Kaysun Corporation says it has improved its production processes, gained the confidence of its prospective customers, and grew the medical side of its business by 14%, after achieving MedAccred accreditation in plastics injection moulding.

Kaysun, based in Manitowoc, Wisconsin, has offered custom injection moulding and engineering solutions to OEMs for the design, manufacture and assembly of complex, tight-tolerance plastic parts, for over 70 years. The company attained MedAccred accreditation after meeting the exacting audit requirements, as set by MedAccred OEM Subscribers – BD, Boston Scientific, Baxter, Edwards Lifesciences, Johnson & Johnson, Medtronic, Philips, Stryker and Roche Diagnostics.

The company was already certified under ISO 13485 but wanted to enhance its processes and systems to better align with the rigors, demands and strategies of the medical industry, and prospective medical device customers. Several of Kaysun’s target customers in the medical device sector advised that to be considered for a partnership, injection moulders must have MedAccred accreditation.

During the auditing process, Kaysun navigated various challenges. The structured MedAccred approach necessitated some internal adjustments to the allocation of resources, to more up-front medical device product design and development, issue detection and correction, and risk mitigation.

Kaysun’s success in passing the rigorous audit criteria earned them MedAccred accreditation in plastics injection moulding in January 2019. Two years after accreditation, revenue from its medical business increased by 10%, and the year after, further increased by 14%. The company has been re-accredited several times since the initial audit, and currently maintains a dedicated team and a relationship with PRI to ensure it can satisfy all accreditation requirements. 

In addition to the tangible changes, the MedAccred program also shifted the cultural mindset about quality processes and products within the company. 

Ray Dorow, quality manager at Kaysun, says the complexities of medical devices require detailed documentation and handling which, prior to engaging in the MedAccred program, were often seen as “necessary functions.” With MedAccred, all levels of team members understand the ‘why’ behind our approach to a particular medical device and the need for proper validation, documentation, and quality control. The greater awareness has cultivated a culture of continuous improvement, collaboration, engagement, and pride in owning all aspects of each project.”

Dorow says the MedAccred programme enabled Kaysun to strengthen its infrastructure in terms of quality assurance, metrics, and documentation of engineering approach and process development; as a result, people were empowered with a quality-first mindset. 

“This led to a holistic review of the moulding process, inclusion of more aspects in validation, and a more impactful system for identifying issues and correcting them prior to formal production.

“As more major medical device manufacturers require suppliers to hold MedAccred accreditation, it’s clear they acknowledge the qualitative difference it makes in their supply chains, operational efficiencies, and devices. MedAccred has compelled Kaysun to further embrace excellence.”

Other positive outcomes of the MedAccred program for Kaysun, included:

• More structured, stable, and repeatable production process
• Better proactive planning
• Enhanced scrap management
• Increased overall efficiency of medical device manufacturing programs
• Improved customer confidence – any injection moulded part meets dimensional requirements and quality expectations.