Analyzes End-Users Expectations, Clinical Studies, and FDA Guidance Documents and 510(k) with Sharps Safety Indication Application
PRLog - Jun 07, 2013 - ATLANTA -- MediPurpose™, a manufacturer and master distributor of medical products, today announced the publication of a new white paper, Reinventing a Better Safety Heelstick: Defining, Translating and Validating Safety Features.
The white paper describes the redesigned babyLance™ safety heelstick’s safety features—and the processes with which they were integrated and validated, which included:
• Gathering end-users’ expectations for a safety neonatal heel incision device
• Analyzing the U.S. FDA’s Guidance Document on Medical Devices with Sharps Prevention Features
• Translating product requirements into design specifications
• Validating safety features before launching the new device in August 2012
• Applying for U.S. FDA 510(k) with sharps safety indications in January 2013
“Safety is a crucial aspect of the device and is required to meet the needs of an increasingly safety-conscious and safety-regulated market,” said MediPurpose founder and CEO Patrick Yi. “Further, without its safety features, MediPurpose could not submit babyLance for a U.S. Food and Drug Administration 510(k) with sharps prevention indications—which enables us to legally market it as a “safety heelstick.”
To date, babyLance is believed to be the only infant heelstick device marketed in the United States with 510(k) clearance for sharps prevention features.
About babyLance Safety Heelsticks
After investing more than a year in the redesign of its babyLance safety heelstick, MediPurpose launched the all-new heel incision device in August 2012.
babyLance is available in two models, each with a specific blade penetration:
• babyLance BLP (preemie): 0.85 mm depth
• babyLance BLN (newborn): 1.0 mm depth
Specifically designed to meet end-user expectations for the ideal heelstick, the new babyLance provides enhanced stability, comfort and ease of use.
To download the white paper, please visit www.medipurpose.com/downloads.
For more information about babyLance safety heelsticks—including no-cost product sample requests—please visit http://www.medipurpose.com/babylance .
About MediPurpose
Founded in 1999, MediPurpose is an innovative medical device company headquartered in Singapore, with offices in the United States and Europe.
Known for its popular babyLance™ safety heelstick, SurgiLance™ safety lancet and MediPlus™ advanced wound care products, MediPurpose has leveraged its success in the medical device industry to become a master medical product distributor that provides unique solutions for both medical product manufacturers and distributors.
MediPurpose's Medical Device Innovation division offers angel funding and developmental expertise for new medical device inventors and innovative medical product companies (http://www.medipurpose.com/innovation/) 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 .
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The white paper describes the redesigned babyLance™ safety heelstick’s safety features—and the processes with which they were integrated and validated, which included:
• Gathering end-users’ expectations for a safety neonatal heel incision device
• Analyzing the U.S. FDA’s Guidance Document on Medical Devices with Sharps Prevention Features
• Translating product requirements into design specifications
• Validating safety features before launching the new device in August 2012
• Applying for U.S. FDA 510(k) with sharps safety indications in January 2013
“Safety is a crucial aspect of the device and is required to meet the needs of an increasingly safety-conscious and safety-regulated market,” said MediPurpose founder and CEO Patrick Yi. “Further, without its safety features, MediPurpose could not submit babyLance for a U.S. Food and Drug Administration 510(k) with sharps prevention indications—which enables us to legally market it as a “safety heelstick.”
To date, babyLance is believed to be the only infant heelstick device marketed in the United States with 510(k) clearance for sharps prevention features.
About babyLance Safety Heelsticks
After investing more than a year in the redesign of its babyLance safety heelstick, MediPurpose launched the all-new heel incision device in August 2012.
babyLance is available in two models, each with a specific blade penetration:
• babyLance BLP (preemie): 0.85 mm depth
• babyLance BLN (newborn): 1.0 mm depth
Specifically designed to meet end-user expectations for the ideal heelstick, the new babyLance provides enhanced stability, comfort and ease of use.
To download the white paper, please visit www.medipurpose.com/downloads.
For more information about babyLance safety heelsticks—including no-cost product sample requests—please visit http://www.medipurpose.com/babylance .
About MediPurpose
Founded in 1999, MediPurpose is an innovative medical device company headquartered in Singapore, with offices in the United States and Europe.
Known for its popular babyLance™ safety heelstick, SurgiLance™ safety lancet and MediPlus™ advanced wound care products, MediPurpose has leveraged its success in the medical device industry to become a master medical product distributor that provides unique solutions for both medical product manufacturers and distributors.
MediPurpose's Medical Device Innovation division offers angel funding and developmental expertise for new medical device inventors and innovative medical product companies (http://www.medipurpose.com/innovation/) 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 .
Read Full Story - New White Paper Describes Design and Validation of babyLance Safety Features | More news from this source
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