Our design, bioscience, usability, CRO, and manufacturing teams all meet during project kickoff so everyone understands the project’s end performance, timing and cost requirements. The design and bioscience teams begin to define assay parameters, identify materials, design concepts, and conduct feasibility studies. Usability, clinical research and manufacturing teams offer simultaneous input.

Because many design firms do not have usability, clinical and high-volume manufacturing in-house, their clients often do not find out about issues with the proposed design until the clinical validation phase, or worse yet, the transfer to manufacturing stages. This can cause delays as the manufacturer now must go back to the design firm to fix issues that could have been foreseen if usability, clinical and “design for manufacturing” expertise were available in-house.

Concepts are selected and prototypes of the proposed design are fabricated in-house then shared with the client for initial feedback.  We then transfer the assay to be compatible with a highly automated cartridge workflow, evaluate its performance, reliability/reproducibility and conduct usability testing on prototypes to gather real user feedback. Design adjustments are made (if needed) to improve performance, usability, manufacturability and reduce cost of goods.

While many design firms have in-house prototyping capabilities, few have the ability to test designs soon after they are made. Our in-house bioscience and usability teams can test prototypes in our Bio Safety Level 2 (BSL2) facilities, get user feedback and quickly involve the design team to make changes based on new input.  New prototypes are quickly fabricated and tested.

With a final design locked down, a clinical study is then conducted by our in-house CRO team to validate the design and produce data needed for FDA and EU regulatory approvals. Planning for the various stages of manufacturing will occur at this point as well, based on a balance between future volume and costs.

Faced with finding a qualified Clinical Research Organization that understands their technology, many developers and manufacturers lose weeks or months of critical time in this phase. TE has a specialized CRO team in-house and IVD is our specialty. We understand precisely what needs to be done and what the FDA and EU regulators expect to see in your regulatory submission, and we schedule your trials to coincide with the completion of usability studies.

With the technology validated and cleared for market, our manufacturing team will implement the most efficient manufacturing process possible, made possible because we applied “Design for Manufacturing” principles early in the process. We will move your device through progressive stages of manufacturing volume thanks to our unique manufacturing infrastructure. With footprints in the US and Europe, the IVD solutions team is capable of transitioning your product from low volume runs through to high volume automated production as market demand grows.

Waiting until the end to involve manufacturing expertise is why many manufacturers get unpleasant news from their contract manufacturer in the form of higher-than-expected manufacturing or assembly costs. This is typically due to poor material selection, overly complicated designs that slow cycle time and inconsistent performance when pushing for increased manufacturing cycle speeds. Planning the “ramp up” stages of manufacturing is critical to avoid surprises.

Bringing a new microfluidic technology to market - and making it a commercial success - requires in-depth understanding of design, materials, regulatory and manufacturing processes. Our integrated engineering, clinical, testing and manufacturing teams in the US and Europe are ready to tackle your toughest challenge, as we have done for so many in vitro diagnostic and life science clients worldwide. Few companies can match the combined expertise we offer in the following areas.