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Incorporated by Larry Estes in November of 1976, Estes Design and Manufacturing, Inc. is a full-service sheet metal fabricator offering customers a combination of product design, engineering, rapid prototyping and manufacturing services using advanced technology, including 3D laser welding. From conceptual design to full production, our staff of engineers, CAD designers, and manufacturing professionals collaborates to create an environment for rapid response manufacturing across a broad range of product and industry applications: medical devices, appliance, HVAC, office furniture manufacturing, aerospace, and more. Today, Estes employs a staff of more than 100 associates, and its manufacturing facility is housed in 85,000 square feet to provide even the largest companies with quality products and services. Estes has made it a priority to acquire the latest fabricating technology and to utilize automation when it adds value to the process ensuring customers the most cost-effective solutions to their manufacturing challenges.

Situation

Estes holds within its core philosophy the value of creative, innovative thinking. As a long time medical tray manufacturer, Estes employed innovative thinking and set out to simplify medical trays, reducing the components and the weight while improving the sterilization performance and materials utilized. With added success in this market segment, it became critical to growth that Estes expand their ISO 9001 certification and certify its quality system to the ISO 13485 Medical Devices standard. Estes had demand for a compressed implementation period which necessitated identifying an external resource who could commit the time required to retooling the system, as well as being competent in ISO 13485 and system implementation. Estes knew where to find such a resource and immediately turned to Purdue TAP.

Solution

Purdue MEP came in and performed a gap analysis audit and was then able, in conjunction with Estes Quality, to mark a clear path forward to ISO 13485 implementation and certification. Purdue MEP worked hand in hand with Estes quality, engineering, planning, and management teams to understand and refine existing processes and help craft new ones to expedite the path to implementation and certification. Purdue MEP administered training for risk management, ISO 13485 Internal Auditing, and also served as lead auditor for Estes’ first ISO 13485 Internal Audit.

Results

Utilizing Purdue MEP to assist in its ISO 13485 implementation, Estes took what would have been most likely a six-month process and compressed it to three months. With the flexibility to devote an experienced resource to the project, Estes was able to implement it with minimal disruption or delay. Further, Estes was recommended for ISO 13485 certification by its registrar DNV-GL on the first attempt, a testament to the quality of work and training Purdue MEP provided. As a result of the certification, Estes approximates an additional $7 million in sales over the next three years.

 

“Our relationship with Purdue MEP is one we value greatly. Their services are of very high quality, they do what they say they are going to do, they conduct their business in a highly professional manner, and they are enjoyable to work with. I consider this project to have been a resounding success. The coaching and hands-on work provided by Purdue MEP to assist us through the transition to ISO 13485 was invaluable and right on track, as evidenced by the successful outcome of the audit. The Specialist conducting the project is obviously an expert in his field. I would offer my endorsement of Purdue MEP without reservation.”

— Ron Estes, V.P. Operations

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