Delve

Delve is a product innovation firm with 55+ years of experience serving healthcare, consumer, and commercial industries. The company operates from four U.S. offices in Boston, Philadelphia, Madison, and San Francisco, employing over 200 professionals across research, strategy, design, and engineering disciplines. Delve has completed over 10,000 projects and holds more than 1,800 patents.

The firm specializes in bringing connected medical devices and digital health platforms from concept to market, with particular expertise in FDA regulatory compliance, human factors engineering, and microfluidics diagnostics. Their cross-disciplinary teams integrate industrial design, mechanical engineering, electrical engineering, software development, and user research throughout the development process. Notable healthcare work includes FDA-cleared devices like Lazurite's ArthroFree wireless surgical camera, Dexcom's G6 continuous glucose monitoring system, and Trice Medical's Mi-Eye+ diagnostic device.

Delve's client portfolio includes major medical technology companies such as BD, Johnson & Johnson, and Stryker, alongside digital health startups and mid-market innovators. The firm has received over 200 design and innovation awards and maintains active thought leadership through technical white papers, tolerance analysis tools, and educational content on medical device alarm design and connected product development.

Choose Delve when launching a complex medical device or connected health product that requires FDA regulatory navigation, human factors validation, and production-ready engineering. Their value proposition centers on reducing technical risk through integrated teams that prevent the disconnects common when working with separate design, engineering, and regulatory consultants.

Expect a structured development process with formal research phases, design controls alignment, and design history file documentation built into deliverables. Projects typically span 6-18 months depending on regulatory class and technical complexity, with teams remaining engaged through manufacturing transfer and post-market activities.

Healthcare represents a core focus for Delve, evidenced by long-term relationships with BD, Johnson & Johnson, and Stryker, plus successful FDA clearances for clients like Lazurite and Trice Medical. The firm demonstrates specific expertise in medical device design, digital health platforms for chronic disease management (diabetes, cannabis therapeutics), surgical instrumentation, diagnostic equipment, and connected health wearables.

Their healthcare work spans medical devices (continuous glucose monitors, arthroscopy cameras, joint diagnostic tools), digital therapeutics platforms, and IoT health wearables with corresponding mobile applications. Technical resources addressing microfluidics challenges, medical device alarm design, and FDA regulatory delays indicate active engagement with current healthcare product development concerns beyond general industrial design.

Medical device companies developing Class II or Class III products requiring FDA clearance or approval, particularly those with connected features, digital companion apps, or novel diagnostic technologies. Organizations with $500K+ development budgets seeking a single partner to manage research, industrial design, mechanical/electrical/software engineering, human factors, and regulatory documentation. Well-funded startups or established companies launching new product categories where reducing time-to-market risk justifies premium consulting investment.