|Cutting Edge Instruments|
Product: Dental Burs
Cutting Edge Instruments (CEI) manufactures carbide dental burs used by dentists. CEI recognized that achieving ISO 13485:2003 certification would allow them to expand their sales and marketing efforts in Europe and Canada, and increase U.S. military and government sales. ISO 13485:2003 is a requirement for applying for the Canadian CMDCAS and the European CE mark certifications. CEI engaged the Vermont Manufacturing Extension Center (VMEC) in October of 2004 to assist them in preparing for these certifications.
VMEC is a part of the New England Manufacturing Supply Chain Consortium (NEMSC), a partnership that seeks to align manufacturing system capabilities to opportunities to pursue defense supply chain solicitations. NEMSC supported the project from the outset. The first step was to perform a gap analysis of the existing ISO 9002-compliant quality system. VMEC tapped the vast expertise of Joseph Azary of Azary Technologies LLC. Azary Technologies specializes in helping companies prepare their quality systems to meet the requirements of medical device and FDA certification. Mr. Azary used the results of a gap analysis to work with VMEC and CEI personnel to incorporate the more stringent requirements of ISO 13485:2003 into their quality system. CEI also brought in Edgar Bothe, a quality consultant, to help supplement their available internal resources. The combined effort allowed the company to modify their system in just over two months. This included review of all documentation, modifying procedures where necessary, training personnel, and verifying compliance to the new system so that "living the system" continues to yield the largest business benefit possible to the company.
CEI was audited and recommended for ISO 13485:2003 certification in January 2005. They are now applying for CMDCAS and CE mark certification. The immediate business effects are both internal and external. During the process of transforming their system, they established new metrics for monitoring the performance of the business to business objectives. They also used the data developed to progress further with their capital improvement plans. CEI estimates that achieving these certifications will result in just under $1,000,000 in new sales this year. Working with VMEC allowed them to realize a cost savings of $4,000 in reduced work in process and $4,000 in savings due to improved design procedures. The company invested $18,200 in software and workforce practices. The quantified impact from this project includes $33,000 in direct labor cost savings. Given their accelerated progress on capital equipment purchases, two new positions will be created in the production area.