is,” explained Dr. Lotan to audience members. “A
good example is Henry Ford who said: “If I had
asked my costumers what they wanted, they would
have told me a faster horse.” If you don’t define the
need, you’ll go looking and just find better horses.
But, Dr. Lotan said, if you better define the need as
requiring something else entirely, “then maybe you
will find a better solution.”
To further teach this process, Todd J. Brinton,
MD, gave Academy attendees a detailed talk on
needs assessment. Dr. Brinton has been the Fellowship Director for the Stanford Program in Biodesign since 2006. He arrived at Stanford in 2000,
planning to pursue a track designed for residents
interested in a career as a physician-scientist and
happened upon the new Biodesign program under
the leadership of Paul Yock, MD (Biodesign’s Director and the inventor of the over-the-wire Rapid
Exchange angioplasty and stenting system, which
is the primary approach used worldwide).
The program’s multidisciplinary approach and
focus on medical technology innovation appealed
to Brinton; he joined as a fellow in 2004, after
completing his medicine and cardiology clinical
training, and later as faculty in 2006. He is also an
interventional cardiologist.
Many people assume that the greatest innovators—and Dr. Brinton noted here the accomplishments of Tom Fogarty, MD (founder of more than
45 medical device companies), and John Simpson, MD, PhD (who invented and commercialized
the first over-the-wire balloon catheter used for
percutaneous transluminal coronary angioplasty),
are just untouchably brilliant individuals.
“Which in fact they are,” said Dr. Brinton. “But
I’ve had the opportunity to work with both of them
and I’d say the thing that they do that is unique is
they have a process. This isn’t just a one-off idea
in the shower; they in fact have a process where
they work through and develop their ideas, and
understand the fundamental value that it brings to
the patient.”
This process involves looking with both broader and more narrow lenses at the issue, generating multiple needs, winnowing down those needs
based on possible clinical impact, stakeholders,
other treatment options, and market characteristics, and finally, after filtering your multiple ideas
through multiple filters, defining in one sentence
your “needs statement,” said Dr. Brinton.
He stressed not ignoring the market assessment. It may seem “capitalistic and harsh,” but not
understanding this is often a stumbling block for
physicians who “just want to help their patients.”
The simple fact, said Dr. Brinton: “You will not have
an impact if you can’t build something, borrow
some money, and develop a technology that will
ultimately return value to them and to patients.”
Another common problem for physicians who
turn to innovation is failure. “As a physician you’re
expected to be perfect and your career will be
defined by, hopefully, how few mistake you make,”
30 CardioSource WorldNews
said Dr. Brinton. “But the thing about innovation
is that your career will be defined by, hopefully,
the few successes you have because failing is an
everyday occurrence in innovation. You have to be
prepared to fail and don’t be afraid to fail.” Heck,
don’t even think of it as failure: Thomas Edison’s
point of view was, “I have not failed. I have just
found 10,000 ways that won’t work.”
Superseding needs can also derail great innovation. So, if an innovator is working for 10 years
on a way to prevent stroke in patients with atrial
fibrillation and by the time the technology is ready
to come to market someone has figured out how
to cure atrial fibrillation, well then, “you’re out of
business,” said Dr. Brinton.
“So keep in mind that if someone’s a little bit
lower on the limb of the tree and they’re working
a little closer to the fundamental problem than
you are, that’s a superseding need. Doesn’t mean
you don’t have a novel technology, but be aware
where others are climbing.”
And finally, Dr. Brinton said: “Don’t lie to yourself. Don’t do the things that go past it to the next
processing level without asking the difficult questions. Is this the right project to be working on?
Only then can you assess the long-term viability of
the project.”
a new solution that is much easier, much cheaper,
lower technology, less invasive.”
But don’t ignore intellectual property. “Nobody
ever remembers who was second,” said Dr. Lotan,
who related a personal experience to participants
where he was beat to the patent by another innovator and ultimately lost any chance of marketing
his innovation.
Prototyping is another part of the invention
stage that can throw clinicians. Julio Palmaz, MD,
famously prototyped his coronary stent with a
metal lathe that a workman had left in his garage,
but most clinicians aren’t quite so industrious. Nevertheless, prototypes impor tantly help reduce risk
and increase the probability of success, according to Dr. Durfee. They are also crucial for selling
your idea to investors. For example, 3D printers
have revolutionized this field and there are several
organizations that can help produce a physical or
virtual prototype of your innovation.
Virtual prototyping is a way to “reduce, but not
eliminate” the need for expensive and time-consuming animal experiments, noted Dr. Durfee, and it is an
approach that has been embraced by the FDA and
device industry. “Part of their mission is to promote
and advance computational modeling and simulation
as a means for providing safety and efficacy data for
the regulatory approval process,” he said.
➍ Design an Entry (Startup) and Exit Plan
“Don’t lie to
yourself. Don’t
do things that go
past it to the next
processing level
without asking
the difficult
questions.”
-Todd J. Brinton, MD
➌ Go Invent!
Once an opportunity has been identified and a
“needs statement” created, it’s time to create the
solution. This is where all parties have something
to contribute: the technology folks, the clinicians,
and those money people who keep their eye on
the ball.
“You have to have fresh eyes on the problem,”
said Dr. Lotan. “If you come with fresh eyes and
new technology, you can definitely come up with
To help inform the startup process, the Academy of
Innovation Day brought in Kathleen A. Marshall,
the Founder and President of MAXIS, a clinical
market development provider that helps medical
device companies with clinical research, market
development, and early commercialization needs.
Ms. Marshall focused her comments on five key
concerns that need to be answered by any startup:
when and how to invest in clinical proof; how to
negotiate regulatory obligations; when and where
to commercialize; how to get financing; and how
to increase value? In other words, “How do I get
the value of my startup on an ever increasing level,
which comes back to investing in clinical proof,”
said Ms. Marshall.
According to Ms. Marshall, some of the mistakes common to inexperienced innovators is getting stuck with their technology (“plan to iterate”)
or indication (“it’s going to narrow and change”);
trying to commercialize too early (“CE does not
stand for commercialize early!”); and not managing
relationships with investigators properly: “These
individuals are on a journey with you to quantify a
clinical and scientific value… and will advocate for
you about the value of your invention.”
In the startup process, she said, as in the needs
assessment process, it remains important to embrace failure.
“The sooner you fail, the faster you’ll succeed,
and that is as true in the clinical world as it is in the
R&D development world,” said Ms. Marshall. “People often want to do one big clinical, but it is much
February 2016