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.
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:
The Engenious team’s partnership has been instrumental to the progress we have made thus far. We value their knowledge, creativity, flexibility, preparation, and willingness to think outside the box to get things done. Their insight and experience has been vital to moving the program forward.
Scott Summersgill,
Director of Manufacturing, Sienna Biopharmaceuticals, Inc., Westlake Village, CAEngenious moved our product development forward with their ability to quickly design experiments and build and test precision mechanical medical devices.
Cary Dikeman,
CEO, Nexus Medical, Lenexa, KSI have worked with people on the Engenious team a number of times over the past 15 years on both class II monitoring and class III cardiac devices. I have been consistently impressed by their med device knowledge, the timeliness and quality of their deliverables, and the breadth and depth of their experience.
Pete Andriola,
Director of Electrical Engineering, St. Jude/Thoratec, Pleasanton, CAWe 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
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
Great teamwork starts with a conversation!