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RESEARCH AND DEVELOPMENT

Our Research & Development division is committed to pioneering next-generation
healthcare solutions. Our portfolio spans Continuous Metabolic Monitors, Smart Fertility Monitors, IVD Instruments & Reagents , and Point-of-Care Solutions,
designed with precision, sustainability, and affordability in mind.

Our multidisciplinary team of scientists, engineers, and innovators works closely to integrate clinical expertise, user needs, and regulatory compliance into every stage of development. Through this synergy, we transform groundbreaking concepts into sustainable medical technologies that enhance patient outcomes and set new standards in diagnostics.

Concept & Feasibility

Early feasibility studies and user-centered concept designs ensure that innovation is both practical and impactful.

Design & Prototyping

Concept validation to functional prototypes while risk management & design controls guide development toward safe & scalable outcomes.

Validation & Compliance

Rigorous analytical validation, preclinical testing, & collaborative clinical studies, ensuring reliability & regulatory readiness.

Launch & Scale-Up

Regulatory approvals, manufacturing readiness, scalable production with optimized cost with sustainable processes for global launches along with post-market surveillance support.

FROM PROTOTYPE TO MARKET, PRECISELY COMPLIANT

We translate prototypes into scalable products through a disciplined design-for manufacturing approach. From material selection to assembly processes—is optimized for efficiency, sustainability, and cost-effectiveness without compromising quality or precision.

Our development is guided by global regulatory frameworks, ensuring every product meets the highest standards of safety and reliability. From ISO 13485 and IVDR to US FDA requirements, compliance is embedded into our design and validation processes from the very start.

Strategic R&D in Precision Healthcare

At AetherBio, Research and Development is a disciplined process that transforms complex clinical challenges into actionable solutions. Our R&D strategy integrates translational science, engineering rigor, and user-centric insights to design devices and diagnostics that are accurate, scalable, and clinically meaningful. Every initiative aligns with long-term sustainability and regulatory foresight.

Design for Manufacturing with Operational Precision

Design for Manufacturing (DFM) at AetherBio goes beyond efficiency—it ensures every prototype is manufacturable at scale while maintaining stringent quality standards. We optimize material selection, assembly workflows, and supply chain integration to reduce variability, minimize cost, and accelerate market readiness without compromising device performance.

Iterative Prototyping and Clinical Validation

Our development pipeline emphasizes rapid prototyping paired with iterative testing in controlled and clinical environments. Each design cycle incorporates analytical validation, human factors evaluation, and real-world feedback to ensure devices meet stringent functional, regulatory, and usability standards before advancing toward scale-up.

Embedded Regulatory Compliance

Regulatory strategy is embedded into every stage of product development. From ISO 13485 design controls to IVDR and US FDA 21 CFR requirements, our approach ensures compliance is proactive, not reactive. By integrating risk management, documentation, and validation early, we streamline approvals while maintaining the highest standards of safety and efficacy.

From Innovation to Market Impact

AetherBio’s R&D framework bridges the gap between scientific innovation and commercial deployment. By harmonizing design, validation, compliance, and manufacturability, we accelerate time to-market, enhance adoption, and deliver reliable, impactful diagnostic solutions that redefine standards in precision healthcare.