We Create Medical Devices

About Medical Devices

We Create Medical Devices

Let's Talk Medical Devices

Great teamwork starts with a conversation!

Medical Device Product Development

Engenious Design specializes in medical device product development and design. We are innovative and passionate about designing and creating new products, as well as improving existing ones. We are here to help medical device companies create new products and apply the latest technology in medical diagnostic and therapeutic devices. Our clinical insights program provides us with a better understanding of what is needed by clinicians and emerging needs that are coming next. Helpful feedback from professionals gives us the opportunity to design and develop the next innovations in medical devices and equipment.

Avoiding common mistakes in medical device product development is essential to lowering risk in medical device research and development. We work with clients like you to develop new medical devices, giving you a strategic advantage with clinician-focused data to enhance the design of new medical devices or improve existing products.

We strive to bring our clients nothing but excellence in the medical device product development field. Engenious Design was built to collaborate with you as part of your team to deliver the next big breakthroughs in medical devices.

Rapid Process in 8 steps

Our specialties include Electrical, Mechanical, and Embedded Software Systems, FDA Class I, II, III, and PMA Devices, and Internationally Distributed Devices.

Plan

PLAN

Specify

SPECIFY

Architect

ARCHITECT

Design

DESIGN

Prototype

PROTOTYPE

Verify

VERIFY

Validate

VALIDATE

Transfer to Production

TRANSFER TO PRODUCTION

Our Experience Produces Results

At last count, our portfolio included over 35 commercially-released products. Because of our team’s work, there are hundreds of thousands of medical devices operating reliably in the field, improving lives worldwide. The life-saving nature of our work drives us to move with a sense of importance, urgency and satisfaction.

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Life Support Ventilation

Engenious breathed fresh design into a life-support critical-care ventilator, bringing holistic solutions including human factors, labeling, mechanical, electrical, and embedded software to bear.

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Mechanisms

Engenious spun up a compact, battery-powered handheld device with mechanisms that apply topical nanoparticles in-clinic for a medical startup partner.

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Electrosurgical Systems

Engenious blended into a client’s RF electrosurgery team to create real-time feedback control and measurement system for a 300W surgical system. Find out more >

Take It From Our Clients:

We are built to be rapid and integrated!

We have a Micro-Electronics Lab, a Model & Machine Shop, a CNC Milling Machine, and SLA and FDM 3D printers to build, test, and iterate quickly

Our Team is Our Secret Weapon

We have it covered and we’re serious about getting our important work done quickly, and with excellence

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Electrical Engineering

Sensors, analog signal conditioning, power supplies, amplifiers, motor control, FPGA, wireless, high-reliability electronics

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Mechanical Engineering

Mechanisms, enclosures, thermal design, fluid handling, gas control, GD&T, optics, high-reliability mechanical design

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Embedded Software

Real time microcontrollers, PID control systems, network, device drivers, filters, audio/video, wireless, high-reliability software

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Systems Engineering

Requirements, architecture, risk management, and expert technical coordination of highly-integrated engineering teams

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Industrial Design

Interactive products, handles, grips, controls, indicators, models, and user-centered holistic design that works from the inside-out and outside-in

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Interaction Design

Graphical user interfaces, multi-language, iconography, information hierarchy, UI navigation, wireframing, concept development

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Project Management

Experienced planning and coordination, collaborative progress management, risk management, budget controls

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Graphic Design

Labeling, packaging, instructions for use, clinical education and support materials, identity and exhibit graphics applications

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Boutique Manufacturing

Work instructions, process validation, rapid, short run, production-equivalent, device history records, controlled environment

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Regulatory Compliance

Device classification, regulatory planning, quality system compliance, notified body evaluation

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Human Factors

Planning, formative and summative studies, design for usability with a focus on user needs, intended uses, and use cases

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Test Engineering

Test planning, test procedures, execution, records for complex electro-mechanical devices

Team Portfolio

 Our team’s recent projects include an impressive list, if we do say so ourselves.

  • Life Support Ventilator
  • Video Quadcopter
  • Heart Pump Accessories
  • Wearable Electronics
  • Pulse Oximetry
  • Urology
  • Glucose Meter
  • RF Electrosurgery Unit
  • High-End Consumer Goods
  • IV Therapy
  • Surgical Lighting
  • Drug Delivery
  • Surgical Tools
  • Robotics
  • Vascular Compression Devices
  • Wireless HD Video Streaming
  • Blood Diagnostics
  • Neurological Assessment

OUR CREDENTIALS

Speak For Themselves

  • A culture that is built on the letter and intent of standards
  • Proven Quality Management System
  • ISO:13485 and 21 CFR 820 compliant
  • Rapid production-equivalent devices in house

Let's Talk Medical Devices

Great teamwork starts with a conversation!