New White Paper Describes Clinical Validation of New babyLance Infant Heelstick Device
Study Completes Two-Year Redesign Phase, Enabling Launch of New Neonatal Medical Device
Oct. 17, 2012 - PRLog -- ATLANTA -- MediPurpose(
Prior to launching its all-new babyLance infant heelstick last August, MediPurpose spent nearly two years on its redesign. Throughout that process, the company actively engaged end-users to learn their requirements for an ideal heelstick device, and to validate that its new device was meeting their expectations.
In summer 2012, MediPurpose conducted a series of clinical use studies (CUS) to validate its latest babyLance design. In those studies, 37 neonatal nurses at five hospitals in California, Georgia and Austria were given actual production babyLance heelstick devices to use on infants in a clinical setting. The nurses were asked to complete an evaluation survey and report their experiences to MediPurpose.
According to the white paper, the new device garnered perfect scores of 100 percent for safety and an average of 94 percent for usage, which exceeded MediPurpose's minimums for acceptance. These scores were consistent with the positive results from an earlier simulated use study (SUS) in which neonatal nurses evaluated babyLance with artificial infant heels. Further, the CUS results enabled MediPurpose to conclude the babyLance redesign project and initiate product launch.
The white paper is the latest in a series of publications that illustrate the intensive research and testing MediPurpose performed for its new heel incision device. These include white papers on the simulated use study, heelstick cut profiles for babyLance and leading competitors, a heelstick trigger activation survey conducted at the 2011 NANN convention, and an overview of its research on neonatal heelstick user preferences.
"MediPurpose certainly did not invent the infant heelstick -- a medical device that has been around for several years," said MediPurpose founder and CEO Patrick Yi, who led the babyLance design team. "However, the market has expressed the need for a neonatal heelstick that better satisfies end-user requirements. By listening carefully to the end-users, we are confident that our new babyLance meets those requirements."
Yi said that his company's confidence is fostered by the knowledge that its new babyLance:
* Is designed with intensive input from a diverse range of highly qualified users.
* Provides a preferred pull trigger activation mechanism that is comfortable and easy to use.
* Is assured to provide safety and quality from a proven and trusted manufacturer with worldwide distribution channels.
Additionally, Yi said "the results further validate MediPurpose's medical product innovation process and capabilities."
About babyLance Infant Heel Incision Devices
The new babyLance infant heel incision device is a fully redesigned iteration of MediPurpose's original safe, easy and effective heelstick device.
Used by neonatal caregivers to collect blood samples from infants, the new babyLance features an ergonomic design to provide a secure and stable grip.
Combined with a redesigned trigger mechanism, the heelstick device is easy to activate, helping to deliver a consistent incision without damaging the baby's tender nerve fibers.
babyLance heelstick devices are available in two models:
* The babyLance BLP (Preemie), which delivers an incision depth of 0.85 mm.
* The babyLance BLN (Newborn), which delivers an incision depth of 1.00 mm.
To download the white papers, please visit http://www.medipurpose.com/
For more information about babyLance -- including pricing and no-cost product sample requests -- please visit http://www.medipurpose.com/
Founded in 1999, MediPurpose is a leading medical device company headquartered in Singapore, with offices in the United States and Europe.
Known for its popular babyLance(tm)
MediPurpose's Medical Device Innovation division offers angel funding and developmental expertise for new medical device inventors and innovative medical product companies that seek entrance into new medical device markets.
For more information about MediPurpose's medical products and solutions for inventors, innovators, manufacturers and distributors, please visit http://www.medipurpose.com.