Translational medical devices and integrated platforms

Overview

The Ozdoganlar Lab develops manufacturing-enabled, clinically oriented medical device platforms that integrate microfabricated components, sensing/actuation, packaging, and workflows into deployable systems (handheld, wearable, or implantable). Our emphasis is on advancing device concepts beyond proof of principle by engineering for repeatability, scalability, usability, verification/validation readiness, and real-world operating constraints.

Our approach

We take a platform engineering approach: co-design device architecture, manufacturing process, and intended clinical workflow from the start. This includes design-for-manufacture/assembly, early performance metrics, and structured pathways toward verification/validation and usability testing aligned with translation expectations.

Why it matters

Many promising biomedical inventions stall because they lack:

Reliable performance across users and settings

System integration (mechanical and/or fluidic design, sensors, electronics, packaging, and workflow fit)

Validation readiness (clear metrics, verification/validation planning, documentation aligned with adoption)

Key research thrusts

Handheld / near-patient device platforms aligned with bedside/POC workflows

POC biosensing and multiplexing platforms with scalable manufacturing pathways

Implantable and wearable systems with packaging and biointerface considerations

Reliability and validation planning: repeatability metrics, failure-mode analysis, verification/validation readiness

Manufacturing-to-clinic translation: process controls, scalable fabrication, integration planning

Sample projects

BIO-INSYNC (ARPA-H): Biointegrated Implantable Systems for Cell-based Sensing and Therapy: A CMU-led ARPA-H program developing implantable “living” systems that use human cells to continuously measure hormone levels and deliver precise replacement doses, aiming to reduce the burden of lifelong daily treatment. [1]

Biosensor Tattoos for Biomarker Monitoring: Skin-compatible biosensing platforms designed for practical, minimally invasive monitoring with translation-oriented design considerations. [2], [3]

POC Multiplexing Biosensor Array (scalable manufacturing): Platform concept targeting multiplexed point-of-care sensing with manufacturability-first development. [4]

NIH R01 (NIGMS): Handheld Tissue Force Microscope for In Situ Tissue Mechanics Mapping: Development of an actively stabilized handheld instrument with tremor compensation, integrated force microscopy, and optical/visual tracking to perform localized dynamic mechanical analysis (DMA) on embryos, organoids, and small tissues, with quantitative validation on known materials and demonstration in vivo.

Methods and capabilities

Precision microfabrication and scalable manufacturing (micromolding, micromachining, process design for repeatability)

Device/system integration (mechanical design, packaging concepts, integration planning)

Microfluidic system/cartridge design, fabrication, modeling, and experimental validation for integrated diagnostic and near-patient workflows

Measurement science and performance characterization (repeatability, failure modes, operating envelopes)

Translation planning artifacts and milestone-driven validation strategies