Health care is an important, huge, and growing piece of our economy. But as a reader named Beth Wieder points out, the design of medical devices isn’t always as user-friendly (or, I would add, as cost-efficient or as practical) as one might like.
For instance, we blogged some time back about a very cheap and portable asthma spacer.
Here is Beth’s note in which she passes along one journalist’s good and compelling idea for improving the design of medical devices. Once you finish reading it, you will probably start thinking of all sorts of things that you’d like to put Steve Jobs to work on:
San Francisco-based journalist Amy Tenderich, who has Type 1 diabetes, runs the Diabetes Mine blog, featuring facts, gadgets, reviews, and opinions on all things diabetes. She started getting wider attention last year with her open letter to Steve Jobs calling for better product design for medical devices.
Most diabetics have several medical devices — pumps, syringes, lancing devices, etc. — with them 24 hours a day, and while we are grateful for these life-saving gadgets, most have considerable room for improvement from a user point of view. This year, she’s opened up the contest up to anyone.
I’m looking forward to seeing what happens when you open up a very limited field (industrial designers working for medical device companies) to anyone with a computer and an idea. Any thoughts?
In related news, here’s an article from The Economist about a research project at Berkeley called CellScope that turns the digital camera on cellphones into a microscope,
which means that with the correct stain it can be used to identify the parasite that causes malaria. Moreover, by transmitting an image directly over the mobile network, the CellScope could greatly help with the remote diagnosis and monitoring of many illnesses.
and 
. You can also watch it on 
Why is it that some industries experience much more rapid design evolution than others?
High-end bicycles, for example, are designed and re-designed so often and by so many people that the technology is always at the cutting edge. But medical devices don’t receive that kind of attention from would-be designers. Both industries have sufficient profit-motive, don’t you think?
Is it because sports equipment offers competition in another sense: the race to be faster/lighter/stronger than the other guy? Perhaps under-designed products like medical devices need a competition to motivate designers; something like the X-prize?
The reason medical devices suck is that every variation of them needs to be FDA certified for use with humans. Even a silly change like the layout of the buttons or a menu requires recertification. This is very very expensive and companies aren’t going to do iterations to perfect a design. Once one is made they do the least they have to to keep up. I worked as a software engineer at a medical device place and the FDA part of the cost of our device was about 70% of the retail cost.
But have you noticed lately all the commercials for free blood sugar meters? My guess is that all the relevant patents have run out, so they’re switching to the razor/blades model where they give you the meter and you have to buy the specific test strips that only fit in that one meter.
@ MPD, #2- so is this cue the Regulation Booing chorus?
Seriously- the FDA has done less regulation in the last 7.5 years than the previous 30. Who can forget the pet food scare where our best friends were dying from chinese made plastic pet food? Or how about the long delay in the FDA warning the public about Vioxx? No, I’d say this FDA is about as business friendly since the Reagan FDA.
In terms of medical device design- what is more profitable? Multiple units with single purposes or an all in one product that does it all? Well, perhaps if there was competition in the medical device field, the latter. But if not? Probably the former. Capitalism isn’t all about innovation- many times, its about milking the public and staving off new innovations simply because the owners of production can. It’s called a symptom of a calcified economy- where capital (or owning the means of production) has accumulated in vast quantities in relatively few hands.
Still, I’d rather have an FDA than none; after all, it was TR reading Sinclair’s “The Jungle” which blew the lid on the Chicago slaughterhouse industry and what exactly (excrement) went into sausage… TR was at breakfast and threw out his plate, then demanded that someone find out if Sinclair was right.
Dubner should write a story on IDEO, the design firm. They do a lot of work with medical devices. I once toured their facilities and their approach to design is really interesting.
The major functions of the FDA regulatory system as far as medical devices are concerned are to ensure the following:
that a products made under that system is safe and effective,
that the processes developed to manufacture the product always produce the intended product,
that the raw materials, tools, and equipment used in the manufacture of the product are safe for the product’s intended use,
that all the people involved in the manufacture of the product and its raw materials are trained to the procedures above and follow those procedures for every individual product made,
and that traceability is established so that for every single finished product, all the components of that product down to raw materials, every facility involved in the manufacture of the product or its components, and every individual person who was part of any process in the manufacture of the product, its components, or raw materials can be identified.
Working under such a regulatory system is very time consuming, requiring massive amounts of documentation. As a result, it is not only extremely costly to develop new products, but changes to existing products are far more expensive than in an unregulated system (such as for bicycles), especially considering that any changes must be shown to not interfere with the safety or effectiveness of the product.
Add to this that most medical devices require deep knowledge of and expertise in a variety of different fields and technologies, rarely contained within one company. So most companies that make medical devices (even the largest companies) rarely make a device without subcontracting out some of the work. This makes changes even more difficult as two (or more) companies must coordinate closely to make and document any changes.
Overall the regulatory system exists to ensure that the medical devices used on your body are safe and effective. Good design, while enjoyable to the user, is a tertiary priority to saftey and efficacy.
Liability concerns offer another major obstacle to making design or process changes. But that’s a whole other issue…
Actually, IDEO was involved in this year’s DiabetesMine Design Challenge contest. They were judges, and are offering free consulting sessions to the two winners as prizes, to help them refine their design concepts.
See http://www.diabetesmine.com/2008/06/diabetesmine-design-challenge-meet-the-winners.html
The interactive agency Adaptive Path in San Francisco responded to the call for a well-designed BGM earlier this year with their Charmr project. Its a fairly elegant design with a lot of thought put into the way diabetics live their lives on a daily basis. It only exists as a concept at the moment but the ideas behind it are a testament to the power of user-centered design to alleviate real-world problems in the medical field.
http://www.adaptivepath.com/blog/category/charmr-project/
Greg (#1): High-end bicycle design is ultimately funded by advertising & sponsorships at competitions. Perhaps when we start having medical testing/diagnosis/procedure competition on ESPN and physicans use devices with “Coca-Cola” or “Tide” plastered across their surfaces, then we’ll get some *real* medical advancement.