The first step in new
is to qualify the market for the
idea, before doing anything else.
Potential developers need to ask
• Does the device solve a clinical
• How will it enhance outcomes
and save money?
• Who will pay for it and how
much would they be prepared
• Which devices, procedures, and
services does it compete against?
• What is the cost/benefit of the
new device compared to the
existing situation? (Most healthcare providers need a financial
benefit as well as a clinical
Once a need and benefit have
been identified, the next stage is
to estimate the size of the market.
If there is a significant market, it is
time to think about the time and
cost of development and make a
business case for investing in the
new device based upon a profit-
able return on investment.
Much of the advice given to
inventors and entrepreneurs tells
them that the first thing they must
do is to patent the idea. This is
bad advice for most inventors. The
drawbacks of patenting too soon
• Spending money on an inven-
tion with no market.
• Patenting a half-formed idea
that is different from the solution delivered by a thorough
• Incurring patent costs and
decisions about which territories
and fees to pay too early as the
clock starts ticking from the date
of the first application.
• Notifying the world about your
idea earlier than is necessary.
The ideal situation is to keep
knowledge of your idea secret
within a small group of trusted
partners and advisors (working
under NDA) and patent the idea
at the last moment before widely
disclosing the idea. MDT
Chief Technical Officer, Intelligent Product Solutions
Successfully bringing an idea from concept to completion
requires coordination, planning, and vision, even before you get
to square one; we call this the Productization Plan. More often
than not, if you were to look back at ideas that seemed to have promise but
failed to reach market, the common denominator would be lack of a credible
and comprehensive plan of execution that covers transitions from one phase
of development to the next.
The Productization Plan is where you do more than identify problem/solu-tion, it is where you capture, schedule, and budget the product’s requirements
throughout the entire process. Will the software and electronics be able to
support the firmware as designed? Can rapid prototyping help identify user
needs early-on? Will the recurring manufacturing costs be sustainable and
provide the right value proposition?
A coordinated team of product designers, engineers, and user experience
specialists working together from the start to create the Productization Plan
provides for the most seamless transition between development phases and
avoids costly delays and budget overruns. MDT
VP of Quality/
Clearly define your
The first critical step in a serious
development effort is to show
a compelling need in the marketplace for your device. It may
seem obvious, but history shows
that often the biggest barrier to
overcome was NOT obtaining
regulatory approval but finding
actual customers. With increasing
pressure to reduce healthcare
costs, all healthcare solutions go
through a cost/benefit analysis.
Be prepared to quantify how the
use of your technology will reduce
overall cost or provide a significantly improved cost/benefit.
Map-out a regulatory approval
strategy. Every regulatory approval
plan starts with a precise state-
ment of intended use. This is the
primary determinant for how the
device is classified. From there,
you’re in a position to evaluate
your options for market entry.
Every region of the globe has
somewhat different criteria for
approval, so your plan for market
entry is directly linked to your
regulatory approval strategy.
Find partners with proven medical device product development
expertise. In addition to navigating
a heavily regulated environment,
it is critical to select a partner
with proven technical expertise in
order to commercialize a successful healthcare product. Expert
application of innovative design
and process controls is essential
to gaining regulatory approval, as
well as assuring a safe, effective,
and reliable product. MDT
Before you invest significant R&D dollars
into making your better mousetrap, find out
if there is a market appetite to catch mice.
President, ALM Communications
First step? Backtrack! I’ve seen many engineering-based com-
panies sink considerable time and R&D into products that
they think are nifty and neat. The problem is that the market
might not agree. Before you invest significant R&D dollars into making your
better mousetrap, find out if there is a market appetite to catch mice. Then,
determine if the way you want to do it — that nanoparticle pheromone-en-
hanced superglue for mice — has the kinds of bells and whistles that will make
it attractive in the market.
Seem like a waste of time? Not when you’ve seen engineers outraged that
the sales department can’t sell their wonderful Rube Goldberg contraption
that they’ve labored on for years. Products born in engineering halls that
aren’t informed by market desires tend to create a lot of internal drama along
those lines. Often, it’s just that the machine is way too pricey for the market
to bear. MDT