Design validation

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Developed by César Delafargue

The Ford company realized in 1957 that making a perfectly functional car was not enough to achieve commercial success. Indeed, nobody wanted to buy it, and the company suffered a loss of 250 million dollars [1]. The goal of validation is to ensure that a design meets the user's needs, and it is just as important as producing a functional design. Indeed, an inadequate validation will result in designing an undesired or unsuitable product, wasting significant amounts of resources, money, and time. The increase in complexity and duration of design projects often causes the initial objectives to get forgotten. Validation closes the production loop and ensures that the functionality intended for the user is fulfilled.

Validation is closely linked to the management of any project that aims to design a product, a system, or a service. It is a very powerful tool to reduce the risks associated with the project and to increase the overall quality of the rendering. This article aims to explain what design validation is, when it should be applied and why it is so important, for example through famous and very costly failures. It then tries to detail how to apply it, through different methods commonly applied by designers. The final point of the article warns the reader about some limitations of the validation such as the difficulty to establish the needs of its users or the long duration of its implementation.


What is design validation?

Definition

According to the U.S. Food and Drugs Administration, “Design validation means establishing by objective evidence that device specifications conform with user needs and intended use(s).“[2]. Validation verifies that a product meets the requirements of the users and the market. The question that designers must ask themselves here is: "Are we building the right product?" It can also be accompanied by other more specific questions like "Is the product solving a real problem?" and "Is there a big enough market out there for the product?".

The key to validating a product is to first define exactly what needs the product is trying to meet. Validation will ensure that each of these needs is met, and will evaluate how effective this achievement is. The purpose of validation is to ensure that the product will find a customer base and be a commercial success when released [3]. It is therefore also about ensuring that there are potential users for the designed product.

Opinions on the place of validation in a design process differ. Indeed, in theory, it should be applied at the end of the design process, just before marketing, because this is when the product can be tested as it will be marketed Cite error: Closing </ref> missing for <ref> tag

[2]

<ref name="Nielsen"> Nielsen, J. (1994). Enhancing the explanatory power of usability heuristics. Proc. ACM CHI'94 Conf. (Boston, MA, April 24-28), 152-158.


<ref name="Guru"> Hamilton Thomas. (n.d.). Design Verification & Validation Process. Retrieved March 22, 2022, from https://www.guru99.com/design-verification-process.html <ref name="Biopharm"> Bandurek, G. R. (2005). Making design validation effective. BioPharm International, 18(3 SUPPL.), 18–24. <ref name="Perforce"> Krüger Nico. (2020). Design Verification vs Design Validation | 6 Tips for Medical Device Makers | Perforce. https://www.perforce.com/blog/alm/design-verification-validation-medical-device

<ref name="MIT"> Olivier de Weck. 16.842 Fundamentals of Systems Engineering. Lecture 9 : Verification and Validation. Fall 2015. Massachusetts Institute of Technology: MIT OpenCourseWare, https://ocw.mit.edu.

<ref name="Youtube"> Drues Michael. (2020). Why Design Validation is More Than Testing: How to validate your validation - YouTube. https://www.youtube.com/watch?v=H3hieepeLJ0 <ref name="Blog"> Yllobre Carlos. (2017). Understanding Verification and Validation in Product Design. https://blog.prototypr.io/understanding-verification-and-validation-in-product-design-ef8c993fd496

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  1. Cite error: Invalid <ref> tag; no text was provided for refs named Failures
  2. 2.0 2.1 eCFR :: 21 CFR 820.3 -- Definitions. (n.d.). Retrieved February 18, 2022, from https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820/subpart-A/section-820.3
  3. Cite error: Invalid <ref> tag; no text was provided for refs named MIT