Monthly Archives: May 2013

Millions struggle with medicine leaflets

Amongst the usual morning conversation, a brief item on BBC Breakfast caught my ear. “Apparently,” the presenter said, “millions of people are unable to read and understand essential information about their medication, according to a report out today”. Many people said they struggle to make sense of the instructions that come with prescriptions.

A closer look revealed common perceptions of the usefulness and readability of medication leaflets. These were typical comments;

Usually they [medicine leaflets] are clear enough, but sometimes lapse into gobbledygook

Unfortunately, the leaflet that comes with drugs usually contains a page and a half of side effects and less than one line regarding how to take the medication, usually “as instructed”.

Stick to what’s written on the box. I believe reading the instructions can just lead to more confusion for some

The leaflets inside could also have bigger fonts for those with difficulties.”


You might be surprised to learn that EU regulation already requires leaflets to “be written and designed to be clear and understandable, enabling the users to act appropriately…[1]. They must be tested “with target patient groups to ensure that [they are] legible, clear and easy to use”[2].

Perhaps you’ve experienced poor leaflet design as a patient using prescription or over-the-counter medicines. You may have been put off reading by the mass of information, or chosen to ignore the leaflet entirely.

Maybe you’re involved in developing medical devices, pharmaceutical products or combination products. You might be thinking that leaflets and instructions for use could be better designed with the reader in mind. Sure, there are things that must be included to comply with the law, but that doesn’t prevent good design.


6 tips for good leaflet design

If, like me, you have experienced any of these, then you will find these 6 tips for good design useful. You may even start to think about how you can use them.

(If you would find a handy reference guide useful, hello(Replace this parenthesis with the @ sign) please, I'd like a copy of '6 tips for better leaflet design', there’s no sign up and we don’t share your details).

1. Writing Style;

  • A clear, easy to read writing style, with simple punctuation, interspersed with short bullet pointed lists

2. Choice of typeface;

  • An easy to read font, such as a serif. Heavily stylised fonts can be difficult to read
  • Use appropriately sized type, such as 14 point for headings and 12 point for text
  • Minimise use of capitalised words

3. Legible, logical design and layout of information;

  • Line spacing of at least 1.5, to increase text clarity
  • White space between paragraphs, to rest the reader’s eye
  • Good contrast between the text and background. Select a paper that is not glossy, thick enough to prevent printing on the reverse page showing through
  • Consider using columns to help the reader navigate, with either space or a vertical line as separation between them

4. Headings;

  • Can help the reader navigate the information quickly
  • Use of bold text or different colours help headings stand out
  • Consistent style and placement is very helpful for quick navigation

5. Colour;

  • Contrast and relationship between colours is as important at the colours chosen
  • Generally, place dark text against a light background
  • Light text on a dark background can be useful to highlight warnings

6. Symbols and other graphics;

  • Provided that the meaning of the image is clear and its size makes it legible
  • User testing is important to demonstrate that the meaning is understood by the target audience.

Take action

Guidance is there, in plain English, so what’s stopping people?

Is it cost, the leaflet regulatory process, the absence of a burning platform to drive improvement?

If you’re involved in developing instructions for use, what’s stopping you?

Share your experiences, add your comments to this post.

If you would find a handy reference guide to the 6 tips useful, hello(Replace this parenthesis with the @ sign) please, I'd like a copy of '6 tips for better leaflet design' (there’s no sign up and we don’t share your details). 

1 Article 63(2) of Directive 2001/83/EC

2 Article 59(3) of Directive 2001/83/EC

Road testing the big picture

Get the right people together, in the right place, at the right time, with a shared idea and a similar outlook.

It’s amazing how quickly something can grow from that crucible.

It’s just 90 days since we were in the right place, at the right time, with three other groups who have a similar outlook.  Last week, the Medical Devices Alliance was born.  Less than ninety days to set up an alliance – perhaps that sounds quick.  It doesn’t stop there.

MDA press release photo We’ve put our heads together in the alliance, shared our knowledge of what works well, and what doesn’t, from the perspectives of quality, design, engineering, marketing, risk, suppliers, usability and clinical …


… the result could perhaps be described as Medical Device Development 2.0.  We think it’s a straightforward approach;

Define – Develop – Industrialise – Launch

How can you encapsulate the key steps of device development in this four stage eraser smallprocess?  I’ve been working (with help and feedback from our team) on an idea for an eye-catching, simple way of knitting together the key disciplines to see the whole picture. It’s an idea that draws upon something familiar.

In the past week, we’ve been on a brief road trip to share it with a select group of companies.  What we saw on the trip – people grasping the concept very quickly; nodding heads and smiling faces are common responses, before asking if they can have a copy.

Now to put the finishing touches to the picture and get it published, coming soon to this blog.

At the core of the MDA there’s Three Circles, University Hospital of North Staffordshire, Haughton Design and  Linki.  We’re working with 5 other organisations right now to iron out how they will fit in the mix.

Exciting times!

Four becomes five

We’re delighted to welcome David Andrew to the Three Circles team.

David Andrew photo for blogDavid brings a wealth of practical experience of software development and validation in regulated industries, including nuclear, along with a wicked sense of humour!  His expertise is a strong complement to our skills, helping you develop medical devices incorporating software so they’re compliant from concept models through to regulatory submission.

Matthew and David have previously worked together on quality and validation projects for pharma and biotech clients, having lots of fun while getting the job done quickly and thoroughly.  So it’s great to have the opportunity to work together again.