Early Feasibility Studies for IVD Devices
Test the viability of your IVD device concept and get it to market with TE Connectivity's early microfluidic feasibility studies.
If you want to bring a complex assay to the market, you need to determine whether it's technologically (and commercially) viable. TE's expertise in small-scale clinical studies provides valuable insights before a larger pivotal study is performed.
Our team provides end-to-end support for microfluidic device feasibility studies, including full in-house clinical research and usability testing. Because of our specialty in microfluidics and in vitro diagnostics (IVD), we have deep knowledge of the regulatory requirements associated with your device classification and can advise you on larger study designs and regulatory strategies. Of course, early microfluidic feasibility studies may also reveal unanticipated issues with design or performance. In that case, TE can help correct them prior to conducting a more expensive clinical study.
Core Competencies
- Microfluidic Feasibility Studies
- Project Scoping and Planning
- End-to-End Project Management
- Study Design and Protocol Writing
- Site and Laboratory Identification, Qualification, Selection, and Management
- Study Participant Recruitment
- Electronic Trial Master File (eTMF) Creation and Management
- Electronic Data Capture (EDC) Design and Build
- Customized Data Dashboard
- Statistical Planning, Data Management, and Analysis
- ISO 20916 Compliance (for IVD clinical performance studies)Regulatory Strategy DevelopmentFDA Q-Sub Submissions and Meetings
- Dual 510(k) and CLIA Waiver, 510(k), De Novo and EUA Submissions
- Regulatory Agency Liaison
- Human Factors Engineering (HFE) ComplianceTask Analysis
- Formative and Summative/Validation Testing (In-House Testing Lab)IFU/Quick Reference Guide (QRG) Analysis and Comprehension Testing
- Design Feedback from Human Factors Experts
- Friendship Groups, In-Depth Reviews, Expert Reviews, Card Sorting, Wireframing, and Journey Mapping
Proven Expertise, From Concept to Market
Clinical Research Services
Reduce your overall project risk and improve your odds of regulatory clearance with TE's early microfluidic feasibility plans and clinical research services. TE facilitates the clinical research necessary to evaluate device design concepts in the scope of clinical safety and device functionality while establishing a direct collaboration with the FDA and designers. TE has extensive experience across the clinical and regulatory landscape—we've achieved numerous dual and straight 510(k) clearances and CLIA waiver submissions for IVD clients worldwide.
| Point-of-Care | Self-Test IVD | Liquid Biopsy | Cell Therapy | Single-Cell Analysis | Drug Delivery | Next-Gen Sequencing (NGS) |
|---|
Device Usability Testing
TE’s in-house usability testing and HFE services provide crucial insights for product development, regulatory approval, and clinical research. Usability testing facilitates the development of microfluidic devices by confirming that requirements and functional features are effective, ensuring that your designs will deliver a superior user experience and achieve commercial success. Our team has the expertise to perform human factors testing required in support of regulatory submissions.
