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.
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.
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.
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 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.