ISO 13485 · 25+ years engineering medical, consumer & IoT devices

Innovative product design for a connected world.

We design and develop medical, consumer, and industrial devices engineered to stand up to clinical, regulatory, and strategic scrutiny.

$300M+
In client acquisition value
25+
Years of innovation
100+
Devices developed
Built for outcomes

Technology platforms engineered to perform under scrutiny.

From RF energy systems to vascular and surgical platforms, we develop devices that stand up to clinical trials, regulatory review, and the demands of real-world use.

RF Energy Platforms

Precision RF generator systems

Programmable RF energy platforms, from waveform control and power electronics to disposable interfaces and clinician UX.

Vascular & Interventional

Minimally invasive device platforms

Mechanisms and delivery systems for vascular access and closure, balancing tactile feel, reliability, and high-volume manufacturability.

Neurovascular

Neurosurgical Resection Console

Surgical console for brain tumor removal and clot evacuation with toggleable white and blue excitation light for glioma visualization. Hand-held directional light with non-ablative, non-thermal resection.

Proven across Fortune 500 medtech programs and emerging innovators.
Industries

Where we ship.

Medical Devices
Medical Devices

Class I, II & III Development

FDA-ready medical devices engineered under ISO 13485.

Consumer
Consumer

Consumer Products

Beautifully engineered, mass-manufacturable consumer hardware.

IoT
Connected World

IoT Development

Secure connected devices, including Microsoft Azure Sphere.

Industrial
Industrial

Industrial Products

Rugged, reliable systems for industrial environments.

Process

From sketch to scale.

Start a project
01

Discover

Requirements, user research, regulatory landscape.

02

Design

Architecture, industrial design, human factors.

03

Develop

EE, ME, firmware, software, prototyping.

04

Verify

V&V testing, design history file, FDA/MDR readiness.

05

Transfer

DFM, supplier qualification, manufacturing handoff.

Our Work

Two decades of innovation.

  • RF Energy

    Programmable RF Generator Platform

    End-to-end design of a precision RF energy system — power electronics, waveform control, and disposable interface electronics for interventional procedures.

  • Neurovascular

    Neurosurgical Resection Console

    Embedded control, motor drive, and sterile-field user interface for a Class II surgical platform deployed across major hospital systems.

  • Cardiac Monitoring

    Wearable ECG Patch

    Ultra-low-power analog front-end, BLE telemetry, and firmware enabling multi-day ambulatory cardiac monitoring on a single-use form factor.

  • Defibrillation

    Compact Public-Access AED

    High-voltage capacitor charging, ECG rhythm analysis, and voice-guided UX engineered into the smallest fully-featured AED in its class.

  • Infusion & Fluidics

    Precision Infusion Pump Electronics

    Closed-loop motor control, occlusion sensing, and safety-critical firmware compliant with IEC 60601 and IEC 62304 software lifecycle.

  • Targeted Temperature

    Esophageal Thermal Regulation

    Sensor fusion, fluid temperature control, and embedded software for a hospital-grade patient temperature management system.

  • Pathogen Inactivation

    UV Blood-Product Illuminator

    Optical dose control, RFID tray tracking, and closed-loop verification for an FDA-cleared blood pathogen reduction instrument.

  • Connected Sensing

    Sub-GHz Environmental Mesh

    Custom sub-GHz radio stack, low-power MCU firmware, and cloud telemetry — delivered with a 30% bill-of-materials reduction.

  • Connected Consumer

    Smart Sports Sensor Platform

    9-axis IMU fusion, BLE pairing, and embedded analytics translating raw motion into real-time performance metrics on mobile.

Project details generalized.
Fresh from the bench

Engineering insights, straight to your inbox.

One short brief a month: breakthrough devices, regulatory wins, and lessons from the bench.

Read by engineering leaders across med tech firms Monthly · 3-min read
Request a Quote

Tell us about your device.We'll respond in 24 hours.

From early concept to acquisition-ready product — share your goals and we'll map a path.

  • ISO 13485 quality system maintained through a notified body, active certificate 
  • Concept, Requirements, Industrial Design through partners, requirements and system engineering, mechanical engineering, Electrical, mechanical, firmware & software, testing, integration verification, agency testing management and regulatory filing support under one roof
  • Track record of device development, concept through launch, through acquisition

Replies within 24 hours · NDA on request