Sample Projects
Disc Dynamics, Inc. is a start-up company with private investor funding and a promising implant-based technology for motion-preserving spinal therapy. Devicix designed a computer-controlled system to deliver their implant. We worked closely with DDI's staff and medical advisors to identify the system requirements, understand their business objectives, and develop a project plan to that fit their corporate strategy. Devicix built several prototypes used to obtain CE approval and for clinical and validation testing in support of a 510(k) application to the FDA. The device has been transferred to a manufacturer through documentation, training and procedures prepared by Devicix. We are also designing accessory equipment and providing software updates to DDI. A relationship with Devicix allowed DDI to focus their internal resources on their core technology, while Devicix developed the capital equipment. This client is a physician seeking to improve care of ventilated patients in an intensive care unit. From his original needs description Devicix created early functional prototypes. We participated in "Voice of the Customer" surveys of ICU staff and physicians. From this feedback we are proceding to design and build units for a clinical study. Our client is a private startup that has patented technology for a thermal pain alleviation device. They have a continuing process with Devicix to make improvements to their flagship product such as quieting the pump and making the fluid connections more robust. Our designs are transfered to China for manufacture. During surgery medications and fluids must be injected in large volumes or into temperature-sensitive blood vessels. It’s important that injectates be available at all times and at just the right temperature. Enthermics has asked Devicix to implement design changes to a family of clinical fluid and blanket warmers to improve performance and add features. We have also prepared reports and articles based on instrumented tests and analytic calculations that describe heating efficiency, air circulation and patient impact. This client designs and sells advanced, ambulatory life-support equipment. Their products are popular so the in-house engineering team is designing improvements and new models. Devicix provides additional engineering. Projects so far include the design of wireless communications accessories and manufacturing test stations. This new device was conceived by a physician who needs better gastric access in the emergency room. Devicix was involved from beginning with a verbal description to create prototypes and is continuing to design refinement. Devicix is improving the manufacturing documentation at a rapidly-growing manufacturer of cardiac implants. We have written test protocols and validation procedures. From the accumulated data new operating procedures and qualifications have been written. These documents supported a detailed review by the FDA. A startup acquired IP rights to a disposable medical device with an active mechanism. Devicix completed a first phase of evaluating technical and manufacturing feasibility and is now designing for the clinical evaluation and regulatory submission. An individual inventor approached Devicix with an idea for a customizable media system. We performed proof-of-concept and brainstorming sessions to demonstrate several ways to system could be configured and operated. The information developed was captured directly into US and PCT patent applications written at Devicix. Outside counsel assumed control of the IP for filing and subsequent management.
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• Engineering and regulatory management of CT contrast injector • Measurement of cardiac stroke volume and blood resistivity during high level exercise • Heart rate variability data collection system and analysis software • Airless paint sprayer electrical controls • Ambulatory heart rate / activity monitor and study of free-living energy expenditure • Inhaled nitric oxide gas delivery and calibration systems for BPH in term neonates • Blood-warming cannula for extracorporeal circulation • Application specific servo controls for industrial automation • Miniature blood superoxygenator and back-pressure oxygenator controller for life support • Security PTZ video domes and controls |
• High-speed room respiration calorimeters for 24 hour human substrate utilization measurement • Pre-term infant energy expenditure, water vapor loss and heart rate analysis system and study • Hypothermia management system for ischemia research • Programmable servo controllers • Servo amplifiers and step motor controls • Pneumatic, electric, and manual pumps and valves • Low contamination valving • Injection molded and extruded medical disposables • Eye image stabilizing device for optical slit lamp • Actuator systems for syringe pumps • Disposables packaging |