“Our commercial team have appointed a design agency to come up with ideas for us”

This is a direct quote from someone I have been communicating with over the past few months about Front End Innovation.

Now, I have nothing against design agencies, when I worked at Unilever we used them all the time, and for precisely the same deliverable this company are after. The issue I have with this statement has a lot to do with value for money, and whether a few people in a design agency and a few people in the customer organisation can come up with enough ideas of true value and opportunity for this global consumer health company.

Where do the best ideas come from? How do we make sure these ideas are on strategy for where our business is going in the future? How do we use idea generation to create a culture of “all working together”, rather than “have you seen the latest bright idea from marketing/development/senior management (delete as applicable), do they know anything?”

We have always seen the best ideas generally come from the people within the organisation, as they understand the company, and they also know how to make the ideas stick in that organisation. This is because we are all creative, in some form, and we always want to please, but to get the most out of your people you need some way of telling them what areas you want ideas from and how they can submit and talk about those ideas.

The generally accepted way of achieving this is idea management – you have a need, and you share that need with your network of employees, or even people from outside your organisation, using some sort of browser based application. People can create ideas, build on ideas and even vote on ideas, which is all great stuff, as they feel involved in the future direction of the organisation, rather than having it imposed upon them.

As a small health warning, make sure that you have enough people to assess the ideas as they come through, or you run the real risk of disenfranchising your employees, as they will feel you don’t care, if you don’t feed back to them on their idea. Also consider, how you recognise the efforts of the most prolific idea contributors in your organisation. This is not all about money, but can be non-monetary awards too, as your actions in this area will drive how people feel about the company, as much as being asked to participate in the first place.

The best example of this comes from Nissan. They encourage all their employees to come up with ideas and improvements in processes. One person found a clip used on an engine was not really necessary and could be dispensed with. When this was investigated further, the company identified this clip was used on several different engines and removing it gave the company a saving of several million dollars.

How did they recognise that employee?

They knew that giving him a percentage of the net saving would drive the wrong behaviour and start to negatively affect the strong team culture they had, so they rewarded his team by giving them a microwave oven so they could make hot food during their shifts, which in the North East of England in winter is a huge benefit!

If you would like to see how we deliver idea management at Pure Insight, click HERE to learn more!

Getting your Human Factors submissions approved by the FDA is a bit like passing a maths exam

This post is a little different from my normal innovation related posts, but a few days ago I had the honour to interview Ronald D Kaye.

For those of you who don’t know who Ron is, allow me to enlighten you. Until late last year Ron worked at the FDA, where he was responsible for the pre-market assessment of medical device user interfaces within the FDA’s Office for Device Evaluation (ODE). In short, if you are a medical device manufacturer, and you want to sell your product in the largest healthcare market in the world, you need to convince Ron’s (former) team that the way your users (patients, healthcare professionals etc) interact with your product is safe and risk free for them. And just to be sure a user interface is not just the buttons your press on a blood pressure monitor, or similar, but also the instructions you write on your pack of aspirin or paracetamol.

Although Ron has now retired, the guidelines that he and a colleague wrote a few years ago are still being used by the FDA. In addition, the people currently working at the FDA in Human Factors assessment, were recruited and trained by Ron. In short, his opinion matters!

In a wide ranging discussion Ron talked about the development of Human Factors testing at the FDA, what the problems were and why they wanted to see manufacturers considering how users would actually use the product being developed. He also highlighted some of the common mistakes companies make in submissions. Things such as, measuring the wrong things, just because they can (measuring how long it takes a user to open the packaging was the best one for me!), providing irrelevant data, not completely understanding all the appropriate risks associated with the device, and most importantly not talking to users and understanding how and why they interact with a device in a certain way.

He also talked about seeing a body of evidence that you have done the work in your submission, understood and categorised the risk, understood the user interactions and designed out the problems that could cause issues with users.

This got me thinking about an analogy.

If you have kids going through exams at the moment, especially maths, you will find that most kids know the answer to the question and will get it right, but more marks are given to candidates who showed how they got to the answer, demonstrating they understood the question being asked! Exactly the same principle applies to FDA Human Factors submissions!

My interview with Ron has been written up as a white pape. If you would like a copy, then contact us at Pure Insight on info@pure-insight.com, and we will happily send you one.

What do companies really say in their FDA Human Factors submissions?

WA981177When I was growing up in the late 1970’s and 1980’s in the UK there was a comedian in the UK called Jasper Carrott (look up Funky Moped and The Magic Roundabout, if you want to see him at his best). One of the funniest sketches he had was reading out real driver statements from car insurance claim forms – “the accident was caused by me waving to the man I hit last week!” is one of the highlights.

In my recent conversations with Ron Kaye (see my last blog for who Ron is) I asked him for some examples of really bad submissions from companies, and he shared the following three with me.

“Probably the most unusual was a submission from an Israeli company in which the human factors section stated in general terms that human factors was a high priority for the device and provided data to back that up.  The data was a set of 10 signed affidavits by nurses who claimed they used the device and found it to be intuitive and easy to use.  (I’m not sure if they were paid before or after they signed). That was some strange HF “data” indeed”

“Another submission that comes to mind also stated how human factors was such a high priority at their company.  They proceeded to explain how much design experience they had by adding up the experience of all of their design engineers that equaled something like 90 years.  Then they proceeded to explain how each of the engineers used all of the functions of the device and how they unanimously declared that it was easy to use and not dangerous in any way.” 

“An interesting meeting with a manufacturer involved the manufacturers device for which there were two modes – the “patient mode” for the home user (patient) and the “physician mode” in which the physician could set parameters for alarm thresholds, etc.   The human factors concern I wanted to discuss with them was that patients could get into the physician’s mode and change parameters either on purpose or inadvertently.  Their response to me was that it takes extra steps that are difficult to figure out (they weren’t that difficult) to get into the physician’s mode and since physicians (MDs) are known to be more intelligent than home users, I should not be concerned because the home users were too unintelligent to figure out how to get into the physician’s mode.” 

Now, I am sure that most of you are now rolling your eyes and thinking your company would never do that, and those submissions were so amateurish, but these things do happen and there are still some large companies out there that ignore the human factors aspect of their device development.

If you want to learn how you can improve your human factors submissions to the FDA, and adopt a “right first time approach” then get in touch with us. We run a variety of courses on human factors for medical devices, which have content delivered by the people who write the standards and also have indirect and direct involvement from the FDA.

You can find out more at http://www.pure-insight.com/medical-device-training.html

Technology advances, but we forget about the carbon based life-form that has to press the on button!

budget-usability-testing-toolMy first blog of a New Year.

Every January I am always interested in what is coming out from the CES event, held in Las Vegas, as a sort of post-Christmas party. There is always a wow factor, new things, new technologies, and now even new companies launching at this event.

Without doubt the technology is advancing at an unbelievable rate, and technology can do more and more for us, making our lives simpler, giving us more time to do the things we like to do, and, dare I say it, removing human error from the equation.

Nowhere is this more true than in the area of healthcare. The recent publication from Jeremy Kooyman in the November 2015 edition of MEdSim highlights the advances in computer aided surgery (videos of a computer peeling a grape are cool to watch and give confidence!), but the key thing to the success (and therefore safety) of all these devices is the interface that the flabby, carbon based life-form (you and me) needs to operate.

The FDA recognises this is an issue and has some pretty stringent testing of user interfaces of all medical devices, ensuring that patient and operator safety is taken into account and designed out at the early stage.

Achieving this at all stages of development of the medical device involves using all sorts of techniques that are found in innovation and product development across a wide range of industries, not exclusively healthcare.

It starts with Contextual Enquiry, an in-depth interview technique, to establish what the user is trying to achieve and what their needs are. This is a more immersive technique than asking people in a focus group, where the opinions of others and the “desire to please” tends to override the real needs of the user.

When you have the needs, it is about assessing the risk, and then managing that risk. Everything we do has some sort of risk associated with it, but there are different levels of risk involved. For instance, boiling a kettle and nuclear power are both essentially about boiler water, but the risks involved and the impact of something going wrong are vastly different. Understanding the risks in any device are vital in your ability to design out those risks in the development process.

Finally it is about understanding scenarios, different usage situations which could occur. Our normal reaction with any scenario planning process is to assume “that would never happen” and to only think of positive outcomes, whereas the reality is thinking “what is the worse that could happen” is key to the development of the interface. Generally, unless a scenario is impossible to achieve, the likelihood is that someone, somewhere will make it happen, no matter how improbable that may be. In this instance, aligning the most negative scenario to the risk involved is key.

In summary, success in designing any user interface, whether it is a medical device, or another product that customers interact with, a suite of techniques is required to understand what is the job to be done that the customer wants, what are the associated risks, and how do you plan for all possible scenarios, and all this needs to be done before you start building products to show potential customers!

A good personal example of not doing this properly is a brand I worked on in 1999, called Physio Sport. In the product design we had a closure that would only work as intended when it had been rotated through 180 degrees. We didn’t test, we didn’t assess the risks, and we certainly never scenario planned. We were so close to the product that we could never foresee that customers wouldn’t understand the technology and try and open the product as a normal closure, and then complain, as they couldn’t put it back together again! It all seems obvious now, hindsight is normally like that, but it cost £1000’s to put right, and certainly cost more to rectify than it would have done to think about it in the first place!

How the lack of Knowledge Management can cost you time, money, frustration, resources…and so much more

dim_3225909__large_rangeThere is a saying that goes along the lines of “we can never know what we know”, and this is very true of this little story.

There was a project team working in a global tyre manufacturer. The project they were working on had got stuck; there was a technology barrier they could not overcome.

The team did all the normal, big corporate stuff to overcome this problem. They brainstormed, reached out to their suppliers, spoke to technology companies and universities, but still they could not find a viable solution to their problem.

This endless search went of for about 6 months and in desperation, one of the team members decided to reach out to a company who they hoped would help them, by making a patent search, just to see if anyone, anywhere, had a potential solution to this technology.

This company sat down with the project team and they entered the information into the patent search system, and within a few moments, they had success, and three potential patents had been found, with the exact solution they were seeking.

Eureka! Euphoria! All these emotions swept over the project team. Six months of frustration, budgets over-spent, delays experienced, and now they can see a glimmer of light at the end of this tunnel.

Who owns this great, project breakthrough technology, they asked?

Only on closer examination did they see. The owner of this technology, patented and in the public domain, was the company who, each month was paying their salary, had set the project brief and had become frustrated with the delays – it was the company THEY ALREADY WORKED FOR!

The moral of this little tale? Capturing what companies know is vital, whether it is needed now or in the future (see my Gorilla Glass story), but making sure that everyone knows where to look for the information is even more vital.

The Power of Knowledge Management


I heard this story a couple of years ago at the CoDev conference on Open Innovation. It was told by a practitioner from Dow Corning, and I have used this little tale in many workshops I have delivered since then.

Back in the 1960’s a scientist at Dow Corning (Pyrex etc) was working in their lab and they came up with a technology that made glass much, much stronger. The scientist, pleased with the invention, took the idea and prototype to the company bosses at the time. They looked at the idea, and said to the scientist “we like the idea, but we are a glass company, and our whole business model is based around the key fact that glass breaks and customers go and buy more of it. If we have stronger glass, our sales would go down”.

The advice they gave the scientist was to work on things that were important to the business at the time, but to archive the idea, just in case it became something useful in the future.

Now, archiving today is easy. You can save something to an internal server, cloud based server, give it keywords, so it can be retrieved by someone at a later date.

Imagine what archiving was like in the 1960’s? It would have meant typing everything up, collating it, storing it in a manilla file and filing it in some metal filing cabinet, in some office, in some building, somewhere in the Dow Corning empire.

Let’s roll the timeline forward a few decades, to the start of the 21st century. Glass is still an important material, but its use has expanded from windows and kitchenware into new technologies, such as smart phone covers, laptop screens, TV screens etc, and what was happening was consumers were using this new technology and the glass screens were getting broken (how many times have you been playing with your son or daughter on a Nintendo Wii and, determined not to lose, you have enthusiastically thrown the control through the screen of the TV, as you attempted a Roger Federer style backhand, or a Babe Ruth home run?)

What was happening was that glass screens were being broken, whether through the enthusiastic parent, or just increased use. The manufacturers put up with this for a while, as customers were buying more product from them, to replace the broken ones, but eventually, enough was enough, and they approach Dow Corning for a potential solution…

Normally, when you want new technology to solve a need, you are talking possibly years of research and development before the product is ready for the market. But, when meeting Dow Corning, someone in that company remembered that 40+ years earlier a scientist had created a product, that wasn’t right for the market then, but might just be right now…

Eight months from that first meeting, a new product called Gorilla Glass was launched and it is almost certainly in the screen of the smartphone, tablet, laptop or monitor that you are reading this blog on now.

Consider this. How good was the knowledge management at Dow Corning, which ensured that the invention from that scientist 40 years earlier, had been preserved, and transferred from paper file, to tape storage disk, to intranet server and maybe even to a cloud server? And, that the people in that meeting, at the start of the 21st century, either knew that it existed, or they knew who to ask, or more likely, they knew what to search for, and they looked for what the company already knew first, before embarking on an expensive project to re-invent something that had already been invented.

The power of knowledge management.

We teach innovation mindset in school and then…forget it!

IMG_4353AI came across this photo outside the classroom of my 7 year old godson, when I was collecting him from school one afternoon.

What struck me was here, in an infants school, were the base principles of a successful innovation culture, which SO many companies struggle to implement and work with in the “grown up” world.

I was particularly taken in with the comment in the bottom right hand corner of this photos, which  says “I made a mistake – mistakes help me improve”. This made me think of a workshop I ran for a multinational company in the USA a couple of years ago, whose direct quote was “we never fail a project, because when we do, we sack the project manager”.

What happens to us as we grow up and we forget, or choose to ignore some of the simple things we are taught at school.