invent a portable breath analyzer capable of detecting recent marijuana use. The system was developed to support point-of-use testing in law enforcement and workplace environments requiring reliable impairment detection.

Starting from an early concept sketch, Triple Ring collaborated with Hound Labs to develop a high-sensitivity breathalyzer platform combining chemical detection and portable instrumentation technologies.

Challenge

The system needed to detect Δ-9 THC in exhaled breath with clinical-grade sensitivity while maintaining portability and reliability in field conditions.

In addition to engineering challenges, the project required validation of THC pharmacodynamics in breath, including generation of peer-reviewed scientific evidence supporting detection feasibility.

Four conceptual sketches of the handheld Hound Labs cannabis breathalyzer device with different design features highlighted.
Exploded view diagram showing the components of the Hound Labs handheld cannabis breathalyzer, highlighting its interior parts and mechanical design.

Solution

Triple Ring assembled multidisciplinary development teams to design and validate a fully integrated breath analysis platform combining microfluidic sampling and portable device technologies.

Development efforts included:

  • Designing a portable breath capture device optimized for reliable sample collection
  • Engineering microfluidic lab-on-a-chip cartridges supporting sensitive compound detection
  • Integrating control station hardware capable of processing and analyzing captured samples
  • Supporting validation activities that produced peer-reviewed pharmacodynamic data
  • Developing prototype systems suitable for demonstration, testing, and continued product development
A portable cannabis breathalyzer kit by Hound Labs with carrying case and digital handheld device.

Outcome

Triple Ring delivered fully functioning prototype systems consisting of a breath capture device, control station, and microfluidic cartridges.

The system produced clinical-grade data at the point of use, supporting detection of recent marijuana use and enabling development of a first-in-class breath-based detection platform.

Triple Ring Talent

The Story Behind the Innovation

At Triple Ring, we draw on a deep bench of expertise across diverse disciplines matched to each innovation challenge. For this project, our team combined microfluidic engineering, biological sensing, portable instrumentation, and clinical validation expertise to develop a first-in-class breath-based THC detection platform capable of delivering clinical-grade results at the point of use.

David and Kevin collaborated with many talented colleagues across Triple Ring and Hound Labs on this project.

Meet our team
A portrait of David Shack, a smiling man wearing glasses and a blue checked shirt against a blurred background.

David Shack, PhD

Mechanical Engineering & Applied Sciences

Dr. David Shack directs the development of complex scientific measurement and analysis systems across multidisciplinary teams. His work integrates algorithms, software, fluidics, and optical technologies, helping advance tools that support precision research and clinical applications.

A portrait of Kevin Limtao, a smiling man with glasses wearing a blue-striped shirt.

Kevin Limtao

Biomedical & Systems Engineering

Kevin Limtao connects system requirements, architecture, and integration across complex medical and diagnostic technologies. His work helps teams align design, risk, and performance throughout the development lifecycle, ensuring systems function reliably from early concepts through deployment.

Medical team performing surgery in an operating room equipped with advanced technology.
Key Innovation By coupling high-speed laser-based optical imaging with machine learning workflows, we compressed oncology tissue analysis timelines from days to minutes — directly inside the OR.
Logo with a stylized "B" in blue, red, teal, and yellow, next to the text "BLACKLIGHT SURGICAL" in light letters on a gray background—featured in Triple Ring Technologies' case study on our intra-operative tissue pathology system.

Intra-Operative Tissue Pathology

Client

BlackLight Surgical

Overview

BlackLight Surgical engaged Triple Ring to develop a high-speed biochemical imaging platform designed for intra-operative tissue analysis. The system leveraged picosecond pulsing laser technology and machine learning workflows to enable rapid tissue identification during surgical procedures.

The resulting platform supports real-time clinical decision making by allowing clinicians to distinguish between normal and diseased tissue directly in the operating suite.

Challenge

The system required integration of advanced optical imaging technology capable of performing rapid biochemical analysis during surgery. Reliable performance was required across demanding clinical environments and complex workflows.

Delivering this capability required precise integration of optical, mechanical, software, and machine learning systems into a clinically deployable architecture.

A 3D rendering of BlackLight Surgical's advanced intra-operative tissue pathology medical device cart with dual screens displaying user interface, tissue pathology imagery, and diagnostic data.
Medical professional operating BlackLight Surgical's advanced intra-operative tissue pathology medical device cart with dual screens displaying user interface, tissue pathology imagery, and diagnostic data.
Medical imaging comparison displaying a visible image with scan overlay next to a scanned image highlighting specific areas of interest.

Solution

Triple Ring assembled multidisciplinary engineering and scientific teams to design and integrate the imaging platform using structured development and validation methodologies.

Technical execution focused on:

  • Integrating laser-based optical imaging technologies capable of rapid tissue analysis
  • Developing machine learning workflows that supported real-time tissue classification
  • Using simulation and modeling tools to guide system design and performance optimization
  • Establishing ISO 13485-compliant design and documentation processes

Outcome

Triple Ring delivered a fully integrated intra-operative biochemical imaging platform supporting clinical studies and real-time tissue visualization.

The system was developed to ISO 13485 standards and documented within a Quality Management System transferred to BlackLight Surgical, enabling deployment of advanced intra-operative imaging workflows.

Triple Ring Talent

The Story Behind the Innovation

At Triple Ring, we draw on a deep bench of expertise across diverse disciplines matched to each innovation challenge. For this project, our team combined high-speed laser optical imaging, machine learning, mechanical engineering, and quality systems expertise to develop a fully integrated intra-operative tissue analysis platform capable of distinguishing healthy from diseased tissue in real time.

Todd, Cameran, and Shehadeh collaborated with many talented colleagues across Triple Ring and BlackLight Surgical on this project.

Meet our team
A portrait of Todd Harris, a man with glasses wearing a black shirt against a grey background.

Todd Harris, PhD

Physics & Optical Science

Dr. Todd Harris applies expertise in optics and imaging physics to the development of advanced sensing and illumination technologies. His work combines optical modeling with system design, helping teams translate complex physical principles into dependable, high-performance solutions.

Portrait of Cameran Casale, a person with long, straight brown hair, wearing a white shirt and a necklace, smiling against a blurred background.

Cameran Casale

Bioengineering

Cameran Casale contributes to the development of imaging, microfluidic, and diagnostic technologies across multidisciplinary programs. Her work supports system integration and testing efforts, helping teams refine complex devices for reliable performance in research and clinical environments.

A portrait of Shehadeh Dajani, a smiling man wearing a suit and tie against a blurred background.

Shehadeh Dajani

Aerospace & Mechanical Engineering

Shehadeh Dajani supports the development of safety-critical embedded systems used in regulated medical technologies. His work spans software and system integration across feasibility, clinical, and production stages, helping ensure reliable performance throughout the development lifecycle.

A laptop displaying Dose Insight's Design For Sterilization (DFS) software, a 3d model editing interface with a highlighted dose mapping on the shape.
Key Innovation By translating Monte Carlo radiation physics into an intuitive cloud-based platform, we moved sterilization planning from a late-stage liability to an early-stage design input.
A yellow hexagon logo with white diagonal lines sits next to "Dose Insight" on a light gray background, reflecting Triple Ring Technologies' case study on technical product development for sterilization simulation software design.

Design for Sterilization (DFS)

Client

Dose Insight

Overview

Dose Insight partnered with Triple Ring to develop Design for Sterilization (DFS), a simulation platform designed to support early-stage sterilization planning in medical device development. The system leverages Monte Carlo simulation technology to model radiation dose distribution and guide sterilization strategies before physical prototypes are built.

The platform enables engineers to evaluate sterilization performance directly from CAD models, supporting faster development timelines and reducing reliance on late-stage empirical testing.

Challenge

Medical device sterilization validation is often addressed late in the product development process, after devices have been fully designed and manufactured. When sterilization issues arise at that stage, they can introduce significant costs, delays, and redesign requirements.

The goal was to determine whether advanced computer modeling could enable sterilization strategy development earlier in the design cycle. This required creating accurate Monte Carlo simulation tools that were powerful enough for complex modeling, yet intuitive enough for non-expert users to operate effectively.

A diagram illustrating the Dose Insight workflow for simulating device sterilization, involving a web interface for uploading cad models, cloud-based monte carlo simulations, and reports on dose distribution.
A screenshot of Dose Insight's Design For Sterilization (DFS) software showing the user interface and a 3d model with a highlighted dose mapping on the shape.
A screenshot of Dose Insight's Design For Sterilization (DFS) software showing the sterilization dose report mapped onto a 3d model.

Solution

Triple Ring developed a simulation-driven platform that integrates advanced radiation modeling with user-friendly software workflows. The system enables users to simulate radiation sterilization scenarios directly from digital models, allowing teams to refine designs before committing to costly manufacturing steps.

Development focused on:

  • Applying Monte Carlo simulation techniques to predict radiation dose distribution
  • Designing user-friendly graphical interfaces that enabled early-stage analysis
  • Building scalable cloud infrastructure capable of supporting large computational workloads
  • Validating platform performance across multiple sterilization technologies
A person using Dose Insight software on a laptop.

Outcome

The DFS platform significantly shortened medical device development cycles by enabling sterilization strategies to be implemented early in the design process. The system provides precise radiation dose mapping for complex medical devices, allowing teams to evaluate sterilization performance before physical testing.

By enabling iterative design refinement without extensive prototyping, the platform reduced development costs and minimized the need for expensive late-stage testing. The resulting technology established a validated approach to integrating sterilization planning into early product design workflows.

Triple Ring Talent

The Story Behind the Innovation

At Triple Ring, we draw on a deep bench of expertise across diverse disciplines matched to each innovation challenge. For this project, our team combined Monte Carlo simulation, applied radiation physics, software engineering, and cloud infrastructure expertise to develop a platform that enables medical device teams to validate sterilization strategies directly from CAD models — before a single prototype is built.

Daniel and Tobias collaborated with many talented colleagues across Triple Ring and Dose Insight on this project.

Meet our team
A portrait of Daniel Badali, a smiling man with glasses and a beard against a gray background.

Daniel Badali, PhD

Optics & Applied Physics

Dr. Daniel Badali brings deep expertise in advanced algorithms, optics, and radiation physics. His work bridges software and hardware, enabling complex simulation, imaging, and sterilization technologies that help turn sophisticated concepts into reliable medical solutions.

A portrait of Tobias Funk, a smiling man with grey hair wearing a striped shirt against a blurred background.

Tobias Funk, PhD

Experimental Physics & Instrumentation

Dr. Tobias Funk develops advanced instrumentation that applies ionizing radiation to scientific and medical challenges. His work spans imaging, simulation, and system design, helping translate complex physical principles into practical technologies used in real-world environments.

A happy dog wearing One Health Group's Voyce heart monitor with a bandaged leg on a vet examination table while a veterinarian works in the background.
Key Innovation By packaging continuous biometric and wireless monitoring into an animal-ready wearable, we unlocked a new standard of veterinary care.
One Health logo with 'One' in orange and 'Health' in blue, featuring a blue curved line connecting the words, inspired by Triple Ring Technologies' case study on our technical product development of One Health Group's Voyce physiological monitor.

Veterinary Vital Sign Monitor

Client

One Health Group

Overview

One Health Group partnered with Triple Ring to develop a non-invasive wearable physiological monitoring system designed to capture biometric data from animals in real time. The system was developed to support continuous health monitoring in veterinary settings while improving patient comfort and enabling early detection of health issues.

The resulting wearable platform integrates physiological sensing and wireless communication technologies to enable long-term monitoring and provide actionable health insights for veterinary care providers.

Challenge

One Health Group required development of a wearable monitoring device capable of accurately measuring physiological signals in animals while remaining comfortable and suitable for continuous use. The system needed to support long-term data collection and deliver real-time alerts without interfering with normal animal movement.

As a lean startup organization, One Health Group relied on a fully outsourced R&D model. The project required multidisciplinary engineering expertise to design, prototype, and validate a complex sensing platform while rapidly demonstrating feasibility and reducing development risk.

Black pet collar with integrated One Health Group's Voyce physiological monitoring device.
A drawing of a hand assembling the One Health Group's Voyce animal physiological monitor onto a collar.
A digital illustration of One Health Group's Voyce physiological monitor on a dog with a transparent section showing internal anatomy.

Solution

Triple Ring led the development of a wearable physiological monitoring platform using a structured feasibility and product development approach. Industrial design, sensing technologies, and system integration were coordinated to ensure reliable performance and comfort across extended wear conditions.

Key contributions included:

  • Designing wearable hardware capable of supporting continuous physiological monitoring
  • Conducting rapid feasibility testing to validate sensing and alert functionality
  • Refining industrial design to improve comfort, usability, and durability
Black pet collar with integrated One Health Group's Voyce physiological monitoring device.

Outcome

Triple Ring delivered robust functional prototypes capable of generating high-quality physiological data suitable for ongoing product development and validation. The system demonstrated the feasibility of continuous biometric monitoring in veterinary applications.

The successful development effort supported One Health Group’s technology roadmap and strengthened its value proposition, enabling expanded partnerships with strategic investors in the veterinary health industry.

Triple Ring Talent

The Story Behind the Innovation

At Triple Ring, we draw on a deep bench of expertise across diverse disciplines matched to each innovation challenge. For this project, our team combined physiological sensing, wireless systems, industrial design, and startup-focused R&D expertise to develop a wearable continuous monitoring platform capable of capturing real-time biometric data from animals in veterinary settings.

Brian and Steve collaborated with many talented colleagues across Triple Ring and One Health Group on this project.

Meet our team
A portrait of Brian Wilfley, a smiling man with white hair and glasses in a blue shirt against a gray background.

Brian Wilfley, PhD

Experimental Physics & Instrumentation

Dr. Brian Wilfley leads the development of complex measurement and instrumentation systems grounded in experimental physics. His work combines theoretical insight with hands-on experimentation to advance technologies used in imaging, inspection, and scientific analysis.

A portrait of Steven Kuhn, a smiling man with a white mustache and glasses against a gray background.

Steve Kuhn

Embedded Systems & Software Engineering

Steve Kuhn develops embedded software and real-time control systems that support complex hardware-driven technologies. His work focuses on software architecture, motion control, and system simulation, enabling reliable operation across integrated device platforms.

Close-up photograph of colorful microplastics on finger tips with gray background.
Key Innovation By solving for real-world interferents at the miniaturization stage, we produced a field-deployable monitor that performs where benchtop instruments cannot.

Ocean Microplastics Monitor

Client

Various

Overview

Triple Ring supported the development of a portable microplastics monitoring system designed to measure plastic particle concentrations in aqueous environmental samples. The system was developed to enable field-based quantification of microplastics and support environmental research initiatives.

The resulting platform integrates particle detection and separation technologies into a miniaturized unit capable of replacing larger laboratory-based instrumentation while maintaining measurement accuracy under real-world conditions.

Challenge

Environmental researchers required a field-deployable system capable of accurately detecting and quantifying microplastics in complex environmental samples. Traditional benchtop instruments were not suitable for field use due to size, cost, and sensitivity to environmental conditions.

The system needed to function reliably in the presence of common interferents such as air bubbles, biological materials, sand, and other particulate matter. Achieving consistent performance under these variable conditions required robust system integration and miniaturization.

Comparison of current vs triple ring's microplastic testing methods, highlighting efficiency, cost, and portability differences.

Solution

Triple Ring collaborated with research partners to integrate sensing technologies into a compact and ruggedized platform capable of supporting field-based environmental monitoring. Engineering efforts focused on miniaturizing complex instrumentation while maintaining detection accuracy across diverse environmental samples.

Technical work included:

  • Designing miniaturized detection systems that replaced benchtop instrumentation
  • Developing algorithms to distinguish plastics from environmental interferents
  • Integrating sampling and analysis components into a portable architecture
  • Validating system performance under field-relevant conditions
Illustration of real-time microplastics concentration data being transmitted via satellite or cellular tower to a centralized mapping system.
Two researchers in life jackets on a boat testing for microplastics in the surrounding water.

Outcome

Triple Ring delivered a portable microplastics monitoring system capable of operating outside traditional laboratory environments. The system successfully demonstrated reliable particle detection and measurement in real-world environmental conditions.

The field-ready platform enabled successful demonstrations to research partners and funding organizations, supporting ongoing efforts to advance environmental monitoring technologies and improve understanding of microplastic pollution.

Triple Ring Talent

The Story Behind the Innovation

At Triple Ring, we draw on a deep bench of expertise across diverse disciplines matched to each innovation challenge. For this project, our team combined miniaturized sensing system design, particle detection and separation technologies, and ruggedized hardware engineering to develop a portable microplastics monitor capable of replacing laboratory instrumentation in real-world field environments.

Erick and Sheila collaborated with many talented colleagues across Triple Ring on this project.

Meet our team
A portrait of Erick Blankenberg, a smiling man with short hair against a blurred gray background.

Erick Blankenberg

Electro-Mechanical Systems Engineering

Erick Blankenberg contributes to the development of electro-mechanical systems with a focus on controls and optimization. His work supports software and hardware integration for imaging and instrumentation technologies, helping teams refine system performance through coordinated design and testing.

A portrait of Sheila Hemami, a smiling woman with graying hair

Sheila Hemami, PhD

Electrical Engineering & Enviromental Sciences

Dr. Sheila Hemami brings interdisciplinary teams together to develop technologies that address complex environmental and healthcare challenges. Her work focuses on early-stage innovation and cross-sector collaboration, helping transform emerging ideas into solutions that are practical, deployable, and sustainable.

A conceptual rendering of the at-home diagnostic device next to a bathroom sink.
Key Innovation By introducing quantitation to lateral flow immunoassays through integrated optical and embedded systems, we brought high-quality multiplexed diagnostics within reach of the home and low-resource settings.

At-Home Quantitative Diagnostics

Client

BARDA

Overview

The Biomedical Advanced Research and Development Authority (BARDA) selected Triple Ring to design, build, and test a low-cost quantitative biomarker detection platform intended for at-home and low-resource healthcare settings. The system was developed to support multiplexed biomarker analysis using compact, user-friendly instrumentation.

The resulting platform integrates biological sensing, embedded electronics, and optical detection technologies into a portable diagnostic system designed to support lab-at-home, point-of-care, and direct-to-consumer workflows.

Challenge

BARDA identified the need for a low-cost diagnostic platform capable of delivering quantitative biomarker measurements outside traditional laboratory environments. The system needed to support multiplexed testing while remaining accessible for use in resource-limited settings and CLIA-waived environments.

Achieving this capability required integration of complex biological, optical, and electronic subsystems into a compact and manufacturable design. The platform also needed to extend the measurable range of lateral flow immunoassays while maintaining usability and cost targets suitable for broad deployment.

An isolated conceptual 3D rendering of the at-home diagnostic device next to a cup with blue liquid
Illustration showing two steps: 1) A test strip is dipped into a liquid in a cup. 2) The strip is inserted into a small, rectangular digital device.

Solution

Triple Ring applied multidisciplinary expertise across biological sciences, engineering, and embedded systems to develop a scalable diagnostic platform capable of delivering quantitative results from multiplexed lateral flow assays.

Development efforts focused on:

  • Designing multiplexed lateral flow assay (LFA) detection systems capable of quantifying biomarker concentrations
  • Integrating biological, electrical, mechanical, optical, and embedded software subsystems into a unified platform
  • Developing workflows suitable for CLIA-waived, point-of-care, and at-home diagnostic environments
  • Extending the quantitative measurement range beyond that of conventional lateral flow assay readers
  • Conducting system-level integration and verification to support development of a handheld diagnostic platform

Outcome

Triple Ring delivered a functional multiplexed diagnostic platform capable of quantifying biomarker concentrations across multiple test channels. The system demonstrated improved quantitative measurement range compared to conventional lateral flow assay readers.

The platform supported deployment across diverse clinical environments, including at-home and point-of-care settings. Ongoing development efforts include system integration and testing of a handheld version designed to further expand accessibility and usability in remote and low-resource healthcare environments.

Triple Ring Talent

The Story Behind the Innovation

At Triple Ring, we draw on a deep bench of expertise across diverse disciplines matched to each innovation challenge. For this project, our team combined biological sciences, optical detection, embedded electronics, and diagnostic platform engineering to develop a low-cost multiplexed biomarker detection system capable of delivering quantitative lab-grade results in at-home and resource-limited healthcare settings.

Rachel and Chris collaborated with many talented colleagues across Triple Ring and BARDA on this project.

Meet our team
Smiling woman with long blonde hair wearing a blue shirt and dark blazer, photographed against a blurred gray background.

Rachel Gerver, PhD

Bioengineering & Applied Science and Systems

Dr. Rachel Gerver advances microfluidic and point-of-care technologies from early development into real-world application. Her work spans technical leadership and systems development, helping teams bring complex innovations to market where they can deliver meaningful impact.

A portrait of Chris Todd, a smiling man wearing a blue polo shirt.

Chris Todd

Mechanical Engineering

Chris Todd focuses on biomedical diagnostics and precision instrumentation, integrating fluidics, optics, and mechanical systems. His work supports the development of regulated medical technologies from early concepts through manufacturing, helping teams deliver reliable diagnostic solutions at scale.

A lab technician in a white coat holds blood samples near laboratory equipment, showcasing the legacy IVD product modernization process while ensuring 510(k) compliance.
Key Innovation By reverse engineering lost institutional knowledge and validating component equivalency, we unlocked a Special 510(k) pathway without redesigning a full platform.

IVD Platform Refresh

Client

Fortune 500 IVD Company

Overview

A Fortune 500 diagnostics manufacturer worked with Triple Ring to modernize a legacy in vitro diagnostic (IVD) platform facing component obsolescence and software limitations. The project focused on refreshing the system architecture while maintaining regulatory equivalency with an existing FDA-cleared product.

The resulting platform replaced obsolete hardware, migrated legacy software, and introduced updated industrial design elements while preserving compatibility with established manufacturing and regulatory pathways.

Challenge

The client faced the obsolescence of critical hardware components, including single-board computers and microcontrollers, within an existing diagnostic platform. Compounding the challenge, original firmware source code was unavailable, and institutional knowledge associated with the system had diminished over time.

In addition to restoring functionality, the refreshed system needed to maintain regulatory equivalence to the original device in order to qualify for a Special 510(k) submission. This requirement demanded careful reverse engineering, system validation, and modernization without introducing unintended performance deviations.

Close-up of a computer hard drive circuit board, showcasing blue circuitry and an attached circular component with orange connectors, reminiscent of the precision needed in legacy IVD product modernization and 510(k) compliance.
A person is sitting at a desk using a laptop and monitor, both displaying lines of code. A tablet with a blank page is also on the desk, suggesting plans for legacy IVD product modernization.

Solution

Triple Ring implemented a structured modernization strategy combining reverse engineering, hardware redesign, and software migration. The development effort focused on preserving functional equivalency while introducing modern components and improving long-term maintainability.

Development efforts included:

  • Reverse-engineering legacy hardware and firmware to recover system functionality and requirements
  • Migrating existing software to a modern operating system architecture
  • Replacing obsolete components while maintaining compatibility with legacy subsystems
  • Updating mechanical and electrical subassemblies to support manufacturing continuity
  • Preparing validation and documentation packages supporting regulatory equivalence requirements

Outcome

Triple Ring delivered a fully refreshed IVD platform supported by a comprehensive regulatory submission package demonstrating equivalency to the original FDA-cleared device. The updated system maintained functional continuity while addressing long-term hardware and software sustainability.

The refreshed design integrated seamlessly into existing manufacturing workflows, enabling uninterrupted production and maintaining cost targets. The modernization effort positioned the platform for continued market competitiveness while ensuring regulatory compliance and operational reliability.

Triple Ring Talent

The Story Behind the Innovation

At Triple Ring, we draw on a deep bench of expertise across diverse disciplines matched to each innovation challenge. For this project, our team combined reverse engineering, embedded systems, software migration, regulatory strategy, and industrial design expertise to modernize a legacy IVD platform — restoring long-term sustainability while maintaining full regulatory equivalency with the original FDA-cleared device.

Rob and Anne collaborated with many talented colleagues across Triple Ring on this project.

Meet our team
A portrait of Robert de Saint Phalle, a smiling man wearing a blue shirt, with a blurred background.

Robert de Saint Phalle

Interdisciplinary Product Design

Robert de Saint Phalle shapes product design strategies that connect engineering, user experience, and emerging technologies. His work helps teams translate complex ideas into thoughtful, functional products that bring new technologies to life.

A photo of Anne Preut, a woman with wavy brown hair smiling, wearing a green top and small gold hoop earrings, against a blurred gray background.

Anne Preut

Biomedical & Systems Engineering

Anne Preut leads systems engineering efforts that integrate hardware, firmware, assays, and fluidics across complex diagnostic technologies. Her work aligns cross-functional teams throughout the development lifecycle, helping ensure systems perform reliably from early feasibility through production.