A hand holds a white electronic device with indicator lights and a brush tip over a marble countertop in a bathroom.
Key Innovation From unmet clinical need to company formation: the path to an at-home diagnostic solution.

At-Home Biomarker Measurements for Women

Client

Two X Labs

Practice Areas

TechBio & Life Sciences

Core Disciplines

Overview

A venture studio engaged Triple Ring to identify commercially viable opportunities within women’s health. Former Stanford Biodesign Innovation fellows at Triple Ring applied the Biodesign process and evaluated unmet clinical needs transforming one of the highest-potential opportunities into an early-stage diagnostic concept.

The program combined market discovery, clinical insight, and rapid technical innovation to create an at-home, semi-quantitative biomarker measurement platform designed for low-cost, CLIA-waived testing.

Challenge

The project began with a broad question: where are the greatest unmet opportunities in women’s health? Triple Ring interviewed healthcare providers, key opinion leaders, and other stakeholders while analyzing publicly available data to identify unmet clinical needs with meaningful market potential.

One promising opportunity emerged: a low-cost system capable of performing semi-quantitative biomarker measurements at home. Delivering clinically meaningful performance within the constraints of an affordable, CLIA-waived diagnostic platform presented a significant technical challenge.

A hand holds a white electronic device with a brush tip and a row of five indicator lights, one of which is green, against a white background.
A white test device is dipped into a glass of water, then removed, showing a green light and indicator bars, illustrating a water testing process.
Diagram shows a white electronic test strip device with dimensions, LED indicators, and labeled views from the top, front, and side perspectives.

Solution

Triple Ring applied multidisciplinary product development expertise and the Biodesign methodology and to rapidly progress from opportunity identification to proof of concept.

The program combined clinical insight with rapid innovation by:

  • Applying the Stanford Biodesign process to identify and prioritize unmet clinical needs
  • Evaluating opportunities based on clinical impact, market potential, technical risk, and commercialization potential
  • Brainstorming and refining technical concepts through an interdisciplinary team of scientists and engineers
  • Developing an initial proof-of-concept prototype for an at-home semi-quantitative biomarker measurement system
  • Generating assay data and product visualizations to support company formation, fundraising, and commercialization plans

Outcome

Within weeks, Triple Ring developed an initial proof-of-concept prototype and demonstrated promising system performance.

The resulting intellectual property, and initial data, was used to form a startup company, Two X Labs, and an executive team was recruited to raise outside investment. Triple Ring continues to support commercialization through medical device development expertise and collaborative government proposal development, helping position the company to secure additional non-dilutive funding. The project demonstrates Triple Ring’s ability to identify unmet clinical needs, rapidly de-risk innovative concepts, and help launch new medical technology ventures.

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 clinical needs assessment, biodesign methodology, assay development, diagnostic device engineering, and commercialization strategy expertise to identify an unmet opportunity in women’s health and rapidly advance it from concept to fundable startup.

Rachel and Todd collaborated with many talented colleagues across Triple Ring and TwoX Labs 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 and Systems

Dr. Rachel Gerver advances bioengineering and microfluidic technologies from early development into real-world application. Her work spans applied science and systems leadership, bringing complex innovations into practical use.

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

Todd Harris, PhD

Physics and Optical Science

Dr. Todd Harris applies expertise in physics and optical science to the development of advanced sensing and illumination technologies. His work combines optical modeling with system design, enabling dependable high-performance solutions.

Gloved hands hold a small, transparent microfluidic device with parallel channels and attached tubing against a light background.
Key Innovation Closed-loop microfluidics cut the cost and complexity of cell therapy manufacturing.

Closed-Loop Cell Therapy Manufacturing

Client

Scaled Cell Solutions

Practice Areas

TechBio & Life Sciences

Core Disciplines

Overview

Scaled Cell Solutions, a venture-backed startup, engaged Triple Ring to rethink cell therapy manufacturing with the aims of reducing cost, shortening time to dose, and expanding patient access. By Integrating a ground-breaking workflow, biophysical analysis, and novel gene delivery technology, our work built a foundation for disrupting cell therapy production.

Challenge

Current cell therapy manufacturing processes rely on technologies that introduce risk at every step as cells are transferred between functional modules within complex, high-cost workflows. These fragmented processes resist automation, increase variability, add contamination risk, and limit patient access to potentially life-saving therapies.

Triple Ring invented a closed-loop approach that reduces complexity, lowers cost, and shortens time to dose while maintaining safety, efficacy, and product quality.

3D illustration showing clusters of pink and purple spherical cells with textured surfaces floating against a dark blue background.

Solution

Triple Ring developed enabling technologies designed to streamline and modernize cell therapy manufacturing through an integrated closed-loop architecture.

The solution combined several novel technologies:

  • A microfluidic-based end-to-end manufacturing platform
  • Modular high-throughput cell selection technology
  • Advanced non-viral gene transfer technologies
  • Modular subsystems capable of operating independently or within an integrated workflow

Outcome

Triple Ring developed innovative technologies that advanced cell therapy manufacturing through a microfluidic-enabled, closed-loop, end-to-end production platform.

The system eliminates cold-chain storage challenges, reduces extensive quality control measures, and shortens patient wait times. The system architecture represents a significant advancement over traditional cell therapy manufacturing approaches, whose complex and costly workflows continue to limit patient access.

Importantly, the modular cell selection and transfection subsystems operate independently or in tandem, providing flexibility for both early research and later clinical applications. The functionality of the system was successfully demonstrated at the prototype level.

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 combined cell biology, microfluidics, gene delivery, bioprocess engineering, and systems integration expertise to invent a closed-loop manufacturing platform with the potential to transform patient access to cell therapies.

Gene, Roger, and Ryan collaborated with many talented colleagues across Triple Ring and Scaled Cell Solutions on this project.

Meet our team
A portrait of Gene Napolitano, a smiling man with glasses wearing a checked shirt and purple fleece

Gene Napolitano, PhD

Molecular Cell Biology

Dr. Gene Napolitano brings scientific leadership to drug discovery and in vitro diagnostics programs. His work connects expertise in cell and molecular biology with diagnostic and therapeutic development across a broad range of disease areas.

A portrait of Roger Tang, a smiling man with gray hair, a beard, and glasses, wearing a blue shirt, against a blurred background.

Roger Tang, PhD

Bioinstrumentation and Product Development

Dr. Roger Tang leads the development of complex medical technologies spanning bioengineering, instrumentation, and applied science. His work brings together scientific, engineering, and product development expertise to guide technologies from early concept through commercialization.

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Ryan McGuinness

Biotechnology and Product Development

Ryan McGuinness connects innovators, technologies, and strategic partners to accelerate the development of novel healthcare technologies. His work helps organizations build the technical, commercial, and funding foundations needed to move promising ideas toward commercialization.

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.
Beckman Coulter logo featuring a stylized circular design next to the company name in bold, uppercase letters.
Key Innovation Advanced algorithms multiplied analytical power fivefold — without new hardware.

Flow Cytometer Data Analysis

Client

Beckman Coulter Life Sciences

Practice Areas

Industrial TechBio & Life Sciences

Core Disciplines

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.

A patient in Aim Medical Robotics' MRI-compatible surgical robot, nested inside a white MRI machine with physician in the background.
Logo with large white letters "AiM" on the left and smaller "MEDICAL ROBOTICS" on the right, featured in Triple Ring Technologies' case study on our technical product development of an MRI-compatible surgical robot, all on a light gray background.
Key Innovation First-principles robotics delivered precise motion control inside an MRI.

MRI-Compatible Robotics

Client

AiM Medical Robotics

Practice Areas

Smart Medical Devices TechBio & Life Sciences

Core Disciplines

Overview

AiM Medical Robotics engaged Triple Ring to develop a portable robotic system capable of performing neurosurgical procedures simultaneously with magnetic resonance imaging (MRI).

The resulting prototype established the technical foundation for an MRI-compatible robotic platform designed to support image-guided neurosurgery.

Challenge

MRI environments rely on strong magnetic fields that prohibit the use of ferromagnetic materials commonly found in traditional robotic systems. Additionally, the limited physical space inside MRI systems imposed strict form factor constraints.

These requirements demanded innovative design strategies to enable reliable robotic motion and positioning inside the MRI environment.

Solution

Triple Ring applied first-principles engineering and multidisciplinary design expertise to create an MRI-compatible robotic system.

Key elements of the solution included:

  • Design of multi-axis robotic systems optimized for MRI environments
  • Application of MRI physics principles to guide system architecture
  • Development of MRI-compatible components and assemblies
  • Rapid prototyping and testing to validate system performance
  • Engineering solutions addressing constrained spatial and material limitations
A photograph of a functional prototype of AiM Medical Robotics' MRI-compatible neurosurgical robot with a black mannequin head shown for scale.
A patient with eyes closed in AiM Medical Robotics' MRI-compatible neurosurgical robot and MRI machine.

Outcome

The collaboration produced a prototype robotic system with four degrees of freedom, establishing the basis for AiM Medical Robotics’ MRI-compatible neurosurgical platform.

The system demonstrated the feasibility of robotic-assisted neurosurgery within MRI environments and enabled further development of image-guided surgical technologies.

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 MRI physics, multidisciplinary robotic design, and rapid prototyping to develop a four-axis robotic system capable of performing neurosurgical procedures inside a live MRI environment.

Chris and Chris collaborated with many talented colleagues across Triple Ring and AiM Medical Products on this project.

Meet our team
A portrait of Christopher Mitchell, a smiling man with gray hair wearing a patterned shirt.

Chris Mitchell, PhD

Bio and Electrical Engineering & Program Management

Dr. Chris Mitchell brings deep experience leading multidisciplinary teams developing complex imaging and medical device systems. His work focuses on guiding technical programs from concept through implementation, helping translate advanced technologies into reliable, real-world solutions.

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 person holding a Hound Labs device displaying a "pass" result for a cannabis breathalyzer test.
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.
Key Innovation Microfluidic lab-on-a-chip technology brought clinical-grade THC detection out of the lab.

Cannabis Breathalyzer System

Client

Hound Labs

Practice Areas

TechBio & Life Sciences

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.

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.

A conceptual rendering of the at-home diagnostic device next to a bathroom sink.
Key Innovation Quantitative optics in a lateral flow assay brought multiplexed diagnostics into the home.

At-Home Quantitative Diagnostics

Client

BARDA

Practice Areas

TechBio & Life Sciences

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.

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 person holding a transdermal patch applicator
Key Innovation Precision pressure engineering across skin types put daily self-dosing in patients' hands.

Microneedle Patch Applicator

Client

Confidential

Practice Areas

Combination Products TechBio & Life Sciences

Core Disciplines

Overview

The client selected Triple Ring to design a reusable applicator supporting the delivery of a novel micro-needle patch for transdermal drug administration. The system was intended for patient-administered use in home settings and required consistent mechanical performance to ensure reliable drug delivery.

The resulting combination product integrated a reusable applicator with a micro-needle patch system designed to enable uniform pressure application, supporting consistent adhesion and controlled dosing across diverse patient populations.

Challenge

The client developed a microneedle-based transdermal patch that required significantly greater uniformity of application pressure compared to traditional adhesive patches. Achieving reliable drug delivery required development of a reusable applicator capable of delivering consistent mechanical force during use.

The applicator needed to function effectively across a wide range of skin types, including variations in thickness, age, moisture content, and anatomical placement. In addition to performance requirements, the design needed to meet durability expectations for repeated home use while maintaining low production cost.

3D view of an innovative commination medical device microneedle patch applicator for transdermal drug delivery. White and orange ergonomic handheld device with attachment
Diagram of a transdermal patch delivering medication through the skin with drug-coated tips penetrating the epidermis.

Solution

Triple Ring applied interdisciplinary expertise across materials science, mechanical engineering, and life sciences to design an applicator capable of delivering controlled pressure during patch placement. The development effort focused on optimizing performance across diverse user conditions while maintaining manufacturability and reliability.

Key development efforts included:

  • Designing precision mechanical systems capable of delivering uniform pressure during patch application
  • Selecting materials optimized for durability, manufacturability, and patient-safe use
  • Engineering applicator geometry to accommodate variation in skin thickness, moisture, and elasticity
  • Validating device performance across simulated patient-use conditions
A four-panel illustration showing the steps for using a handheld transdermal patch applicator: from resting position, opening, applying on skin, to pressing the dispenser button.

Outcome

Triple Ring delivered a reusable applicator integrated with a micro-needle array patch, forming a single-entity combination product designed for intracutaneous drug delivery. The system enabled rapid drug absorption while supporting consistent dosing performance.

The completed applicator enabled the client to advance into clinical trials and demonstrate the effectiveness of the technology to healthcare stakeholders. The underlying technology was ultimately acquired by a vaccine manufacturer, supporting continued development and commercialization.

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 mechanical engineering, materials science, and life sciences expertise to design a reusable applicator capable of delivering consistent, uniform pressure across diverse patient skin types — enabling reliable transdermal drug delivery in home settings.

Walt and Gabe collaborated with many talented colleagues across Triple Ring 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 Gabe Chow, a smiling man wearing glasses and a blue jacket with a blurred background.

Gabriel Chow, PhD

Materials Characterization & Development

Dr. Gabe Chow specializes in materials characterization and mechanical system development across macro to nanoscale environments. His work supports the design, testing, and reliability of advanced materials and mechanical systems, helping translate innovative concepts into durable, real-world solutions.

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 Reverse engineering lost design history made a Special 510(k) viable.

IVD Platform Refresh

Client

Fortune 500 IVD Company

Practice Areas

TechBio & Life Sciences

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.

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.