Key Innovation
By utilizing a computational breakthrough, we turned a pocket-sized device into a tool capable of synthesizing clinical-grade cardiac diagnostics.
Cable-Free Synthesized ECG
Client
HeartBeam
Practice Areas
Core Disciplines
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
Cable-Free Synthesized ECG
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
Client
HeartBeam
Practice Areas
Core Disciplines
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.
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.
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.
Key Innovation
By integrating algorithms to compensate for variable tissue morphologies within a compact handheld form factor, we unlocked reliable, real-time StO₂ measurement directly inside the surgical theater.
Real-Time Tissue Oxygenation Status
Client
ViOptix
Practice Areas
Core Disciplines
Overview
ViOptix collaborated with Triple Ring to design and develop the Intra.Ox™, a non-invasive, handheld tissue oxygenation monitor designed for use inside the surgical theater. The device enables real-time measurement of tissue oxygenation, helping surgeons assess tissue viability and make informed decisions during procedures.
By combining optical sensing technology with advanced algorithms and a portable handheld design, the system supports improved surgical workflows and enhances clinical decision-making during tissue transfer procedures.
Challenge
ViOptix sought to develop a quantitative tissue oxygenation monitor capable of delivering real-time, highly sensitive measurements in a surgical environment. The system needed to be easy to use, reliable, and capable of generating unlimited readings throughout a surgical case.
Key technical challenges included:
- Designing an easy-to-use multi-wavelength tissue oximeter
- Developing smart algorithms to compensate for variable tissue morphologies
- Creating a compact handheld form factor suitable for surgical use
- Supporting reusable packaging and surgical workflows
- Ensuring consistent performance across varying tissue conditions
In addition, the system needed to accurately capture oxygen concentration in resected tissue while minimizing artifacts caused by surrounding tissue components.
Real-Time Tissue Oxygenation Status
Overview
ViOptix collaborated with Triple Ring to design and develop the Intra.Ox™, a non-invasive, handheld tissue oxygenation monitor designed for use inside the surgical theater. The device enables real-time measurement of tissue oxygenation, helping surgeons assess tissue viability and make informed decisions during procedures.
By combining optical sensing technology with advanced algorithms and a portable handheld design, the system supports improved surgical workflows and enhances clinical decision-making during tissue transfer procedures.
Challenge
ViOptix sought to develop a quantitative tissue oxygenation monitor capable of delivering real-time, highly sensitive measurements in a surgical environment. The system needed to be easy to use, reliable, and capable of generating unlimited readings throughout a surgical case.
Key technical challenges included:
- Designing an easy-to-use multi-wavelength tissue oximeter
- Developing smart algorithms to compensate for variable tissue morphologies
- Creating a compact handheld form factor suitable for surgical use
- Supporting reusable packaging and surgical workflows
- Ensuring consistent performance across varying tissue conditions
In addition, the system needed to accurately capture oxygen concentration in resected tissue while minimizing artifacts caused by surrounding tissue components.
Client
ViOptix
Practice Areas
Core Disciplines
Solution
Triple Ring and ViOptix worked side-by-side to invent subsystem- and system-level solutions that enabled reliable real-time tissue oxygenation monitoring. The development effort spanned concept generation through clinical validation, with a strong emphasis on modeling, algorithm design, and usability.
Triple Ring applied deep clinical and technical expertise to accelerate development while supporting the needs of a virtual startup environment. Complex modeling techniques, including Monte Carlo simulations, were used to evaluate optical performance and optimize system behavior early in the design process.
Engineering efforts focused on:
- Designing multi-wavelength optical sensing systems capable of detecting tissue oxygenation levels
- Developing algorithms that compensated for variability in tissue characteristics
- Optimizing handheld system architecture to support surgical usability
- Validating measurement accuracy across simulated clinical environments
Outcome
The ViOptix Intra.Ox technology received FDA clearance after demonstrating its ability to produce accurate, instantaneous estimates of percent saturated oxygen (StO₂) without requiring capital equipment or dye injection.
The device is now used during tissue transfer surgeries to support real-time assessment of tissue viability, enabling earlier intervention and improving both clinical and financial outcomes. The program progressed from concept to clinical validation and FDA 510(k) clearance in approximately 18 months, demonstrating the efficiency of the collaborative development approach.
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 advanced optical modeling, Monte Carlo simulation, algorithm development, and user-centered device design to bring a first-of-its-kind handheld tissue oxygenation monitor from concept to FDA clearance in just 18 months.
Jeremy and Nick collaborated with many talented colleagues across Triple Ring and ViOptix on this project.
Nick Hawson
Medical Device Strategy & Program Leadership
With 25 years spanning engineering, program leadership, and innovation consulting, Nick has helped bring groundbreaking medical technologies to market for companies ranging from early-stage startups to global blue-chip firms.
Jeremy Ford, PhD
Biomedical Optics & Physiological Sensing
Dr. Jeremy Ford brings a decade of biomedical optics expertise — from tissue-illumination systems and physiological sensing to optical-thermal simulation and neural inhibition — backed by a Vanderbilt PhD and extensive peer-reviewed research.
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.
Cannabis Breathalyzer System
Client
Hound Labs
Practice Areas
Core Disciplines
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.
Cannabis Breathalyzer System
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.
Client
Hound Labs
Practice Areas
Core Disciplines
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
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.
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.
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.
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.
Intra-Operative Tissue Pathology
Client
BlackLight Surgical
Core Disciplines
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.
Intra-Operative Tissue Pathology
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.
Client
BlackLight Surgical
Core Disciplines
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.
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.
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.
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.
Key Innovation
By coupling wearable optics with injectable dyes, we enabled continuous, non-invasive kidney monitoring without repeated blood draws or lab visits.
Transdermal GFR Measurement
Client
MediBeacon
Practice Areas
Core Disciplines
Overview
MediBeacon partnered with Triple Ring to develop a photonics-based transdermal detection system designed to measure kidney function using fluorescent tracer technology. The system enables non-invasive monitoring of intravenously injected tracers to generate clinically actionable measurements of glomerular filtration rate (GFR).
The resulting wearable detection platform integrates optical sensing and physiological measurement technologies to support real-time kidney function assessment in clinical environments.
Challenge
MediBeacon required development of a wearable optical detection system capable of monitoring fluorescent tracer signals through human tissue. The system needed to achieve high sensitivity and accuracy while remaining comfortable and practical for clinical use.
In addition to performance requirements, the device needed to meet strict constraints related to cost, usability, and manufacturability. The development effort required careful balancing of optical performance, ergonomic design, and regulatory compliance within a wearable form factor.
Transdermal GFR Measurement
Overview
MediBeacon partnered with Triple Ring to develop a photonics-based transdermal detection system designed to measure kidney function using fluorescent tracer technology. The system enables non-invasive monitoring of intravenously injected tracers to generate clinically actionable measurements of glomerular filtration rate (GFR).
The resulting wearable detection platform integrates optical sensing and physiological measurement technologies to support real-time kidney function assessment in clinical environments.
Challenge
MediBeacon required development of a wearable optical detection system capable of monitoring fluorescent tracer signals through human tissue. The system needed to achieve high sensitivity and accuracy while remaining comfortable and practical for clinical use.
In addition to performance requirements, the device needed to meet strict constraints related to cost, usability, and manufacturability. The development effort required careful balancing of optical performance, ergonomic design, and regulatory compliance within a wearable form factor.
Client
MediBeacon
Practice Areas
Core Disciplines
Solution
Triple Ring collaborated closely with MediBeacon to design and deliver a non-invasive wearable detection system capable of supporting accurate GFR measurement. The development effort leveraged expertise in light-based tissue analysis and system-level modeling to optimize detection performance while supporting user comfort and clinical usability.
The team addressed these challenges by:
- Applying advanced photonics expertise to optimize signal detection through tissue
- Using modeling and simulation tools to refine optical system performance
- Designing wearable hardware that supported patient comfort during extended use
- Aligning development processes with clinical validation and regulatory expectations
Outcome
Fully integrated wearable GFR detection systems were developed under ISO 13485 design controls and delivered to support critical clinical trials. The resulting devices enabled accurate, non-invasive measurement of kidney function through optical detection of fluorescent tracers.
The platform supported the advancement of MediBeacon’s GFR monitoring technology toward clinical validation, enabling real-time physiological measurement while maintaining patient comfort and usability.
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 photonics, transdermal optical sensing, wearable device design, and advanced simulation expertise to develop a clinical-grade wearable system capable of measuring kidney function non-invasively through fluorescent tracer detection.
Gus and Ed collaborated with many talented colleagues across Triple Ring and MediBeacon on this project.
Gus Lowell
Systems Architecture & Electrical Engineering
Augustus “Gus” Lowell defines the architecture of complex software and hardware systems across multidisciplinary programs. His work establishes the frameworks that connect data processing, control, and safety-critical functions, helping ensure technologies operate reliably as integrated systems.
Ed Solomon
Electrical Engineering & Advanced Technologies
Ed Solomon connects advanced engineering with business strategy to help bring innovative technologies into practical use. His work supports system architecture, partnership development, and technology adoption, helping organizations move complex ideas toward successful deployment.
Key Innovation
By packaging continuous biometric and wireless monitoring into an animal-ready wearable, we unlocked a new standard of veterinary care.
Veterinary Vital Sign Monitor
Client
One Health Group
Practice Areas
Core Disciplines
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.
Veterinary Vital Sign Monitor
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.
Client
One Health Group
Practice Areas
Core Disciplines
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
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.
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.
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.
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
Practice Areas
Core Disciplines
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.
At-Home Quantitative Diagnostics
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.
Client
BARDA
Practice Areas
Core Disciplines
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.
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.
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.
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
Practice Areas
Core Disciplines
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.
IVD Platform Refresh
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.
Client
Fortune 500 IVD Company
Practice Areas
Core Disciplines
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.
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.
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.