Diagnostics & life sciences

Expertise and Resources to Achieve Commercialization

Projects Completed

Patents Filed

Years Experience

What We Do

Common Project Types Across the Continuum of Diagnostic Commercialization

Point-of-Care Instruments

Cartridge Design & Development

Pre-Built Technology & Proof of Concept Prototyping

Centralized Lab Equipment Development

Commercial Roadmapping & Health Economics Modeling

Regulatory Pathway Strategy, Assessment & Submission

Controlling Risk

From Concept Through Manufacturing

We specialize in the design, engineering, and manufacturing of diagnostic technologies. Our team has experience with a multitude of platforms, including point-of-care, centralized lab equipment, cartridge development, as well as early-stage technology development and proof-of-concept prototyping with our pre-built technology stack.

Learn More →

Human-Centered Digital Experiences

Meaningful Digital Touchpoints & Data Collection

We have deep expertise in user experience and user interface design for diagnostic systems and companion mobile solutions. Our process is rooted in understanding user needs and enabling seamless data collection. We have experience with a multitude of cloud platforms allowing for scalable connectivity, data exchange, remote accessibility, and better learning.

Learn More →

Clinical & Economical Evidence

Understanding Reimbursement, Pricing, and Go-To-Market Strategies

We partner with clients to successfully navigate the complex reimbursement landscape of novel diagnostic platforms. Our relationships with payers and providers help our clients understand coverage and pricing considerations, ensuring go-to-market strategies are aligned and viable.

Learn More →

Global Regulatory and CRO Services

Establishing your Product Pathway

We are recognized for our well-established relationships with FDA, EMA and market authorization agencies worldwide. With our track record of successful diagnostic product submissions, we’ll help you determine the required regulatory pathway — whether that be 510(k), PMA, or De Novo classifications. Our team of clinical research experts can help design and manage trials on a global scale.

Learn More →