TE Connectivity Medical - IVD Solutions

COMPAMED 2013

F36

TE Connectivity Medical- IVD Solutions | Excellence in Microfluidics | "TE offers an end-to-end solution for OEMs bringing new IVD and life sciences technologies to market."⟶ https://www.te.com/ivdsolutions

Successfully moving customer products form concept or design, clinical research (CRO) to manufacturing is our specialty, TE is a trusted partner in Microfluidics and Clinical Research. We are one of the largest medical device contract manufacturing company in the world and a key CDMO player in the microfluidics market. We offer a consolidated supply chain for your product and a unique array of design, testing, usability, CRO and manufacturing capabilities. We can help bring your product to market faster than ever before.

⟶ [From Development and Clinical Research Services to Contract Manufacturing] PDF
https://www.te.com/content/dam/te-com/documents/medical/global/te-connectivity-ivd-solutions-from-product-development-and-clinical-research-services-to-contract-manufacturing-excellence-in-microfluidics.pdf

⟶ [Human Factors Engineering HFE and Usability Testing Services] PDF
https://www.te.com/content/dam/te-com/documents/medical/global/te-connectivity-ivd-solutions-human-factors-engineering-hfe-and-usability-testing-services.pdf

⟶ [Cartridge Contract Manufacturing and Reagent Blister Pack ] PDF
https://www.te.com/content/dam/te-com/documents/medical/global/te-connectivity-ivd-solutions-contract-manufacturing-and-reagent-blister.pdf

LEADING CMDO PARTNER FOR MICROFLUIDIC SOLUTIONS - Supporting all stages of the product life cycle

• Product Concept  | Assay analysis and transition Microfluidic concept
• Product Development |  Microfluidic automated system development Reagent integration engineering (Dry, Liquid, Lyo) Blister pack custom design Cartridge-to-equipment interface
• CRO and UX |  Clinical Research Organization In-house usability testing
• Transfer to Manufacturing |  Production line set-up Automated and customized Blister reagent manufacturing pilot
• Manufacturing | Manufacturing partner Blister high volume partner
 
Product Development Services: 

• Assay Transfer
• Microfluidic Design
• Reagent Integration
• Instrument Development
•  Blister Pack Design
• Consumable Material Selection

GLOBAL FOOTPRINT FROM DESIGN TO MANUFACTURE
• ✓ Best-in-class Microfluidic CDMO Partner
• ✓ Design Centers - PD, UX and CRO
• ✓ Centers of excellence (automation, laser cutting, polymers ...)
• ✓ State-of-the-art qualified pilot lines
• ✓ Global IVD Footprint (US and Europe)
• ✓ TE Medical Manufacturing Global Footprint

● Microfluidics Design Hubs
● Pilot-lines and Scale Up Manufacturing Plants
● Manufacturing Plants

⟶ TE's Area of Expertise |
"Tap our expertise to reduce your project risk 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. TE, as a trusted partner, offers unrivaled expertise in the areas shown below."

● Point of care ⟶  Unrivaled expertise in design, usability testing, clinical research and manufacturing scale up of low-cost, accurate consumable cartridges and associated instruments.
● Liquid Biopsy ⟶ Our team has worked with numerous manufacturers on advanced microfluidic technology using blood samples
● Drug Delivery⟶ Life Science and pharmaceutical companies are working with us to design and manufacture drug delivery devices for different applications
● Next Gen Sequencing ⟶ Unleash the power of NGS to do RNA or DNA sequencing. Our engineering team can help make your microfluidic and microsensors concepts a reality.
● Single Cell Analysis ⟶ Design, development, and manufacturing of microfluidic isolation techniques for single-cell analysis.
● Cell Therapy ⟶ We help manufacturers apply microfluidics in developing innovative cell therapy technologies.

⟶ Learn more  https://www.te.com/usa-en/industries/medical-healthcare/ivd-microfluidic-solutions/areas-of-expertise.html

Products

•  Assay Transfer:TE helps to bring your conceptualized or newly developed assays to market and scales them to mass manufacturing. With a deep understanding of microfluidic assay functions, regulatory requirements, and system validation, TE ensures that your assay transfer is successfully implemented into a quality-driven framework
•  Microfluidic Design: TE’s microfluidic engineers work to ensure that all functional attributes are reliable and scalable, including biological and chemical assay process integration, microchannel geometries, and different fluid handling mechanisms (microvalves, mixer etc.) with 20+ years of proven microfluidic expertise.
•  Reagent Integration: Our experienced team integrates dried and liquid reagents right into your IVD device, bringing extended shelf life, contamination control, and improved usability. TE offers customized reagent integration techniques including  spotting, lyophilization, liquid handling, and gelification.
•  Instrument Development: TE’s combined approach to microfluidic cartridge and instrument development assures a seamlessly integrated interface. Our engineers work to optimize manufacturability through a holistic approach to development, allowing you to save time and resources.
• Blister Pack Design: TE develops customized, reliable reagent blister packs designed to fit right into your IVD point-of-care device. TE's experts employ Finite Element Analysis (FEA) and stability studies to optimize blister volumes and reduce reagent costs. Our blister designs ensure protection and preservation of reagent stability during manufacturing, assembly and long-term storage.
• Consumable Material Selection: With the expertise of our experienced microfluidic technical and manufacturing teams, trust TE to provide guidance on microfluidics materials selection and assist in the scaling up of mass production for any application.

⟶Contract Manufacturing Services: TE Connectivity's IVD Solutions team is a full  contract development and manufacturing organization (CDMO)  that tailors automated manufacturing services to fulfill your IVD and Life Science consumable and other critical microfluidic components (e.g. reagent blister pack) needs to meet any volume requirements.

• Cartridge Contract Manufacturing: TE manufactures high-precision, high-volume, and cost-effective microfluidic cartridges with a quick turnaround, through our extensive expertise in microfluidics design, nano/micro-fabrication, polymer science, and automated assembly.
• Reagent Blister Pack Manufacturing: Point-of-care devices can benefit from preloaded onboard reagents. TE designs and manufactures reliable blister pack solutions that offer longer shelf life, lower reagent costs, and reduced waste.
• How to scale up :TE's IVD Solutions team has the expertise to bring your project to market quickly and successfully.

⟶Transfer to Manufacturing Services:  TE moves innovative, newly developed IVD devices to Manufacturing by developing pilot lines, bridging manufacturing gaps, and integrating quality-focused automation. TE’s expert team is here to help meet your individual requirements.

• Pilot Line Development:  TE’s pilot line development services help bridge the gap from small batch to moderate-volume production as your product continues to meet growing demand. From novel processes to certified clean room assembly lines, TE manufactures products at the volumes you require without sacrificing quality and/or reliability.
• Design for Manufacturing and Assembly (DFMA):  With cost, safety, and efficacy targets in mind, TE’s process & manufacturing engineers formulate a design risk matrix that focuses on the optimization and simplification of manufacturing methods based on performance, materials, assembly, target volumes, and costs.
• Process Automation:  TE’s experienced process engineering team works to develop automated manufacturing methods for your IVD and Life Science devices . TE integrates automation, resulting in improvements to test efficiency, calibration scheduling, regulatory compliance, and equipment traceability.
• IVD Assay Transfer:  Taking your developed IVD assay from the lab to directly manufacturing phase, can be a challenging process that could require additional time and cost. TE’s IVD specialists help transfer your assays to more cost-effective product with a focus on efficacy, manufacturability, and reproducibility.

⟶HFE & Usability Testing Services  TE Connectivity’s extensive in-house HFE and usability services put user experience at the forefront of development so that your device is well-understood and safe in the hands of consumers.

• HFE and Usability:  TE’s in-house HFE and usability testing services deliver actionable product insights at every step of development, allowing you to go to the market with  confidence in the usability and efficacy of your medical device.
• Formative and Summative Validation Testing:  Our comprehensive formative and summative testing phases recruit a wide range of participants to uncover and validate hidden vulnerabilities in product displays, mechanical controls, alerts, labels, and tools that may create issues down the line.
• IVD Instructions for Use Testing:  TE verifies and validates medical device IFUs so that they’re written with accuracy, readability, and user comprehensibility. Our team provides medical device IFUs that offer safe and effective instructions to intended users, laypersons, and medical professionals alike.

⟶IVD Clinical Research Services:  TE Connectivity is experienced in IVD clinical studies, regulatory submissions and clearances. Our team works in tandem with you during product development to fulfill all clinical and regulatory needs, ensuring that your device meets all requirements for regulatory approval.

• IVD CRO Services:  TE's Clinical Research Organization (CRO) conducts cost-effective clinical studies for IVD consumables, instruments, and other devices. TE provides all appropriate clinical trial planning, study design and execution, protocol development, IRB approval, data management, and report writing services.
• Early Feasibility Studies:  TE fast-tracks IVD device development with early feasibility study expertise. Our experts help verify potential investments and validate conceptual solutions with small-scale usability and pre-clinical studies before incurring the cost of larger validation studies.
• Regulatory Pathway Consulting:  TE´s expertise with FDA regulations, liaising, feedback, and approval pipelines for IVD devices helps increase cost effectiveness and chances of clearance. TE offers the study design, protocol writing, IRB submission, subject enrollment, document preparation, and data analysis required for FDA 510(k) and CLIA Waiver...
• EU & FDA Regulatory Compliance:  Obtaining a CE marking in addition to a 501(k) or PMA clearance can be a daunting task. TE can help ensure that your IVD product complies with EU IVDR and FDA regulations. TE can also provide full CRO studies and act as a regulatory liaison to ensure that your engineering success is also a regulatory success.

●⟶Learn More:  https://www.te.com/usa-en/services-trainings/microfluidic-solutions.html

Services

●⟶Areas in which we excel

• • Study Design & Recruitment
• • IFU/QRG Comprehension Testing
• • Usability Study Execution
• •Formative/Summative Testing
• • 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

⟶ TE's Area of Expertise |
"Tap our expertise to reduce your project risk 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. TE, as a trusted partner, offers unrivaled expertise in the areas shown below."

● Point of care ⟶  Unrivaled expertise in design, usability testing, clinical research and manufacturing scale up of low-cost, accurate consumable cartridges and associated instruments.
● Liquid Biopsy ⟶ Our team has worked with numerous manufacturers on advanced microfluidic technology using blood samples
● Drug Delivery⟶ Life Science and pharmaceutical companies are working with us to design and manufacture drug delivery devices for different applications
● Next Gen Sequencing ⟶ Unleash the power of NGS to do RNA or DNA sequencing. Our engineering team can help make your microfluidic and microsensors concepts a reality.
● Single Cell Analysis ⟶ Design, development, and manufacturing of microfluidic isolation techniques for single-cell analysis.
● Cell Therapy ⟶ We help manufacturers apply microfluidics in developing innovative cell therapy technologies.

⟶ Learn more  https://www.te.com/usa-en/industries/medical-healthcare/ivd-microfluidic-solutions/areas-of-expertise.html

CASE STUDIES:

https://www.te.com/usa-en/industries/medical-healthcare/ivd-microfluidic-solutions/articles-overview.html