Introduction
CV invited me to post here, and I will attempt to provide a perspective based on my industry. When I develop a new product, I follow a process called “Quality Function Deployment.” This is a structured process that translates a customer need into engineering characteristics. In the following paragraphs, I will provide a highly simplified example of pharmaceutical development, and relate it to a new aftermarket exhaust being developed.
Product Performance
Let’s say that a the standard treatment for a bacterial infection currently takes 2 weeks, and has a high adverse event rate. The customer’s need is to eliminate the infection in less time, with fewer adverse events. The product performance is then based on how fast the drug kills the bacteria in the patient, and rate of adverse events. Clinical studies provide means to measure this performance against a standard treatment (and/or no drug at all).
Ok, so let’s start an active comparison to the AR example:
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Product Testing
Unfortunately, it usually isn’t quite so simple to jump straight into human clinical testing. Before we start clinical tests on humans (in-vivo testing), we develop ways to quantify the product’s attributes outside of humans (in-vitro testing). An example of in-vitro testing would be how well this new drug can kill bacteria in a test-tube. These tests that are used to develop the drug, and often become specifications for how we verify that we are making the drug correctly.
But even that isn’t easy. These in-vitro tests must be “validated”. To make a validated measurement, we develop a testing procedure that is precise and accurate within a pre-defined range. The primary purpose of this test method “validation” is to control variation. Without validation, it can be difficult to impossible to isolate a source of variation. In problem solving, the source of variation is often referred to as the “6 Ms”: man, machine, method, measurement, materials, and mother-nature.
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Transfer Functions
Now comes the MOST important part: verifying that the performance (clinical results) can be predicted with the in-vitro testing (lab results). In the very simple example, the test-tube potency must relate to the bactericidal capability in clinical studies. Without this relationship, the in-vitro test is meaningless. We call this relationship a transfer function.
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Discussion
Defining and meeting the customer need is everything.
In the AR aftermarket exhaust example, neglecting to translate a dyno improvement to a measureable acceleration improvement means that the product has not proven its ability to meet the customer need. In the Pharma example, people go to jail if the company markets a product without clinical verification. It is a heavily regulated industry, because the price of failure is usually tragic.
The auto aftermarket industry is NOT heavily regulated by government agencies. It is primarily consumer regulated. That is where a website like AR comes in, demanding excellence from vendors, and rewarding those that deliver.