The application of IVD devices has revolutionized the way rare diseases are identified and managed. With extensive expertise and advanced technologies, we offer comprehensive IVD device development services specifically tailored for rare disease diagnostics. Our services aim to expedite your journey from diagnostic research to successful commercialization.
Overview
Rare diseases encompass a diverse range of conditions, often characterized by complex and heterogeneous symptoms. Traditional diagnostic methods may not be sufficient to accurately identify these diseases, leading to delayed or misdiagnoses. Here, the application of IVD devices becomes invaluable. These devices provide targeted and specific diagnostic capabilities, enabling early detection and precise characterization of rare diseases.
Fig. 1 Schematic diagram of in vitro diagnostic devices. (Zhang, JingJing, et al., 2020)
Common IVD Devices for Rare Disease Diagnosis
Rare disease IVD devices come in various types, and these devices are designed to analyze biological samples and provide valuable information about the patient's health condition. Here are some of the common types of IVD devices.
| Device Types |
Applications |
| Immunoassay devices |
These devices utilize specific antibodies to detect and measure the presence of various analytes, such as proteins, hormones, antibodies, and infectious agents. Common immunoassay methods include ELISA, chemiluminescent immunoassay (CLIA), and lateral flow assays. |
| Molecular diagnostic devices |
Molecular diagnostic devices utilize nucleic acid-based techniques to detect and analyze genetic material, such as DNA or RNA. Commonly used diagnostic methods include PCR, microarray, DNA sequencing, etc. |
| Chemistry Analyzers |
These devices typically employ spectrophotometric, electrochemical, and immunoassay-based testing to assess analytes such as glucose, cholesterol, electrolytes, enzymes, and hormones. |
| Hematology Analyzers |
These devices are designed specifically to analyze blood samples, which can measure parameters such as cell count, hemoglobin level, hematocrit, etc., to evaluate blood cell morphology and identify abnormalities. |
| Coagulation Analyzers |
Coagulation analyzers are used to evaluate the clotting ability of blood and monitor the effectiveness of anticoagulant therapies. |
| Point-of-Care Testing (POCT) Devices |
POCT devices are portable and provide rapid diagnostic results at the point of patient care. Examples of POCT devices include glucometers, rapid antigen tests, and handheld analyzers. |
| Urinalysis Analyzers |
Urinalysis analyzers are used to assess the physical and chemical properties of urine samples for the diagnosis and monitoring of various urinary tract diseases and conditions. |
Our Services
The application of IVD devices promotes the early identification and accurate diagnosis of rare diseases. Our team of experienced scientists, engineers, and regulatory experts is dedicated to delivering high-quality and innovative solutions for the development of cutting-edge IVD devices. Our workflow for IVD device development encompasses several key stages, ensuring a systematic and efficient process from inception to final product release.
Workflow of IVD Device Development
Development Plan Formulation
By understanding client requirements, we identify key parameters, target analytes, regulatory considerations, and desired performance characteristics for IVD devices. Based on this information, we develop a comprehensive plan.
Prototype Design
Our skilled engineers and scientists work closely with our customers to transform their ideas into functional prototypes. We utilize state-of-the-art design software and modeling techniques to create 3D representations of the IVD device. Through iterative refinement and feedback loops, we ensure that the prototype meets the desired performance criteria, usability requirements, and regulatory standards.
Styling Machine Development
Our team collaborates with industrial designers to integrate the functional prototype into an aesthetically pleasing and ergonomic device. We consider factors such as user interface design, ease of use, and human factors engineering to enhance the overall user experience.
Device Verification and Optimization
We conduct comprehensive testing and evaluation to ensure that the device meets the desired performance specifications and regulatory requirements. We also optimize the device's performance through iterative refinement, addressing any identified issues or areas for improvement.
Optional Device Types
- Immunoassay devices
- Molecular diagnostic devices
- Chemistry analyzers
- Hematology analyzers
- Microbiology analyzers
- Coagulation analyzers
- Urinalysis analyzers
- Point-of-care devices
- And More
Our Advantages
Time-saving services with high efficiency
Professional and experienced team
Cutting edge technology platform
Numerous service cases and customer praise
By leveraging our expertise and cutting-edge technologies, we aim to support our customers in bringing innovative and reliable IVD devices to the market. If you are interested in our services, please don't hesitate to contact us for further information and pricing details.
References
- Zhang, JingJing, Tian Lan, and Yi Lu. "Translating in vitro diagnostics from centralized laboratories to point-of-care locations using commercially-available handheld meters." TrAC Trends in Analytical Chemistry 124 (2020): 115782.
- Slomovic, Shimyn, Keith Pardee, and James J. Collins. "Synthetic biology devices for in vitro and in vivo diagnostics." Proceedings of the National Academy of Sciences 112.47 (2015): 14429-14435.
All of our services and products are intended for preclinical research use
only and cannot be used to diagnose, treat or manage patients.
