Excellence in Microfluidics
TE offers an end-to-end solution for OEMs bringing new IVD and life sciences technologies to market.
How we help clients bring new technology to market faster
From microfluidic cartridge design to high volume mass production, TE’s IVD Solutions team offers a broad array of services to OEMs looking to bring microfluidic products to market quickly and successfully, all backed by TE Connectivity, a leader in medical device contract manufacturing and sensor technologies. Our proven stage-gate process delivers real value to our customers while continual risk reduction delivers increased technical and commercial certainty at every step.
We’re ready to tackle your project
We invent, innovate, iterate and collaborate, and we combine those skills to help companies successfully introduce new diagnostic technologies. Our team would love the opportunity to work with you on your next project.
Getting design, testing, clinical and manufacturing teams in the same room
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.
Why It Matters:
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.
Moving through iteration and testing phases more quickly
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.
Why It Matters
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.
Saving time by moving quickly into clinical validation
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.
Why It Matters
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.
Seamlessly moving you through phases of manufacturing
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.
Why It Matters
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.
Areas in which we excel
DESIGN & DEVELOPMENT | CRO & CLINICAL RESEARCH | USABILITY TESTING & HFE | TRANSFER TO MANUFACTURING | CONTRACT MANUFACTURING
|DESIGN & DEVELOPMENT
||CRO & CLINICAL RESEARCH
||USABILITY TESTING & HFE||TRANSFER TO MANUFACTURING
• Microfluidic Cartridge Design
• Assay Transfer and Integration
• Blister Reagent Pack Design
• Consumable Rapid Prototyping
• Materials Engineering
• IVD System & Instrument - Interface Design
• Study Design & Protocol Writing
• EDC Design & Project Management
• Trial Master Files (eMTF)
• Regulatory Planning
• ISO 20916 Compliance
• Project Scoping & Planning
• Study Design & Recruitment
• IFU/QRG Comprehension Testing
• Usability Study Execution
• Equipment & Fixturing Design
• Pilot Lines & Gap Manufacturing
• Lean Process and Automation Development
• High Volume Consumable
• Production , Assembly and Final Packaging
• Reagent Integration (Dry and Wet)• Blister Manufacturing
• State-of-the Art Bonding & Surface Treatment Automated Processes
• High resolution Micro Injection Molding
Reduce your project risk by tapping 40+ years of combined expertise
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.
Proven IVD Expertise, From Concept to Market
IVD Microfluidic Solutions
Transfer to Manufacturing
We cost-effectively move IVD devices from development stages to mass manufacturing by utilizing design-for-manufacturing-and-assembly (DFMA) techniques. +30 years’ experience in process automation, polymer microinjection molding, silicon micromachining, reagent integration and highly automated QC/inspection techniques.
TE's Area of Expertise
TE transform the healthcare and research landscape with innovative expertise in molecular diagnostics, microfluidic development, manufacturing, & more. Our services facilitate personalized medicine, automation, improved treatment efficacy, and cost-effectiveness for a wide array of applications. TE´s bring your innovative concepts to life