Case Studies
TriE Medical works with all types of customers, from individual startups to large medical firms. These case studies detail the successes of our clients in turning their ideas into reality.
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Multiple Generation Non-Invasive Stimulation Device Design
Client Request
A client requested TriE to assist in designing and to build a non-invasive, portable, battery operated stimulation device for therapeutic treatment. TriE worked closely with our client to develop a proof-of-concept prototype to verify the application. After data was collected from the proof-of-concept prototype, TriE assisted in designing and manufactured a second generation device to add additional functionality, enhance ergonomics, and provide a menu of options through a Graphical User Interface.
Services Performed
- Developed ergonomic mechanical packaging and designed multiple prototypes to verify form and fit.
- Designed the electronics interface and custom battery pack.
- Designed a computer Graphical User Interface and custom embedded software.
- Integrated and tested fully functional prototype.
- Validated software and performed preliminary device testing.
- Prepared full documentation package.
- Updated design for user feasibility.
- Completed a pilot build for additional field units.
The Results
TriE is continuing to support the feasibility studies and is working with our client to design and build the third generation device that will undergo an FDA submission prior to release into the marketplace.
TriE has been a wonderfully supportive and cooperative developmental partner in working with us. The relationship has been both productive and highly enjoyable. In our joint meetings a visitor would have difficulty knowing which individuals are from which company. We view TriE as an extension of our R&D group.
L. Smith, Client
Fluid Delivery System Device Design
Client Request
A client requested TriE to assist in designing a fluid delivery system. TriE Medical was instrumental in working on the electronics, software development, mechanical design, and technical documentation package. Multiple prototypes were built and our customer conducted successful user feasibility studies with the Generation 1 device.
Due to the success of the first generation prototype our customer requested for TriE Medical to work on the second generation device. The second generation device has been completed and a 510(K) application has been submitted to the FDA.
Services Performed
- Complete Electronics Design (Schematics, Custom PCB Design / layout, custom drive design)
- Full Software Development and Validation
- Mechanical Design
- Integrated and Tested fully functional prototypes
- Technical documentation necessary for FDA 510(K) Submission
- Supported certified safety testing to IEC60601-1, IEC60601-2, IEC60601-2-24
- Conducted device performance testing
- Second generation product design
- Assisted with manufacturing transition
- Designed custom PCB test fixtures for use in manufacturing
The Results
TriE is continuing to support the customer with design and development activities. The customer’s product has successfully been CE marked. Currently, TriE is working on software updates to make the device flexible to include multiple language translations.
TriE Medical’s technical capabilities, collaborative methods and knowledge of the Medical Device space make them a very valuable partner in our product development process.
Auto Injector Device Design
Client Request
A physician inventor requested TriE Medical, Inc to assist in designing a single use, disposable auto injector for drug delivery. TriE Medical provided innovative industrial/mechanical design services that would meet the rigorous product size and delivery requirements. In addition, TriE provided a detailed documentation package.
Services Performed
- Worked with client on mechanical concept refinement and human factors evaluation.
- Generated detailed Industrial Design utilizing SolidWorks.
- Conducted Failure Mode Effects Analysis (FMEA) to evaluate potential hazards and implemented design safety features.
- Generated functional prototypes.
- Conducted bench testing evaluations for drug delivery amount verification, actuation mechanism, safety features, and material evaluation.
- Wrote and executed product verification protocol.
- Provided detailed documentation package.
The Results
TriE Medical is providing technical support to assist our client with technology transfer.
My experience with TriE was outstanding and I have only gloriously flattering things to say about your company. Thanks for a great experience!
T. Beller, Client