Originally Published MX May/June 2002
BUSINESS PLANNING & TECHNOLOGY DEVELOPMENT
The Many Paths to Design ExcellenceThe winners of this year's Medical Design Excellence Awards are united by a common focus on effective medical design.
Renee DiIulio
When John Bottjer
purchased Geiger Instrument Co. in 1995, he knew that its long-term future was
uncertain. The company had manufactured thermal cautery units for more than
80 years, and change had been slow in coming. The company's then-current cautery
unit had not been updated in more than four decades. A redesign "was a
matter of survival for Geiger," Bottjer recalls. "The previous unit
had stable sales with little growth potential and was insufficient for the company
to continue long term."
As part
of the turnaround, the company was renamed Geiger Medical Technologies and relocated
to Monarch Beach, CA. More importantly, though, Bottjer set out to update the
company's flagship thermal cautery unit. He began with an intense period of
analyzing the market and interviewing users. Then, together with an electronics
expert from Houston and a student from the Art Center College of Design in Pasadena,
CA, Bottjer redesigned the product.
 The Thermal Cautery Unit Model 150, by Geiger Medical Technologies (Monarch Beach, CA). |
 John Bottjer |
Bottjer's achievement is a testament to the power of effective medical design. Good design can energize a stagnant company or create the foundation of a new one, increase market share or create entirely new markets, and give a rapid start to a new product or repay agonizingly long development and regulatory approval times. Above all, it can improve patients' lives.
The 2002 Medical Design Excellence Awards (MDEA) celebrate the ways in which medical device companies have leveraged good design into corporate success. As the sampling of winning companies profiled here suggests, companies took many different paths to their achievements. All of them, however, share a commitment to design excellence.
Innovating Tradition
Another company
to win an MDEA this year for redesigning a longtime flagship product is Welch
Allyn Inc. (Skaneateles Falls, NY). Though a large and well-established company,
Welch Allyn nonetheless emphasizes innovation. As laid out in its mission statement,
the company's strategy is to "strengthen its position in a variety of fields
worldwide by continually enhancing and leveraging its core technologies."
In 2001, Welch Allyn launched seven new or redesigned products. Three won MDEAs
this year, an unprecedented achievement.
 The PanOptic Ophthalmoscope by Welch Allyn Inc. (Skaneateles Falls, NY). |
One of these, the
PanOptic Ophthalmoscope, is a reintroduction of the product on which the company
was founded in 1915, and which has been a key contributor to its financial success.
During a "Big Bang" discussion, a company team decided that it would
make a "big bang" if Welch Allyn could significantly expand the ophthalmoscope's
field of view and therefore strengthen its lead in this technology. With specific
goals, including retrofitting the product to the same base of handles currently
available, the team succeeded in expanding the field of view from 5° to
25°. Marketed to hospitals and physician offices through both distributors
and the Welch Allyn sales force, the product has sold better than anticipated,
generating a high rate of adoption among medical students.
 Peter Soderberg |
Company president
and CEO Peter Soderberg claims two secrets to his company's design success:
team effort and attention to customer needs. "We generally have tight unit-cost
and customer-satisfaction goals when developing a product," says Soderberg.
Fairy dust doesn't hurt either; teams are able to spend money without formal
approval in the early stages. The MDEAs, says Soderberg, provide recognition
for successful design. But more importantly, he adds, the awards offer positive
testimony about the people and the environment at Welch Allyn.
As in the case of Welch Allyn, the design achievements of the Medical Carbon
Research Institute LLC (MCRI; Austin, TX) grew out of a combination of tradition
and innovation. In 2002, MCRI won an MDEA for the On-X Valve, a mechanical heart-valve
prosthesis. The On-X valve mimics the function of the natural human valve so
closely that hemodynamic clinical results are nearly equivalent.
"The company, founded in 1994, may seem new, but the core of MCRI is actually
30 years old," says MCRI team member Jon Stupka. In the 1960s, MCRI president
Jack Bokros, PhD, developed pyrolytic carbon with heart surgeon Michael DeBakey
for use in replacement heart valves. Bokros has since made carbon parts for
more than 90% of all mechanical heart valves produced, founding a series of
companies along the way.
 Jack Bokros |
In a continuation of this tradition, he and his MCRI associates patented the first 100%-pure medical pyrolytic carbon, On-X carbon, a key component of the winning On-X valve. Describing it as the first major advance in biomedical carbon materials technology since Pyrolite carbon, Bokros says it is stronger, tougher, and more easily incorporated into a wide variety of devices than any previous pyrolytic carbon.
Start-Ups: Kick-Starting New Traditions
If innovative design
is beneficial to established companies, it is crucial to start-ups. For two
such companies, winning an MDEA this year reflects the credibility and exposure
that can come from well-designed products, and on which growth is based.
Align Technology Inc. (Santa Clara, CA) is just now seeing word of mouth help
spread the news about its MDEA-winning product, Invisalign. A method of straightening
teeth, Invisalign involves two components, ClinChek and Aligners. ClinChek is
an Internet-based system for three-dimensional clinical modeling of a course
of treatment. The resulting data are used to make a series of clear, removable
Aligners to be worn for two weeks, each one corresponding to a stage of tooth
movement.
 The On-X Valve by the Medical Carbon Research Institute (Austin, TX). |
The product was
conceived by company cofounder and chairman of the board Zia Chishti. After
having gone through the embarrassment of wearing braces as an adult, Chishti
noted that the retainer he subsequently wore could also move his teeth, but
only within a limited range. With a background in computer science, he realized
that a series of devices similar to his retainer could be designed with rapid
prototyping technology to create a replacement for braces.
 The Invisalign teeth-straightening system by Align Technology (Santa Clara, CA). |
With Kelsey Wirth,
now company president, he founded Align Technology. The two developed the business
plan while students in the MBA program at Stanford University and secured funding
from local venture capitalist groups.
 Amir Abolfathi |
The company had
to surmount challenges related to training practitioners and a requirement for
in-office Internet access, but thereafter the product was readily accepted.
The company markets Invisalign primarily itself, supplementing its efforts with
one distributor in Israel and one in North America to target general practitioners.
According to Amir Abolfathi, vice president of research and development, the
concrete recognition provided by the MDEA will lend further credibility to the
product's design.
 The Cbyon Suite from Cbyon Inc. (Mountain View, CA). |
 S. Mitchell Seyedin |
Funded by venture
capital firms, Cbyon turned to the market to develop a successful product. "We
relied on our clinical collaborators to tell us what they needed image guidance
equipment to do to support their minimally invasive surgeries. One element of
the feedback revolved around product cost and the necessity to create a device
that was cost-effective, intuitive, and easy to upgrade," says Seyedin.
Cbyon uses different hardware and software to achieve this aim. Now the company
will focus on exposure.
"Winning the MDEA validates our product and efforts. Being a newcomer to
the image-guided surgery arena, recognition by our peers and industry builds
confidence among our existing customers and provides an opportunity to tout
our accomplishments to potential customers," says Seyedin.
Long and Short Views
For many companies,
not only recognition, but a marketable product, is a long time coming. In development
since 1992, the Duplex Drug Delivery System made by B. Braun Medical Inc. (Bethlehem,
PA) finally reached the market in 2001. The Duplex system is a ready-to-use,
multichambered bag that stores a drug, or drugs, and diluent in separate compartments
until the IV is ready to be administered.
 The Duplex Drug Delivery System by B. Braun Medical Inc. (Bethlehem, PA). |
After conducting
extensive market research utilizing more than 250 clinicians, a B. Braun team
determined the parameters for a drug-delivery system that addressed the process
by which drugs are mixed and administered. Ron Earle, group senior vice president
at B. Braun, notes that B. Braun has made this product one of its largest single
investments in technology. "We are now ready to sell the product and expand
its use," says Earle. "We've placed the product in a separate business
unit to exploit the technology as much as possible. Winning the MDEA lends credence
to our investment while increasing awareness of the product."
Another 2002 MDEA-winning product with a long development time is Dermagraft,
made by La Jolla, CA–based Advanced Tissue Sciences Inc. (ATS). A cryopreserved,
tissue-engineered, allogeneic, human dermal replacement, Dermagraft provides
healthy, metabolically active tissue to enhance wound closure.
In contrast to B. Braun, ATS cannot yet finance its own research. Instead, it
relies on Wall Street and investment groups for ongoing funding, says Dawn Applegate,
PhD, director of technology development at ATS. The publicity resulting from
the MDEA, she observes, helps provide positive exposure to these groups.
 Dawn Applegate |
ATS funded Dermagraft
primarily through a joint venture with Smith & Nephew (London), a European
leader in wound care. The two partners split costs and profits evenly, says
Applegate.
)
Dermagraft by Advanced Tissue Sciences (La Jolla, CA). (click to enlarge) |
Because it can
take years to get such a product approved, ATS chose its market carefully. Diabetic
foot ulcers, for which the product has FDA approval, are considered life threatening.
Such conditions are granted an accelerated approval process. Regardless, says
Applegate, the product took 10 years to get to market.
Because Dermagraft is the first living-tissue engineered product to be marketed,
it has met with some challenges, including the training of physicians in its
handling and use. Yet the company has approached these problems as innovatively
as the product itself. It anticipates significant sales this year, particularly
because diabetic foot ulcers represent a larger market than the first approved
application, which was for burn treatment.
 SimpleJect Auto-Injector System by Amgen (Thousand Oaks, CA). |
"Tissue engineering
has not yet had a blockbuster product to help generate exposure and funding,"
says Applegate. However, she adds, "the industry is hitting its 12th year
in which other industries, such as biotechnology, have caught on. This year
will be interesting."
 Craig Lester |
While the winning design for some products comes from a long and painstaking course of development, that of others is propelled by a need for rapid introduction and adoption. According to Craig Lester, a marketing manager for Amgen (Thousand Oaks, CA), the driving force for the development of the SimpleJect Auto-Injector System, another MDEA winner, "was the need to facilitate rapid adoption of Kineret, Amgen's new medication for rheumatoid arthritis." Because the drug is injected, Amgen realized patients suffering with this condition would need an easy-to-use device to self-administer the drug. The company used an advisory board as well as focus groups to fine-tune the instrument.
Conclusion
For all the diversity
of this year's MDEA-winning companies, they share in common a sharp focus on
their corporate missions and their markets. The MDEA competition provides recognition
for companies that have successfully transposed this focus into well-designed
and engineered products that meet the needs of the marketplace.
The recognition that comes with winning an MDEA can bring companies closer to
achieving their corporate missions. In addition, as Ami Mehta, marketing manager
for B. Braun Medical's drug-delivery division, says, "It feels good."
Another mission accomplished.
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