BY SEAN FENSKE | EDITOR-IN-CHIEF
Once upon a time, long ago, identifying what we covered in the pages of MDT
was a much easier task. There were essentially two “worlds” — the pharmaceutical
“world” and the medical device “world.”
Sure there were other outlier technologies
that weren’t exactly grouped in either, and
there were also drug delivery technologies
(or combination products, if you prefer) that
brought the two worlds together in one
drug/device solution. But for the most part,
there was a clear division of medical technologies that made things very neat and clean.
In more recent years, those lines between
types of technologies aren’t so crystal clear.
As such, you start to see these areas creep
into the focus of MDT. That’s already been
happening with technologies such as biologics, which have been combined with medical devices similar to how pharmaceuticals
are being merged with them, a practice that
only continues to grow. Another example
of “recent” changes is the entire realm of in
vitro diagnostics. These technologies are really their own “world,” not exactly matching
the more traditional definitions for pharmaceutical or medical device.
While biologics and IVD were perhaps
responsible for the beginning of the lines
being blurred, there are even more emerging technologies that will really make an
impact on the medical device industry as
they become more common.
We’ve been hearing about stem cells for
years now, but seemingly each day, there
is mention of a new method or technology
that leverages them for yet another medi-
cal breakthrough. The use (and manipula-
tion) of stem cells seems to have become a
much less debated topic than it once was,
but it doesn’t mean that the challenges of
using them have decreased (or my regular
discussions with my associate editor Sam
on whether they are actually “medical de-
vices” or if we should cover them regard-
less of any such label that’s put on them).
The one aspect that still rings true, howev-
er, is that they will undoubtedly continue to
be researched and as such, new discoveries
regarding their use will emerge. They may
represent yet another “blurred line,” but they
are also a wonderful opportunity to enhance
healthcare and address an array of diseases.
Growing Human Tissue
We’ve run news on a number of human tissues and organs being grown in labs around
the world. Lungs, skin, ears, hearts, livers,
and more have appeared in petri dishes that
enable the testing of new drugs or diagnostic
technologies. The applications for growing
human tissue and organs are only in their infancy though. Obviously a major goal would
be to have the ability to grow these “parts”
for use in the human body. Eliminating the
need for organ donor lists would virtually be
the equivalent of a “miracle cure” for many.
But is a lab-grown human tissue or
organ a medical device? It’s “
manufactured” and implanted just as a mechanical
pacemaker would be, for example, but it
obviously doesn’t “feel” like the same thing.
Just yet another example of the lines being
blurred in this wondrous industry of ours.
3D Printed Med Tech
Additive manufacturing (i.e., 3D printing) is
a fantastic technology that’s already influencing and changing the way things are being
produced. In the design and manufacturing
realm, it offers great time and cost savings in
the creation of physical prototypes, is being
employed for molds, and is even being used
to generate short run production ready parts.
Undoubtedly, advantages with this process
will continue to be realized.
In the realm of medtech, however, 3D
printing creates a conundrum. If a doctor
Editorial Advisory Board
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, Analog Devices
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.
3D Printing, Stem Cells
Blur MedTech’s Lines
wants to print a part or tool in his or her
office to use in a clinical procedure, what’s
the FDA going to say about that? What
about the patient’s insurance company?
Should these considerations stifle the innovation that 3D printing in the healthcare
space offers? I doubt anyone would say yes,
but there does need to be a review of how
we can ensure this is being done safely.
Could 3D printed medical device designs
be submitted to the FDA for approval,
thus allowing them to be sold to doctors
to print in their offices? Do 3D printing
machines need to go for review to determine that they can ensure the repeatability
necessary to generate the parts or tools to
spec each time without fail? These are only
a few of the disruptive questions that are
brought up by 3D printing in healthcare.
This changing landscape of medtech,
while making my job of determining what
we cover a little more difficult, is actually a
fabulous thing. The fact that revolutionary
technologies that combine multiple aspects
of medicine are emerging makes for overall
better healthcare solutions. Whether it means
being able to diagnose faster, replace diseased
human organs, regrow skin, print surgical
tools on demand, or just provide better overall healthcare in some way means that I’ll
gladly accept the flip side of making labeling
these “medical devices” a little harder.