Pioneering Early Detection of Cancer

Liquid Biopsy Platform for Enrichment and Imaging of Circulating Tumor Cells (CTC’s)


The Challenge

Design an automated IVD instrument capable of performing liquid biopsy for early detection of metastasis and monitoring of patients during treatment — all through non-invasive blood testing.

The Solution

RUBYnanomed selected Veranex for a multi-year project to develop the instrument and consumable. The project is run seamlessly by remote teams in Braga, Portugal, and US-based Veranex employees.

Project Phase 0

Understanding, Contextual Inquiry, Concepting

We used RUBYnanomed’s existing prototype as a jumping-off point to develop a fully automated processing system that could hit the performance and through-put needs of the client. We also developed an understanding of user needs, created a task analysis, and further refined opportunities for development. The team identified focus areas and par concept generation, leading to a defined product architecture and four-channel design.

Project Phase 1

Technical De-Risking, Feasibility, Design Vision

Veranex moved forward with technical development and prototyping of cartridge and capital to determine feasibility on bench. The final prototype was hand-delivered in Portugal by the engineering team and included training and a live demo. We worked on concept generation around key usability considerations on the cartridge architecture to determine impact to capital and held a Design Language Workshop with the client to define brand values and aspirations. These inputs were synthesized into a single aesthetic design direction and fed into several rounds of exterior design concept sketching, refinement, and selection of direction. Additionally, we reviewed low-fidelity prototypes of capital and cartridge as well as interactive VR simulation in a lab environment and 3D animations to help tell the product story and develop interest from potential labs.

“The development and industrialization of a medical device is a long and winding road. Finding the fitting industrial partner to develop a science-led innovative product is just step one. We came to learn through this partnership that a successful product development program is much more, and ours is based on solid planning, iterative design and implementation, and effective communication. It naturally turned into a seamless collaboration between two close teams that could not tell their geographic distance.”

Dr. Lorena Diéguez

Combining Specialties to Jumpstart the Development Process

Our team’s expertise in microfluidics and cartridge development enabled us to move quickly in concept generation and prototyping/testing, which meant we were able to overcome and avoid technical challenges that could have slowed the process down.

The on-site visit at the conclusion of Phase 0 allowed for a jumpstart on understanding user needs and system requirements. Leveraging a larger team for the visit gave us the ability to show expertise and prowess across a gamut of specialties including engineering, human factors, industrial design, and biomedical science. We followed a robust process — investigating and understanding both technical and human-centered challenges, developing solutions, and efficiently determining the best path forward based on the needs of the client.

Our relationship with the client contributed positively to the success of the program. We built up trust through consistently delivering on time and on budget while remaining flexible. RUBYnanomed is now seeking to expedite its time-to-market, show clinical results using the system Veranex developed and, secure the funding needed to bring its life-changing technology to the US and EU markets.

“The relationship with the client really contributed positively to the success of the program. After earning their trust through consistent execution and clear communication, they saw us as partners in product development and were engaged, curious and contributed positively throughout the development process.”

Christopher Chaput, Sr. Manager, Product Development Program Management at Veranex