At EOI, we've been building advanced instruments for a long time. One reason for our success is our large inventory of working designs, and another is the way we go about doing it. This post walks through a typical sort of development plan for a challenging customer requirement, in the form of a hypothetical email proposal outline for a fibre-coupled noninvasive glucose sensor similar to the one we did in 2013.
(You can also read about a recent project that went a lot like this, except with a single prototype stage.)
I hope you and yours are doing well.
The blood solute project is an interesting one that will make a difference to a lot of people, as well as being financially promising. Your team looks like a very good group of people to work with, so I expect it'll be a lot of fun. The project goals as outlined focus on getting a working preproduction version through an FDA animal study as soon as possible, together with a close eye on on design for manufacturing.
We propose to develop a prototype system at time and materials (NRE), in the following stages:
1. Photon budget. Our usual method starts with a theoretical performance calculation, which we call a 'photon budget.' That lets us know how good the measurement could be, which is key to knowing how well the apparatus is performing. Knowing the physical limits enables us to make intelligent tradeoffs between performance, cost, size, and schedule with minimal risk. In our experience, the final system nearly always gets very close to the theoretically optimal performance, and does it without needing a lot of expensive parts. In this case we have our existing transcutaneous blood solute photon budget to start from, so this is not a lot of work. The photon budget includes the fiber bundle design. (We have a supplier that makes very nice custom bundles in a week or so for a decent price.)
2. Simple proof of concept. The photon budget leads naturally to a set of performance specifications. Once those have been agreed, we generally do a preliminary proof-of-concept using hand-modified or entirely hand-wired circuits and simplified optics and mechanics. These days we have enough existing designs that our POC systems are mainly circuit boards in boxes, sometimes modified, and wired up with cables and (in this case) fiber bundles. The POC system allows us to verify the photon budget, and lets you see how the final system will perform. (If you like, we can ship you the POC so your folks can evaluate it—it'll be pretty easy to use.) This approach is fast and inexpensive, and gives you good management control. Thus it reduces the technical and financial risk considerably without sacrificing time-to-market.
For this application we plan to use our low noise constant power / constant current laser driver (The LC120C), and one of our nanoamp photoreceivers (The QL01 / QL02), which we have in stock. The POC system would be suitable for use with tissue phantoms and informal, in-house human tests to help guide the detection algorithm development. While these are obviously not the same as a clinical trial, if the system performs well we will have good confidence in the trial outcome, and so can proceed comfortably to the next stage. (If for some reason it does not do so well, it won't have consumed a great deal of time or money.) Based on our previous experience and our existing products we expect that this development will take about four to six weeks.
3. Brassboard systems for animal trials. After the POC system has been approved, we would be ready to build the preproduction versions, which would include the final optomechanical design, circuit board design / fabrication, and bring-up of 1 to 5 systems for test. We would do this in cooperation with your mechanical and industrial design folks, who are in charge of the product's look, packaging, replication, and so on. (A brassboard is a prototype suitable for use in the field, as opposed to a breadboard, which is a lab system.)
These steps aren't quite this orthogonal in practice. The design will need to be manufacturable at the right unit price, testable, and be able to fit the required form factor, all of which will influence the prototype design as well.
As you know, our focus is high performance, low noise electronics, optics, and software, but we do a fair amount of 3D CAD and EDA in-house, so working with outside groups who specialize in those is straightforward. For the transcutaneous glucose sensor project we bring a track record of working products and the only reliable working example of a transcutaneous ethanol/glucose detector that we know of. Except for a couple of patents that you've seen, and the detailed design of the hand cradle, that proof-of-concept design was based on our pre-existing calculations and other design expertise in fibre-coupled photoemission spectrometers for semiconductor inspection.
We have many existing designs and products that we designed for similar challenging applications.
We are bringing three different sorts of IP that potentially apply to this project.
1) The optical design, front end, and instrument design know-how that allows us to consistently produce instruments that extend the state of the art while keeping the bill-of-materials cost very low. This cost/performance advantage is our key technical skill. Designs we create are heavily influenced if not directly based on many years of experience. "Building Electro-Optical Systems" has helped a generation of researchers and product designers, as we hear over and over from workers in the field.
2) Experience in fiber-coupled transcutaneous blood solute detectors, including detailed photon budgets, detailed fiber bundle design, and theoretical models.
3) Several existing products and designs that are likely an excellent fit for the final product.
The value of this IP to the customer is higher performance, faster time-to-market, and, most critically, greatly decreased technical risk. We've done this stuff very successfully for a very long time, and we know where the potholes are.
We propose a two-tier license. The first (lower) tier is for items 1 and 2 above, and would apply to whatever we design for you, irrespective of whether it embodies our existing detailed designs. The second tier would apply if our existing products (whether modified or not) are actually incorporated in your product. We're quite happy either way, but in our experience using pre-existing products is generally a big win, especially since the BOM cost reduction is more than enough to pay the royalty. Based on our existing deals, we suggest rates of 2.5% and 5% for the two tiers, but the exact terms will obviously depend on how much of each kind of IP is included, TAM, competitive landscape, and so on. We want to succeed together with you.
This is a great project and we'd love to be involved in making it a reality. I look forward to hearing from you.