Is Your Technology Ready for Commercialization?

Issue 19.

Imagine a truly new technology. Something that is not a simple progression of prior technologies, but is truly new to healthcare - or even new to humanity. It might seem like SciFi today. Yet if you are successful, it will join MRI scanners, and surgical robots, and even perhaps CRISPR as technologies that are embodied in the tools that physicians and other healthcare providers use every day. Where do you start in order to move it there?

Not every technology is ready for development

Some technologies are little more than science. An amazing physical, medical, biochemical, genetic or other principle, which has potential applications limited only by imagination, but which is not anywhere near ready to be used on patients. Such a technology is both inspiring and dangerous (to your company's health, at least). The recent glut of AI tools is a great example of this situation.....Ask the venture capitalist folks how many variants of a generic AI tool they have seen in the past two years, if you doubt me. When you have a hammer, you are looking everywhere for a nail to use it on. I've seen this over and over in the world of biomaterials. "Isn't this cool? Where can we use it?" And honestly, many of them really WERE cool. But unless you start with the problem, you will often find yourself forcing a technology into a solution that no customer actually wants.

"Bench to Bedside" is the cry for technologies that are taken from basic science through development to products that are used in clinical applications. But such efforts require different skillsets along the path. The steps from....

• Fundamental basic science (The "R" in R&D) skills that give way to
• Applied research toward a problem that might be relevant to healthcare, leading to
• Development (the "D" in R&D) skills that help identify a customer need and envision possible solutions that could work, while testing them in relevant models for confirmation of their potential, to
• Clinical, Manufacturing and Validations skills that confirm that the selected solution can actually meet regulations and will truly work in solving the problem that was identified, to
• The post-market work which shows that, in actual usage - the way healthcare workers use the product in real life- the product does what it is expected to

..... are all steps along the path from bench to bedside. I have yet to meet a single person who has deep expertise in all of them, though many of us have familiarity with most and deep understanding of one or two.

Some technologies are farther along this path than others. An important development skill is the ability to assess where a technology is.....what proofs are still needed before it can be thought of as reliable enough to take forward into a product. A number of government agencies, ranging from NASA to DARPA, utilize variants of a Technology Readiness Level (TRL) scale (variously, with levels 1 to 8 or 9) that classifies technologies according to how close they are to being deployable.

Basic research is what I am doing when I don't know what I am doing. Werner Von Braun

To be clear, I've never been aware of a company that exactly uses TRL's. But all R&D teams have ways of assessing where they are on the technology risk continuum - "It looks interesting, but it is very early" is a comment I often heard from my R&D colleagues about a technology we were considering for acquisition. They meant that it had potential, but there was a long way to go through development before they would know if it could be used in a product. (see an earlier Articulated newsletter - #11 This Many...)

Yet even though the specific framework may only be applied to government contract work, the structure of TRL's is valuable as a language for talking about technology and its known capabilities. Here, rather than consider the specifics of any one scale, I want to talk about the approaches to programmatic risk reduction that are embedding in the process of moving from the lowest TRL to the highest.

NASA Technology Readiness Levels, published on the NASA website by Catherine G. Manning.

TRL's Allow Programmatic Risk Comparisons

Suppose that you have three ways to approach a new product:

1. Using a technology that is new to you and your team. You understand in scientific principle, but have no proof that it can work in an animal model of disease. (Perhaps TRL 1 or 2)
2. Using a technology that is well understood by others. It has been successfully used to address disease in an animal model, and perhaps even in humans- but your team has never used it in a product, has never developed a manufacturing process for it, and doesn't yet know how to control its quality. (TRL 5 or 6)
3. Using a technology that you and your team have successfully used to develop other products as part of a platform of products. You understand the limits of the technology, what aspects of usage, process, patient population etc. contribute to its quality and suitability in treatment. (TRL 7 or 8)

Which do you use? There will be other factors - opportunity for innovation, cost, time in development, etc. But I think you can see that these technologies are not all equally ready to become products. Many managers would work on developing a product with #3, while further moving #1 and #2 through R&D to understand the boundaries, capabilities, limits and potential of each, and holding them for a future product in the portfolio.

TRL's for a medical device, extracted and edited from an NIH website (National Heart, Lung and Blood Institute). A downloadable spreadsheet in the original format is available from the link.

Research-Development-Deployment Progression

The progression of TRL's is from research to development, to deployment.

The early stages- Research- are about the technology itself. What are the principles, the science (chemistry, physics, physiology, system dynamics, etc.) underlying the technology?

The middle stages- Development - are about understanding the boundaries and applications of the technology, and achieving proof of principle against a defined customer problem. Can I show the technology working in a relevant (animal, computer, finite element or other) model which is relevant to the human disease state? When will it work and when will it not work? What are the effects of different manufacturing processes on performance?

The late stages - Deployment - are about validating your understanding of the technology in its targeted clinical usage. Is it safe in the clinic? Is it effective? How do I maintain quality throughout the manufacturing and supply chain? How is its performance affected by temperature, storage, shipment, etc.?

Research is not development. And development is not deployment. Cutting corners here can definitely make for significant delays later on.

I find out what the world needs. Then I go ahead and try to invent it. Thomas A. Edison

Know your place....

By having a sense of where a technology is in this progression, you have a good awareness of the time to market, risks along the way, chances of ultimate success, and relative potential of candidate technologies. If you are investing, this awareness is a critical factor in understanding time to exit, performing diligence on technologies for acquisition and managing the risk in your portfolio. If you are in R&D at a company, this awareness is foundational for technology roadmaps as you plan your future technologies, platforms and offerings. If you are looking at competitors, this awareness is an important aspect of assessing pipelines for time to market entry and risk of not entering.

Having an intuitive feel for Technology Readiness is built over time, and constantly pays dividends in the form of better quality and more risk-aware decisions.