Challenge

For the past 10 years, Triple Ring has assisted pioneering Continuous Glucose Monitor (CGM) manufacturer, Dexcom, in responding to customer demands and mounting competition.  Dexcom has engaged Triple Ring at critical points in the company’s history as market forces required rapid evolution of product designs to address usability, reliability, and manufacturability. Triple Ring contributed critical analytical expertise and design inputs while simultaneously enabling new features and increasing manufacturing yields at high volume. Over time, Dexcom and Triple Ring collaborated seamlessly and efficiently to shorten time to market for 2 generations of CGM devices.

Outcomes

Dexcom, together with Triple Ring, developed and optimized a fully automated one-touch deployment mechanism for their award-winning G6 platform. Five years later, the G7 successor was released with a completely new applicator that combined deployment of the wearable and sensor into a single step. Triple Ring executed a mutually supportive analytical and empirical strategy to investigate design issues, resolving both undesirable behavior and generating real-life data for improving model accuracy. This approach maximized learning at each design cycle, ensured a robust and reliable product, and expedited time to market.

Value Propositions

• Deep experience in user-centered design and design for manufacture (DfM)
• Deep expertise in system-level analysis, mechanism analysis and finite element simulation
• Proven success in test development and fixture design for capturing complex phenomena
• Rapid execution of benchtop and preclinical testing
• Proven processes and approaches that significantly reduce time to market

Challenge

HeartBeam sought to develop a personal, cable-free, and easy-to-use cardiac monitoring solution for in-clinic and at-home use by patients, enabling physicians to assess where vague cardiac symptoms warrant additional diagnostic testing or treatment. Our objective was to create a credit card-sized, ECG recording device that leverages vectorcardiography (VECG) and is integrated with cloud-based software to deliver critical data to physicians in real-time.

Outcomes

The HeartBeam-Triple Ring collaboration produced a personal, cable-free synthesized 12L ECG solution that empowers patients to record synthesized 12L ECG data at home. The device was integrated with a smartphone application to communicate with the HeartBeam Cloud where synthesized 12-lead ECGs are overlaid with baseline data. Physicians are now able to remotely view results and direct next steps for patients in the comfort of their own home. This multidisciplinary and fast-paced program resulted in a 510(k) submission to FDA, and clearance in 2024 for the hardware that leverages vectorcardiography and collects 3D ECG, while the synthesized 12L ECG algorithm is pending FDA clearance.

Value Propositions

• Comprehensive product development, including early R&D, industrial design, product development, manufacturing, and regulatory approval
• Relevant and specific expertise in wearable medical device design
• Regulatory and manufacturing support, including preparation for a 510(k) submission and design transfer
• Variable resources applied just-in-time

Challenge

ViOptix engaged with Triple Ring Technologies in a co-development partnership to design and develop their Intra.Ox non-invasive, quantitative, handheld tissue oxygenation monitor. Design requirements included real-time tissue monitoring inside the surgical theater with high sensitivity and reliability. Technical challenges faced in the Intra.Ox product development program included:

• Design of an easy-to-use multi-wavelength tissue oximeter
• Smart algorithms to automatically compensate for variable tissue morphologies
• Handheld form factor
• Reusable packaging
• Unlimited readings within a surgery case

Outcomes

The ViOptix Intra.Ox technology received FDA clearance after the company and Triple Ring demonstrated its capability to produce accurate, instantaneous estimation of percent saturated oxygen (St02) without the need for capital equipment or dye injection. The Intra.Ox device is now used at various stages of tissue transfer surgery to positively affect clinical and financial outcomes.

Value Propositions

• Deep, relevant clinical and technical domain knowledge
• Concept to clinical validation and FDA 510k clearance in 18 months
• Complex modeling, including Monte Carlo simulations to accelerate design process
• Urgency to drive value and support fundraising
• Capital efficient, variable resource R&D expertise tailored to the needs of a virtual startup

Challenge

AiM Medical Robotics required a portable robotic system to perform neurosurgery simultaneous with magnetic resonance imaging (MRI). MRI relies on incredibly strong magnetic fields to produce detailed images of the inside of the human body. These strong magnetic fields prohibit the use of ferromagnetic materials that are found in typical robotic hardware. Furthermore, MRI systems feature a small bore around the patient table which severely restricts the form factor of potential robots. Triple Ring overcame these hurdles by employing first-principles thinking and creative engineering.

Outcomes

The partnership led to an innovative prototype design with 4 degrees of freedom that served as the basis of AiM Medical Robotics’ industry-first robotics platform.

Triple Ring Value Proposition

• Experience in designing multi-axis robots for multiple applications
• Deep expertise in the physics of MRI
• Demonstrated capabilities in designing MRI-compatible systems and components
• Rapid design, prototyping, and production to meet tight timelines and funding milestones

Challenge

Leo Cancer Care partnered with Triple Ring to design a computed tomography (CT) imaging system for a novel radiation therapy concept that drives better patient outcomes and improved patient experience. Leo Cancer Care is a bold innovator in radiation therapy, developing breakthrough products that treat patients in a more natural, seated position. The system images and positions patients for radiotherapy in one device with the patient upright, improving accuracy while increasing comfort and lowering stress – all contributing factors to better outcomes. Triple Ring collaborated with Leo Cancer Care to design a gantry and CT scanner which scans patients in upright and lying down positions. This concept is central to the platform, making large rotating gantries for the radiotherapy source obsolete, and enabling a fixed beam, slow patient rotation strategy.  Leo Cancer Care and Triple Ring together overcame multiple design and technical challenges to transform this novel concept into a safe, accurate, and patient-centric platform.

Outcomes

The Leo Cancer Care and Triple Ring collaboration led to the creation of an innovative gantry design that featured upright radiation therapy as a new standard of care.

Triple Ring Value Proposition

• Experience designing large multi-axis robotics
• Deep expertise in the physics of radiotherapy delivery devices
• Mechanical design of robust and reliable capital equipment to ISO13485 standards
• Advanced simulation and modeling to streamline system design, development, and test
• Shared sense of urgency to meet aggressive schedules and assure funding milestones

Challenge

Prisma Imaging partnered with Triple Ring Technologies to design, model, build, and test a functional prototype equine CT scanner for imaging on live animals in a veterinary clinic setting. Prisma Imaging invented a next generation large animal CT imaging system capable of generating high quality images in a vastly safer workflow for equine patients. This complex prototype system included a robotic gantry, motion capture and correction, X-ray imaging, radiation safety, and CT reconstruction engine. Such an extensive system required Triple Ring to leverage its cross-disciplinary expertise and implement a top-down systems engineering approach.

Outcomes

Triple Ring delivered a gantry-mounted CT imaging system, which enabled live-animal imaging at our headquarters in California on horses that were consciously sedated, not anesthetized. With its integrated cutting-edge motion tracking subsystem and correction algorithms, the system performed equivalently to current standard tabletop technology, even in the presence of natural patient movement. The X-ray system was supported by a robust mechanical subsystem and the combined motion/imaging system was carefully controlled by custom software/hardware.

Triple Ring Value Proposition

• Fully outsourced engineering services, from conception to assembly
• World class image reconstruction architecture and algorithm development capabilities
• Hands-on experience assembling complex hardware
• Deep expertise making complicated systems work, with deliberate and careful subsystem and integration testing
• Flexible and customizable lab space to support exotic applications, such as live-animal imaging

Challenges

Triple Ring Technologies was tasked with designing, integrating, testing, and delivering an innovative high-speed laser-based intra-operative biochemical imaging platform. The system leveraged picosecond pulsing laser technology for intra-operative tissue analysis. A user-centric design and workflow facilitated by machine learning successfully enabled real-time clinical decision making in the surgery suite.

Outcomes

Through Triple Ring’s proven product design and development process, Blacklight Surgical’s breakthrough imaging platform was built and delivered to support critical clinical studies. The system was designed to ISO13485 standards and fully documented within a Quality Management System (QMS) established by Triple Ring and transferred to Black Light Surgical.

Triple Ring Value Proposition

• Multidisciplinary science and engineering teams capable of design and development, integration, verification, test, and system build
  • Included Engineering (Mechanical, Electrical, Software, Systems, BioMedical,and Test), Optical Science, Machine Learning, Industrial Design, Quality Management, and system assembly.
• Efficient design process featuring extensive modeling and complex simulations to derive requirements and guide prototyping.

Challenge

MediBeacon required expert assistance to develop a photonics-based transdermal detection technology to monitor intravenously injected fluorescent tracer agents and provide clinically actionable measures of kidney function. MediBeacon has brought combination products into the clinic which match fluorescent tracers with innovative detection systems to provide accurate physiological measurements in real-time. Triple Ring, in collaboration with MediBeacon, designed and delivered a non-invasive, light-based wearable detection system as a critical component of their glomerular filtration rate (GFR) monitoring product. The detectors were designed and developed to meet strict product requirements of sensitivity, accuracy, cost, comfort, and ease of use.

Outcomes

Fully integrated wearable GFR detectors were developed under ISO13485 design controls and delivered for critical clinical trials.

Triple Ring Value Proposition

• Highly relevant expertise in light-based tissue analysis
• Advanced modeling and simulations to speed design process
• Program structure that included skin in the game
• Deep experience in meeting critical milestones for venture funding

Challenge

To accurately measure biometric data and improve outcomes in the veterinary setting, Triple Ring Technologies developed a noninvasive, remote digital monitoring device for One Health Group. Triple Ring’s experts designed a wearable physiological monitor that improved patient comfort, achieved long-term continuous monitoring, provided real-time feedback and alerts, and was cost-effective and easy to use.

Outcomes

The robust functional prototypes generated high quality physiologic data that supported One Health Group’s value proposition and enabled expanded partnerships with strategic investors in the veterinary health industry.

Value Propositions

• Client outsourced R&D to Triple Ring which provided expertise tailored for a virtual startup company
• Deep and relevant clinical and technical domain knowledge
• Concept to clinical validation services
• Urgency to drive value and support fund raising

Challenge

Triple Ring Technologies designed and developed a novel intra-operative radiation therapy device for Empyrean Medical Systems and facilitated submission of a complete design package to FDA for 510(k) clearance.  The compact, mobile, robotically guided, low-energy, intra-operative radiation therapy device was designed with the patient in mind and with a tight focus on usability.

Outcomes

A full system was designed, integrated, verified, clinically validated, and submitted to FDA for marketing clearance.  Post 510(k), the device design was transferred to manufacture and launched into the market.

Triple Ring Value Proposition

• Innovative custom x-ray source design for true 3D beam directionality
• Valuable intellectual property created
• Advanced modeling and Monte Carlo simulation to speed design process
• System integration and transfer to manufacture services
• Strong track record of FDA clearance for device designs