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Medical Technologies
IVD Solutions
POC and Device Microfluidics
POC and Device Microfluidics: Small Technology with a Big Impact
Navigate the complexities of user recruitment for IVD usability studies with TE Connectivity’s experienced insights. From strategy to participant onboarding, optimize your process.
Learn more about the design and material decisions that increase the odds of a smooth transition to commercialization for your microfluidic device.
Learn more about how in vitro diagnostics (IVD) is impacting STI testing in POC and OTC tests and the potential trends moving forward.
The IVD Solutions team at TE is expanding its clinical trial sites in Australia, enabling them to conduct IVD clinical trials following the Therapeutic Good Administration (TGA) requirements. These clinical trial sites in the southern hemisphere can provide FDA developers with the data they need to be prepared with solutions for next year's respiratory illness season.
An LDT is a test developed and manufactured inside a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory for use only within that laboratory, and while the FDA has had the authority to oversee LDTs, until this proposed rule, the FDA has exercised enforcement discretion over LDTs.
IVD Clinical Trial Study Design Tips for Respiratory and Oncology Devices
TE’s IVD Solutions team goes deep on various bonding technologies used to join layers to one another.
TE’s IVD Solutions team explains how microfluidic chips can be used for cell culture applications, including pros and cons.
TE’s IVD Solutions Team explains the advantages of using microfluidics for SCA compared to traditional techniques.
A microfluidic system must have the ability to move fluids (including the sample) in the device. In the most basic system, this may be done with capillary action and “passive” flow. However, most systems have some sort of pump.
TE’s IVD Solutions Team explains “wettable” surfaces, how they are created and their impact on microfluidic chips.
TE Connectivity specializes in development, testing and manufacturing of blister packs for microfluidic cartridges.
TE’s IVD Solutions Team explains the various methods and materials used to make microfluidic device prototypes and factors you need to consider.
TE’s IVD Solutions Team explains how you can automate workflows using blister packs for on-board delivery of liquid reagents.
TE’s IVD Solutions Team explains how microfluidics are being used to revolutionize liquid biopsy workflow
Microfluidic systems require careful consideration when it comes to chemical, thermal, and physical interactions with reagents. Interactions between the reagent and resin (or plastic/polymer) need to be minimized as much as possible to avoid leaching, system degradation, absorption, and unreliable assay outcomes.
The first component to be considered when designing a microfluidic system is the device itself. It may not be obvious, but the device material can chemically interact with the other reagents in a manner that can be harmful to the assay.
Most “diagnostics manufacturers” are the responsible parties behind the product’s application for approval and eventual distribution to the market, even though they use contract manufacturing for some or all of the physical product. In other words, an IVD manufacturer by FDA definition is not necessarily the organization which physically creates the final product.
Microfluidics technologies like this can transform the diagnostics landscape, and as engineering methods improve, manufacturing becomes faster and more accurate. A microfluidic chip can be manufactured with sub-micrometer precision, making this technology ideal for applications such as DNA/RNA analysis, cell-culture, lab-on-a-chip, or organ-on-a-chip, among many others.
As we learned at the start of the COVID-19 pandemic, the diagnostics’ market landscape can change overnight. The creation of new diagnostic devices requires a lot of time, patience, effort, and resources, yet to remain competitive in the market, a developer must move rapidly through a lengthy prototyping process to ensure that the device is still relevant, meets regulatory requirements, and meets the end user’s needs when it launches.
The couponing process is used for a wide variety of products. Some cutting-edge or esoteric inventions require going beyond this approach for better ways to achieve the same ends, as do applications whose coupon testing plans might otherwise be too time-consuming or wasteful of costly raw materials.
Three Things to Consider When Choosing Your IVD Product Development Partner
User requirements for IVD devices are derived from the needs, intentions, and actions of the users of the device. The key users of IVD devices include the operators and handlers of the device or materials.
Factors to Consider in IVD Device Design
Traditionally, diagnostic testing is done in distant, sophisticated laboratories using expensive equipment, performed by trained personnel and ordered by licensed physicians. Contrast that with how a home-use OTC diagnostic test, such as a pregnancy test is used.
Microfluidic devices (and their cousins, nanofluidic and mesofluidic devices) are increasingly used in an impressive array of bioanalytical applications. These range from familiar in vitro medical diagnostic assays to assays for environmental contaminants, biosafety threats, and food diagnostics.
Usability testing is closely linked to the IVD product’s stage, its audience, and its usage context. It is a subset of market research focused on product functionality, and its timing is tied to development and launch decisions.
The valuable experience with the product development process and the relevant materials thereof means the organization in question can offer an initial objective assessment of your prototype’s readiness for the usability testing process. Then it can guide you through any product fixes needed as usability testing reveals deficits or opportunities.
Microfluidic systems demand IVD device designs that take chemical, thermal, and physical interactions with reagents into careful consideration. Interactions between the reagent and the plastic/polymer must be minimized to avoid absorption, leaching, system degradation, and erroneous assay results.
The basic process works like this: after generating an initial product design for a diagnostic or medical device, the engineering team will consult with key stakeholders, marketing, senior management, the Scientific Advisory Board, and possibly even investors or board members. Based on the feedback it receives, the engineering team may revise the product design and develop a prototype.
When designing a microfluidic device, the goal is to meet the product’s requirements and design it to be easily manufacturable. During this phase, you should consider the optimal processes, materials, process parameters, and tolerances.
TE’s IVD Solutions Team explains how microfluidics are applied to syndromic multiplex testing and benefits offered by the technology.
TE’s IVD Solutions Team explains the steps to getting Emergency Use Authorization for a monkeypox PCR or antigen test.
TE’s IVD Solutions Team has helped numerous COVID-19 test manufacturers meet FDA EUA requirements and our clinical and regulatory teams are ready to assist you in obtaining monkeypox EUA as quickly as possible. Time is of the essence as you must notify FDA of your intent to file an EUA no later than October 7, 2022.
