Featured insights and articles

A small diagnostic company planned a two-year, $1.5M path to 510(k) clearance. Three years and $4M later, they still hadn't submitted. The team shares where internal capabilities were overestimated, where cost-saving decisions created costly rework, and why integrating clinical, regulatory, and analytical work from day one matters more than the submission itself.

Medical device development is a complex, high-stakes process that demands specialized expertise across preclinical testing, clinical research, and regulatory strategy. Arete Biosciences supports MedTech companies as an integrated CRO partner, helping teams navigate evolving regulatory requirements, generate robust clinical evidence, and move efficiently from early development to market approval.

IVD-focused CROs help diagnostic companies manage the complexity of developing in vitro diagnostic tests by providing specialized expertise in assay development, analytical validation, and regulatory-ready data generation. Arete Biosciences operates as a true development partner, integrating directly with sponsor teams to reduce risk, shorten timelines, and advance IVD programs from early concept through regulatory readiness.

IVD product development is a tightly regulated process of designing, validating, and commercializing diagnostic tests that must demonstrate analytical validity, clinical performance, and regulatory compliance from concept to commercial launch. Arete Biosciences supports this journey by integrating scientific rigor, quality systems, and proactive regulatory strategy across every stage of development.

LGBTQ+ college students face a disproportionately high risk of HIV, yet stigma, confidentiality concerns, and gaps in inclusive campus healthcare continue to hinder early detection. Campuses can improve outcomes through expanded screening tools, LGBTQ+ affirming provider training, mobile testing clinics, and strategic community partnerships.

Clinical trials are the backbone of medical progress, yet they are notoriously slow, expensive, and often fail due to obstacles like poor patient recruitment and protocol design. Artificial Intelligence and Machine Learning are not just optimizations; they are a fundamental shift that promises to solve these centuries-old problems, bringing life-saving drugs to market faster and more efficiently.

When public health emergencies emerge, such as new infectious outbreaks, rapid access to reliable diagnostic tests is crucial. The FDA’s newly finalized guidance on IVDs during emergencies (September 2025) establishes a clear, structured framework for how the agency will manage diagnostic testing under Section 564 Emergency Use Authorization (EUA) declarations.

Dr. Shalini Gupta, Founder and CEO of Asima Health, left academia to develop decentralized, point-of-care cancer diagnostics for earlier detection. Partnering with U.S. accelerator Arete Biosciences, Asima is advancing to clinical validation in Chicago and Tampa, with its first multi-cancer test launching next year.

Embedded consulting integrates external consultants directly into client organizations, offering deeper understanding, sustainable solutions, and seamless knowledge transfer. While challenges like resistance and objectivity exist, the model's collaborative approach drives lasting transformation and growth.

Opting for an Electronic Data Capture (EDC) database over traditional paper-based forms can vastly improve the robustness and efficiency of your clinical study documentation. Arete Biosciences' dedicated in-house data management team designs and deploys fully compliant, tailored EDC systems that streamline real-time monitoring, error resolution, and data validation for your clinical trials.