Craig Bonsignore

For quite some time, I’ve had this crazy idea that medical device development sould be more like Linux and less like Windows. More Wikipedia, less Encyclopedia Britannica. Open, community driven, adaptive, dynamic. But medical devices aren’t typed up on crumb filled keyboards late at night. Instead, they are the product of years of investment, research, development, and clinical trials, and these are not things that can be replicated easily or shared freely. Despite some remarkable advances in minimally invasive device development, is amazing how little we collectively know about the fundamental interactions that exist between devices and the human body. The world of devices is proprietary, by necessity. But the other half of the interaction, the human body, is quite the opposite. Everyone on Earth has at least one body of their very own, yet we continue to lack fundamental data about how it works, and how it interacts with medical devices. Researchers, clinicians, industry, and regulators all have a common interest in having standardized, uniform, and freely available data on human biomechanics. While the scholarly traditions of peer reviewed research and publications have produced some welcome and necessary advances, the community at large has access to a paper thin slice of the data informing these publications. Industry probably conducts even more relevant and detailed studies in the context of developing commercial medical devices, but virtually none of this data is available to the community. Why not? In an era of social media, cloud computing, unlimited network storage, and unprecedented collaboration, why can’t the community develop clinical and imaging protocols to collect the data that everyone needs? Why can’t we collaboratively draft these protocols online? And why can’t we upload all the data we collect in a common and accessible format, so others are free to remix, reuse, reanalyze, and contribute back to the community? These are some of the questions that have been rattling around in my mind for a while, and motivated the creation of openmedsystems.org, and are the topic of my talk today at the FDA / NIH / NSF Workshop on Computer Methods for Cardiovascular Devices. A link to the slides can be found at http://aspect.openmedsystems.org/aspect-blog/openmedsystemsrockville2june2009.

Instructions: Drive about 15 minutes from the Pleasanton Home Base, down Calavaras Road to Geary, and into the Sunol Regional Wilderness. Pay $5 if somebody happens to be collecting money. Park at the Green Barn. Drink the first of three bottles of water. Put the second in your back pocket. Walk down the path, cross the foot bridge over Alameda Creek, and follow the signs for Canyon View Trail. The first mile has some steep uphill climbs; it isn’t too bad once you’re past the squeaky cattle gate. A cool spring day is the bast time for this gig: the hills are green, and carpeted with yellow, orange, and purple wildflowers. At some point, you may need to take a detour around some cattle. Within 45 minutes or so, you’ll hear the rushing waters of “Little Yosemite” below. The clear waters of Calaveras Creek run through a series of waterfalls, between rocks, and around swimming dogs. Sit on a rock, and drink the bottle of water in your back pocket. From here, its a level walk of about 30-45 minutes down Camp Ohlone Road back to the valley floor, the Green Barn, and that last bottle of water. A two hour, three mile hike, 2.5 hours door to door, and back to the Home Base in time for Evan to wake up from his nap.  More photos on Flickr.

In December, I began work on an epic project. Seeking to recreate one of the greatest accomplishments of my life, and share the experience with my young son, I began inserting cloves into an otherwise perfectly serviceable orange. I had completed one such clove orange in my youth, and for many years, this strange smelling object hung in a closet by a twisted strand of wire. Now, I would recreate the grandeur of this most monumental accomplishment, one small, sharp, aromatic, dried flower bud at a time. Evan found this interesting for approximately four seconds. Undeterred, in the course of several days, with the help of an unlatched safety pin, and the support and/or ambivalence of my family, Phase I of The Clove Orange Project was complete.

While the Insertion phase was rewarding on its own accord, the acute result was somewhat unsatisfying relative to my youthful remembrances. I recalled my childhood cloven orange to be rather more dense than this specimen, and was left to wonder if modern cloves had somehow evolved stronger repulsive forces, or if I had gotten somewhat lazier or less diligent about packing density in the years that have passed. Then I recalled the Shriveling Effect. Over time, the perforated orange would shed its Precious Bodily Fluids, concentrating its cloven-citrus essence as its diameter and density shrinks. This motivated somewhat obsessive compulsive data collection, measuring the mass of this curious Object at regular intervals for three months. Again, this activity would not have been possible without the support and/or ambivalence of my lovely wife and son.

I am now proud to present, for the first time ever on the Internets, definitive data on the mass of a clove orange as a function of time, while sitting in on a countertop in a suburan residential kitchen in Northern California. To help put this important dataset in perspective, I have helpfully prepared a chart comparing Clove Orange Mass with the value of the Dow Jones Industrial Average, normalized to be equal to the 227 gram mass of the Clove Orange on December 8th, 2009. The accompanying chart bears a hopeful and optimistic message: While the world economy and US equity markets seem to have been deteriorating at an exponential rate in the past three months, an investment in the Dow 30 would have performed significantly better than an investment in the water molecules contained within this particular cloven orange during the same period. So things really aren’t that bad, even if they do smell a bit strange.