MicroGEM International hired SHEPPiD to work on concepts in February 2020 for an immune monitoring device. The conceptual phase closed just as the COVID-19 pandemic struck that spring. MicroGEM quickly pivoted the technology to being a COVID-19 tester, which made our initial concepts obsolete as the size, volume, and use-case scenario were much different. The project was successfully funded with over $50 million dollars through the NIH (National Institute of Health) RADx program.
The MicroGEM Sal6830 SARS-CoV-2 Saliva Test is authorized for use under FDA Emergency Use Authorization (EUA) only. It is authorized for use at the point of care (POC), i.e., in inpatient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. The MicroGEM Sal6830 SARS-CoV-2 Saliva Test is also authorized for laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform high, moderate, or waived complexity tests.
The Sal6830 SARS-CoV-2 Saliva Testing Kit is authorized for sale and importation in Canada pursuant to section 5 of the Interim Order respecting the importation and sale of medical devices for use in relation to COVID-19.
SHEPPiD was responsible for industrial design, design for manufacturing, brand design, package design, labelling design, photography, sales and marketing images, and user manual and quick reference instructions. Through the major development of the project, SHEPPiD Director Adam Shepperdley sat on the MicroGEM management team and was responsible for design governance and reporting to the leadership team.
Major Value Proposition:
Our team remained agile and adapted to the ever-changing scope and design requirements. Although many work requests were out of our core competencies, our team executed on those tasks efficiently and effectively. Taking on a leadership role within a client’s organization was a first, and it proved to be a major asset to successfully delivering the project.
Features and benefits to the user:
Sal6830 Point of Care PCR System
Sal6830 Mobile Workstation
- Eliminates contact with the patient’s saliva sample
- Simple surfaces that make sanitizing quick and easy
- Simple intuitive features to guide the user through steps of usage
- Integrated touchscreen and scanning system
- Overlap features to prevent dust and light leakage
- 4-part enclosure design
- Textile and ergonomic handling features
- Integrated power management system
- Wide stable base to prevent tipping of the device
- Cable management features
- Rotation and movement locking 4-inch castors
- Integrated sliding work surface
- Attachment features for off-the-shelf Rubbermaid bins
- Storage for 20 sets of extra cartridges