Recently, I saw a news piece out of Carn- egie Mellon University ( bit.ly/oct1430) where researchers supported the use of
“video game” style trials of life science hypoth-eses to prevent the instances of error and fraud.
Massive online laboratories would be established
that would allow non-professional investigators
to test the hypothesis of researchers who would
normally use high-throughput experimental
techniques. Additional benefits might be realized
from the use of the multitude of researchers
in that an enormous amount of data could be
captured from the online experiments.
There are obviously concerns with this
approach as much of the online participants
would not be made up of professionals, but in
their own experience with setting up this type of
community (an RNA-design project called EteR-NA), the researchers found that those involved
developed a significant understanding of RNA
design through the gaming experience. Similar
comprehension might be gained from other
projects and specialized communities could form
where certain investigators tend to participate in
specific types of trials.
Of course, my first thought was wondering if
this same type of trial system could work in the
development of medical devices. Unfortunately,
I think there are many parameters that differ
from the researchers’ application and that of a
medical device that would be made commercially available. The idea of it though, is interesting
and I still wonder if there are elements of the
project that could be adapted for the medical
device industry. Say, for example, with software
development and security testing.
Some time ago, I wrote a column about the
use of open source software being used in medical devices to help prevent concerns with security ( www.mdtmag.com/oct1440). Open source
software has the benefit of being developed by
a community. Or at minimum, a community
BY SEAN FENSKE | EDITOR-IN-CHIEF
Carlos Castillo, Biomedical Engineer & Research
Biomedical Engineering Advisor, Loma Linda
University Zhang Neuroscience Laboratory
Michael Drues, Founder & President,
Marc Dubreuil, Vice President of
Business Development, Farm Design
Stephen Holloway, Associate Director,
Medical Devices and Healthcare IT, IHS
Jinny Lee, Vice President of Strategic Marketing,
Advanced Technology, Edwards Lifesciences
Tom O’Dwyer, Director of Healthcare Technology,
Michael Pereira, Senior Vice President of
Technology & Operations, Ximedica
Alan Schwartz, Executive Vice President,
mdi Consultants Inc.
Thomas M. Tsakeris, President, Devices and
Diagnostics Consulting Group
Jan Wittenber, Member of IEEE and Fellow at the
Center for Medical Interoperability
Derek Young, Founder & CEO, i360medical Ltd.
6 / October 2014
manufacturer is looking to tell.
Atop all of that is the regulatory aspect.
Would the FDA actually green light clinical
trial protocols that involved an online “gaming”
system to test some portion of a medical device
development project? I’m not sure if they’ve even
come close to addressing
such a question.
As much as I can’t
imagine ever seeing
this type of community
coming into fruition for
any design that’s tied to a
medical device OEM with commercial interests,
I have to admit that the concept of it fascinates
me. The advantages gained by leveraging an
entire community of individuals interested in
making a product better by either enhancing a
design or through the careful testing of a soft-
ware component are fantastic.
Perhaps a compromise is possible where a
much smaller “community” is established and
the collaboration takes place online behind registration walls and password protected websites.
Then again, as we’ve all heard through endless
“hacking” stories in the news, no amount of online security can be counted on to ensure a truly
safe and protected environment.
Perhaps this “dream project” would best be
served by first using the open source development model in the online security environment
to make that function more effectively so that
we may better safeguard projects like these.
participates in the testing and debugging of it.
On the other hand, the downside of considering open source software for use is that virtually
anyone has access to it. For medical device
manufacturers, that could mean competitors
in the space. Not to mention manufacturers
that are not necessarily direct competitors but
would rather be classified as counterfeiters
in another country where the open sourced
project would simply be “stolen” and developed
there with no investment necessary into R&D.
And while the hardware wouldn’t be shared
online, the software might offer several key differentiators that make a product unique in the
marketplace. No commercial entity is going
to be willing to reveal
that kind of information
about their product before it launches and be
“punished” for it even
if it could potentially
address problems before they’re discovered in
Getting back to the original news item, would
there actually be any way to use this approach
for the actual medical device hardware and
to test and/or enhance it? Again, there’s the
problem of competitors having access to a proprietary design and having covered this market
long enough, I tend to believe that aspect alone
puts this idea into the “bad” pile. But if that
wasn’t a concern, I wonder if, through 3D printing, the hardware could actually be printed out
and “tested.” This gets into the realm of a sort
of “open source” design process, which I have
actually seen being put forward when it comes
to projects for developing nations such as the
creation of a low cost microscope or a 3D printed respirator device. Open source for the greater
good can be a truly inspirational story; I’m just
not sure it’s a story a commercial medical device
Would the FDA actually
green light clinical trial
protocols that involved an
online “gaming” system...?