Can a sample carry its own test?

Field research and clinical workflow map

Completed 2015–16

Concept and paper-test prototypes

Built

Patent application (US20190145900A1)

Published 2019 · listed abandoned

Team, accelerators and competitions

2016–17

Clinical validation of diagnostic accuracy

Not established

Commercial product

None

04Situation

Sanguine began as a design question in Rensselaer's Inventor's Studio: could low-cost diagnostic signals be integrated into the process of collecting and handling a blood sample? I founded the venture and led it: field research and product definition first, linking clinical workflow to technical feasibility and commercialization, then a team I built to take it through accelerator programmes and competitions. ^[S07][I02]

The problem that started it is a resource one. In settings where a laboratory is hours away, a sample is drawn, transported, tested and reported in separate steps, each of which can fail or be delayed. Paper-based diagnostics — tests printed on treated paper that change colour in the presence of a target — promised to collapse some of those steps, but mostly as separate strips handled separately. The question was whether the test could travel with the sample, inside the thing that already holds it.

05Research

The early work was field research before it was engineering: observing how samples were actually collected, labelled, moved and read, and where the handling broke down. That produced a clinical workflow map and a short list of constraints any device would have to respect — it could not add steps for the person drawing the sample, it could not introduce a new contamination route, and it had to be readable by someone without training or equipment. ^[I01][I02]

From there the work moved to concepts and paper-test prototypes: where a window could sit, how a strip could be sealed and still contact the sample, and what a legible result looked like in poor light. The hero figure is a schematic of that concept, not a photograph of a prototype. One early prototype is on the public record: it is the first figure of the patent application (Fig. 3, below). The other originals are in the 2015–16 archive and will appear when recovered.

06Design decisions

Integrate the test into the container. The defining decision was to treat the collection bag or vessel as the device, rather than designing a better standalone strip. It is what the name promises and what the application describes; it is also what made the engineering hard, because a window in a sealed container is a new failure mode.

Define the product before perfecting the chemistry. As founder, I spent the early effort on the workflow, the user and the commercial path rather than on the assay itself, on the grounds that a technically excellent test that added a step for the nurse would not be used. The chemistry was taken further once the team was in place.

Build a team rather than work alone. In 2016 I hired a team to work on Sanguine with me (Mitchell Erbe, Vincent Arena, Michael Smith and David) ^[I23] so the venture could run accelerator programmes, competitions and the patent filings at once. I coached the pitch; in 2017 Vincent presented it at the competitions below. The alternative not pursued was continuing alone.

07Artifact

Three things exist from Sanguine:

• A published U.S. patent application, US20190145900A1, System for implementing paper diagnostic testing, naming me as sole inventor and Sanguine Diagnostics as applicant. It rests on a provisional application of May 2016 and a second in April 2017, entered the international (PCT) route in May 2017, was published in May 2019 and is currently listed as abandoned. ^[S06][S39] It is an application, not an issued patent, and its more general paper-device claims are broader than the original self-testing-bag concept. Its drawings are on the patents page.
• Early prototypes and sketches of the concept — colorimetric strips, sealed windows, container forms — in the 2015–16 archive, pending recovery.
• The venture's competition record. In January 2017 Sanguine won an award at Siena College's inaugural biomedical business-plan competition; the coverage identifies Sanguine as founded by me and names Vincent Arena, who presented for the team, as the award's recipient. ^[S07][S14] In March 2017 Sanguine was a finalist in the Advanced Technology track of the New York Business Plan Competition's Capital Region round and won its Capital Region Cup; Vincent entered and presented for the team, and I coached him. ^[I21]

08Outcomes

Sanguine did not become a product. Its diagnostic accuracy was never clinically established, the application was not pursued to grant, and no device was marketed. What it produced was a defined problem, a documented concept with a public record, a workflow map that still reads correctly, and a team that took it into competitions and accelerators.

The 2017 competition results were the venture's, won by the team I employed and led, with Vincent Arena presenting and me coaching. My part was founding and leading the venture, the field research and product definition, and the invention: I am the application's sole inventor, from the first provisional in May 2016 onwards.

09Reflection

Sanguine was my first encounter with the gap between an invention and a product, and with how much of the latter is workflow rather than mechanism. Everything I did later at Ford — starting from the garage rather than the drawing — came from watching a good idea stall on the step it added for the person holding the sample.

It also taught me how to lead a team around an idea: define it well enough that others can work on it without you in the room, say clearly what is and isn't proven, and credit the people who carry it in front of judges. That is the posture this page tries to keep.