Industrial design

How the device is held, read and operated, worked out with the people who will use it and tested against IEC 62366-1 rather than assumed.

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When industrial design is the right step

After the concept is proven and before the mechanical detail is fixed. Form, controls and labels are cheap to change here and costly later.

Design for real users
A device used by a scrubbed surgeon, a nurse on a night shift or a patient at home. Each user brings different hands, training and stress.
Give a prototype its form
A working prototype that now needs a form, controls and a finish that people can hold, clean and read.
Build the usability file
Evidence of a usability engineering process under IEC 62366-1, which regulators expect in the design file.

What you bring, and what you get back

You bring

The intended use, and who the users are
Your prototype, or the concept you chose
Complaints or feedback on similar devices, if you have them
Brand guidelines, if you have them
Access to users or clinicians for studies, if you have it

You get back

Use specification and user profiles
Concept sketches and form models
Formative usability evaluation records
Industrial design CAD, ready for mechanical design
A colour, material and finish specification
Use-related hazards for the risk file

Formative tests shape the design, the summative test proves it

IEC 62366-1 asks for two kinds of usability evaluation. Formative evaluations run during design, with a few users at a time, to find use problems while they are cheap to fix. The summative evaluation comes at the end, on the finished design, to show that users can do the critical tasks safely. A new problem found in the summative test sends the design back, so problems found early cost less.

How industrial design works

Step 1
Study the users
Who uses the device, where, under what pressure and with what training.
Step 2
Model the options
Form and interaction concepts, built as models and tested with users.
Step 3
Refine
Form, controls, labels, colour, material and finish, with the risks of use in view.
Step 4
Hand over
Surfaces for mechanical design, and the usability inputs for the design file.

Questions clients ask

Is industrial design just how the device looks?

No. It sets how the device is held, read, cleaned and operated, and each of those can cause a use error. Appearance is one output among several.

Do we need a usability study if the device is simple?

A simple device may need a smaller study. IEC 62366-1 still expects a use specification, an analysis of use-related hazards and a summative evaluation of the user interface.

Can the form change after mechanical design starts?

It can, but each change moves parts, tooling and sometimes tests. Settle the form and controls first, and hand over agreed surfaces, to keep those changes small.

What does the colour, material and finish specification cover?

The colours, materials, textures and coatings of each visible part. For a medical device, each surface must also withstand the cleaning and disinfection agents named in the instructions for use.

Designers sketching on a tablet in front of a board of notes

Designers beside the engineers

Industrial design is one of nine disciplines in one team at our design office in Navi Mumbai. The surfaces and usability inputs pass to the mechanical and electronics engineers in the same team.

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