Cardiac Analysis Platform

Full Class II medical system software development: Embedded, Mobile, Cloud, Documentation

The client obtained ~$11M in VC and Series A funding for product development of a machine learning based system. They possessed in-house algorithmic capabilities but lacked other specialized software resources. We provided a turnkey solution, including digital hardware development, and all required software. The software solution included embedded code for all system microcontrollers, mobile (iOS) software for iPad devices which served as the GUI and wireless comms platform, and HIPAA Compliant cloud-based software for data management, security, and automated analysis workflow. We provided all software and documentation for a Class II FDA submission in an aggressive timeframe.

In addition to the full software architecture, design, digital hardware co-development, and verification services, we performed all of the FDA Process/Product Documentation Services for the software and related product portions, including Product Requirements, Software Requirements, Architecture, Verification Test Plans and Results, Risk/Hazard Analysis and Mitigations, FMEA, etc.

Our joint success on this product development enabled the client to raise an additional $90M in Series B and C funding, and led to subsequent FDA 510(k) clearance of the entire system.

• Client: Analytics 4 Life (now CorVista Health)
• Industry: Medical, Cardiology

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Power Data Expressway

Custom Real-time Linux Driver Development with highly demanding hard-real-time (very low latency) response requirements.

The client, a Fortune 100 (and Dow 30) corporation and leading aerospace manufacturer, was developing a critical power sub-system for the Airbus A400M. The client's system required an extremely fast and consistent real-time response from their Linux-based system when communicating with new custom hardware. They contracted with a major global engineering consultancy, but that engineering team failed to obtain the required results.

The client then turned to us, and we provided a successful solution via a custom Linux kernel driver, kernel modifications, custom data management software for Linux, and hardware/software issue analysis and resolution, including debugging of the client's custom hardware.

The A400M went on to find an important place as a new generation of European airlifter technology; as of 2023, a total of 178 A400M aircraft (representing end product revenue of over $25B) have been ordered and 118 built to-date.

• Client: United Technologies (Hamilton Sundstrand)
• Category: Aerospace

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Neuro-modulator Treatment for Acute Heart Failure Syndrome

Complete Embedded Software solution for a multi-controller mixed-signal design with hard real-time requirements.

The client obtained $13M in Series A funding for heart treatment devices.

They then required a full embedded software solution on an extremely aggressive timeframe. The solution included the output of multiple synchronized cardio stimulation waveforms for direct patient application, and therefore required precise timing and synchronicity. The hardware was not yet developed and the client requirements were evolving rapidly. We worked with the client and their hardware consultant to architect the digital hardware appropriately, and refine/develop the necessary requirements documentation. We then designed the protocols and embedded software for all microcontrollers as well as application management software. We finally tested and refined the system, resolving issues in conjunction with the client and hardware resources. The project was completed on schedule for First-in-Man clinical trials.

Our joint success on this product development enabled the client to raise an additional $23.5M in Series B funding.

• Client: NeuroTronik
• Category: Medical, Cardio, Neurostimulation

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VNS Therapy Implant ASIC

High-criticality ASIC embedded software development and verification for a family of implanted medical devices.

Cyberonics, the worldwide leader in Vagus Nerve Therapy implants and largest VNS treatment company in the world, was nearing the completion phase, or 'final tape-out,' for their platform-specific Application Specific Integrated Circuit (ASIC) for the treatment of drug-resistant epilepsy and depression. They retained significant in-house embedded software resources, but none were sufficiently knowledgeable in hardware and high-criticality software design to be entrusted with a mask ROM software design.

Cyberonics approached me to architect, design, implement, and verify the software for them, and I delivered this product successfully and on-time so that they could incorporate the software into their ASIC release. This software environment was unique in that it could not be tested on actual hardware prior to release, no verification platform existed, and once released, any software issues would cause an ASIC respin with costs in the millions of dollars and months of schedule time. Furthermore this mixed-signal ASIC was developed for use on multiple next-generation class III medically implanted neruostimulator devices.

Cyberonics went on to target this ASIC for a new generation of core products, and for the fiscal year following this project and ASIC release, reported year-on-year revenue growth of 10.9%, equaling a growth of $27.7 million in revenue. Furthermore, Cyberonics successfully achieved a merger later in the following year with Sorin Group to form LivaNova PLC.

• Client: Cyberonics (now LivaNova)
• Category: Healthcare, Class III Medical Implant, Neurostimulator

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Mammotome Surgical System

High-criticality Hardware and Progammable Logic Design and Verification for a class III Surgical Device

The client, a Fortune 100 corporation and global leader in MedTech, possessed significant surgical mechanical skills but at the time had never developed a device incorporating electronics (nor embedded software). As part of a greater engineering team, we developed the programmable logic and a significant portion of the board-level digital hardware for this novel surgical system. We also developed the FDA-required documentation for these subsystems. In addition we worked closely with external software resources to perform system bring-up, debugging, issue resolution, and software/hardware verification.

The Mammotome system went on to be used in 300,000 biopsy surgeries in the first year of production, and as of 2020 had been used in over 10,000,000 surgeries worldwide.

• Client: Ethicon Endo-Surgery (a Johnson & Johnson Company)
• Category: Medical, Surgical Systems

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Single-Entry Robotic Assisted Surgery System

Provided FDA Process and Documentation Consulting Services for a Class III Robotic Medical System

The client was developing an extremely sophisticated and complex full robotic system for performing surgery. They had previously run into significant issues with a 3rd party development house. They contracted with a new company, a major contract development house with which we had a significant working relationship. We performed extensive FDA process documentation services involving System Requirements, User Needs, Business Goals, Software Requirements, System Architecture, Verification Test Plans, Failure Mode Effects Analyses (FMEA), Documentation Review, Issue Determination, Documentation, Tracking, and Resolution, and Requirements Traceability.

The client went on to turn their first revenue of $20M in the first fiscal year following project completion, with their first positive operating income of $4.1M in the same year.

• Client: Titan Medical
• Category: Medical, Surgical Systems

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Multimodal Target Tracking

Led a multi-site team of software, hardware, and mechanical engineers to deliver on an aggressive schedule.

The client, the largest manufacturer in Britain and the largest defense contractor in Europe, required an integrated system with software, hardware, and mechanical architecture and design requirements to be completed on a very aggressive timeframe. In coordination with client project management, we developed the core requirements, architecture, and software, and managed external resources to bring together a successful product on-schedule, exceeding all client expectations.

This product significantly improved targeting accuracy, leading to a reduction in collateral damage and contributing to the essential goal of saving lives.

• Client: BAE Systems (formerly British Aerospace)
• Category: Defense

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Patient Temp Control Device

Complete requirements, architecture, hardware, and software for a multi-module wireless patient therapy system.

The client had contracted with a provider of personal-level refrigeration and heating systems but the contractor lacked embedded software, electronic hardware, and wireless design capabilities. We designed and managed the manufacture of both wireless miniaturized patient-attached sensor devices, and control base stations, using Bluetooth Low Energy for our protocol design. We completed the product development on-schedule, from initial requirements development through prototype manufacturing and integration/verification.

This product boosted life-saving efficacy in high-risk environments, making it possible for soldiers and others to survive at a higher rate.

• Client: United States Air Force
• Category: Medical

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Machine Learning Seizure Prediction and Detection

Embedded Software and Application Software Development

We provided the extensive embedded software and application software development as well as FDA documentation development and review services required by the client in order to complete their product development cycle, meet their schedule, and prepare FDA submissions.

For the fiscal year following this project, Cyberonics went on to report year-on-year revenue growth of 10.9%, equaling a growth of $27.7 million in revenue. Furthermore, Cyberonics successfully achieved a merger later in the following year with Sorin Group to form LivaNova PLC.

• Client: Cyberonics (now LivaNova)
• Category: Medical/Healthcare

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Low Voltage Verve PWM Lighting

Full turnkey Product Development (Requirements, Architecture, Hardware, Software, Mechanicals, Manufacturing)

The client, a Fortune 500 global manufacturer of home improvement products, including Delta Faucets and Behr Paints, acquired an energy efficient lighting subsidiary but required engineering services to create a smart home/lighting control system hub.

Required product features included wireless and embedded Linux-based GUI control of multiple lighting, monitoring, and control channels via a set of customized peripherals.

We led the entire product development, including full project management, from the requirements phase through prototype manufacturing, verification, and integration. Our management solution included interfacing with domestic and offshore client sites to capture product requirements, coordinate GUI Design, and coordinate engineering support.

We developed a multi-board hardware solution, with our team providing the hardware architecture, detailed design, PCB layout, fabrication, and assembly. We also designed the embedded software and programmable logic for all embedded and stand-alone microcontrollers and programmable logic devices, as well as BSP/application/graphical user interface and control software on an embedded linux processor. Once our design was mature, we built prototypes and provided hardware integration, as well as hardware-software integration and verification. Finally we assembled and led a team of mechanical engineers to integrate the system into a series of mechanical prototypes.

We successfully demonstrated the completed product on-schedule for executive management and at a technology trade show, raising the profile of the new division.

• Client: Masco
• Category: Lighting, Home Automation

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Real-time Trans-venous Ablation Lesion Imaging

Full embedded software, application software, GUI, and programmable logic delivery for a class III surgical system

The client, a novel surgical startup spun off from a major medical holding corporation, obtained over $1M in venture funding to begin development of an intravenous catheter for use in cardiac ablation surgery.

The client possessed mechanical and analog hardware resources but required outside help for software and digital hardware. We developed the embedded software, programmable logic, real-time data analysis/manipulation/visualization, system control, and video/metadata logging software, as well as additional software tools, and supported the surgical staff during numerous procedures utilizing the hardware and software prototypes.

Our successful product development engagement enabled the client to successfully complete First-in-Man clinical trials, and to subsequently obtain additional funding in excess of $3M, enabling them to continue marketing. We supported the client in-person as they pitched the device to multiple major medical manufacturers.

• Client: LuxCath
• Category: Medical, Surgical Visualization and Guidance

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Industrial Handheld Cable/Label Printer

Full embedded software development and team management.

The client, an international leader in cabling and physical infrastructure with annual sales in excess of $1B, was developing their next-generation cabling/label printer. They began development in-house but quickly ran into significant technical roadblocks which imperiled their development timeline. They then reached out for 3rd party help. We rapidly analyzed and resolved their initial major firmware issues, resulting in significant project progress within only the first week of engagement.

We proceeded to customize our product development processes to their specific rapid-schedule needs. We led a team of seven software engineers to take over and complete the entire device's embedded software within the client's tight timeframe.

The product was released to market successfully, and Panduit went on to surpass $1.6B in annual revenue by 2022.

• Client: Panduit
• Category: Industrial, Handhelds

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Intra-venously Implanted Cardiac Analysis Platform

Full turnkey development of micro-scale intravenously implanted electronics and software.

The client, a startup with IP consisting of a novel intravenously implanted cardioverter/defibrillator, raised $50M in venture funding from Medtronic and Johnson & Johnson. They came to us in need of an extremely miniaturized, very low power cardiac analysis platform for implantation within the inferior vena cava, directly adjacent to the right ventricle. We worked with analog and mechanical engineering staff to jointly develop requirements, created a workable mechanical, hardware, and software architecture, and developed the analog and digital hardware design and microscale PCB layout. We then developed the embedded and external interface software, performed verification and integration, and delivered the finished product on-time.

The client went on to perform a variety of successful clinical trials.

• Client: Innerpulse
• Category: Medical, Implants, Cardiovascular Electrostimulation

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Custom Self-Building Mesh Network

Custom wireless network design and architecture

The client, a Swiss multinational corporation ranking on the Fortune Global 500, was developing a new wireless power meter design. The product concept called for a self-assembling mesh network of intelligent power meters. However, this product was being developed in 2001, prior to the existence of standardized mesh networking protocols.

We teamed up with the client and additional 3rd party resources to design a sophisticated wireless mesh networking system, which could assemble itself into a self-structuring and self-healing system of nodes and repeaters. The resultant system design allowed the meters to gather data from all nodes within wireless range (and beyond wireless range when additional nodes could self-determine that they could link themselves together as repeaters) to reach all nodes, allowing the power utility installer to place nodes and then allow our network design to figure out how to wirelessly network on the fly.

Over the next complete fiscal year following project end, the client's relevant core division, Power Technologies, reported year-on-year EBIT increase of 9% despite a significant economic downturn.

• Client: ABB Ltd.
• Category: Smart Power Meters, Utility, Wireless Mesh Networking

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Automotive Rear Obstacle Detection Radar

Requirements, Architecture, Analog Hardware, Wireless/RF Design, Design for EMC (Electromagnetic Compliance)

The client, a long time manufacturer and developer of automotive technology, contracted to develop a next-generation automotive obstacle detection microwave radar which could overcome the detection shortcomings of previous generations. We worked with a group of analog and mechanical engineers to successfully architect and design the required system.

• Client: Rostra Precision Controls
• Category: Automotive, Obstacle Detection

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Drug Delivery Inhaler Subsystem

Precision motor control hardware and software design

The client, a specialty pharmaceutical and medical device company with $26.5M in Series A funding, had need of a precision motor control system involving finely-tuned control of DC motors at high velocities and high motion profile frequencies. We designed and implemented the full system for them, including control software, hardware, algorithms, system interconnect, and Electromagnetic Compliance architecture.

The client subsequently experienced a successful exit when they were acquired by Novartis (Sandoz), a Fortune Global 500 pharmaceutical company.

• Client: Oriel Therapeutics
• Category: Medical Devices, Inhaler Therapy

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Mobile Industrial Leak Detection

Complete Embedded Software System

The client, a global provider of turnkey injection and leak location products and services for the Utility infrastructure industry, had need of a mobile hydraulics system but lacked embedded software expertise. We designed and implemented the complete embedded software system for a mobile hydraulics system, using an ultra-low-power microcontroller.

This design subsequently enabled the client to greatly simplify their system architecture, resulting in the savings of thousands of dollars per unit.

• Client: PFT Technology LLC
• Category: Industrial, Utility Infrastructure

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Hard real-time data comms subsystem

Custom Nvidia Linux Device Drivers and Applications

The client, a significant early-stage life science firm with $35M in Series C funding, had significant software resources but required specialized custom linux device driver modifications and C-based linux application development to meet their aggressive real-time data timing requirements on a manufacturing-style line. We assessed and debugged driver and other hardware and software issues related to 3rd party peripherals, developed and tested the necessary software, and met all timing requirements to assist them in their push to market.

In a challenging technical scenario where multiple 3rd party design resources had failed to provide the required results, we successfully resolved design issues and met all of the client's timing requirements.

• Client: Targan
• Category: Manufacturing, Industrial, Veterinary

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