commercial aptamers

Commercializing Aptamers Part 5

This icon was on the cover of Zen and the Art of Motorcycle Maintenance which we introduced in the previous blog. “And it occurred to me there is no manual that deals with the real business of motorcycle maintenance, the most important aspect of all. Caring about what you are doing is considered either unimportant or taken for granted.” (Robert Pirsig). I chose this theme for this blog series on commercialization because the key to successful product development is not following the manual, the key is to invent what is necessary. I am providing a framework for how to rationalize the process but this framework has to be imbued with personality, the important work is outside of this, it is getting your product development to actually fit the manual. Now, we will continue where we left off.

  • Design of product concept

Generally, now you are ready to work with a product design team to develop drawings and prototypes for your product. Remember that what you need to demonstrate efficacy with for regulatory approval is exactly the same product that you will be commercializing. In designing a prototype there is a need to bring together product performance, cost of production, and ease of use for end users.  The design process should address all of the problems that were encountered with technology transfer. The design process is very much an interactive one, there is a need for clear articulation on your part of what you need the product to be able to do, then there is often a reiteration of this after receipt of the first designs. Design itself is a reiterative process.

  • Testing for sensitivity, specificity, contaminants, everything that could go wrong

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 a product development process is not only the readiness of the product, it is also the understanding that you have built within your team regarding how the product works. How each element of the process interacts with other elements. A key part of commercial competitiveness is understanding how to guide end-users when their results with your product are not what they should be. This is realized in a trouble-shooting guide, but the basis for the directions in such a guide are your overall understanding of the product. 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.

There is a need for someone in your company to personally own the product development process, to care for it deeply. The development process builds the corporate memory of driving the product on all kinds of roads, in all kinds of weather. Successful product development is not achieved by checking off boxes, it is achieved by caring enough and understanding enough to be sufficiently creative to solve problems that arise. There is no distinction between the company you are and the products you sell.

neoaptamers