End-to-End Support for Life Science, IVD and Cell Therapy Manufacturers

From microfluidic cartridge design to high volume mass production, we now offer a broader array of services to manufacturers looking to bring microfluidic products to market quickly and successfully, all backed by TE Connectivity, a world leader in medical connector and sensor technology.

Design & Development

•    Microfluidic Cartridge Design
•    Blister Reagent Pack Design
•     System Design
•    Instrument Interface Design
•    Assay Integration/Bioscience
•     Rapid Prototyping 
•    Materials Engineering 
•    ISO 13485 Compliance

Clinical Research

•    Project management from conception to completion
•    Study design and protocol writing
•    Site and laboratory identification, qualification, selection and management
•    Electronic trial master file (eTMF) creation and management
•    Electronic data capture (EDC) design and build
•    Customized data dashboard with daily updates throughout the study
•    Statistical planning, data management and analysis
•    ISO 20916 compliance

Usability Testing

•    Human factors development
•    Project scoping and planning
•    Task analysis
•    Study participant recruitment
•    Formative and summative/validation testing (in.house testing lab)
•    IFU/QRG analysis and comprehension testing
•    Design feedback from human factors experts
•    Friendship groups, in depth reviews, expert reviews, card sorting, wireframing and journey mapping

Manufacturing

•    Process Automation / Transfer to manufacturing dedicated teams
•    Pilot Lines and small volume manufacturing
•    Global footprint High Volume Manufacturing (US and Europe)
– Micro-injection Molding
– Reagent Blister Manufacturing
– Cartridge Manufacturing and Assembly (Bonding, Surface Treatment, etc.)
– Packaging
– Customize QC (including specific Assay QC expertise)
•    ISO 13485 Compliance

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.