Our Rapid Diagnostic Test Development Process
At Atomo we work with rapid diagnostic manufacturers and assay developers to bring the world’s most consumer-friendly rapid diagnostic test platform that delivers more accurate results.
Our Product Development Process
Our aim is to change how diagnostic testing is performed in both point of care settings and in the home. We are a world leader rapid test manufacturer creating integrated, user friendly rapid diagnostic tests platforms.
Atomo has an established track record of working with OEM partners in the rapid diagnostic manufacturing space such as NG Biotech, Lumos and Access Bio to deliver quality products and solutions.
With the growing demand for point of care and at-home rapid diagnostics, Atomo can be a launching pad for any lateral flow assay company to diversify and improve their current offerings by leveraging over a decade’s worth of R&D to produce tests that are light years ahead of industry standards.
Our Partnership Development Pathway
Atomo’s robust product development process is compliant to ISO 13485 and FDA CFR 820 and provides a rapid and effective route from design to commercialisation.
Atomo uses a phase gate approach product development process with design reviews at the end of each stage and can support a robust documentation package to support regulatory submissions. Atomo’s team of engineers will work directly with lateral flow manufacturers and assay developers. We strive to understand your rapid test requirements and look to eliminate pain points.
Design, Prototyping and Pilot Production
While each platform differs to a degree in its operational capacity, each device in the AtomoRapid™ cassette range includes patented rapid diagnostic test platforms that meet requirements for professional use and self-test applications. The first step of the partnership development pathway is the selection of the appropriate rapid diagnostic test platform. To do this, we conduct a full analysis of your user requirements, with research centring on human factors and user testing to ensure the solution we determine is most appropriate for your needs. We then undertake concept feasibility studies in order to progress to the development of functional prototypes before assisting with the management of intellectual property.
Verification and Validation
Each platform in the AtomoRapid™ range is customisable to suit your analyte and test strip accordingly. Each platform has full clinical validation and comes with company-wide quality assurance. We utilise an FMEA manufacturing process analysis and can assist and support with regulatory submissions.
Commercial Launch and Rollout
Our commercial launch and rollout process involves full manufacturing process validation. All of our products are manufactured at our own high quality manufacturing and assembly facilities. As part of our commercialisation process, we offer a full suite of brand, packaging, and marketing assistance. Once your product is launched, our commercial team can be provided continued post-launch support to ensure the best chance of success.
