Adhesive Bandages Are A Regulated Medical Device Didn’t You Know
August 14th, 2007 by Kevin
Cool Consumerist Pay Phone Design
(suffering from the infamous blue screen of death - not so cool if it was your pump, eh?).
Adhesive bandages happen to be a Class 1 medical device while glucose meters are Class 2. Implants are Class 3. And a lot of grey in between.
Just for kicks I thought I would help out non-industry innovators by linking to the first step in figuring out what federal regulations apply to your “great new idea” on the way to making a more friendly medical device. After reading the most recent post at DiabetesMine (and Eric’s post), I am left to wonder if most people really do believe it’s possible that millions of dollars are not already being spent every year to make diabetes devices and systems of care easier, better, faster… oh and differentiated from their competitors with cool new features?
Who would be willing to buy their kid’s next life saving medical device from a design firm? Not me. I for one am glad we have engineering driven medical device companies in charge of making medical devices even if what they come up with may not always feel like cutting edge.
Last 5 posts by Kevin
- Release Your Inner Biker & Help Fund the Cure - November 6th, 2008
- Hey MODY's - You've Not Been Forgotten - September 17th, 2008
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August 14th, 2007 at 5:18 pm
Sure, we all believe that pharmaceuticals are spending millions of dollars developing these devices. What we know is that they aren’t spending much on the way humans interact with their devices (besides the pokey parts). It costs so much to get the pokey parts right that the pharmaceuticals don’t bother hiring an AdaptivePath like company to get the packaging right.
Do I want AdaptivePath building the end device? No. Do I want them helping the pharmaceutical companies make something more usable? Heck Yeah. My guess is, whichever company starts thinking about the human interaction will sell more product. A win for the company and a win for the consumer.
The real question is… why are you so offended by a new approach to a sticky problem?
August 14th, 2007 at 7:59 pm
Kevin
You make a valid point. Bringing a medical device to market is not easy in any sense. It requires a lot of effort to get it through the various FDA requirements (on top of the usual challenges of developing a new device).
I wouldn’t want to buy a diabetes device from a design company. But I WOULD like to buy a diabetes device where some design thought has been put into it.
The point I keep making that the many (most?) diabetes device makers stopped once they got the reliability and the functionality down. They didn’t consider the higher order thinks like usability and others. I also have seen very few pieces of software that appear to be part of a whole system including the device itself (I’ve not seen the Diabetech product).
If we don’t demand a design perspective from our device makers, then they’ll continue to churn out functional devices that don’t satisfy our needs as people. We’re not automatons with devices that are added for extra efficiency. We’re people and we need devices that assist us in helpful and friendly ways.
I think that Adaptive Path has done a fair job at picking up Amy’s challenge. I’d love to see others do the same.
August 15th, 2007 at 2:05 am
Thanks for your comments Carl and Bernard. For the record, I have had the opportunity to participate in serious market research with meter and insulin pump companies so I can tell you that they do hire firms like the one at Amy’s blog to help them investigate new feature candidates, UIs, etc… that include the obvious things you say they missed and a slew of things that are not so obvious. Decisions ultimately do have to get made, features don’t make the cut or may work funny this time and the cycle of innovation continues… although at a much slower pace than what we see in the cell phone market for example. New phones every 6 months seems to be the norm now for new gadgets. That cycle time and the economics to support a variety of devices to serve varied consumer preference is not currently a reality for glucose meters, pumps and cgms.
As an example of what’s possible these days however, one weekend a few years ago a few guys I know got together and cracked open a glucose meter, connected it to a wireless module with some custom firmware, added some cool LED functionality as an enhanced UI, included a lancing device, designed a custom casing, created the plastic, and put everything together in about 5 days… and it worked!!! As a very cool all in one prototype glucose meter with lots of consumery features. Not sure why that’s relevant other than people should understand that even after you build these devices you still have major design decisions that need to be made that influence the final production device not to mention what you find in field testing, business aspects, etc…
So please understand that the question in my post above has more to do with wondering if people have an appreciation for the process or not as well as thinking that new designs need to go way beyond video and white boards before we should tout them as ‘an example for industry to follow’.
August 15th, 2007 at 2:38 pm
I think having a design firm look at the problem with a fresh set of eyes is beneficial. ANY point of view and idea is beneficial. Sometimes, thinking “outside the box” with no regard to regulations and even “what’s possible” can create a new way of thinking about a problem and can bring about revolutionary change. So while this EXACT design may not ever make it to market, some of the IDEAS might. And that can change lives.
August 17th, 2007 at 11:57 pm
An appreciation for the process? The process changes as products mature. Look to any field, and this is the natural order of things. Products are initially designed by engineers intent on solving problems. And engineers do a great job of making things work. But let’s be honest, engineers (and developers and programmers and…) aren’t the best at making things work for people. As products spaces mature, who “leads the charge” changes over time. Enter designers. Sure, ‘design minded’ people may not understand all the intricacies of how something works. But designers are great at seeing things how could be, and casting that vision through prototypes or stories. This is the same of engineers and architects. Sure, a good architect will also be a good engineer, but knowing too much about how things really work keeps us from imagining how things might (really) be. It’s exactly this ‘what if’ thinking that should excite those who have the knowledge to make one person’s dream a reality.
In software development, we are seeing this rather titanic change in process. It used to be that data and logic drove the end user (UI) experience. Fortunately, technology has advanced to the point that we can now design the ‘ideal’ experience and make the logic and data fit that vision. This is the evolution of software design. Which is following the same trajectory as product design.
I was in the audience when the Adaptive Path unveiled this project, and I know some of these folks personally. My mind was filled with mixed enthusiasm. Sure, this was an exciting ‘experience-driven’ idea. But I started wondering about battery life, and other realities. However, at least now we have a different set of challenges to think about solving. And that’s the entire point of their project. The world didn’t need ILM until George Lucas set about redefining special effects with Star Wars.
If you go back to Amy’s original post, she comments that “medical device manufacturers are stuck in a bygone era; they continue to design these products in an engineering-driven, physician-centered bubble.” Adaptive Path (and many other companies) are trying to change this to an experience-driven, engineering-supported process. And current ‘market’ research methods and traditional methods are more suited to incremental improvements than new innovations.
August 18th, 2007 at 10:30 am
There is philosophy (e.g. I design all my products with the user experience as top priority) and then there is process as we are using it (complying w/ regulations, making sure your design is OK from a liability perspective, etc.). The point here is that user experience based designs are paramount (see our GlucoMON, we are true believers in human factors over all else). But reality dictates certain constraints that should be appreciated by the wider community - it’s easier to get an iPod to market than a medical device, period. Our wireless devices have to meet all certifications an iPod does plus FCC, wireless carrier certification, FDA, HIPAA etc approval. So people need to understand that there are great efforts being made by many people but the fruits of those efforts take awhile to see. So my call is please don’t be dismissive that no one is working on it; instead find, promote and appreciate those that have dedicated themselves to making things better and help them get their innovations to market. The only problem I have w/ the Charmr stuff is this lack of acknowledgment that people have been working for years to get user experience based devices to market and that there are realities that prevent that from happening as quickly as people would like.
August 18th, 2007 at 12:11 pm
My thoughts on Stephen’s comments including a healthy dose of disagreement
A good process has integrity and rarely changes while objectives and decision points within the process may change frequently according to external influences on the product under development.
So, why do most technology projects fail? One reason is because people ignore the limitations of the data needed to support the resultant project be it availability, reliability, context, etc…
It’s a nice idea to think that data and logic are an after thought following design. However, anyone who’s taken a tech product to market and stuck around to live with the fallout in customer support can tell you that a design that presumes to be king (for a product that depends on data) which views data as merely a serf that only serves the king’s wishes is a product that hopefully never makes it to market or if it does, leaves the user disappointed and frustrated. In the case of a medical device, the results could be grave indeed.
Where is the ‘different set of challenges’ offered? I saw nothing that hasn’t already been discussed and documented previously and I think the Adaptive Path team acknowledged that fact (kudos to Adaptive for their humility in proposing their new idea as it was new to them). If you were to ask the Adaptive team to comment on this point I think they would be the first to tell you that other designers have already thought of these features and in combination. Unfortunately, the buzz that followed and perhaps the way it was presented disregards the efforts of hard working people already in the industry many of whom chose this field because of a desire to improve the lives of patients.
In my experience, revolutionary product design comes from people who are passionately and intimately familiar with all of the realities that influence needs-based technology and therefore gives them the depth and scope to guide their design through to an amazing breakthrough. Designing a car that ignores the hard constraints of the road that it needs in order to achieve its baseline objective of transportation would be silly.
Don’t get me wrong – I’m glad that design experts spent a few weeks looking at ways to make devices more user friendly for people with diabetes. The press that comes from this is priceless. But, when their efforts are pointed to as a new idea in a field void of patient-centric design, its a statement that is simply false.
August 18th, 2007 at 9:13 pm
In reading the comments I am strangely encouraged to see that so many have such passion to improve the quality of life for persons with type 1. I have been very excited about the progress and developments by diabetech, and I am also excited about the progress made by others, including Adaptive Path. Innovation is possible, and indeed, probable, from either side, and I think the the assumption that a design driven innovation would lead to a product that would not be able to meet the medical requirements, etc. is a faulty one. Good design should inspire good products, not a pretty incompetence. I think it is unfair to dismiss the efforts of either group.
As parents of a child with Type 1, I have had to come up with numerous “hacks” to make products work better. The desire for better designed products is evident everywhere in this community - including the rubber jacket survey that brought me to this sight. Why should we need these after market hacks when we could someday have a product that doesn’t need them? I know that when we chose an insulin pump for our child, we looked at the capabilities, the statistical data, etc. My son looked at the colors and shapes. I also searched (fruitlessly) for a better interface and relationship between pump and meter. Why? Because he is deserving of good design, AND good product. Note - I am not commenting on the lack of good design in existing or up and coming products, I am merely commenting that no one has the only path to good product development. Just as Eric commented that the excitement over the Adaptive Path design is dismissive to those who have been innovating on this front, it is dismissive to consider the design to be some sort of paint job on an existing piece - I would ask that if one is capable, why is the other not? I would think that having a good idea should inspire people to wonder how one could make it work - maybe someday I will not be buying extra pump packs, meter skins, pump jackets, and countless other devices and accoutrements just to have things work well together and do the best job managing diabetes. I am tired of the “bungee cord” solutions we are forced to endure. I am looking forward to the numerous solutions from every source that will make our lives easier and healthier, and I am grateful to all attempts. Thanks!
August 19th, 2007 at 7:09 pm
Thanks Erin. Your are right - no one group holds the exclusive pass to “the path to good product development”.
You made me laugh thinking about all of the hacks, tricks and rules of thumb that we’ve all had to learn on our own over the years in order to keep our kids safe and the bungee cord analogy is priceless. Rest assured that we’ll keep doing our part.
Keep in mind also that the more you support innovative new products from Diabetech and other innovators in this field sends a concrete message to industry, health insurance companies, government and health care providers. Quiet acceptance of the status quo will only beget more bungee cords.
August 20th, 2007 at 11:36 am
Kevin,
Believe me, you have my support - I am so glad you are investing your skills in the future of our children. Thanks!