diagnosticsatomodiagnostics.com/wp-content/uploads/2019/05/... · enhance your rdt offering,...
TRANSCRIPT
DIAGNOSTICS
Atomo is committed to developing best-in-class lateral flow test devices. Our product portfolio includes platform devices with assorted functionality to meet most in-market needs. This focus on usability and simplicity in design has led us to create devices ideally suited for both professional and self-test applications.
Atomo Diagnostics is a specialist medical device design and original equipment manufacturing (OEM) company with unique proprietary technologies that improve rapid diagnostic testing by emphasising ease-of-use, accuracy and performance.
Atomo’s patent and platform portfolios provide an efficient and low-risk pathway from product development to commercialisation of your test.
YOUR RAPID DIAGNOSTIC TEST
A standard multi-component test kit
Accurate Blood CollectionThe easy-to-use blood collection
unit is designed to collect exactly the right sample volume, ensuring
optimal test performance.
Integrated Buffer DeliveryThe unique, patented mechanism delivers the required quantity of chase buffer at the touch of a button.
Easy-to-Read DisplayThe in-built electronic reader and digital display eliminates risks associated with misinterpretation of test results.
Built-in Safety LancetThe auto-retracting safety
lancet eliminates the risk of hazardous sharps
injuries by locking the needle inside the device
after use for safe disposal.
Test StripThe device can be adapted to accommodate most blood-based lateral flow test strips.
Our expertise in device development and track record in re-imagining point of care diagnostics mean we can offer you best-in-class solutions with excellent usability, convenience and performance.
Atomo rapid diagnostic test platforms
ATOMORAPID RDT PLATFORMS Integrated lancet
Integrated blood collection
Integrated buffer delivery
Digital reader & LED display
Digital reader & LCD display
Dual test strip
Galileo
Pascal
Newton
Fleming Optional
Elion
Faraday
In Development
Our unique and award-winning AtomoRapid lateral flow RDT platforms are fully customisable to suit your requirements and can be adapted to match the specifics of your test strip.
Atomo device technologies put the end user first, simplifying test procedures, mitigating common user errors and enhancing test performance.
Integrated device platforms
Lance Finger Deliver BloodCollect Blood Deliver Buffer Read Result
Benefit from our expertiseAtomo will partner with you to create user-centered solutions that will enhance your RDT offering, whether you are seeking to introduce new test applications or to upgrade and reinvigorate an existing product.
We offer custom modifications of existing AtomoRapid platforms or bespoke product developments to meet specific requirements.
MARKET LAUNCH
PRODUCT VALIDATION
PRODUCT VERIFICATION
DESIGN OUTPUT
DESIGN INPUT
USER NEEDS
PHASE 1 AND 2 PHASE 3 AND 4 PHASE 5
Design Input Verification
User Needs Validation
Development PathwayAtomo’s robust product development process is compliant to ISO 13485 and FDA 21 CFR 820 and provides a rapid and effective route from design to commercialisation.
PHASE 1 AND 2: Design, prototyping and pilot production
• Analysis of user requirements
• Concept feasibility studies
• Development of functional prototypes
• Human factors research and user testing
• Management of intellectual property
PHASE 3 AND 4: Verification and validation
• Clinical validation
• Company-wide Quality Assurance
• FMEA manufacturing process analysis
• Support with regulatory submissions
PHASE 5: Commercial launch and rollout
• Full manufacturing process validation
• High quality manufacturing and assembly facilities
• Brand, packaging and marketing assistance
• Post launch support
Design and Innovation Regulatory Affairs
Manufacturing Final Assembly
Award Winning DesignAtomo rapid diagnostic test platforms have been recognised internationally for innovative design, performance,
and ease-of-use.
AustraliaAtomo Diagnostics Pty. Ltd.Level 2, 701-703 Parramatta RoadLeichhardt, NSW 2040AustraliaT: +61 (0)2 9099 4750E: [email protected]
United KingdomT: +44 (0)1295 722867
LB
L-015-0
6
Discover how partnering with Atomo Diagnostics can provide your business with an efficient and low-risk pathway from product development to commercialisation of your rapid diagnostic test.