• Mike


I recently sat down with a founding team and they shared two pieces of advice that they received, which they also happily ignored:

Piece of Advice #1: You should take this technology and make a diagnostic [for suggested disease X] using it.

Piece of Advice #2: You should take this technology and use it to discover a therapeutic [for suggested disease X]

These are noble and awesome goals for sure, and the intention behind the advice is good.

Here’s the thing, if it can do both of those things (and the advice relies on that fact), isn’t the work to be done really scaling this technology so many, many teams can use it to generate diagnostics and therapeutics? If you wanted to have the biggest impact on human health, the answer is pretty clear.

These founders agreed, and that is the path they have chosen. They commercialized for RUO, which we will cover in a bit more depth. They already have 10+ early access customers using their solution – the way I see it, they are not just tackling just one diagnostic or disease, they are now taking more than ten shots on goal, and they can scale to take 1000s.

Research Use Only

This is the beauty of enabling technologies for research, and it's enabled by the designation RUO. RUO stands for Research Use Only – and its a label and designation that means the products are not subject to nearly any regulatory controls under the In Vitro Diagnostic Regulation (EU) or FDA.

There is no filing requirement with these agencies, and while we don’t have the time or space to cover what happens when this is done with the intent to use them for diagnostic purposes (“Laboratory Products for “Research Use Only” (RUO) – Often a Dangerous Claim.” Johner Institute. 20 November 2021. link), its key in accelerating research work and how we work with companies to get to market ASAP.

space shuttle kurt cotoaga unsplash - Michael Stadnisky

We are focused on RUO in its ethical and commercially critical purpose – enabling researchers. RUO means that you can offer and sell products to customers today. We are operating under the assumption that your innovation will either solve something that currently sucks (revolution of the boring [link to previous blog post of this name]) or is an early stage research tool – in either case, solving a core customer problem that you know better than anyone.

RU-Woah (couldn’t help myself)

This is incredibly important for all sides of the equation and here are some of the key implications of RUO commercialization:

  1. You can offer an early access program for your products early in the product development life cycle. This enables validation and iteration around your product market fit. Critically, have you addressed the customer pain point(s) you were trying to solve for in the first place? Can you get a sense of the value of your product and how it was used in detail? Is this an indispensable tool now for the customer or not? I cannot emphasize enough how important this is – choosing the right customers to work with early to get the right feedback to begin your iterations.

  2. You can sell a finished product immediately with no restrictions, there is no waiting for a regulatory path or approval as you expand your product portfolio. Following the radical customer intimacy that you are establishing with your early adopters, you can advance this to determine

  3. What else is there to be done with your product before you sell it to other customers who may not be willing to take on the “risk” of a new product or do more real work to make it, well, work. (For instance, let’s say you start with a conjugation kit and then move to conjugated antibodies.)

  4. Is there an opportunity to break out products by application or for different discovery workflows? This is important, and its full contact product management that will pay strategic dividends.

  5. You can engage actively at every step of the way with your customers and learn more about their applications. If done right, RUO commercialization is really a partnership. You are bringing value to researchers who really invest in your technology. (and as an aside, if you are doing this right, its wonderful) Life science researchers are really open about their applications and in the tools world, proprietary info doesn’t really need to be shared (e.g. on the molecules being screened or the target being drugged). You only need to know the needs, not the target. This virtuous cycle should be started as early as possible (see 1, above).

In the end, RUO commercialization means that you start and “finish” with the customer iteratively, and become intimately familiar with how they are using your product, its adjacent workflows, and how and what else you can improve and solve for. You will know… quickly if you are on the right track.