Springing into action

Published: 5-Sep-2013

Not all component production for medical devices currently requires a cleanroom or ISO 13485 certification but Steve Dicke, Connecticut Spring and Stamping, believes the writing is on the wall

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Since Connecticut Spring & Stamping (CSS) made a strategic decision to grow its medical business, the company has taken a number of actions to stay a step ahead in the rapidly growing medical field. Among the most important was the decision to obtain certification under the ISO 13485 standard for quality management for design and manufacturing of medical devices.

While not, as yet, required by customers of prospective clients, the company believes the standard will be specified in future, and this was the underlying impetus for its decision to obtain the certification. Furthermore, the company predicts greater use of cleanroom technology for the assembly of medical products in the future and believes ISO 13485 certification positions its business well for this eventuality.

For more than 25 years, CSS has supplied medical device OEMs with tight tolerance springs used in minimally invasive handheld surgical devices, as well as metal stampings for handheld surgical devices, endoscopic clip appliers, suturing devices, and staple removers. In 2001, the company took the decision to focus more on the medical market, which was about 8% of its overall total at that time. Since then, the medical business has grown to 25–30% of total company revenue, which has also seen high year-on-year growth. Ultimately, CSS would like 50% of its business to be in the medical market within the next few years.

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