The picture above is of Robert Pirsig, author of Zen and the Art of Motorcycle Maintenance. This book had a profound impact on me. He articulates the thought that a high level of engagement is necessary for excellence, and that this is also the key to living life fully. You need to be so engaged in what you are doing that you lose the distinction between yourself and what you are working with. The distinction between human and machine is lost as you and the motorcycle navigate a curve together. This may seem like an inappropriate enter into the development process, but I think it fits perfectly. Successful commercial development of product is not the sum of its parts, it is a dynamic process where all parts interact and the level of engagement necessary to succeed must be complete.
The purpose of this blog is to walk through the order of events I recommend to successfully commercialize an aptamer based diagnostic product.
- Demonstrate that a separate laboratory can reproduce your results (Technology transfer).
This might seem like a strange place to start, you know that your aptamer works, you have tonnes of reliable data. That’s fine, but this is an essential first step towards developing a product that can be approved by regulatory agencies, and commercialized. For this step, the aptamer application does not need to be reduced to the prototype that will be approved and sold. This is transfer of the raw platform from your laboratory (or ours) to another lab. This forces you to develop a standard operating process document that covers all aspects of application. In essence this document forces you to verbalize all the decisions that you make in your lab in your experiments. For instance, when and why do you discard a specific experiment because something was wrong? The process of technology transfer is always more difficult than you think it will be. Problems arise that were not anticipated.
Going through technology transfer forces the first articulation of what will be needed to move a product from research discovery to commercial product.
- Build a mathematical model of the system.
I know that this is not traditional. Most people went into biology because they do not like mathematics… But there is a reason math was invented, I see the entire process of product development as being one where we are trying to find a straight line through multiple dimensions. It is not possible or reasonable to hold in your head all the possible interactions between design and performance. Build a mathematical model of the system, and adapt the model as you gain understanding. We need to build a map of the space you are exploring. Also, this map will be useful as a guide for the next product you commercialize.
- Design of product concept
Generally, now you are ready to work with a product design team to develop drawings and ultimately prototypes for your product. We are moving from product concept to product. Design has to achieve a balance between performance, ease of use, and cost of production. The design process should address all of the problems that were encountered with technology transfer. We work interactively with design firms in Canada to support customer products. They draw pictures, and we explain to them why what they have drawn will not work.
- Testing, testing and more testing
It is necessary to develop a full understanding of how your product performs with all types of samples. The testing process is interactive with the design and manufacturing of the final product. Testing lays the basis for a quality assurance and a quality control strategy. I had it explained to me once that quality control was counting the horses to know how many have escaped from the barn. Quality assurance is ensuring that the horses cannot get out of the barn in the first place. Both are necessary.
A key part of testing is working with a variety of matrices and test samples. It is not always true that your target spiked into a relevant matrix will perform the same as the endogenous target within the same matrix. Also, all matrices are not created equally. We have found much more variation in saliva across individuals than we do with serum, or with urine.
- Final product design and validation
Based on learnings from step 3 it is implicit that there will need to be accommodations to your product design. These will need to be validated. Throughout this entire process it is crucial that everything is tracked so that any change can be evaluated in terms of performance. Eventually, this tracking exercise becomes your Standard Operating Procedure (SOP), and the mathematical model becomes your basis for tolerances. From the SOP you extract just that portion that is necessary for the end-user to know, and reduce this to a product insert document. It is useful to start developing product insert documents early in the process and to do blind tests with others in your lab to see if they can follow the instructions. Remember that your goal is not to write a product insert guide that is understandable to you, it is to ensure that others will use the product appropriately.
The outcome of these steps will not only be a product ready for regulatory approval, and production, but also a full understanding of what it is you have developed and how each part interacts with each other. There is a need for product development to be led by one person who sees how everything fits together, who owns the product and the process and can teach it to others. The goal of the process is for anyone to be able to kick start the motorcycles you are producing and listen to them purr.