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Thinking about Life Sciences

http://blog.aesisgroup.com

Tuesday, February 20, 2007

Medical Design Excellence Awards Offer Decisive Glimpse Into Future of

Health Care

I’ve just returned from Los Angeles where I served as a judge for an industry award contest. It wasn’t the
Oscars.
Instead, I and 14 other jurors were locked in a conference room at the Sheraton outside of LAX. Over three
days, we carefully and diligently selected the winners of this year’s Medical Design Excellence Awards
(MDEA). While the Academy Awards get much more recognition, the MDEA winners may very well save
your life some day.
The actual results are confidential with the overall winners to be revealed in the April issue of Medical Device
& Diagnostic Industry (MDDI). The gold and silver awardees will be announced at the annual Medical
Design & Manufacturing East (MD&M East) conference from June 11 to 14 in New York City.
Unfortunately, this column will not tell you who won. Without giving specific examples, I do think it would
be of interest to see what caught the judge’s eyes and what it takes to be an MDEA winner. Such
considerations have important implications for future trends in the medical device industry.
First, let’s review the process
The 15 judges came from a wide spectrum of background and interests in the medical device and
equipment industry. They fall into three major groups: engineers, designers and clinicians. Many of them
shared experience in multiple sectors. We had the whole range from leading academicians to hard-core
industry veterans. After an initial, high-level review of all the entries (a 30 percent increase over last year’s
submissions), they were distributed by category (10 in all) into five groups of three jurors each. Each group
then reviewed in detail the entries in their respective categories and then – for cross-validation – debated
their rankings with one of the other juror groups. Next, the top candidates from each category were
presented to the entire panel, votes were tabulated and gold and silver designations (with an additional
round of voting) were assigned. Throughout the process, points were earned or detracted for a variety of
consistent criteria including design and engineering innovations, functional innovations, patient benefits,
business benefits and anticipated improvements to overall health care.
The rigorous process of cross-validation and multiple voting along with the various quantitative
assessments made this as objective a process as possible. Admittedly, pure objectivity is never possible and
information is often incomplete. Some entries came without the actual equipment. It’s difficult, for
example, to ship an MRI machine. Complete evaluations are often not possible. This was evident in those
products incorporating complex software whereby an evaluation of all possible bugs and algorithmic
scenarios was not feasible. The extensive experience of the judges comes into play and gut feelings –
Malcolm Gladwell likes to call it “rapid cognition” – also figure into the assessments.
Overall, we were very impressed with the level of innovation and are comfortable with our final
assessments. We had fairly uniform agreement on the winners and those who needed to try harder next
time. In having the opportunity to see such a wide swath of medical innovation, we also had a chance to
observe some very interesting and important trends. Without referencing specific products, that’s what I’ll
share with you here.

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Design Counts
The success of the iPod has more to do with design than any technological innovation. While MP3 players
certainly existed before the iPod, elegant and simple design is what has made it the predominant MP3
player in the market. This reawakening of design consciousness represents a sociocultural trend that is
definitely playing out – albeit perhaps delayed – in the health care industry as well.
Because safety and efficacy have always been preeminent, pure design considerations have often been
secondary. As many people are aware, the result has been hospital equipment that is frankly ugly and often
unfriendly to users. While hospital and clinic architecture has advanced and we can count some medical
buildings as being beautiful, the innards and the equipment are often forbiddingly unaesthetic. By and
large, that has been OK so far. However, with the latest crop of MDEA entrants, we’re seeing an
increasing emphasis on functional aesthetics. For example, we saw smooth edges that fit better in the hand
and attractive packaging that makes it easy to retrieve instruments or devices. We’re going to see more of
those in the hospital. That’s a good thing.
Back to the Basics
In line with the increasing emphasis on design, we observed some of the best products leveraging very
basic geometrical and technical elements. While nobody gets an award for inventing the wheel, adding a
wheel to something – simple as it may seem – can render an otherwise mundane or unwieldy product
much more useful and innovative. The ancient Greeks believed the sphere was the perfect form in three
dimensions. It can be remarkable what one can do with that fact. “Back to the basics” was often a
successful formula.
The Rise of Smart Devices
While resurrecting basic elements can be a very powerful component of compelling design, we did see a
continued flourishing of smart devices – namely, devices and equipment embedded (or integrated) with
electronics and its accompanying software. This is a trend that everyone is aware of – just look under the
hood of your car – but was surprisingly evident in a great many of the MDEA candidates.
We saw this in the fanciest imaging technologies as well in much more basic packaging products. It is clear
that medical devices are becoming increasingly based on informatics and this trend will certainly continue.
That being said, some important takeaways should be noted.
The phenomenon of “software for software’s sake” (which some say helped contribute to the dot-com
bust) definitely did not score high points. Over-engineered software – as in the type we often see on
desktop computers today – is always frowned upon but especially in mission-critical applications such as
health care. Additionally, the trend toward increasingly proprietary electronic systems in which one
company’s devices cannot communicate with others was also problematic. While we realize this is not
necessarily the fault of the manufacturer (e.g. such standards often do not yet exist), those systems that at
least made an attempt at a more open platform framework were considered to be less functionally limited.
Open standards for health care IT will no doubt be increasingly the case in the future. Companies that
wish to design successful devices should keep this in mind.
Simplicity Rules
While electronics have increasingly infiltrated medical equipment and devices, simplicity of design and use
was a key criterion for the judges. Health care itself is intrinsically very complex so that devices playing
just one role in the entire care process must absolutely be as simple as possible. Eager engineers often
throw up their hands in exasperation at seemingly highly trained clinicians who complain about having to
twist an extra knob or about using one extra tool. This is the thought that probably comes to mind: “With
all that education, you still can’t flick a switch?” Apart from the additional complexity, consider the
common scenario when that “magic” extra surgical device falls on the floor and is no longer sterile. What
do you do then? That ingenious little extra step has now converted the smooth operation into the
proverbial “dog-and-pony show”. That’s not good for clinicians or patients alike. The judges recognized
that you can be brilliant without being complicated. As Albert Einstein once said: “Everything should be

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made as simple as possible but not one bit simpler.”

Safety is Key
In a previous column, I wrote about the increasing emphasis on safety both in pharmaceuticals and
devices. This trend was very evident in this latest round of the MDEA both in terms of innovations that
emphasized safety improvements as well as in safety being an important judging criterion.
To some extent, the safety element integrates the previously outlined concepts of aesthetic design, simple
execution and intelligent process. For example, devices in which the software element actually helped to
minimize or even eliminate errors scored very highly among the judges. On the other hand, devices that
piled on additional functionality sometimes raised safety concerns as additional and more complex
functions provide more opportunities to make errors.
Despite all the innovation we’ve seen, the medical device industry is fundamentally quite conservative.
This conservatism is largely driven by the premium on safety. As such, radical innovation – particularly
where it may compromise simplicity and safety – was not necessarily a characteristic of the MDEA
winners. It should also be noted that all submissions must have had regulatory approval at least
somewhere in the world. This requirement obviously eliminated some of the more futuristic innovations.
My fellow MidwestBusiness.com columnist, Michael Rosen, wrote an excellent column last week on the
“Deconstruction of Big Pharma” in which he cites economic imperatives as driving secular change in the
industry. For reasons we won’t go into here, a dearth of innovation as evidenced by the well-known sparse
product pipelines in the industry is also to blame. As we saw in this round of the MDEA, innovation is alive
and well in the medical device industry. In addition to the economic shifts occurring, this innovation will also
contribute to the shift in power and market capitalization we’ve been seeing from pharma to the device
industry.
By the way, in a previous column, I wrote about publication bias and how it influences (in often unforeseen
ways) medical and investment decisions. We can also expand on that theme by adding the phenomenon of
“award bias”. In award bias, the natural focus is on the winners. By corollary, no company advertises that they
did not win an MDEA accolade. Still, I think we have as much to learn – perhaps even more so – from the
losers.
Was the losing product not simple enough? Did it have a potential safety flaw? Was it functionally limited
because it was too proprietary?
Though I don’t mean to be glib or platitudinous, I would hope that such industry awards (this includes the
Oscars) are more than just about “winners” and “losers” but about the entire industry engaging in continuous
learning. An industry that doesn’t learn will ultimately fail, and in that case, there will be no winners.
Ogan Gurel, MD MPhil
gurel@aesisgroup.com
http://blog.aesisgroup.com/

Medical Design Excellence Awards MDEA medical technology medical design smart devices practice of medicine safey Aesis Research Group Ogan
Gurel MD

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