ZELTIQ™ (pronounced Zel 'teek), founded in 2005, is a science-based medical-device company that is dedicated to the development of non-invasive procedures for the reduction of unwanted fat tissue through lipolysis. The ZELTIQ system utilizes a patented method called Cryolipolysis™; the use of precisely controlled cooling to remove fat. This method is designed to only kill fat cells without injury to the skin or other tissue that results from more invasive procedures such as liposuction. This non-surgical approach may be most suitable for patients who only need minimal fat reduction, as well as for those who are unwilling or hesitant to undergo surgery for fat removal.
The Product:
Zeltiq’s CoolSculpting medical device cools fat tissue allowing the body to absorb and dispose of it.
Cooling is delivered through body-area specific applicators and is controlled by the master control unit.
The Product:
Zeltiq’s CoolSculpting medical device cools fat tissue allowing the body to absorb and dispose of it.
Cooling is delivered through body-area specific applicators and is controlled by the master control unit.
Project Objectives and Scope:
Demand for the Zeltiq CoolSculpting product was ramping well in excess of the forecast. Rather than increase internal capacity to address the ramp Zeltiq needed a partner that could handle the variability of their product’s demand and provide the company flexibility in its response to the ever changing demand. Zeltiq also needed the partner to be able to achieve forecast cost targets and to reduce component quality variability which was reducing first pass yields of the product.
Challenges:
Critical to success of the partnership with OnCore was that there be no slippage in demand fulfillment while transitioning production from Zeltiq to OnCore. The issues of addressing the cost targets and improving first pass yields needed to be addressed and remediated while transferring production between Zeltiq and OnCore.
Approach:
OnCore Medical’s Customer-Focus-Team developed a transfer plan involving a “send” and “receive” team. OnCore engineers and operations team members worked on-site at Zeltiq preparing to “send” the product to OnCore’s San Jose facility. Once knowledge transfer was complete the product was transferred to the “receive” team. At the same time root cause analysis was being performed on critical product components that were failing. Identifying and resourcing problem components resulted in 26% first pass yield improvement as well as an initial cost reduction.
Key Success Factors include:
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Developing a custom transition/ramp plan that addressed and mitigated potential risks
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Rigorous DFM analysis for process and product design improvements
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Dedicated Customer-Focus-Team integrated with Zeltiq’s team to assure rapid issue resolutions
Business Benefits:
Transferred production in 90 days
26% First Pass Yield Improvement
100% Ship-by-date on demand 50% above forecast
Immediate 5% cost reduction
About OnCore:
OnCore Manufacturing Services, LLC is a leading provider of product commercialization services for low-medium volume, high-complexity products to international blue-chip aerospace and defense, industrial, and medical companies. With manufacturing facilities in Springfield and Wilmington, MA, Longmont, CO, San Marcos and San Jose, CA and Tijuana, Mexico, OnCore manages customers’ high-complexity products while providing them maximum flexibility to manage their business in a close, collaborative relationship. More information is available at www.oncorems.com.
For more information contact wellbeing@oncorems.com
