Alden Kay

Alden Kay, Vice-President of Manufacturing, DynaMed Division, Gall's Inc. (download)
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According to Alden Kay, DynaMed Vice President, "All emergency and paramedic vehicles in New York and New Jersey must carry a stair chair.
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"We took all our competitors' products, looked at what needed to be changed and improved, then used Project KickStart to develop a better chair," Kay says.
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According to Kay, he and his team have used Project Kickstart to design four products, including the Stair Chair Model 4000.In designing the Model 4000 and other DynaMed products, Kay says he finds Project KickStart 's phases, people, goals, and tasks features to be most beneficial to successfully completing design projects.

The Benefits

Alden Kay and his DynaMed design team find the following benefits in using Project KickStart:

VisiJet (VJET) appointed Robert Javidi its Director of Operations and R. Alden Kay its Director of Quality Assurance and Regulatory Affairs.
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Javidi has more than 15 years experience in medical manufacturing, most recently as Founder and Principal of MedDevice Packaging, and Kay previously was Director of Quality and Regulatory for Instromedix, a cardiac monitoring company.

"We took all our competitors' products, looked at what needed to be changed and improved, then used Project KickStart to develop a better chair," Kay said.
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"With Project KickStart, I get the results I want, and I get the job done," explains Alden Kay, vice president of manufacturing for DynaMed, the Carlsbad, California-based division of GALL's Inc., which specializes in emergency rescue equipment.
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"All emergency and paramedic vehicles in New York and New Jersey must carry a stair chair," explains DynaMed's Alden Kay."We wanted to design a chair that went beyond the basic requirements, one that makes emergency medical technicians' work easier."

Emergency work can often be back-breaking.
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Since discovering Project KickStart through a 1999Web search, Kay and his team have used it to design four products.The Stair Chair Model 4000 is the jewel in the crown.

In designing the Model 4000 StairChair and other DynaMed products, Kay said he has found Project KickStart 's phases, people, goals and tasks features to be most beneficial.

Alden KayAlden has over 30 years of experience with quality systems, regulatory requirements and manufacturing, the last 25 years of which have been spent in the medical device industry.Alden comes to Visijet from Instromedix, a Card Guard Company who is a leader in the manufacture of cardiac event monitoring equipment.Alden created the Quality and Regulatory departments for Instromedix and successfully led them through ISO certifications, CE Mark regulatory approvals and three FDA regulatory 510(k) approvals.Prior he was with DynaMed, a market leader of emergency rescue and paramedic equipment where he served as Vice President of Manufacturing, and was responsible for all regulatory affairs, quality assurance, manufacturing, facilities, environmental compliance and research and development activities, as well as implementing ISO 9001 certification.Prior to DynaMed, Alden joined Intramed Laboratories, a small start-up company manufacturing miniature fiber optic endoscopes.As Manager of Regulatory Affairs and Quality Assurance for Intramed, Alden created the Quality Department, was responsible for all CE Mark regulatory approvals, and six FDA regulatory 510(k) approvals.Alden has also held various Quality and Manufacturing Engineering positions with Baxter Healthcare.

Alden is a graduate of California State University, Long Beach, with a B.S. in Industrial Technology.His professional certifications include Certified Six Sigma Engineer and ASQC Certified Quality Engineer.He has also been a co-chair of the AAMI-FDA (Association for the Advancement of Medical Instrumentation- FDA) technical session on Design Considerations and a speaker on the design challenges of reusable sterile medical devices at the 30th annual AAMI meeting.