‘I need a new device for such-and-such a procedure, can you help
me develop this device?’” he said. “Sometimes the device we
develop is as simple as a handle with a syringe built into the
handle—really a simple thing. We’re getting a lot more of those
types of projects—a small company coming to us, or a doctor.
Even some of the larger companies are kind of looking for these.
One of the projects I recently worked on was taking a respiratory
product into a new market. The new market was neonates, so it
was a matter of taking a product that fit adults and make it fit very
small infants. It’s not like it was a brand-new technology, but it
still [required] going through the process, including all the regu-
latory and validation requirements.”
Browka said that a sizable part of the design business involves
companies deciding to look at ways to refresh existing products or
simply at being able to bring about cost savings by reengineering
or rethinking the product.
“Sometimes it’s reconfiguring an existing product line, or
they’ll acquire a technology by buying out a smaller company so
they’ll own a new package of products and would like to simplify
the combined product line,”he said.
The discussions that are part of planning a product are impor-
tant, but, as Browka put it,“we also jump to reality very quickly—
that’s an important step in going from concept to reality.”
From a design perspective, one area that seems ripe for growth
is home-use products.
“We did a catheter project for paraplegics and quadraplegics
where they could self-introduce their catheter,” Browka said.
“It’s a pretty big deal, and there was an integration of design
More Built-In Controls
Pat Jones, engineering team leader at Penn United Technologies
Inc., a Cabot, Pa.-based company whose Penn United Medical unit
provides manufacturing solutions for medical customers, said that
the medical group is seeing more controls and electronics incorporated into the devices.
“Before, the doctor or the surgeon would have to activate certain functions, now they’re incorporating things like that into the
In terms of design requirements, Jones said tolerances continue
to get tighter, and that’s been fairly consistent—though often“dif-ficult to meet”some of the tolerances.
He said that“it’s part of our responsibility to help educate our
customers’design staffs on what the capabilities of our processes
are,”Jones said.“We have actually sent engineers to our customers,
and we’ve had customers come into our training center and spend
three days learning about how the process works. The manufac-
turing process needs to be part of the design process, and some-
times our expertise can help identify manufacturing processes that
can save on part and assembly costs.”
Simulation is a much bigger part of the process.
“Now you can run through multiple iterations of your design
FEATURE: Design Trends
prior to having to prototype it,” he said.“You’re getting so much
more knowledge about the part itself and incorporating it with
Visualization Model as a New Approach
University of Minnesota’s Erdman said despite market challenges,
bright spots of opportunity remain.
“I think that home care has been and will continue to be very
important—world-class monitoring systems, sensors and data
systems to communicate vital signs and disease conditions,‘Oba-
macare’ or not, that’s the future. Underneath that umbrella are all
these gadgets and nano-devices, sensors, actuators and labs on a
chip—all this that people have been able to develop in other ways,
funded through work on space research, defense, aviation, games
and other funding mechanisms all over the world and now find-
ing their way into medicine.”
He added that a lot of that cutting-edge development is hap-
pening at UofM.
“I’m just so excited every day to see these new technologies. It
seems to me like we’re on this accelerated curve, despite the recession,” he said.
Erdman noted that he and colleague Dr. Daniel Keefe have been
working for almost three years with FDA on new approaches to designing medical devices using virtual environments, adding that
“there’s no doubt in my mind that the future will bring very different ways of engineers dealing with data and design, and it’s not just
for the medical device industry. The supercomputer of a dozen years
ago is what we have in our iPad today, almost, so this is a huge
change for the people in an analytical, computational environment.”
As for how that might fit in the future, he said the regulatory
process needs to be changed from total reliance on animal and
human trials to minimal reliance on such methods.
“The only way we can really get there is to have reasonably
good models of how our devices interface with human tissue and
blood,” he said.
Erdman said the agency has been very responsive on the question of visualization, with a considerable number of FDAers being
exposed to what he and Keefe are developing. The entire first-day
theme of the university’s design conference this year was on
“There is a buy-in on using analytical modeling as part of the
regulatory process,”he said,“But it goes beyond that. It goes into
a collaboration. We are talking about having a public/private partnership focused on developing the infrastructure where there is a
totally open system, which is the only way both FDA and companies can work together.”;
Jim Stommen is the retired editor of industry publication Medical
Device Daily. Based just outside Atlanta, Ga. (sometimes you’ll also find
him driving along the coast with the top down in Southern California),
Stommen is a freelance writer focusing on the medical product sector.