Medical Design Briefs - February 2022 - 3

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Following the Patient Journey
A key challenge for medtech product designers and developers is the identification of unmet clinical needs that can be addressed by current or newly
developed technologies. Below, Kelly Powers, formerly senior vice president of science and technology at Bard Access Systems (BAS), recalls the steps
that led to the development of the world's first power injection peripherally inserted central catheter (PICC) line, which became a market leader and
powerful revenue source for BAS from its introduction. Now an adjunct assistant professor and entrepreneur in residence in the department of surgery
at the University of Utah College of Medicine, Powers frequently advises medtech innovators on their approaches to developing new generations of
medical devices.
One great example of how clinical insight
can reveal opportunities for innovation is
the development of power-injectable central
catheters. In this case, the opportunity
was found by following patients from their
time of diagnosis, through treatment and
follow-up.
Kelly Powers, Adjunct
Assistant Professor
and Entrepreneur,
University of Utah
College of Medicine
Computed tomography (CT) imaging is
essentially a spinning circular x-ray, and it
has become the principle diagnostic tool for
just about everything nowadays. To perform
a CT scan, technicians typically deliver to the
patient a radiopaque contrast agent that increases the density of
the blood, making it easier to see the body's internal structures.
Every hospital of any size has a CT machine that is running almost
constantly and is used for everything from nondescript abdominal
scans to detailed brain scans-and especially for detecting and monitoring
cancer.
However, cancer patients present a significant challenge for CT
imaging, because they have often received so much intravenous
chemotherapy that their veins are no longer accessible for the
delivery of contrast agents. A central venous access catheter might
still be used to deliver those caustic chemotherapy drugs, but in
many cases when that strategy is being used, the patient has
already lost all peripheral access. Veins are no longer visible or
available for catheterization, and CT technicians are generally not
experts in how to gain vascular access in such circumstances. Their
only recourse is to call in a technician with an ultrasound unit, so
that the patient's veins can be viewed and accessed.
A hospital CT unit can typically process about four or five patients
per hour if everything runs smoothly. Each patient is gowned,
injected with a contrast agent, and imaged-and within about 10 to
15 minutes the technicians are prepping for the next patient. But if
a patient in this queue presents with difficult vascular access that
requires the attention of ultrasound technicians so that a contrast
agent can be delivered, the unit's schedule can be disrupted for the
whole day.
This problem was discovered by teams from BAS and its product
development partner Medron (Flexan), a contract manufacturing
organization specializing in cleanroom manufacturing of silicone
and thermoplastic components for medical technologies. The
teams worked together to follow and document the experience of
patients who were receiving various courses of diagnosis and treatment.
Their observations clearly revealed a clinical need that was
begging to be addressed (see Figure 1).
Figure 1. A robust product development process starts with having members
of the development team involved in visiting local area hospitals and speaking
with clinicians. Click on the image above to watch an interview with Eric
King, Flexan vice president for product development (center), where he discusses
how clinical insight can reveal opportunities for innovation.
Building on this clinical insight, we worked with Medron (Flexan) to
develop the world's first power injection peripherally inserted central
catheter (PICC) line. The first year it was launched, product
sales were over $80 million, and it quickly became the standard of
care. Sales are now over $700 million annually.
This story demonstrates the vital importance of having product
development people involved in visiting customer sites and speaking
with clinicians. Our vascular access customers were never going
to ask for such a product, because they were unaware of the domino
effects on scheduling that would only surface after a difficultaccess
patient had been imaged and released. In most cases, in fact,
the technician who finally inserted the patient's catheter never
even knew the problem existed. But once the BAS/Medron team
identified the underlying causes of the problem, and assessed the
clinical need for a solution, it was obvious that this had to be the
next big target for our product engineering teams.
Although the benefits of this new product were very clear, it was curious
that the clinical need wasn't obvious to any of the people who
were buying or using preexisting versions of the device. They simply
didn't know about the problems down the line. And, of course, the
people down the line simply saw the problem as something they dealt
with. They didn't realize there could be a technical solution.
Read On
To find out more about the extraordinarily productive partnership
of BAS and Medron (Flexan), visit the two-part white paper
on " Life Cycle Support for Medical Devices, " available online at
https://www.medicaldesignbriefs.com/ei21/flexan-pt1 and
https://www.medicaldesignbriefs.com/ei21/flexan-pt2.
Medical Design Briefs, February 2022
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Medical Design Briefs - February 2022

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