Arete Biosciences

Arete Biosciences is a multidisciplinary product development firm serving the diagnostics and medical device sectors. Founded in 2016 and based in Carlsbad, California, the company operates with approximately 40 employees who work across product development, industrial design, clinical operations, and regulatory affairs. The firm has completed over 30 client engagements and supported clients who have collectively raised $500 million in capital.

The company's approach integrates cross-functional teams from the start of product development, combining scientific R&D, engineering, industrial design, and regulatory strategy into a unified process. Their services span assay and consumable development, system engineering, clinical trial management, quality system development, and FDA regulatory strategy. Arete also operates a venture arm that provides direct investment and operational support to early-stage companies.

Arete has worked with clients across point-of-care diagnostics, molecular testing platforms, proteomic technologies, and precision medicine. Their client portfolio includes both venture-backed startups and established diagnostics companies navigating product commercialization and regulatory clearance pathways.

Organizations should consider Arete Biosciences when they need a partner who can navigate the complexities of diagnostics product development with integrated technical and regulatory expertise. The firm excels in situations requiring tight coordination between industrial design, engineering, and regulatory teams, particularly for products facing compressed timelines or seasonal study windows.

Clients can expect a collaborative approach where Arete's team works alongside internal staff rather than operating in isolation. This model works particularly well for organizations seeking to augment existing capabilities or those needing comprehensive support across multiple product development functions simultaneously.

Arete Biosciences operates exclusively within healthcare, focusing specifically on in vitro diagnostics and medical devices. The company has deep expertise in FDA regulatory pathways including 510(k) clearances, clinical trial design for diagnostic performance studies, and quality system compliance with ISO 13485 and 21 CFR Part 820 requirements.

Their work spans infectious disease testing, precision medicine applications, proteomic biomarker platforms, and point-of-care molecular diagnostics. The clinical operations team manages multi-site studies, investigator relationships, and protocol execution specifically for diagnostic device validation, demonstrating specialized understanding of the unique regulatory requirements in this healthcare subsector.

The ideal client is a diagnostics or medical device company—either venture-backed or established—developing point-of-care, molecular, or proteomic testing platforms. They need integrated support across product development, clinical validation, and regulatory pathways, and value a partner who can embed with their team for sustained collaboration rather than providing arms-length consulting.