Arete Biosciences
A multidisciplinary partner for healthcare and life-science ventures that combines R&D, product development, industrial design, clinical operations, quality/regulatory strategy, and venture support. Offers end-to-end services from de-novo assay development and instrument engineering through pilot production and regulatory submissions, with embedded teams or fully outsourced engagement models.
Industries
Nr. of Employees
small (1-50)
Arete Biosciences
2270 Camino Vida Roble, # K, Carlsbad, CA 92011
Products
End-to-End Product Development
Comprehensive support for bringing medical devices from concept to market, including design, engineering, quality management, and regulatory compliance.
Clinical, Quality & Regulatory
Expertise in clinical trials, quality assurance, and regulatory compliance for in vitro diagnostics and medical devices.
Assay Development
Development of assays including nucleic acid extraction, PCR, isothermal amplification, and next-gen sequencing library preparation.
Consumable Design
Design and development of consumables and cartridges, including process development and integration of assay chemistry.
Platform Design
Design and development of instruments, automated workflows, and user interfaces, including risk management and usability testing.
Human Factors Engineering
Integration of human factors engineering principles to ensure safety, usability, and regulatory compliance in product design.
End-to-End Product Development
Comprehensive support for bringing medical devices from concept to market, including design, engineering, quality management, and regulatory compliance.
Clinical, Quality & Regulatory
Expertise in clinical trials, quality assurance, and regulatory compliance for in vitro diagnostics and medical devices.
Assay Development
Development of assays including nucleic acid extraction, PCR, isothermal amplification, and next-gen sequencing library preparation.
Consumable Design
Design and development of consumables and cartridges, including process development and integration of assay chemistry.
Platform Design
Design and development of instruments, automated workflows, and user interfaces, including risk management and usability testing.
Human Factors Engineering
Integration of human factors engineering principles to ensure safety, usability, and regulatory compliance in product design.
Services
End-to-end product engineering for diagnostics and medical devices including assay development, consumable design, instrument engineering, embedded software, subsystem prototyping, and manufacturing readiness.
Concept development, CAD refinement, prototyping, packaging, labeling, IFU design, and human factors engineering to align user experience with regulatory requirements and manufacturability.
Clinical strategy and execution, custom clinical data systems, QMS development, regulatory strategy and submissions, verification/validation studies, and sample logistics.
Direct and in-kind investments, fundraising and investor support, business strategy, market mapping, IP/regulatory pathway guidance, incubation and execution support to align product milestones with funding objectives.
End-to-end product engineering for diagnostics and medical devices including assay development, consumable design, instrument engineering, embedded software, subsystem prototyping, and manufacturing readiness.
Concept development, CAD refinement, prototyping, packaging, labeling, IFU design, and human factors engineering to align user experience with regulatory requirements and manufacturability.
Clinical strategy and execution, custom clinical data systems, QMS development, regulatory strategy and submissions, verification/validation studies, and sample logistics.
Direct and in-kind investments, fundraising and investor support, business strategy, market mapping, IP/regulatory pathway guidance, incubation and execution support to align product milestones with funding objectives.
Expertise Areas
- Assay development and reagent formulation
- Microfluidic consumable and cartridge design
- Medical device and instrument engineering
- Embedded software and firmware for devices
Key Technologies
- Microfluidics
- Lyophilization of reagents
- Embedded firmware and device control
- Optical detection (fluorescence/absorbance)
News & Updates
In-vitro diagnostics (IVDs) in times of crisis: what manufacturers, labs and clinicians need to know
Discussion of regulatory guidance and operational considerations for IVDs during public health emergencies, focusing on FDA EUA frameworks.
Case narrative describing partnership to advance a multi-cancer test from prototype to clinical validation and planned CLIA-lab launch.
Article on embedded consulting models, benefits and implementation considerations for organizations engaging external teams as integrated resources.
In-vitro diagnostics (IVDs) in times of crisis: what manufacturers, labs and clinicians need to know
Discussion of regulatory guidance and operational considerations for IVDs during public health emergencies, focusing on FDA EUA frameworks.
Case narrative describing partnership to advance a multi-cancer test from prototype to clinical validation and planned CLIA-lab launch.
Article on embedded consulting models, benefits and implementation considerations for organizations engaging external teams as integrated resources.