Microfluidics

Comprehensive Microfluidic Solutions for Diagnostic and Life Sciences

Approaches to Creating Lower Cost Complex Microfluidic Consumables

MICROFLUIDIC PLAYS AN EVER INCREASINGLY ESSENTIAL ROLE IN THE DEVELOPMENT OF RAPID, QUALITATIVE, QUANTITATIVE, AND SENSITIVE LIFE SCIENCE AND DIAGNOSTIC DEVICES.
Whether you’re developing a next generation sequencing platform, or a Point of Care multiplexed molecular assay, there’s a strong likelihood that your application will require microfluidics. This involves the miniaturization and integration of existing workflows, typically performed in a laboratory setting, that are manufacturable, scalable, and cost effective.

MICROFLUIDICS CAN INTEGRATE LAB ROUTINES
into a device that can enhance analytical sensitivity, temperature control, portability, automation, and parallelization. Microfluidic devices enable multiple chemical or biological assays to be carried out simultaneously in a shorter reaction time which uses less sample/reagent(s) required to perform an assay. This in turn leads to shorter analysis time, reduced cost, and minimizes the amount of waste produced.

The challenge in developing a microfluidic device is that developers of sample-to-answer solutions are frequently focused on designing an innovative product, but sometimes come up with designs that do not consider high volume manufacturing processes. This can lead to a considerable waste of time and money.

In going from concept to commercialization of a microfluidic device, there are engineering challenges and constraints that need to be overcome in order to meet the expected performance of an assay. Fluids can behave very differently on a microscale than they do at the bench scale. When designing, developing and manufacturing microfluidic devices, one of the first fundamental steps is to determine the tolerances on the volumes of all aqueous solutions used in the protocol.

It is also important to select the appropriate material(s) from which to fabricate the device. In addition, parameters such as the geometry of a channel, the sharpness of features and the method of manufacture, all impact the device’s performance.

HAVING SUCCESSFULLY COMPLETED THOUSANDS OF MICROFLUIDIC DEVICE PROJECTS
of varying complexity, Gener8 can rapidly translate a microfluidic design from CAD to prototype, and from pilot production to manufacturing. With over 16 years of experience in designing, developing, and manufacturing high-value, cost competitive, custom microfluidic device solutions for life science and diagnostics applications we have a deep understanding of our customers’ needs. We have also developed a strong supplier network for sourcing material and injection molding components. We understand what is required to bring a microfluidic device to market. In doing so we help reduce risk and cost in providing a streamlined supply chain.

As one among many examples, Gener8 developed a now commercialized instrument-driven microfluidic cartridge that rapidly diagnoses antibiotic susceptibility of bacteria in positive blood culture samples. The cartridge contains 13 imaging chambers, on-board dry reagents, an active valve component, and achieves challenging microfluidic flow balancing.

A second example is a PCR assay automation system. An instrument actuates a valve, drives fluids, and provides heating input to a cartridge that fully automates a 28-step PCR assay. The cartridge features a rotary valve, four thin film heater interface chambers, magnetic bead capture and resuspension chambers, as well as an optical window to enable detection.

FROM THE INCEPTION OF A PROJECT,
our team designs your microfluidic device for scalable volume manufacturing to help ensure that it will be a manufacturing success. As early as in the design phase, it is critical to consider the final manufacturing process and supply chain. This allows us to clearly understand the unique challenges and constraints for a particular device in transferring it to a manufacturing process. We begin your microfluidic design project with your end goal in mind. We consider your performance goals, safety requirements and cost target.

We evaluate the physical properties of materials, resins and bonding methods. We consider assay and reagent requirements regarding performance, volumes, concentrations, shelf life, use, and storage conditions. We involve our manufacturing team early in the design process to ensure that your design will transfer to scale cost effectively. In this way, we use fully scalable manufacturing methods by using the same equipment, materials, and assembly methods which enable high quality, scalable manufacturing of your microfluidic devices.

AT GENER8, WE PUSH TRADITIONAL BOUNDARIES
of manufacturing processes in our designs to achieve the desired accuracy but use standard molding and assembly processes to maintain a low cost thereby eliminating the need to use more unusual and expensive methods.

Our multidisciplinary team of scientific and engineering experts can develop microfluidic technologies for cutting edge applications.

Our ability to leverage the capabilities of microfluidics in handling small volumes of samples and reagents not only helps in minimizing the consumption of reagents and reducing analysis time but can also reduce manufacturing costs and increase a device’s efficiency and portability. Our team also takes into consideration the regulatory route for an IVD device and accompanying clinical validation requirements.

Using design-for-manufacturing (DFM) techniques, we can rapidly prototype, iterate, and test microfluidic device designs to shorten the design phase of a project by weeks or months. Gener8 can mold complex microfluidics consumable components for medical and biotech devices at unmatched speed.

Our rapid in-house prototyping, prototype tooling fabrication and injection molding capabilities provide a complete and optimized instrument-consumable solution. We use design and modelling software together with a wide range of prototyping equipment.

AS PART OF OUR IN-HOUSE PROTOTYPING, MICROFLUIDIC ENGINEERS AND INDUSTRIAL DESIGNERS
meet with manufacturing experts to create a design risk matrix that takes production methods, materials, assay(s) chemistries, assembly complexity, target volumes, and cost into account.

The outcome is a device containing the minimal number of component parts and materials that streamline the supply chain that together decrease the number of manufacturing process steps, without compromising the required performance and desired manufacturing cost.

As a case in point, we are frequently asked to rescue struggling microfluidic product designs. During the analysis, we may discover that a particular design methodology will simply not scale well in manufacturing.

Working with Gener8 from the onset of the project will ensure or increase the chance of a seamless connection from product design, material(s) selection, pilot production to high volume manufacturing.

ONE OF THE MOST IMPORTANT, AND OFTEN MOST DIFFICULT CHOICES
to be made is what material to use. The materials selected are the key to the other elements of the project as they need to be compatible with the assay, the chemistry, spotting and/or dispensing processes, and the bonding processes. The bonding process must work with the chosen materials at the required tolerances for production, and result in low scrap rates in order to reduce waste while meeting cost goals. In addition, the material must meet the desired regulatory requirements, must retain its performances over the product’s shelf life, must meet cost targets, and must be available with a practical lead time.

Gener8 maintains a broad and varied inventory of specialized molding resins and bonding materials needed to meet the high-performance requirements of a microfluidic device. These can range from small single channel devices to complex multi-channel devices with sensors, mixers, and valves as well as chambers and onboard reagents. This inventory is maintained through a network of qualified and trusted suppliers, each of whom can meet the necessary regulatory and commercial requirements to provide an efficient supply chain.

WHETHER YOUR DEVICE REQUIRES TECHNICALLY CHALLENGING
injection molded assemblies or simple cassettes, we have the technology, know-how, and expertise to design, prototype, and mass-produce microfluidic devices for your applications.

Gener8 has in-house facilities with a range of different equipment including injection molding, bonding, dispensing, assembly, and metrology equipment, capable of providing scale-up from hundreds up to hundreds of thousands. By leveraging existing equipment infrastructure like processing equipment, clean rooms, metrology equipment, material supply chains, skilled personnel, and a quality management system we can save time to product launch and reduce cost.

Gener8 has built this infrastructure over the last 16 years, during which time we have added capabilities and capacity.

TO CONCLUDE, THE KEYS TO SUCCESSFUL TRANSFER FROM
design to manufacturing are incredibly important. In culminating all prior choices and interdependencies, only products that have been designed from the concept stage for higher volume production can achieve a true high-quality, low-cost outcome. Whether your application involves components for instrumentation or consumables, Gener8 is your ideal partner to design, prototype, and manufacture microfluidic devices for your applications.

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