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Published: 14 May 2018

Validation - proving it does what you designed it for

Validation is a vital concept when it comes to proving what things do.  It is a term commonly used by engineers, scientists, physicians and other people working in evidence based professions.  Validation is also a vital part of product quality assurance.  I usually need to explain how I have validated a new method or tool to my colleagues or customers, because it is an important part of proving my work does what I designed it for.  In addition, like other engineers and scientists, I will often ask how a new method or product has been validated.  If there is no validation evidence I cannot use it for my work unless I validate it myself.

So what does ‘validation’ mean, and why is it so important for quality assurance?


What is validation?

In simple terms, validation is the process of demonstrating that something does what it is has been designed to do.

Scientific measurement is mostly about collecting evidence.  In open ended research this is often to define a phenomenon that is not understood.  For example, cancer researchers take measurements to learn how cancer behaves and what we can do to change it.  They also measure the effects of their experimental treatments to see if the are working as expected and treating the cancer.

This later type of measurement is a type of validation.

In business and manufacturing, validation is often about proving that your product satisfies your customers' needs, this is referred to as product validation.  In medicine, it may be proving that a therapy effectively treats the conditions it is targeting, that a test accurately detects the disease it is testing for, or that a medical device effectively delivers the therapy it is intended to deliver.


A simple example of validation

Lets imagine a new device that is going to change the world by disrupting how we collect basic biometric data.  It is a simple device that clips on your little finger and measures your height, weight and age.  This is going to revolutionise measurement!  Athletes can be categorised quickly at a desk, patients don’t have to be conscious and standing to accurately work our how much medicine they need, and parents don’t have to put marks on their wall to settle arguments about who is taller.

As fantastic as this imaginary device is.  There would be some serious consequences if it did not perform as intended, or was not accurate.  Patients may receive incorrect doses of medicine, gold medals may be unfairly won, and arguments over who is taller may never end.

So before I start producing and selling this device, I wuld perform some validation studies to ensure that I have designed something that accurately measures height, weight and age.  How?  In this case it is easy because I already have access to standard accurate ways to measure height, wieght and age.  There are measuring tapes, bathroom scales, and dates of birth.  All I need to do is take measurements with my device and the standard methods, and compare them to make sure that this new device performs with sufficient accuracy.

Now good validation is not quite that simple. It is important that I use statistics to work out how many measurements need to be taken during my validation experiment.  However, the basic strategy of validating a new product against an exisiting standard or product that is known to perform well is sound.

For the sake of this example, if my design works, then my prototype device will give the same measurements as a measuring tape, a bathroom scale, and caculating age from someone's date of birth.  This also means that I have evidence to show my customers that the measurements from my device are at least as accurate as those from a tape measure, a bathroom scale, and asking someone their age.


Why is validation important?

Now this imaginary example may seem trivial, but think of some examples of your own.  How important is it that a builder's laser level is accurate?  Is it important that my brakes slow down my car when I press the pedal?  Does my computer’s encryption actually stop hackers?  How important is it that my bank's computer systems transfer the correct amount of money into my account?  All of these products, services and systems require validation to know that they are working correctly.  This would typically be done as part of quality assurance.

Validation is also particulary important in regulated industries.  For example, in the medical device and automotive industry, there are rules about what validation evidnec must exisit for a product before it can be legally marketed.  The regulations are intended to ensure the safety of those products.

Now you know what validation is, and why many consumers, professionals and manufacturers take it so seriously.  Manufacturers want to make sure that they product are safe and deliver for their customers, consumers want products that actually work, and professionals need product and services that will delvier for their clients and patients.

Next time you see a great new technology or other solution that seems 'too good' you can ask the manufacturer about validation.  If they have validated the product they are usually more than happy to tell you how and show you the results.

Platypus MedTech Consultants Pty Ltd
+61 2 6198 3242

Level 1, The Realm, 18 National Circuit
Barton, ACT 2600
Platypus MedTech Consulting acknowledges that we live and work on the land of the Ngunnawal, Ngarigo and Whadjuk Nyoongar peoples. We also acknowledge the Traditional Owners of Country throughout Australia where we deliver our services. We recognise their connections to land and waters, the sophistication of First Nations knowledge and their contributions to engineering and science. We pay respect to their Elders, engineers and scientists, both past and present.
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