Do you need help with engineering design for diagnostic products?
Symbient Product Development specializes in design engineering and design-for-manufacturing of innovative medical and life science devices that use plastics. Diagnostic product development is a focus, we have designed and molded hundreds of parts for diagnostic devices. Our highly experienced team consists of mechanical and biomedical engineers, industrial design talent, machinists and molding technicians. We leverage our in-house rapid prototyping, prototype tooling fabrication and injection molding to create proven, manufacturable designs with unmatched speed, efficiency and quality. These designs form our deep portfolio of over 300 successful devices that have generated hundreds of millions of dollars for our clients. They include FDA Class I, II and III devices, developed under our ISO 13485 certified quality management system.
Diagnostic Device Development Starts with Sample Collection
Symbient has developed sample collection devices for all clinically relevant samples including blood, stool, and saliva. Many of our designs have been integrated into the assay cassette, providing a sample to answer solution.
Point of Care Plasma Separation Diagnostic Device
- Determine an intuitive, quick and cost efficient method to collect a precise quantity of whole blood, separate the plasma and deliver a specified quantity of buffer and plasma to a lateral flow strip.
- Design a complete point of care device that accomplishes the above, including the sample collection and processing module, and the lateral flow cartridge.
Unique Features and Accomplishments
- Researched and developed a novel method to separate a specified small volume of plasma from whole blood in less than 10 seconds by using a custom flow through filter stack and a dispensing method that prevents hemolysis.
- Developed an integrated buffer storage and delivery plunger that utilizes a foil heat seal and overmolded elastomer features that control flow during use.
- Utilized creative mechanical design in order to minimize the number of required user steps, and make them intuitive enough to meet CLIA waiver requirements.
- Started with a basic list of product requirements and finished the project with a complete design-for-manufacturing, including assembly processes and testing protocols for product acceptance and release.
Sample-to-Answer Molecular Diagnostic Cartridge
- Develop a low-cost microfluidic cartridge designed for high-volume manufacturing that automates a PCR assay.
Unique Features and Accomplishments
- Performs sample collection, preparation, amplification (via isothermal PCR), and detection of nucleic acid analytes from clinical samples (including blood, saliva, urine, feces, etc), environmental samples (waste water, soil, spores, etc), and food.
- Multiplexed analysis, testing up to 16 analytes from a single sample
- Microfluidic cartridge functional features include:
- 3 pneumatically actuated diaphragm valves, 1 mechanically actuated pop valve.
- Pneumatic interface with instrument to drive fluid through microfluidic channels.
- Fluid channels and wells created by laminating a heat seal over the top of ridged plastic body.
- Metering and mixing wells using hydrophobic vent membranes, assembled using sonic welding.
- Well used for lysing the cells interfaces with a heating element on the instrument.
- Performs active mixing of stored, dried master mix reagents.
- Sample splitting into 16 wells with optical clarity for florescent detection.
- Reduces an 11 Step Assay Protocol to 2 User Steps, for use in a CLIA waived point-of-care environment
Our Process: Design, Fabricate, Analyze and Iterate
In general, the process for our mechanical design and engineering services begins with design, then fabrication of parts and assemblies, analysis of their adherence to requirements, and finally iteration, resulting in incremental improvements. These processes are key to understanding our Steps to Success.
Computer Aided Design and Machining
We use SolidWorks® 3D CAD software along with Enterprise PDM for design control and secure CAD file management. We also utilize CAMWorks, a program that integrates with SolidWorks and enables us to seamlessly create error-free CNC machining tool paths.
CLIA Waiver, Point of Care
By applying our creativity and considerable experience, we can design mechanical and fluidic assemblies that accomplish multi-step assays in just one or two user steps. This simplicity can enable your device to meet CLIA waiver or Point of Care requirements.
As mechanical engineers, we have vast experience in developing devices with mechanical features ranging from the commonplace to the novel. Selected examples can be seen in our Case Studies.
Design Analysis and Physical Testing
A significant part of our design and engineering process requires analysis and testing of both rapid prototypes and injection molded devices, which we fabricate and assemble in-house.
Our product development services include specification of off the shelf components and primary materials such as plastics. There are thousands of types of plastics available, making our expertise in material selection a valuable part of our product development services. We help you select the right type, sub-type, grade, manufacturer and additives to meet the requirements of your device. Learn more about our Material Selection services.
Leverage our extensive experience and specialization in medical disposable products to efficiently determine whether a breakthrough design concept is feasible. We are experts at determining the best rapid prototyping method to use to ensure accurate results.
Finite Element Analysis
We offer FEA analysis using Solidworks Simulation. Simulation allows for linear static and time based dynamic analysis of our designs. Simulation allows us to quickly test and evaluate the design before spending time and money on prototyping. As a result we are able to achieve product requirements with fewer iterations.
If your device will incorporate electromechanical components, we invite you to contact us to learn more about our expertise at specifying, designing systems and integrating these components.
We can design your device to achieve specified heat transfer requirements, which are commonly specified to accommodate onboard heaters, thermo-chemical reactions or heat-generating electromechanical functions.
Call Symbient Product Development today to see how we can help you!