Bridge Design

This article was published on Medical Device and Diagnostic Industry on May 16, 2012.

"In the 2000s, venture capital investments in healthcare and life sciences outperformed venture investments in tech." Device company executives could be forgiven for not having seen this recent quotation in a business press that tends to tout venture investment success by the likes of Facebook and Zynga.  This observation is from "In defense of life sciences venture investing," a recent article in Nature Biotechnology that has been picked up by other heavyweights in the device industry. 

That quote sits in stark contrast to a fact apparent to anyone close to medtech over the last decade or so: the costs of bringing products to market have escalated significantly. These state of affairs has been quantified and publicized in a survey titled FDA Impact on U.S. Medical Technology Innovation by Josh Makower, a medtech entrepreneur. “The average cost of taking a product through 510(k) clearance is $31 million, and the average cost of getting a product through PMA….is $94 million (excluding reimbursement and sales/marketing activities),” Makower reports. “For U.S. companies, these mounting costs are unsustainable in a venture-backed industry where [fewer] than one out of four medtech start-ups succeeds, 50% of all reported exits are less than $100 million, and the total pool of available investment capital is shrinking.”

Evans writes about the use of gaming industry technology to create new ways of guiding surgeons and interventionists to their quarry, with companies like SuperDimension leading the way. He also discusses our prediction that as electronic medical records (EMRs) become more widespread, there will be a greater possibility of smarter devices that will act independently according to the patient’s medical history, in addition to what the sensors are reading.

Click here to read the full article.

This article reflects Bridge’s more general approach to design thinking – we are always on the lookout for general trends in technology that will have a potential impact on medical product design.  Evans recently returned from a trip to the UK and noted a couple of trends in Europe that are slightly ahead of the U.S. that could eventually find their way into medical products.

First, an example with interesting potential in chronic disease management is a new cell phone-enabled technology on sale in the UK by O2 (a large carrier) called the Joggler. It’s a family-oriented “central” organizer (think a touch screen family calendar you keep on the fridge door). It is inexpensive and serves as a way of coordinating family activities by texting reminders to all family members and generally being a place to keep common family information.  It has a large touch screen, is video capable and is rumored to allow third-party apps to run on it.

Above: The Joggler

Imagine the power of this kind of network-connected appliance that is also connected to you personal cell phone or personal healthcare device in the future.  Applications could be created that become a central place for current information about your health to be stored, text reminders could be sent to your cell phone, your doctor could get monthly reports or be notified about exceptional events triggered by readings from your personal monitors.  When more of these personal health monitors (such as BG meters, pill containers, inhalers, etc.) start talking to each other, this could be a boon to managing chronic conditions such as diabetes, asthma or COPD, obesity etc. where a combination of monitoring compliance or reporting diagnostics could be more powerfully and transparently coordinated.  No need to worry about inputting it to your computer or even bothering to have an internet connection with difficult-to-set-up WiFi connectivity.  The always-on cell link could look after that.

Another interesting trend noted on the same UK trip was a way of making print advertisements more interactive that could have interesting medical applications.  Some innovative marketers have added 2D bar codes to their print ads that are readable with a regular cell phone camera.  The idea, seen on a Volvo car ad in the Guardian Newspaper, is that users snap an image of the small 2D bar code. Because of a previously-installed generic app, the phone knows where to send the bar code and the cell-phone user then gets a link to a video sent to them by return, in this case a video showing a Volvo ad.

What Bill found interesting about this idea is that if this technology takes off, it could become an interesting way of expanding the way in which people with various conditions monitor and manage their health. For instance, Advair inhaler users are supposed to note the exact day they open their inhaler package and stop using it after 30 days, due to its shelf life once opened. Who actually does this?

Instead, if the packaging had this bar code printed on it the user could just snap a photo and 30 days later, they’d get a text saying it was time to open a new one.  Imagine if all foods began carrying this bar code and it was linked via web site to help you manage calorie intake for dieting or carbohydrate intake for people with diabetes. How many users bother to read those obscure, icon-laden instructions for use (IFUs)?  What if the packaging for that complex device had this 2D barcode: the healthcare professionals could photograph it on their iPhone camera and then immediately see a short IFU video in their local language that shows them in better-animated terms how to correctly use it?

Bill put together a short list of directions for how to do this yourself:

First, download the free “scanbuy” app to your phone (we tested it on an iPhone but it’s also available to many other phones) from scanlife. You must have this app on your phone for it to work.

Next, aim your camera phone at one of the barcodes below on the computer screen. The first bar code will lead your phone web browser to the Bridge Design blog; the second one will lead to a video demonstration of how to use a product we designed, Cleo (you’ll need to click through on the video to run it). The bar code will work from print, computer, and television. Take a picture.

Above: Cleo video 2-D bar code

Bridge 2-D bar code

Did it take you to our website blog, or to the video? The possibilities are enormous — get on with applying it!

How to improve your creativity and become more innovative in your organization.

Hello, my name is Bill Evans and I make my living as a designer of medical devices. But today I am going to talk to you about creativity. Before I begin in earnest I’d like to ask, how many of you would like to improve your own creativity? I think that there isn’t a walk of life that wouldn’t be improved by a more creative approach.

Witness these two radically different aspects of life – both of which might be characterized as areas one would not expect to find much creativity – but that demonstrate you can apply creativity anywhere to great effect. One example is for the good of mankind and the other didn’t turn out so good. On the left we have person who demonstrated in spades that the allegedly dullest profession on earth is indeed capable of great creativity – it is of course Jeff Skilling of Enron and his corrupt but creative accounting practices. And on the right is a man, Nelson Mandela, who took an aspect of war and conflict resolution, usually known for its blunt application of power and found a much more creative approach with his Truth and Reconciliation Commission, which has now become a model around the world for helping solve seemingly intractable conflicts between warring interest groups.

Now I know from my own interactions with medical device approvals that your professional society’s members are charged with running a tight research process to satisfy the rigors of the FDA and the scientific method. And you might say “what place does creativity have in the process? – it’s not a very important part of my job.” I would still argue that there are plenty of opportunities to apply creativity, whether it is in structuring innovative trials that shorten the approval cycle, or in observing the trial in progress and making creative connections with what you observe to allow the product development team to either fix design problems that are hindering the products success in the field, or to creatively see ways that you can tell them what to consider as improvements for the next generation products.

I know from my own experience that it is the eyes and ears of the field researchers who actually put in the hours observing device users at work who often can have the most insight into what could be better in the future. I wish more engineers spent more time in the field – products would be so much more usable.

Many of you just indicated that you’d like to be more creative. The truth is that most of you used to be much more creative than you are now. Creativity tests (yes they do exist) show that at age 5 most children score highly in creativity, yet by the time they get to 8^th grade their creativity scores have dropped considerably. They’ve had it knocked out of them so they can get through all this rational linear education process. That creative ability is still inside every one of us, and I don’t mean that we’ll all quit our day jobs and end up playing our instruments in Carnegie Hall, hanging our art in MOMA or signing our best seller in Barnes and Noble.

What I am going to describe today is a number of simple activities you can do that will help you unlock the creativity inside of you. You never know: maybe there will be a few second careers as a result of it (that new mystery novel about the machinations of the FDA is going to be a best seller for sure.) But what I know for certain is that as you unlock this side of yourself, you’ll become that little bit more effective in your work and enjoy things in your personal life you thought you left behind many years ago. As Sponge Bob Square Pants said, “It’s about ‘Imagination’.”

The skills that unlock creativity are often about seeing things anew, listening to what people say with a different kind of attention, quieting your own internal voice that keeps trying to direct you in old ways and observing the non-verbal aspects of communication. I hope you can see that all of these things have relevance to what we all do every day, and today I intend to describe a number of things you can practically do to help develop these qualities in yourself.

For this talk to be effective I am going to ask each of you to make a commitment. Ask yourself what kind of educational experience you want. Is it a high, medium or low risk experience? And I say “risk” as being creative or innovating anything always carries potential risk of failure as well as the reward of success. Paradoxically part of succeeding at creativity involves occasionally failing on your way to success (and I’ve failed at a ton of things I’ve tried). This might make you uncomfortable, especially as you are probably used to succeeding in what you do now. This is yet another barrier to unlocking this ability inside of you, get used to the discomfort as creativity is a messy business, becoming good at it means sticking your neck out and risking the embarrassment of failure – but it’s worth it. Is it high, medium or low risk experience? And don’t worry, I’m not going to ask you to embarrass yourselves in front of your colleagues here today!

Now I’m going to suggest a number of things you can do to unlock your creativity muscle. Those of you that wanted a high risk experience just agreed to do at least two of the things on this list, the medium risk people agreed to do one and the low risk people need to re-examine their risk tolerance if they are ever going to unlock the potential I know they’ve got inside of themselves.

My first suggestion is:

Learn to Draw

Some of you may well already draw “realistically”. Kids love to draw and as they go through developmental stages their drawing changes. There is a point at about 10-12 years old where kids either make the transition to draw things realistically or they tend to get stuck drawing in a representative fashion.

If you got stuck at the representative level (and most of us did) then probably what has happened is that the “rational” side of your brain is overpowering the part of your brain that could see the way something actually looks and instead keeps drawing the house or the face in a fairly unsophisticated way.

Many of you will have heard this type of explanation before as the right-brain left-brain argument. The research goes that the left brain processes and controls the rational, analytical and objective parts of us, while the right brain processes the intuitive, random and subjective parts.

Back in the late 70s an art educator named Betty Edwards decided to do something with this research and wrote her best seller on learning to draw: “Drawing On the Right Side of Your Brain.” I’m glad she did because I used it to teach myself to draw before going to art school and now that I find myself in a room full of people who are probably very left-brained I can present a rational left-brained argument as to why you can all learn to draw (or perhaps at nearly 5 o’clock on a Friday, I mean I am in a room full of people whose brains have left – you decide.)

Betty Edwards’ argument is very simple and she is able to demonstrate her hypothesis to you with a couple of simple exercises that I thoroughly recommend you try.

What she says is that if you have not yet made the transition to drawing realistically you need to learn how to quiet the left-brain part of yourself and switch on the right side. And she has an outrageously simple trick to demonstrate to you that you can draw.

Here is one of the illustrations she uses. It’s a sketch of Stravinsky by Picasso. She says “Copy it” but only allows you to look at the cartoon upside down. It’s hard to make heads or tails our of this sketch upside down so in my experience (and I’ve tried this with many people) when people are asked to copy it upside down they focus on copying the lines by actually looking at them very carefully and reasonably faithfully reproducing them – they may get the proportions a little wrong and stretch the image here and there but on the whole after about 10 minutes of trying to copy it they are very surprised when they turn their line drawing up the right way and see they’ve done a pretty good job – “Good grief – I can draw after all!”

From this example Edwards goes on to refine your way of looking at things with a string of equally simple exercises. She’ll have you drawing faces with just the shadows, or trying to draw your hand with your eyes shut just by feeling what it looks like.

I grew up like many of you in this room from a pretty left-brained educational process and this book really worked for me. I found that the more I looked at what was actually there the more I saw and the more able I was to represent it. I could spend hours in a life drawing class focusing on a small detail. Time would pass by without my being aware of it – it was a different state of mind.

Sure I learned to draw but I also took away a very important new way of looking at the world that helps me every day.

Learn to draw - and you learn to see things more as they are.

Do A Creative Writing Class

I am sure many of you have to write quite a lot for your work. And perhaps some FDA submissions might qualify as works of fiction…. But for those of you that skipped that creative writing class 101 (and we have no such thing in my native England) I would suggest that trying your hand at some creative writing is another great way of unlocking some more of your innate creativity.

For this I recommend doing a group class as not only will a good teacher tailor the feedback to each student’s ability but also it allows you to deal with another important part of the creative process – that is dealing with the risk of putting your creative product out there and not having it well received by your fellow classmates. All of us have a fear of failure, of being embarrassed that whatever you did was not good enough, of finding out something you thought was a funny idea maybe isn’t funny to anyone else. Personally I have this little demon sitting on my shoulder whenever I am doing anything you might call creative and he gives me a running criticism of what I’m doing wrong – I have to keep smacking him down to shut him up. This fear can sometimes stop us from trying to stretch out and exercise that creativity muscle. And of course as you try and stretch out in new creative ways as an adult you are often asking yourself to start at such a basic level you feel like a one-year-old taking its first stumbling steps. It’s potentially embarrassing – get over it; you’re probably better at creative writing than you think and the paradox of exposing yourself to potential failure is that you’ll probably meet success sooner than you think (sure you’ll fall over sometimes too).

For those of you that haven’t tried creative writing I know what you’re thinking. “Woe is me” – what an earth am I going to write about creatively. Well just like the Betty Edwards trick of upside down drawing, a good creative writing class will start with simple tricks to un-freeze that 8 year old story teller inside of you. (Did you ever notice what good story tellers and dwellers in fantasy land kids are – yet when we get to adulthood most of us seem to have lost the ability to want to make stuff up.)

Here’s some tricks I’ve observed:

A sneaky teacher will do something like this – throw up a big list of words and ask you to pick 10 words you like. You think this is a random list and without too much consideration for what might happen to the words you pick 10 probably unrelated words you like. You might think “the teacher will ask us why we choose these” or some other such stuff. Of course the teacher is being sneaky to get you over the woe-is-me hurdle – she then ask you to write a prose poem that uses all the 10 words; you’ve got 10 minutes now write!

You didn’t choose the 10 words to go together, yet alone to frame a poem around. The result is that you are caught off guard, and forced to be creative with your seemingly unconnected words. It’s a short exercise that often produces some amusing or clever little vignettes from the class – sure some of them don’t work but everyone gets a chance in a short space of time to write something original AND creative. I’ve heard of variations on this like the teacher dumping out a big box of seemingly unrelated bric-a-brac and asking everyone in the group to take two things from the pile that look interesting – “Now write 200 words connecting these two objects in a story” – you get the idea. Get over the hurdle of what to write about and instead just write –you’ll be surprised at your creative ability.

My personal favorite is the assignment to choose a “found” kind of writing form like a menu, an instruction book, a guarantee, a classified advertisement and write something creatively interpreting and re-purposing that form. One of the students who was a city guide in San Francisco used postcards and wrote short snap shots of exaggerated tourist-speak that she had to put up with each day in her job…. This writer is now a good way through writing a children’s book inspired in part by her success in this class.

The important thing to note about creative writing is that it’s impossible to do it without having to think about the subject in new ways, with a fresh pair of eyes so to speak, by thinking around the subject not necessarily thinking about it head on. And then once you’ve thought about it you’ve then got to communicate this new creative thought to your readers clearly and engagingly.

So it’s a two-fer:

Do A Creative Writing Class – and you’ll improve the way you observe and understand things as well as the way you try and communicate these things to other people.

You may never get published in that literary journal, but you’ll have worked that creativity muscle a little more and that next 50 page report will be that little bit better of a read and based on a broader way of understanding the issues.

Do an Improv Workshop

I got the idea for this section from my experience at an improv workshop with Steve Portigal.

I know what you are thinking; you work in a field where the last thing in the world you want to be doing is making stuff up as you go along. But that’s only one way of looking at what doing a little bit of improv can bring to your everyday life. In reality it has a lot to offer us about listening and observing as well as exercising that creativity muscle some more.

Contrary to the name of the popular chain of comedy clubs, improv is not stand-up comedy. Stand-up is typically highly scripted and rehearsed. And despite its anything-goes reputation, improv is a form of performance that is in fact highly restrained but with several open parameters. It is unscripted and the specific restraints and themes of the performance are typically assigned right before the performance is started. It does not necessarily try to be funny, but “funny” tends to happen. In teaching how to do it they say, “Your first idea is often your best idea” and when you’re starting to dry up try “yes, and….”

Like creativity, improv is spontaneous at its core, but like all these exercises designed to improve your creativity it can of course be taught, exercised and improved. To see what improv can do for you is something that you have to experience by doing. It is of course best demonstrated with simple examples (more of these tricks to fool you into being creative). This is where we come to the section of my talk you’ve all been dreading when I ask for audience participation. It is after all nearly 5 o’clock on a Friday so it’s time to let our hair down a little bit.

Now this exercise is not about acting or prancing about on stage, instead it’s a simple short word game and I promise there is no sting in the tail. I need 6 volunteers to come on stage and form a simple line.

Your job is to tell a story and the audience is going to give you your subject. The rules are simple – each of you can only add one word to the story at a time and then the next person in line adds the next word and then back to the start of the line. Remember – “Your first idea is often your best” and the old trick of “yes, and….” You can decide to finish the sentence or start a new one. The point is that this group of 6 people are collectively telling the story, it belongs to all of you not just one of you. You might say, “I-Just-cycled-around-Stanley-Park.”

Here is the topic (and this is SoCRA’d):

Name a type of thing in a hospital operating room –

A person’s name –

A city in Canada -

OK the story must include these words somewhere (OR thing, person, city), it can be one sentence or many, but you’ve each got to add one word only at a time. If you feel the group is getting stuck just end that sentence or thought and start a new one.

OK go (OR thing, person, city).

Now you’ve seen this demonstration what did people observe – those that participated as well as those watching?

My observations: you’ve got to let go to make it work, the more you focus on your own impending word opportunity the more frozen you can become. You’ve got the stand back a little and listen to the whole rather than on the part immediately before you. The group owns the story not you.

Now I only had time for one very short exercise and there are many more that could be done to make all sorts of points about words and observations.

The main lesson for me when I did some of these exercises is that it really demonstrates how complex listening (and observing) are. How

we can really get in our own way of hearing or seeing what is really going on. So much of what I do when I go out into the field to interact with healthcare professionals is about trying the figure out what they actual do, what they expect my potential new design to do and how to deal with the very difficult subject of trying to understand what “could be” instead of “what has been.” You in the room are often working on new stuff and you know full well the difficulties of, on the one hand, users having to change their habits and on the other of the development team seeing that those great ideas they had back in the lab are not as great as they first thought.

A key to unlocking a better understanding of these issues is to become a better listener and observer of what your users are trying to communicate to you.

An important skill is that you have to learn to be comfortable with silence, creating gaps to let the person you are questioning fill them in without them getting subliminal prompts from you to chase the conversation along in your direction.

Do an Improv Workshop – and you’ll become a better listener (and observer but we didn’t get to that exercise today…)

I am sure many of you in this room play or have played a musical instrument, so this part will be more familiar to you. Probably fewer have played improvised music and it’s the improvising part and its role in creativity that I am most interested in talking about today.

Those that don’t play an instrument are thinking, how on earth can I improvise on an instrument if I haven’t a clue how to play it in the first place. “This is going to take me years to achieve”.

Wrong – just like all the other creativity exercises suggested here today there are some simple tricks that in minutes will have you unlocking the improviser within.

Music does not have to have complex tonal and rhythmic arrangements to be music. It can be very simple. The trick is to pick instruments that have minimal technical skills required to play them. The easiest place to start of course is with rhythm and use simple percussion instruments, but actually there are many simply instruments to use and there is a whole body of educational approaches encompassed in the Orff music teaching methods.

Many of us, especially from the boomer generation like me, faced a music education that got bogged down quickly in technique and theory instead of letting us have a ton of fun messing around making music. The result was that we gave it up young. Hang on a minute didn’t that also happen with all those wonderful creative things we used to do as kids and have now given up – there’s a theme here….

The beauty of improvising music as a group is that within minutes of starting to play it will become apparent to you how powerful non-verbal communication can be in creating something. You can’t talk to your fellow performers but you’ll often end up going in new directions together, you’ll build to an intensity and then lay back slowly all without uttering a single word (and often without the need for any overt gestures either). It’s all about anticipation, expectation, surprise etc all these qualities (often contradictory) will inject something into the improvisation to make it unique and interesting. Of course jazz relies on this form – but it’s by no means the only music to do this.

In fact if you liked the stuff earlier on left-brain right-brain then this is another activity that is a very pronounced right brain skill. When I play music with others I am incapable of talking, although of course it’s easy to sing along! The act of improvising with others truly takes you mind to a different place – but of course like many of the topics we’ve discussed today, you’ve got to let go to get something back.

A drum circle is the easiest way to try it. At this point I have of course gone beyond the pale – I am from California, I’ve worked on you to do all this touchy feely stuff like drawing, creative writing and embarrassed you with improv and now you want me to drum? Pleaaase…. You’ll be breaking out the absinthe next (which by the way is legal in Canada but I don’t recommend it.)

I warned you that creativity was a messy business.

For those reluctant to join into an intimate musical event they have invented the perfect safety-in-numbers version. The Giant Drum Circle.

With sometimes as many as a hundred participants you can have a fairly-low-risk-of –embarrassment experience. Shown here is a drum circle typical of what you might find at Carnivals around the various Latino communities. A good leader (and you need a great leader to bring out the best in any team) will organize the percussionists and slowly introduce the various rhythmic patterns that you’ll be using. You really don’t need to know anything about drumming or music. The leaders will use call-and response techniques straight out of the roots of music in many ancient tribal events. (see on this video). From the mother singing to the swaddled baby to the farmers working in the fields calling out rhymes, the call-and-response is the easiest way to learn.

A typical drum circle will build a base rhythm over perhaps 5 or 10 minutes and then give people room to improvise on top of this. It gives you a chance to get comfortable with the “pulse” so you can stretch out and play some rhythmic counter points on top of the basics. You may not be comfortable at first, but as the words of the proverb and country song go, “You got to dance like nobody's watching.” Especially in smaller groups you will be amazed how much the music breathes, changing gradually with a distinct form that was never written down and never verbalized to change – yet the group is somehow able to react to each other’s contributions and create something greater than the sum of the parts. Your best music will be when you let go and let the group’s music take you with it.

Brainstorming is a form of creativity that is very close to improvising or “jamming”. A successful session has very similar characteristics. It may be verbalized or not. It is possible to “riff” on someone else’s ideas (to steal from musical jargon). A person might suggest a humorous and not very practical idea that injects some laughs, and with the right group of people who are good at not being critical, one of the group members might immediately create a more serious response that “riffs” on the humorous idea but is new in a way that might be more practical. Who owns the ideas? Didn’t the band create the tune? That’s the whole point of good brainstorming, it truly is the group’s idea. Ask the patent lawyers what they think of that one!

It is actually possible to teach people to be better at brainstorming - and I do that from time to time and have written of my experiences here…

Play improvised music with other people – and learn the power of non-verbal communication in creativity and life.

The final lines of this come from a song called "Come From The Heart" recorded by Kathy Mattea, written by Susanna Clark & Richard Leigh.

You got to sing like you don't need the money
Love like you'll never get hurt
You got to dance like nobody's watchin’
It's gotta come from the heart if you want it to work.

There is theme here:

Creativity and innovation are risky but potentially rewarding activities that are very paradoxical:

You risk rejection –to get accepted

You’ve got to let go – to catch something

There isn’t a day goes by where I don’t find that some of the skills I’ve picked up at being creative don’t help inform and improve what I do – whether in my personal or business life.

I was teaching a new researcher the skills of interviewing healthcare professionals just this week and remembered what my improv workshop had taught me about listening.

I watched a bronchoscopist at work with a tricky new interventional procedure when the whole room was riveted to the endoscope video screen I was looking at his hands – observing carefully the nuance of the motion and noting where he was getting frustrated and what his fingers were doing when all around were pointing to the video screen.

In writing a field report about how we could design a new painkiller pump that reduced medical error I pondered hard a paragraph trying to explain how the interaction between human nature and technology could be made more forgiving to the human side of the equation and figured out how to communicate this complex analysis with few words and great clarity, so an upper manager with little field experience could see why it might be worth spending half a million dollars to create software to improve this situation.

As I sat interviewing a person with a chronic disease explain how they lived with their condition I paid closer attention to their body language to better understand what parts of living with their disease made them the most anxious.

All skills I have homed through practicing some creative arts, I hope you find them as useful as I do.

Don’t forget the promise you made at the beginning. Is it to be one or two of these suggestions you try? Please email me with your experiences or feedback – I’d love to know how you get on. Thank you for listening to me today.

This article was originally published in MDDI on August 2008.

The green writing is on the wall: it is time for medical manufacturers to consider the sustainability of their products, packaging, and production processes.  In the consumer world, Wal-Mart is undergoing a major effort to adopt sustainability and even hired the ex-head of the Sierra Club as a consultant on this topic. Clorox recently announced its Green Works line of greener household cleaning products.  Companies with a strong presence in the medical field like Kimberly-Clarkand Philips have long been addressing the problem.

Even if you are not doing something about getting greener, your customers are. Alegent Health, a company with nine hospitals and 8600 employees, has recently named a vice president of sustainability.  When faced with a choice of medical products of similar cost and efficacy, it is likely that customers will purchase the greener product, especially if manufacturers have added green to their brand attributes in a way that customers see has real meaning.

Sustainability broadly means considering the environmental effect of a product throughout its life cycle, not just in its creation and initial use. And it is a daunting topic for the uninitiated.  Although RoHS and other legislation in Europe have brought some sustainability issues to the forefront, it is understandable that many medical manufacturers have been reluctant to embrace sustainability. The device industry is notoriously slow to make changes. In addition, the industry is sometimes exempted from the legislative restrictions required in the consumer marketplace and is therefore less likely to pursue such change. Further, sustainability has an image of increasing costs.

Start Here: Map the Product Life Cycle
Understanding how manufacturers can use sustainability requires mapping a product’slife cycle. This includes raw material extraction; all processing and manufacturing; actual use; and disposal, reuse, or recycling.

Creating a sustainable product is an attempt to reduce the environmental footprint at each stage with some kind of change. Changes do not have to be massive to have a positive effect. For instance, Philips Healthcare considers a product a Green Flagship if it achieves 10% improvement over its predecessor or competitor. A review of Philips products with such status indicates that most achieved improvements in the 25–35% range.

OEMs usually focus on improving efficacy and usability, and minimizing trauma and cost. Like these factors, sustainability has the biggest influence at a product’s conception.  Many sustainable qualities of a product are baked in during the innovation and design stage.  

For medical products, the business model is also important. For example, a one-time-use disposable consumes more resources than a reusable product. Of course there may be clinical, product, or sterility issues that require disposability. Because of such factors, the approaches to sustainability from the general consumer or industrial world do not always translate well to medical products.

Quantifying Design Alternatives

Once a specific device’s life cycle is understood, an OEM can begin identifying the places to lower its environmental impact. The team should quantify the effects of various choices.

One way of enumerating a particular design’s effect is to use software such as Life Cycle Assessment (LCA). This software draws on carefully researched databases, allowing manufacturers to estimate the effect of one type of plastic over another, the weight and material type of packaging, or shipping options.  Leaders in LCA software are European companies with products such as SimaPro and GaBi. 

Although large companies may already own such software or think nothing of purchasing it and training people on how to use it, the software may not be the right place for most device manufacturers to start.

Hans van der Wel, Philips Healthcare’s manager of ecodesign and sustainability, helps run its Green Flagship program. He says the best method for starting out is to “keep it simple. Start with a spreadsheet based on simple indicators. We call ours green focal areas [and] include qualities like the amount of materials, energy, and hazardous substances used.” He says it took Philips 10 years to get to its Green Flagships program.

Example: An RF Surgical Tool

An example product demonstrates how device designers might approach sustainability. A product system includes a disposable and an energy-supplying console.  The following section explores the effects of changing these system elements, which are typical to many medical products.

In evaluating the effect of the various components that make up the whole product, designers need to use real impact data. The LCA software makesfinding data easy. It is probably the best long-term tool, but it requires a commitment of money and training that might slow initial efforts. Alternatively, the Okala Guide is inexpensive ($12) and has a useful table of impact factors that covers common materials and processes. It is used in this example.  The Okala guide combined with a simple spreadsheet may be good tools to get started.

To make this example easy to understand and illustrative of the kinds of improvements possible, not every material or process is compared. In some places, system elements are combined and given overall numbers to ease the reading of the tables.

The analysis focuses on areas in which manufacturers can have the most influence.  In practice, when you consider the whole product, the actual impact reduction achieved might be lower than the numbers shown here. However, on an established product, an overall 20–30% reduction is relatively easy to achieve.

Product Description. A hypothetical radio-frequency (RF) tool for clamping and cauterizing surgical wounds is being considered for redesign. The company hopes to improve sustainability.  The product is a system consisting of a disposable handpiece and an RF energy generator and controller.

The Disposable Handpiece: Consists of a plastic-and-metal handle with integrated mechanisms that provide mechanical advantage to the surgeon’s grip during the procedure, and a wiring harness to connect to the console. The handle is currently single-use (all parts) and is contained in sterile packaging.  It is manufactured at one location but used in all major global markets.

RF Energy Generator and Controller: Consists of a piece of capital equipment that is a power and control source for the disposable. It is based on five-year old electronics and display technology, has no field-upgradable features, and is intended to last five years. The console is built into its own hospital cart.

Two levels of improvement are considered: first, a few options f or redesign of the disposable, and second, a redesign of the reusable energy-generating console. To begin, readers should understand the existing product’s ecological footprint to accurately compare new design approaches.

Calculating the Footprint.

Everything that is used to make, use, or dispose of a product is scored based on its environmental effect. This is calculated using a rating called impact factor.  Impact factor numbers have been gathered or researched and reduced to a standardized unit by an agency such as the makers of LCA software or compiled in resources such as the Okala guide used here. This factor is based on how the particular parameter is used in the product (e.g., per lb material, kWh of energy, tn/miles of transportation, etc.). Totaling the scores yields an overall product rating. In this example, units are in Okala milli points. Impact factor units must be the same for all contributors. Values from sources that do not share units cannot be mingled.

The RF device example looks at the effect for the entire life of the product—about five years. During this time a typical user buys one console and uses 10 disposables per week, yielding a use of 2600 disposables per console lifetime. This means that of the roughly 212,000 impact points, the 2600 disposables used over the product life contribute about 196,000 points. It is important for designers to consider the overall system usage, not just individual parts, in evaluating and comparing the various redesign choices. With this calculation in mind, consider the following possible changes to the hypothetical product.

Scenario 1—Make the Disposable Part Weigh Less (console unaffected).  This scenario simply considers using improved design optimization tools such as finite-element analysis (FEA) to reduce the material needed for both the plastic and metal components (without compromising function).

A slight weight reduction has various virtuous effects. Less material is used, which reduces environmental impact.  In addition, lower material cost helps offset the increased design and validation costs of a lighter handpiece.  Packaging can also get a little lighter to reduce shipping cost and impact.

A modest change to the product, requiring no major changes to the way it is made or used, yields a small but meaningful 6% reduction in impact over the product’s life.

Scenario 2—Make the Disposable Weigh Less and Enable the Wiring Harness to Be Reusable 20 Times. The development team notices that almost half of the disposable’s impact comes from the copper wiring in the leads that connect it to the console. The leads are redesigned to be sterilized and used 20 times instead of just once. The copper content remains the same, but the insulation needs to be beefed up to make the parts rugged enough to withstand reuse.  Also, now they will not be packed with every disposable but instead be shipped one set per box of 20 hand pieces. Overall, the product and packaging are lighter, further reducing impact score. A factor must be added for the sterilization by the hospital. 

Reusing the wiring harness has a very significant effect. Now the impact is reduced 44% overall from the original product. This redesign does, however, require a change in how the product is sold (box of 20 handpieces with just one wiring harness enclosed) and in how it fits into the hospital’s overall workflow. Hospitals must sterilize, manage, and inventory a wiring harness for 20 uses. But copper is also expensive, so now the cost to provide the function of 20 handpieces has decreased. Such savings could be passed on to users in exchange for the task of sterilization, without negatively affecting the manufacturer’s profit per handpiece. It is a balancing act, because the cost of sterilizing at the hospital may outweigh any savings.

Although the market may not yet be ready to make such a change in how it handles wiring harnesses, the example shows how such a change contributes to making the overall system green.  As some large hospital groups become serious about being more sustainable, they may be prepared to make these kinds of changes in the near future.

Scenario 3—Build on Scenario 2 by Redesigning Electronics and Choosing Lighter Materials for the Enclosure.  Now the development team turns its attention to the console and notices that the energy used while the machine is on (usually for a four-hour procedure) affects every disposable. Modern electronics are not only RoHS compliant, but also offer a more efficient package in terms of PCB size. Furthermore, new electronics consume half the energy of older electronics (due to improved sleep modes between uses during the procedure).  Now that the console is smaller, it can be built into a lighter, portable enclosure, rather than integrated into a heavy cart. Such changes have a significant effect on both disposable and capital system elements, and yield an overall 52% reduction.  Notice that if further changes are made to the console electronics to reduce copper wiring by 20–50% (perhaps by some novel pulsing technique or a change in the frequency of the RF), it would further improve the product’s impact score.

A simple spreadsheet scenario like the tables allows a team to see possibilitiesfor redesign. This is obviously a highly generalized example. Only your technical and marketing teams know where the opportunities lie for your specific product in its clinical efficacy and marketing acceptability.

The Disposable Matters More
In this example, it is assumed that 10 disposables are used per week per console—not an unreasonable assumption for this kind of surgical tool. As noted, this means that over a five-year design life, 2600 disposables are used.  Therefore, even a small improvement in the disposable has a magnified effect.  By contrast, if the design team halves the impact of the console it hardly reduces the system’s overall impact. Designers must consider the effect of the whole system’s use.

Although the case study shows that focusing the redesign effort on the disposable has the most affect on environment, there are still things the manufacturer can do to the reusable portion of the product that can further reduce its impact. In the example, 50% more efficient electronics in the RF energy generator lowered the energy portion of the product’s impact 2600 times because each use of the disposable cost 50% less energy.

Conclusion
This exercise shows how changes such as lowering energy use through a better sleep mode for the console can have a greener consequence than, say, using a lighter plastic on the enclosure.  It’s not always the obvious changes that have the most benefit, and unfortunately, finding the changes that have the greatest potential are not formulaic. Each product will have very different aspects that must be rethought.

Perhaps as an industry we need to reconsider what it means to be green.  As Wendy Jedlicka, a sustainable packaging expert, puts it, “The idea that you have to wholly embrace eco like a religion is shortsighted and frankly not sustainable. We need to get everybody doing a little bit of something to mitigate what we are doing right now; then we can keep improving.”


Reference
1. Philips Medical Green Flagships [online] (Amsterdam [cited 28 May, 2008]); available from Internet: www.medical.philips.com/main/company/sustainability/
green_flagships. 

Successful medical device OEMs recognize the importance of an early and extensive partnership with potential end-users.

As the potential of the technology that goes into medical pro ducts grows, so does the need for product design features that make them accessible to users. 

These trends are exactly that trendy. Like any new method, they go out of fashion after a time. Sometimes it ’s for a good reason, but occasionally they are wrongfully discarded for the next new thing. Although many aspects of these trends have something to offer, the biggest improvement will come from taking a more-holistic view of innovation by focusing on three core areas of a business: culture, process, and resources. Try introducing six sigma into the wrong culture and it is bound to fail. Pour resources into a development program with a bad process and it is unlikely to create breakthrough products. This article provides insight into the aspects of company culture that make many successful innovations possible.

The trick is to experience failures quickly. Test ideas in the first months of the development project, way before any serious engineering has been done.  Use every trick in the book to visualize the product and get it in front of customers.  Show sketches, prototypes, and simple foam models. Cheat prototypes into existence by cobbling together existing products or hijacking technology from other industries.  Show early ideas to potential customers.  Get ideas out in the open for people to criticize, but do it as soon as possible.

Paradoxically, teams that learn to be good at failing quickly often learn to become better at succeeding quickly.  To encourage risk, and hence innovation, all team members must become comfortable with this paradox and adjust their expectations as a project moves from concept to refinement.  Taking risks early is inexpensive and potentially rewarding. Taking risks later in a project is much less desirable.  Then, the die has been cast, and linear, predictable behaviors are essential.  This takes almost superhuman management abilities, because unpredictable behaviors must be encouraged early on, but later, when the project progresses or employee reviews come along, the same manager must hold employees accountable to their management by objectives. Or the managers must account for the team’s progress to an upper management that is more skilled at counting beans than at growing them.

A project leader with great interpersonal skills as well as technical chops is key to a successful team. But people are not born this way—they are cultivated.  Along with the top leader, every significant project should have submanagers who are being mentored to take the leadership position on future programs.  Train for the soft people skills as well as the technical know how to cultivate a team.

Project leaders need to be supported by upper management with realistic budget and scheduling that has contingency built in. The entire team does not need to know exactly how much contingency there is; instead, the leader listens to each subteam’s needs and allots it some of the scarce resources.  Other team members must quickly learn the reasons for the allotment so that it is understood that there is sound logic behind it.

But even without a contingency, the schedule needs to be plausible. There is nothing less motivating to a team than shooting at a target that is hopelessly out of range. Obviously, there is never enough time to get every detail of a p roject perfect.

It is inevitable that a team leader will ask for a few miracles and, as the joke goes, these will take a little longer. But when the entire team understands the bigger project goals both technically and from a business perspective, and it is plausible that with a little extra effort these goals can be grasped, people rally to meet the objective.

But in subtle ways, such situations can come up all over an organization as a project unfolds. Sarcastic comments around the water cooler about nascent ideas or overheard phone conversations that poke fun at a part of a project that failed puts innovation in a straitjacket.

Experience often gets in the way of new thinking, but it is an important partner in making things actually happen. Therefore, the entire team needs to encourage a democracy of ideas, especially in the early concept stage.

This article was originally published in MDDI on May 2006.

Looking at broad trends in technology and society can help medtech companies in their long-term technology forecasting.

In few industries do the words of British industrialist James Goldsmith ring as true as they do in medtech: “If you see a bandwagon, it’s too late.” Success in the medical device realm requires disciplined foresight and advance planning.Yet even intelligent people can be spectacularly wrong when predicting the impact of technological trends and making investment decisions accordingly. Banker JP Morgan, after reviewing the new invention of the telephone, stated, “Mr. Bell, after careful consideration of your invention, while it is a very interesting novelty, we have come to the conclusion that it has no commercial possibilities.”

Predicting the impact of technological and social change in the three to five-year future is arguably easier for themedtech industry than for consumer industries; medtech product cycles are longer and change happens more slowly. It can take a medical device company two years to get its next-generation product to market, and it is not uncommon for a product to have a life of five to seven years.

Regardless of such relative predictability, fast-moving changes driven by other industries and new technologies can sometimes wreak havoc on a medical device company’s planning.  However, it is from these slightly chaotic and disruptive events that great new opportunities are born.  When it comes to looking ahead 10 or more years, the medtech industry needs a different perspective to shake up linear thinking and unearth new opportunities.

Long-wave economic theory provides a historical perspective on the major technical revolutions of the past 250 years, and a little immersion in it can have a refreshing effect on one’s thinking about future technological change on the 10- to 15-year horizon.  This article briefly reviews this theory and suggests some ways in which medtech companies can apply long-wave theory for longerterm forecasting.

Long-wave theory focuses on the technological revolutions that have characterized the significant surges of economic growth since the start of the Industrial Revolution in the late 18th century. Long-wave theorists say society is in the middle of such a revolution right now, and if the current revolution follows the pattern of previous ones, the world is in for some exciting long-wave riding.

According to theorists, each revolution lasts about 30–40 years and is characterized by two distinct phases of roughly equal length. First there is the installation phase, during which the technology is developed, refined, and installed around the world. This is the period of greatest upheaval in the established order of business and society. The deployment phase follows, during which the technology begins to improve economic prosperity through increased productivity and spreads significant social advantages in the form of lifestyle improvements.

As a means of understanding the two phases of each revolutionary spurt, one can consider the revolution of heavy engineering,when rapid advances in civil, chemical, electrical, telegraph, and naval engineering laid down a new infrastructure. One effect was the globalization of the food industry: during the northern winter, producers in the southern hemisphere could start shipping vast quan- tities of fresh foods to northern markets.  As a result, established industries went through massive upheavals as their business models were turned on their head by new economies of scale and speedier communication. In the northern economies, however, the resultant growth and cheaper fresh winter foods had an undeniable benefit across wide swaths of society.  

Under long-wave theory, revolutions are like tides in a harbor. They are large, cyclical forces that raise all boats. Medtech has had its own upheavals, including surgery, antibiotics, imaging, and genetics. However, for the purposes of riding the long wave, these must be viewed as components of society’s larger revolutions rather than revolutions in themselves. Just as the transistor’s development in the 1950s can be thought of as the microprocessor revolution in gestation, the combination of biotechnology, bioelectronics, nanotechnology, and new materials may well be the gestation phase of the next revolution 20 years on the horizon.

How does a medical device company create a new product for a well-established market when a handful of competitors seem to have sewn it up? This was the problem facing Smiths Medical MD, (Minneapolis USA) who had recently successfully entered the diabetes market with an insulin pump and were looking to create a new infusion set for the same market. How could this new infusion set be made compelling enough to move customers entrenched with the competitive offerings over to a new product?

This article uses the case study of the design of this infusion set to illustrate how designers and engineers can best refine their design process to create new products that both benefit consumers and make their companies more competitive in the global marketplace. Although it is focused on a new medical device,the design process described here can be used across many product types that have a high degree of human interaction, ranging from consumer and automotive through a wide variety of industrial and scientific equipment markets, ensuring that a product is beneficial for users without sacrificing the company’s competitiveness.

Living with Diabetes

To understand this product challenge it is necessary to understand how patients currently manage their diabetes. Type 1 diabetes, also previously referred to as juvenile or child onset diabetes, is a condition where people stop producing their own insulin. Insulin is a hormone that controls humans’ ability to regulate the flow of glucose in their blood. If a person looses this control, their blood sugar oscillates wildly according to many factors including what they eat, how they exercise and if they are sick.  Such a lack of control over blood glucose leads to many life threatening complications such as loss of limbs and sight, and leads to shorter life expectancy for the millions of people with diabetes. Although much research is centered on finding one, there is currently no cure available. In the meantime people with diabetes have to control their blood sugar by taking regular doses of insulin, often in the form of multiple daily injections using simple hypodermic syringes.

What is an Insulin Infusion Set?

Increasingly, diabetes professionals and patients are recognizing the value of using a small programmable pump to infuse regular amounts of insulin directly.The programmability of the pump and the user’s ability to routinely adjust, or titrate, the dose of insulin allows people much greater control over their blood glucose levels. It also has the added advantage that users do not have to stick themselves multiple times with a needle. Instead they insert a small plastic tube, known as a cannula, into the midriff region of their bodies and let the insulin be pumped in exactly when needed. This connection, known as an infusion set, is typically worn 24 hours a day held on by an adhesive patch, and is disposable, with changes necessary about every 3 days. The cannula has to be introduced into the body with a small needle to help it reach the region of fat just beneath the skin (known as subcutaneous fat). After insertion the needle is withdrawn and disposed of.  A thin plastic tube then connects this infusion site with the pump.

As readers will see from the above explanation, diabetes is not much fun to live with. Patients have to suffer multiple insults to their body, including pricking their fingers for testing blood every few hours as well as sticking themselves to get the insulin in. Infusion sets and insulin pumps help, but as designers and engineers what can we do to make life easier for these people?

How can we make the new product compelling?

To really cater to a user, you have to understand exactly what it is like to live with the disease.  This is the premise with which Smiths approached the design of their infusion set. They asked the question “How could this new infusion set be made compelling enough to move customers entrenched with competitive offerings over to a new product?” Just doing a “me-too” product in the £XM diabetes infusion set market was not likely to win customers over or help the management at Smiths justify the significant R&D expense of a new offering.

Smiths immediately set about creating a small core team of about eight people to begin the development. This was a cross-functional team with mechanical and manufacturing engineers as well as product marketing people. Smiths medical also partnered with an industrial design firm, Bridge Design, at the very beginning of the project to ensure the team was rounded out and to take advantage of Bridge’s previous experience with developing Smiths market winning Insulin pump (Cozmo). The project started with all members on board and a team leader, Tim Bresina, who, although from a manufacturing engineering background, had a broad perspective on what it takes to develop successful medical devices and a real appreciation for what the various disciplines in his charge could do collectively to allow innovation to flourish. Team members often bring preconceptions or pet solutions to the problem they are trying to solve. This is inevitable, but before any serious work began on this project the team set about calibrating their understanding of two crucial things; what diabetics want and to benchmark the competitive landscape.

The “Deep Dive” into the Customers Mindset

To understand users, Smiths had three exploratory submarines in its fleet, all of which were important in taking a “deep dive” into the customer’s mindset. Firstly, its connection and understanding of its present customers was a valuable data point. Smiths had a nascent Diabetes business and a maturing understanding of its customers that were currently buying an OEM infusion set that Smiths branded and sold. The marketing people on the team normally worked in this marketplace, and were thus able to bring this perspective. Secondly, Smiths had assembled a couple of external advisory boards consisting of various types of healthcare professionals such as Endocrinologists (the medical doctor specialists for Diabetes) and Certified Diabetes Educators (CDEs) who are the nurse practitioners who work directly with patients to help them get better control of their blood glucose levels. Regular meetings with these advisory panels helped the team understand emerging trends, providing a forum for rapid feedback on product development ideas. With a patient’s purchasing decision influenced by a mix of doctor, CDE and peer referral, as well as the medical insurers or healthcare systems willingness to cover the cost of specific products, the market for infusion sets is complex. As Smiths was targeting a global market, they used ethnographic research to “get under the skin” of what people with diabetes really desired in the ideal infusion set –and this proved extremely important.  Ethnographic research is a technique of observing and interacting with people to gain a deep understanding of their needs, including needs that the users might have a hard time articulating. There are many ways of doing this research and they vary according the nature of the problem. Smiths enlisted the industrial designers from Bridge Design to do the ethnographic research for Cleo but also made a point of sending along a few of their engineers and marketing people to observe.  Bridge recruited about 50 people with diabetes of various backgrounds and ages all of whom were currently using infusion sets. To ensure a good spread of feedback three different geographic regions of the USA were chosen.

Once the participants were identified they were briefed about the team’s interest in better understanding what it is like to live with the current infusion sets on the market. Disposable cameras were sent out ahead of our interviews and two weeks later we met with them. Fortunately, our subjects were highly enthusiastic about it, and willingly told us what it is like to live with infusion sets, sharing photographs of their infusion routines and in some cases showing us where they were wearing them in the actual interview sessions. Of course, the interviewing process had to be conducted very carefully, with the risk that, if it was too structured, it could have prevented us from pursuing interesting lines of questioning. In practice it is best to have interviewers who bring very few preconceptions to the session but who have a significant understanding of the issues. For instance, participants will often tell little white lies about some of their routines because they know that they are “supposed to do it like this”.  In doing this research there are of course no right or wrong answers, so the role of the interviewer is to make subjects feel comfortable about being honest in their responses and to probe areas where there is concern that actual practice may differ from what is recommended.

Briefing the Team – Getting the Voice of the Customer into the product design process

A few core members of the team then set about preparing for an intense two day team briefing and brainstorming session where about eight team members from all the different disciplines would meet off-site for focused idea generating sessions. The focus of the sessions was not on solving a narrow set of technical issues. Instead it was on understanding the users’ needs for the product and using that insight to focus the whole group on a series of questions that were carefully crafted to elicit design ideas that attempted to meet those user needs. 

Prior to the two-day session, various team members also did some preliminary brainstorming around a sub-set of technical issues. The mechanical engineers from Smiths developed some interesting ideas for sprung mechanisms to assist with extracting the needle from the cannula after it is inserted through the skin.

Bridge Design went out and did some shopping for the project, spending about a day scouring the aisles of supermarkets, drug stores, toy emporiums etc. The designers found many interesting products that could be used in the brainstorming to stimulate the team.  Bridge design hosted the meeting in San Francisco and compiled a two-hour briefing presentation for the team. This briefing gathered all the research, including the ethnographies, benchmarking of competitive products and inputs from marketing and the advisory boards. All team members were encouraged to contribute their own experiences and research to the briefing–exposing the entire team to diverse opinions and interpretations of what the customers wanted. However, with a large patent estate already surrounding infusion technology, the team also had to consider what solutions would be out-of-bounds due to pre-existing intellectual property.

The team then set about debating what the customer requirements were. It is important to understand that users will not always articulate fully their hopes for what a new product might be like. People are very good at judging products and solutions that are already created; they are not good at imagining “What could be”. Therefore in debating the customer requirements the group was trying to get to the very basics of what customers want as well as what they need, which is why it was so important to involve a diverse group who had all had some kind of customer contact. In the case of a medical product, such as the Cleo, the customer is broader then just a typical user, as the opinions of healthcare and insurance professionals also need to be considered.

To organize and prioritize the list of requirements, which were deliberately stated very simply, a scoring system of 1, 3 or 9 points was used.  This scoring system was set up to polarize the scores around some big number differences as arguing about whether a feature merits a score of 4 or 5 does not force a team to make bold decisions about what really matters to the users.

The team also debated other factors such as the users’ current satisfaction with these types of products and the potential impact of meeting a particular requirement to improving sales.  For instance users expect a medical product to be reliable so this would have a neutral effect on sales, whereas creating a highly integrated device (insertion, adhesion, needle safety etc) would be a big plus for sales so is scored more highly. The purpose of the customer requirement ranking exercise was not to get the scoring ‘exactly right’. Instead it is an exercise that takes about two hours and is about the team debating,arguing and reaching an understanding of what these requirements actually mean to users.

This technique is a highly simplified adaptation of a system for product development known as QFD (Quality Function Deployment) that is often used in six-sigma types of product development environments. In practice this author feels that although QFD may be of value on very complex product development processes it is too cumbersome and frankly a very boring way of getting a development team excited about the product possibilities.  But stealing a few of its techniques and simplifying them are useful. (For a more detailed explanation of this brainstorming process see the article “Beyond Brainstorming” on http://www.devicelink.com/mddi/archive/04/09/013.html)

What the team learned from users was that they valued good old convenience and reduction in the steps to use the product. Children and some adults also expressed a dislike of handling the needles required to help insert the set. The requirements in this chart capture the essence of what the team felt customers wanted and importantly give some dimensions to the criteria rather than just blandly stating things like "convenient to use”. This is a much more useful place to launch into a creative brainstorming session than trying to plough through a detailed 50 page customer requirements document.

Setting up the Brainstorming Questions

Next the team set about creating a very pointed group of about six questions that would be used to focus the idea creation process.  This is a skilled task as the questions have to highlight the customer needs without limit or suggesting possible solutions.

The brainstorming itself consisted of about six half hour intense ideation sessions spread over nearly a whole day. Each mini-brainstorm was structured around a particular question centered on an essential customer requirement; ie “How can we reduce & speed steps in the insertion process?” The whole process of being immersed in the design issues off-site over a two-day period really focused the team’s efforts.  Keeping the actual sessions as short sharp bursts of creative energy with rest periods of at least ten minutes between sessions also helped keep the team fresh. Rather than using large white boards or cumbersome flip charts the group used small easily manageable “idea sheets” to sketch or write down their ideas and share them with the team before posting them on the wall. All the usual rules of brainstorming were applied and the team was encouraged to turn any critical thoughts they may have into new insights, building on both other team members’ ideas as well as generating new ones. 

One Idea a Minute

The result was that the team created about 200 idea sheets with innovative solutions focused by the careful preparation. The Smiths engineers shared mechanism ideas with the team and it further stimulated ways of using the mechanisms with a very user-centric appeal.  A smaller group of designers at Bridge Design then took the group’s efforts and sorted the ideas into three categories – Hot, Maybe and Not. As many readers are aware, successful brainstorming tends to focus on creating a large number of ideas rather than fewer higher quality suggestions.  This session produced a solid collection of ideas that were truly “Hot” with an equal number that were mediocre. Once the best ideas were sorted through it became clear that there were a number of innovative solutions that could be synthesized into different product concepts. 

The Whole is Greater than the sum of the parts

In all, about 6 different concepts were explored and the one that offered the most advantages was pursued and engineered by the Smiths team.  

The design attributes are:

• Users told us that step reduction was an important goal so the final product is the first all-inone system: sterile packaging, inserter and needle safe disposal container and reduces the insertion steps from about 15 to only 3. The adhesive patch does not require stripping as it is protected inside the disposable. The user simply unscrews the cap and gently presses the unit into their skin at a speed convenient to them. At the end of the insertion stroke, a spring returns the insertion needle up inside the container into a needle safe location.

• Cleo hides the needle from sight for ease of mind and perceived pain reduction.

• The “on-body” part was made smaller and adjustable to fit any infusion or pump location.

• Cleo is a discreet non-medical looking product that uses a classis bottle “rip-top” appearance to help cue users that this is a disposable product.

• It met the intellectual property goals of creating technology unique to Smiths.

You can view a short video of the insertion process here. You can find more consumer information about the Cleo here.  

Conclusions

Often engineering education focuses on the functional aspects of a product. In medical product design this is often thought of as how medically efficacious the product is. Unfortunately, in practice this view tends to disregard a broader user perspective – “How can you make this product easier for me to use”. In this context “easier” can mean many things.  New medical procedures often require users to change their habits, ergonomics and visual cues, instead of making a new procedure seem like a logical progression from something that they are already familiar with, which can really make adoption easier. An attractive product which appears non-threatening is also effective when trying to help children better manage diseases like diabetes.

The process that Smiths adopted for Cleo was really focused on getting these softer, user desired qualities into the product. It is possible to go back through the project history and see user comments that asked for certain attributes and then follow a trail through the design process to see how those insights really motivated the team to turn their technical skills in the most useful direction.  It is also possible to say that everyone on the team contributed to the design. Ideas were built upon; inspiring technical solutions came from the process. And, if a technical block was met along the path to implementation, the engineers at Smiths were highly motivated to overcome them as they had a good understanding of what their customers wanted, providing them with a sense of satisfaction of knowing that when they got the job done they would have made diabetes just that little bit easier to live with!

Left: Cleo with the cap removed and ready for insertion.  (Note that the adhesive requires no manual stripping.)  Right: After insertion with the needle safely retracted.  

savvy medical device manufacturers.  In the cross-functional development teams that create such products, industrial designers may possess the skills and enthusiasm that can deliver these qualities. 

Thus, industrial design is now integrated into the development process of many medical manufacturers. Similarly, OEMs that understand their users as well as the broader trends in the consumer marketplace, and then tailor their products to them, are often the most successful.

In an increasingly competitive landscape, medical product developers that want to try to stay ahead of the pack are turning to industrial design to accomplish that goal. OEMs need to know how their development teams can best harness industrial design for a particular product. It is also essential for OEMs to be aware of the design trends to watch in the coming decade.

Defining the Product: A Customer-Focused Approach
Through surveys at many medical industry forums, I conducted an informal poll. I asked project managers and design engineers to rank the issues that most interfere with getting a high-quality product to market quickly. The number-one answer was “difficulty of defining the product.” “Resourcing” and “corporate culture” followed closely behind.

Nowadays, it is not good enough to just build a product that is technically superior to or less expensive than competitor’s. It must stand out from the competition on all levels. And it must give customers a compelling reason to change their buying habits or to choose to do a new medical procedure. Getting the development team out into the field to interact with potential customers is the best way to begin to define the product and eventually win market share.

OEMs often call upon industrial designers to use their people skills to better understand the subtleties of customer needs. Industrial designers are good at using their visualization skills and their understanding of multiple disciplines to generate ideas for a development team, acting as agents of change.

There are many ways to integrate a more-customer-focused approach into a design process. The cost of doing so can range from hundreds of dollars, to send members of the design team to a specialized medical academy meeting, to hundreds of thousands of dollars, to conduct in-depth market research.

It’s beyond the scope of this article to delve into all of the available methodologies.  Suffice it to say that the best methods, whether large or small scale, all have basic attributes that can be summed up as call and response.

Call. The team calls out to users and customers to find out how they work, what trends affect their work, and what they want most from a potential new product offering. Sometimes companies gather this information by large-scale qualitative or quantitative surveys. For maximum benefit, members of the design team should have opportunities to participate in the data-gathering process.

Team members should view potential customers actually at work. Industrial designers often are good at this field research.  With a combination of experience and motivation, they can provide a designer’s perspective on the market.  They can often spot opportunities that a focus group analysis might miss.  

It’s important to remember that customers often say they do one thing when observation shows that they really do something different. In such situations, thelead investigator should be as impartial as possible, but participation from the development team should be as broad as possible.

A firm may consider hiring professional facilitators skilled at leading observational research if it can afford them. But it is also important to understand that industrial designers can be impartial enough to be the lead researchers early in the development process.  At that time, they won’t have begun their owndesign work or become committed to their own ideas.

For instance, imagine nurses who are responsible for accurately dispensing potentially dangerous painkillers. A researcher can interview them afterhours in a peaceful environment, or talk to them as they walk the hospital floor. Although the same facts might be conveyed in either environment, the researcher who follows the nurses around during their duties may notice that interruptions constantly demand portions of the nurses’ attention.  Awareness of the nurses’ distracting environment may help designers simplify and clarify the user interface of the drug-dispensing equipment to reduce the potential for errors.

Industrial designers can also add value to these early feedback sessions by conducting product visualizations. Sketches of loosely formed product concepts, whether computer or hand generated, are the forte of the industrial designer. By capturing a long list of potential product features in only a few storyboards, designers can convey ideas very quickly. This activity is also aided by the fact that industrial designers usually have good cross-disciplinary understanding, so they are capable of combining input from many different specialties to produce visuals that everyone can understand.

These illustrations can be shown to potential users to gauge their enthusiasm for overall ideas or features. However, the beginning of the user research sessions is not the time to introduce new product ideas. This stage should focus on information-gathering conversations, and introducing new ideas may lead subjects astray. In some cases, it’s best to simply listen and observe. Sometimes, however, adding a few storyboards at the end of the session can help steer the team more effectively in the next phase, the response.

Response. The team takes what it has learned in the field and synthesizes the data into some whole product concepts. There are many ways to use field research to stimulate the team brainstorming process.1 It is most important to use techniques that remove personal bias from the concepts the team creates.  Use some method of ranking customer input so that the concept-generating phase focuses on the market’s top concerns.  This phase should also bring about a thorough understanding of the competitive landscape by benchmarking the device’s competitors.

Industrial designers can then take the team input and turn it into high-level product visuals. The designers can quickly simulate ideas with physical or virtual models that otherwise might take months or years to refine into actual products.  

However, some caution is required.  On one hand, because industrial designers are not the ones implementing the product modifications, they do not need to be sure that their concepts fit within real-world project constraints. But on the other hand, separation from the implementation details can give designers an important role as agents of change.  For instance, a team may not want to suggest a new display and user interface for a diagnostic product because of cost issues. An industrial designer might look at trends in other markets, the availability of inexpensive color displays, and rising customer expectations of ease of use.  With such data, designers could make the case that an improved display is an essential addition to ensure that the product remains competitive.

Certainly, these ideas can be taken back out into the field for further review with customers. But again some caution is needed, especially in areas where the development team intends to apply more-revolutionary or so called disruptive technologies rather than evolutionary concepts.2 Customers can often judge how a new product will be received if the changes improve upon a product or procedure that already exists. But it is much harder to get feedback on products that require users to imagine a different way of doing their job or treating a patient.  Analyze any rejections or acceptances in light of the qualitative data collected about specific customer needs.

The Value of Bringing in Outsiders
Outside designers can bring a fresh perspective and dramatically different ways of solving a product development problem. Of course, if it’s not done right, outsourcing design can lead to some irresponsible approaches and impractical suggestions. Negotiating this risk is at the heart of the decision whether to outsource industrial design.  The solution lies in getting the right balance into the development team. Depending on the product, doing so may entail drawing entirely from within the company, bringing in industrial design consultants, or a combination of both.

Within a team, the wisdom of experience needs to be tempered with fresh thinking. The newcomers must not be afraid to challenge the status quo, but should respect the knowledge gained from those with in-depth product design experience.

If a company’s products have always followed one course of development but begin to face new threats in market, then it is probably time to bring in outsiders. But if the firm has a consistent track record of innovation, then in-house industrial designers are more likely to be able to thrive.

Smaller medical OEMs frequently bring in design consultants, because they often do not have enough work to justify hiring highly skilled full-time players.  As a rule of thumb, one experienced in-house designer in the device industry can probably handle four significant projects a year. Of course, much depends on the type of product and depth of industrial design involvement.  No matter how industrial design is brought into the team, the designers should not have to report to any one discipline. Rather, they should be responsible to the whole team.

Above all, it’s important to remember that it does not have to cost a fortune to use industrial design. Any amount of customer contact is better than none; even a little industrial design early in the development process can go a long way toward improving the product.

Design-Trend Market Pressures over the Next Decade
Increasing Expectations of Improved Standards of Care. More and more, patients are directing important decisions that affect their own care. Although medical professionals still make many treatment decisions, patients are becoming better informed about alternative treatments or locations for care.  For instance, many expectant mothers now choose the facility where they will have a baby. As a result, many birth centers employ products that will make the whole experience much more enjoyable, personal, and friendly. Many medical devices are employed to deliver a baby, and manufacturers that tailor their products to make them less austere or intimidating will do well in this transforming market.

Also, many procedures that were done in a hospital are moving to lower cost surgical centers or doctors’ offices. Equipment designers must respond to opportunities and challenges created by this shift. This is especially true when the procedure is elective or has a lot of competition. Industrial designers’ skills at improving both doctor and patient ergonomics can make a procedure go more smoothly. Creating a product that looks appropriate and approachable will also improve the experience for both operators and patients.

Sometimes OEMs forget that doctors and patients are also consumers in the general marketplace, and these consumers are learning to love good design there. If a doctor can read a wireless portable e-mail device’s color screen in direct sunlight, why should it be a struggle to read a low-contrast monochrome display on an expensive surgical control console? It is no surprise that patients listening to a thin mp3 player or answering a tiny cellular phone think that their ambulatory medical device restricts their lifestyle.  Medical consumers will reject clunky products, preferring better-designed devices instead.

Appropriate Design for Developing Nations’ Medical Needs. Although developing countries’ healthcare needs are often basic and immediate, they still pose interesting design challenges. The key in designing products for such nations is to be culturally appropriate and toavoid imposing developed nations’ biases. For example, large swaths of Africa and Asia completely missed the wired era of telephone evolution. They instead jumped straight to the latest in cell phone technology, which created demand for ultrasimple low-cost phones.  

Using Design to Benefit from New Opportunities
Making Change Easier. The path to innovative new procedures or products is littered with projects that had significant improvements, but lacked some key element. The missing piece can sometimes be restored with the help of an industrial designer’s contribution.  A good designer will dig into the question, asking, “What design qualities will give customers a compelling reason to change from their current ways?” Relying on pure technical prowess or even an improved outcome will not always work; the broader aspects of a product’s features must be simultaneously addressed.

Sometimes integrating human factors will ease adoption, but if it is done poorly, it could as easily doom a product. Sometimes simply making a product less intimidating in appearance will affect customers’ perceptions. Sometimes a designer’s human factors skills can go a long way toward improving usability.

Integrated Medical Information Systems. Integrated systems have gotten a lot of press lately, though in practice, adoption by hospitals has been slow. Many such systems still need to overcome the problems of inputting and accessing the healthcare information generated by many different systems.

Clearly, once the systems are more broadly implemented and there is agreement on data formats, a new generation of devices will emerge. Designers skilled in solving the challenges of userinterface design will play an important role in making this information-rich environment easier to navigate. For instance, a patient monitor might be able to combine data from its own sensors with risk factors in the patient’s medical records to determine the probability of a serious adverse event.  Rather than just raising a simple alarm, there will likely be a better system for alerting and presenting this information.  It will allow urgent medical care to be given effectively at a stressful and potentially error-prone time.

Design as Part of an Integrated Marketing Strategy
Industrial designers’ problem-solving skills can help medical device OEMs improve their products. But there is another subtle aspect to industrial design that can help a company stand out in a crowded marketplace. The look of a company’s products across its whole product range is a very effective business tool that reinforces and increases customer awareness of a brand. This look is sometimes called design language.  It is commonly used by consumer product companies whose products present a consistent image.Design language goes above and beyond product graphics, packaging, and advertising. When customer loyalty is built in one specialty area, it can cross over into others and affect buying habits. Savvy medical companies can leverage their marketing and advertising dollars by having a consistent brand look.

For example, consider the many instruments, both diagnostic and therapeutic, that often sit outside operating rooms or in hospital halls. This impromptu display is a great opportunity to make sure that people recognize a brand and see that it has passed muster with the purchasing committee. (Incidentally, this is also a good reason to make sure the products weather well in the tough hospital environment.)

Conclusion: The Way Forward
If industrial design is not currently being used effectively within your company, how do you know when it is time to try? When considering outsourcing design, it is important that the company and team culture are ready to accept significant input from outsiders. It’s also a good idea to get the contractors involved right from the start. Before bringing in industrial designers as staff members, ensure that the person responsible for recruiting has experience working with industrial design people.  In the absence of such a person to help, it may be better to work with consultants first to get a feel for what you really need. In any event, just as the last decade has brought increased competition and globalization trends to the healthcare industry, the next decade will bring an intensification of these trends along with new challenges. Industrial design is a powerful tool that can help OEMs meet and exceed customers’ 
expectations.


References
1. B Evans and J Wyler, “Beyond Brainstorming,” Medical Device & Diagnostic Industry 26, no. 9 (2004): 46–53.
2. Clayton M Christensen, The Innovator’s Dilemma: When New Technologies Cause Great Firms to Fall (Boston: Harvard Business School Press, 1997).