Omnica Corp.
Omnica Corporation is dedicated to advancing the medical device industry through innovative design and engineering solutions. With nearly four decades of experience, the company specializes in rapid medical device development, providing comprehensive services that include prototyping, verification, and validation. Omnica's commitment to quality and customer satisfaction is reflected in its high rate of repeat business and long-term client relationships.
Industries
N/A
Products
Integrated ultrasonic surgical platform (client project)
Development of a next-generation integrated ultrasonic surgical system combining ultrasonic cutting/ablation, RF capabilities, digital control algorithms, and touchscreen UI for surgical workflow.
Paper-spray ion source and mass-spectrometry consumables (client project)
Design and integration work for a paper-spray ion source to enable high-throughput direct mass-spectrometry sample analysis and associated consumables.
Microfluidic POC cartridge prototypes
Prototype cartridges and consumables for point-of-care diagnostics, including sample preparation, fluidic routing, and assay module integration.
Integrated ultrasonic surgical platform (client project)
Development of a next-generation integrated ultrasonic surgical system combining ultrasonic cutting/ablation, RF capabilities, digital control algorithms, and touchscreen UI for surgical workflow.
Paper-spray ion source and mass-spectrometry consumables (client project)
Design and integration work for a paper-spray ion source to enable high-throughput direct mass-spectrometry sample analysis and associated consumables.
Microfluidic POC cartridge prototypes
Prototype cartridges and consumables for point-of-care diagnostics, including sample preparation, fluidic routing, and assay module integration.
Services
Medical device design services
End-to-end engineering and design services for medical devices and laboratory instruments, including requirements, prototyping, and design transfer.
In-house prototyping and model making
Rapid in-house modeling and prototype fabrication to accelerate alpha and beta build iterations and reduce supplier turnaround.
Verification and validation services
Verification that designs meet specifications and validation testing (including simulated clinical testing) to establish device safety and effectiveness.
Cartridge and diagnostics development
Design and prototyping of microfluidic POC cartridges, sample prep devices, consumables, and integration of assay modules (e.g., PCR, bead handling).
Design transfer and manufacturing coordination
Prepare documentation, work instructions, and provide assembly and testing training for manufacturers or contract manufacturing partners.
Regulatory and design-controls consulting
Implementation of FDA-compliant design controls and support for regulatory strategy and documentation.
Medical device design services
End-to-end engineering and design services for medical devices and laboratory instruments, including requirements, prototyping, and design transfer.
In-house prototyping and model making
Rapid in-house modeling and prototype fabrication to accelerate alpha and beta build iterations and reduce supplier turnaround.
Verification and validation services
Verification that designs meet specifications and validation testing (including simulated clinical testing) to establish device safety and effectiveness.
Cartridge and diagnostics development
Design and prototyping of microfluidic POC cartridges, sample prep devices, consumables, and integration of assay modules (e.g., PCR, bead handling).
Design transfer and manufacturing coordination
Prepare documentation, work instructions, and provide assembly and testing training for manufacturers or contract manufacturing partners.
Regulatory and design-controls consulting
Implementation of FDA-compliant design controls and support for regulatory strategy and documentation.
Expertise Areas
- Medical device design and development
- Prototyping and model making
- Diagnostics and IVD system engineering
- Embedded firmware and software (SaMD) engineering
Key Technologies
- Microfluidics
- High-speed PCR and precision thermal control
- Mass spectrometry ion-source hardware
- Lateral flow assay consumables