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The development
of medical devices is becoming an increasingly complex business.
Engineering and designing these high-tech instruments can be especially
involved when the client is not sure if their proprietary core technology
will be feasible in practice. In the last few years, the challenge of
transforming an intellectual property (IP) into a marketable device has
emerged a prominent hurdle for prospective clients. They used to declare,
"Here is, build it for us." Now clients are asking, "We
have an idea. Do you think you can make it into a viable
product?"
Most design firms offer basic services.
Those seeking product development
assistance need to recognize that most design and engineering firms offer
only basic services. Their primary activity is to generate mainstream
products. That’s what they do, and if the firm
has been in business for some time, they are probably good at it.
On the other end of the spectrum, there
are firms that specialize in developing high-tech concepts into entirely
original products. Ramping to this level requires a commitment beyond the
usual collection of staff and equipment. The new medical device paradigm
is one of the reasons we originally assembled, and continue to cultivate
an Advanced Technical Services (ATS)
group.
Six person science-based
team.
Our six-person team is comprised of
senior level employees and others with advanced degrees who specialize in
the science-based analysis and practice of research and development. All
of the members have the experience and expertise to address issues few
product development firms are equipped to engage. They make key
contributions on projects based on core technologies or IP that clients
have hired us to incorporate into new or existing systems.
When Volcano Therapeutics came to Omnica,
they presented the concept of a proprietary thermal basket catheter
equipped with heat-sensing thermistors. Our assignment was to design a
specialized cardio-diagnostic instrument with video monitoring
capabilities that would incorporate the innovative catheter. But before we
started work on what would be a considerable development effort, we had to
answer a pivotal question. Would the catheter work
as intended?
Arterial "hot
spots" are future locations of vulnerable plaque.
In a hospital setting a vascular surgeon
would insert the catheter, a thin flexible tube terminated with six to ten
temperature-sensitive sensors, into the patient's femoral artery and
maneuver it through the body to a coronary artery. As the device is
threaded through the heart's arteries, it should sense minute temperature
changes in some locations. These spots are considered loci where arterial
plaque may form. For our client's purposes, if the catheter tip could not
measure clinically significant temperature changes, there was no reason to
continue developing the project. Our challenge was to create a model that
could simulate conditions the catheter would encounter in the human body,
but in a controlled manner so we could determine its sensitivity.
The ATS group devised and assembled the
testing model. They described protocol for the experiment and developed
the operating platform and data collection software required to monitor
the system. The goal as stated was to measure and record "hot
spots" in coronary artery walls. If the catheter was accurate enough
to consistently register a 0.05 degree Celsius temperature change during
the artery model testing cycle, we would have proof of concept.
The system consists of a fluid pump and
flow meter that circulates a saline solution (the same pH as blood)
through a "coronary artery" made of specially molded silicone
tubing. The base of the device contains an integrated heater that
maintains a system temperature of 37 degrees Celsius (98.6 degrees F). For
testing purposes, the catheter is inserted into the closed system through
a hemostasis valve where it can be manually fed through the silicone
"artery". Miniature heater modules mounted at certain points
along the path are used to simulate the arterial "hot spots" the
catheter had been designed to identify.
The testing concept
worked as planned, and the client’s basket catheter concept was
successful. We proved it could sense the arterial locations where
intravascular vulnerable arterial plaque lesions were likely to form.
After this feasibility phase we were hired to develop an entire system
incorporating the new technology.
The result of the
program was Volcano Therapeutics' intravascular thermography device.
We designed a custom keyboard, the PC
cart housing, a handheld control, and the video-based graphical user
interface (GUI) for the operating software. Based on the successful
completion of this project the company successfully raised millions of
dollars for developing new technologies to aid in the diagnosis and
treatment of heart disease.
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