First-Time Exhibitors
Rising‘STAR’ in Biomaterials Benefits Implants
When applied to a material, the term biocompatible
is generally accepted in the medical device industry
as meaning that it will not elicit a strong immune
response from the body and is essentially inert
upon implantation. Some materials experts argue,
however, that biocompatible implantable materials
should not be inert, but rather should actually incite a
reaction—a positive one.
Healionics (Redmond, WA) comes from the latter
school of thought. Launched in 2007, the company
custom engineers a technology dubbed the Sphere-Templated Angiogenic Regeneration (STAR) three-dimensional biomaterial scaffold, which is designed to
facilitate healing while reducing foreign body response.
“A lot of the materials out there are biocompatible,”
says Michel Alvarez, Healionics CEO. “We’re
beyond biocompatibility. We’re into true healing and
biointegration with host tissue.”
Established to commercialize STAR technology,
the company builds on the years-in-the-making
biomaterial breakthrough achieved at the University
of Washington Engineered Biomaterials group
(UWEB; Seattle). There, UWEB codevelopers
Buddy Ratner and Andrew Marshall discovered the
‘sweet spot,’ which Alvarez defines as “the precise
pore geometry that creates these healing benefits.”
With this sweet-spot knowledge, Healionics is able
to create a uniform and consistent porosity akin to
a honeycomb structure on a given substrate using its
proprietary sphere-templating process.
Measuring at least 150 μm thick, the resulting 3-D
scaffold supports
biointegration
and tissue
regeneration
because the body
reacts differently
to the engineered
porous material
Healionics is the developer of STAR
than it does to the biomaterial, a 3-D scaffold that
solid form of the promotes biointegration.
original material,
according to Alvarez. And, because the pore geometry
rather than the material itself is responsible for
promoting healing, the technology can be used with a
variety of substrates. Among them are implant-grade
silicones and biodegradable hyaluronic acid. “We
did not introduce some new formulation,” Alvarez
explains. “We just basically put a really precise and
uniform porous structure to existing, well-established
synthetic materials.”
In addition to supporting angiogenesis, the STAR
scaffold has demonstrated a significant reduction
in foreign body response, according to the company.
Promoting acceptance of a long-term implant by the
body could be useful for such products as implantable
glucose sensors, ophthalmic devices, stimulation leads,
catheters, vascular-access ports, and a variety of
additional applications. —Shana Leonard
■ Healionics
www.healionics.com
Booth #658
Molder Keeps Pace
with Shrinking
Lead Times
To be truly dynamic, something must exhibit
continuous and productive activity or change. The
evolution of Dynamic Group (Minneapolis)—the
company that developed Dynamic Engineering
Inc. and Dyna-Plast Inc., located in the city’s
northern suburbs—reflects efforts to do just that.
Dynamic Engineering formed in 1977 with the
goal to design and make production injection molds
for powder and plastic. Serving several industries,
it focused on medical and dental applications.
Dyna-Plast began 20 years later, offering
customers rapid prototyping and molding services.
“In an effort to apply certain lean principles to
the operation of our business, we now operate as
one business entity with two physical locations,”
explains Jay Williams, vice president of sales and
marketing.
Today, 70% of the group’s business comes from
the medical and dental industries. The company
offers cradle-to-grave product realization from
prototype to production tooling and precision
molding services to medical device OEMs. Over the
Lubricious Coating Provider Maintains
Surface Appearances
In 2005, Ron Sahatjian left
Boston Scientific Corp. (Natick,
MA) with the goal of retiring to the
golf course. Instead of improving
his handicap on the green, however,
he ended up becoming an expert
in other types of surfaces. The
result was Medi-Solve Coatings
LLC (Natick, MA), a venture that
specializes in surface coatings and
polymer chemistry solutions for medical devices.
“What really helped to get us established was that
Boston Scientific let me acquire part of my lab to take
with me,” remarks Sahatjian. “Art Madenjian, also
of Boston Scientific, later joined me to help set up the
new company, and Medi-Solve Coatings was born.”
With more than 40 years of combined experience,
the pair have built a company that offers hydrophilic
coatings, fluoropolymers, drug-delivery coatings,
and antimicrobial systems. It also provides a range
of related services, from process development and
customized equipment support to testing expertise and
radio-frequency plasma surface treatment.
Sahatjian and Madenjian established Medi-Solve
Coatings to provide support to small and mid-sized companies that knew how to design medical
devices but required a lubricious, antimicrobial, or
thromboresistant coating that could outperform
competitive products. “We have been successful
at providing coating formulations and processes to
several customers that coat their products in their
own manufacturing facilities using our formulations,”
notes Sahatjian. The company’s coatings, he adds,
have been CE marked as part of a 510(k) submission
and are applied to products that are marketed in
Dynamic Group offers product development, molding,
and assembly services for applications such as syringes.
Medi-Solve’s offerings include
AquaCoat DEB for balloons and
AquaCoat hydrophilic lubricious
coating, shown here on guidewires and
a microcatheter.
the United States and abroad.
In addition to the more than
100 U.S. patents already held by
Sahatjian and his colleagues, the
company expects to be awarded another patent soon
for its coating technology.
The company’s coatings include AquaCoat LC, one
of the most lubricious coatings available, according to
Sahatjian. It also markets AquaCoat PA, a plasma-activated surface treatment that adheres the coating to
the substrate; AquaCoat DEB, a balloon-based drug-release coating for coronary artery restenosis that is
used when stents are difficult to insert into the body;
and AquaCoat Gel, a coating that the company says
remains slippery and moist outside the body after other
coatings have become tacky and dry.
In addition to offering device coatings, the
company’s next objective is to convert its controlled-environment facility to a Class 10,000 cleanroom to
coat products for final packaging. It also intends to
expand its current testing capabilities, which include
friction and trackability testing and thermal analysis
techniques such as differential scanning calorimetry and
thermogravimetric analysis. It also plans to start an
aseptic polymer solutions effort to provide its customers
with specialty polymer products. —Bob Michaels
■ Medi-Solve Coatings
www.medi-solveassociates.com
Booth #969
years, it has invested heavily in new equipment and
has kept up with customers’ requirements by having
its facilities certified to ISO 9001 and ISO 13485
standards, as well as being registered with FDA.
More and more, customers expect the company to
be a one-stop shop that offers an array of secondary
operations beyond mold manufacturing, according
to Williams. “Our molding facility has grown from
a shop that qualifies tools and runs bridge-type
production to [one] that includes precision medical
molding and assembly in a Class 10,000 cleanroom,”
he says. In addition to its mold manufacturing and
molding operations, Dynamic Group offers inspection
services, precision high-speed machining, specialized
wire EDM services, design modeling, pad-printing,
welding, and other services.
Perhaps more important than maintaining state-of-the-art machining and EDM equipment, the
company listens to the needs of its OEM customers.
Device assemblies are not only becoming more
complex—requiring tolerances on molded plastic
that were uncommon a few years ago—but firms
like Dynamic Group are being asked to do everything
faster. “There is a continuous trend toward less
and less time being afforded to our company in the
development process,” Williams says. “In fact, we
are given less time in every phase of a project than
we were only a few years ago.” But the company
is ready to meet those challenges, especially since
Williams says they do not expect that trend to cease
any time soon. —Stephanie Steward
■ The Dynamic Group
www.thedynamicgroup.net
