As engineers, it’s very easy to fall into the trap of thinking that the quality department is simply there to spoil the fun, or to make the process overly long and complicated. In reality, quality is central to everything your company does, and is the driving force behind customer satisfaction by both striving to deliver goods to a standard that the customer expects, and then measuring it and feeding back.

Everything You Need to Know about Product Prototyping

Quality puts a structure in place that will only allow goods that are fit for use to be delivered, and constantly strives to make the process better. Quality is there to make sure that our production processes do not allow sub-standard goods to leave the building, but does that mean that quality cannot also have a role in the fast-moving and fluid world of prototyping?

Product Prototyping is the act of creating a first product or representation of a product for a demonstration, initial test, or for marketing purposes. By its very nature, prototyping tends to use non-production machinery and employs the skills of technicians or engineers rather than the usual production staff. These are people who are trained to use non-production machinery and have the skills to create complex products using a range of equipment. This would seem to be a completely alien environment for quality as it loses much of the structure that is so important for consistency, but there is still good work that the quality department can do in a prototyping workshop, and to not include them could make your prototyping exercise longer.

One of the quality department’s many functions is to oversee the inspection of goods at stages in production and possibly even a final sign-off. Much of this inspection can be carried out as a visual overview, but there may be occasion to actually take and record measurements. Coordinate Measuring Machines – known as CMM equipment – are a highly specialized and extremely accurate means of measuring both features and the relative positions between them. This kind of equipment is invaluable when producing a first-off example of a new product and can be used to map and characterize the prototype and ensure that it conforms to the required standards. That can mean in terms of physical dimensions or other tested and compared properties and how they might relate to the fully productionised model.

A prototype is generally a precursor to gearing up from a concept item to production, and represents making a saleable item. But production and manufacturing
is a different beast from technician-driven prototyping work, and the generation of documentation for production purposes at this early stage is another field where the quality department needs to be involved. Whether it is work instructions, procedures, or results correlation, the documentation required for the manufacture of a new product will have to fit within your quality system, which means that all new documents will need to be logged on the system, subject to maintenance and updated as required. Creating a paperwork for a new product can be a daunting task, and the sooner it is started, the more successful it will be in the crucial early stages of the product. Not only does it mean that documentation is ready to use by the time that the device is ready for full scale production, but any problems with it will have been ironed out too.

Product Prototyping is a Team Process

But suppose, having made your prototype, you come up against problems and issues that you hadn’t envisaged, and are struggling to overcome? Once again, the quality department can help here too, with their problem-solving capabilities. Almost all quality engineers and managers today are familiar with standard problem-solving techniques such as Six Sigma and 8D to help understand and regularly apply these methods to problems found in production. These tools are extremely flexible and many can be applied to pre-production as well. Six Sigma is primarily aimed at production with a view to instigating product improvement, but some features such as the FMEA can be applied to pre-production with ease. By having quality professionals on your prototype team, you will have an enormous advantage in getting it right the first time.

Quality teams are often maligned for being overly cautious and for not usually taking chances, but by using the quality mindset at the earliest stages of your project, you reduce the risk of problems occurring, and ultimately reduce your time to market.

Pivot International is a product design, development, and manufacturing firm with extensive experience in the medtech industry. If you are interested in engineering a new product or updating an existing product, contact us at 1-877-206-5001 or request your free consultation today.