Project Portfolio

Ambulatory Drug Infusion Pump

Component Obsolescence and PCBA Redesign

PWM redesigned a client’s rigid-flex PCBA assembly for a battery-powered drug infusion pump when the two existing microprocessors reached end-of-life status. Design aspects included USB, parallel and QSPI memory interfaces, parallel RGB LCD interface, and analog sensors. A custom development board to aid early software efforts, as well as a firmware flashing interface board were also designed as part of this project.

Disciplines: EE, SysE/PM

ENT Surgical Navigation System

Feasibility and wireless POC system creation

PWM performed a feasibility study to evaluate the suitability and effectiveness of various wireless technologies to be used in a wireless ENT tool navigation system. PWM had to reverse engineer certain aspects of the existing EM field generator and built a proof-of-concept prototype system to locate tools in an EM field. The prototype utilized BLE development hardware and custom firmware.

Disciplines: Wireless, EE, SW/FW, SysE/PM

Handheld Neuro Stimulation and Test Device

Prototype electrical hardware and firmware development

PWM designed the electrical hardware and device firmware and collaborated with outside industrial design and mechanical engineering partners. The hardware design included a rechargeable lithium-ion battery, OLED display, USB, hardware-based safety lockouts, temperature sensing, and a Peltier drive circuit for controlling temperature. Device firmware development included a closed loop temperature control algorithm, OLED screen development, navigation/menu systems, as well as a serial command-line interface for script-based automatic testing.

Disciplines: Wireless, EE, SW/FW, SysE/PM

Vapor-based Cancer Ablation System

Software verification protocol creation, testing, and QA

Requirements analysis and protocol authoring for five discrete software items and software integration testing, bench testing and software bug tracking, dry-run and formal test execution and formal report generation, traceability matrix creation, software DFMEA analysis, 62304 documentation creation. Multiple FDA regulatory submissions resulted in zero questions relating to software verification. Overall coordination and project management of multiple full and regression verification iterations.

Disciplines: Verification/QA, SysE/PM

Tremor Assessment Smartphone App

Cross-platform app creation integrated with backend data storage

Creation of Android and iOS versions of a smartphone app for initial screening of patients for Parkinson’s and Essential Tremor. Interface with internal phone sensors and external sensor via Bluetooth. Designed and implemented backend database for receiving uploaded session data from smartphones. Released initial versions to Google and Apple app stores.

Disciplines: Wireless, SW/FW, SysE/PM

Intra-Vascular Lithotripsy System

Secure EEPROM programming software and systems engineering

System requirements creation, oversight of electrical and software technical decisions of cross-functional team. Creation of a cryptographic-based EEPROM catheter programmer for production (requirements, software, electronics, documentation).

Disciplines: EE, SW/FW, SysE/PM

Respiratory Motion Management System for Radiology

Systems engineering and compliance testing consulting

Acted as technical liaison between customer and 3rd party electrical safety/EMC test lab, wrote EMC test plan, reviewed and updated system hazard analysis, labeling and user manual, and other technical documentation for FDA submission readiness, cybersecurity consulting.

Disciplines: EE, SysE/PM