Medical device manufacturer views PLM as strategic to achieving continuous improvement in quality, innovation and regulatory compliance.

Owen Mumford is a specialist in the design and manufacture of lancets for blood sampling and systems for self-injection. The company has introduced a number of groundbreaking products resulting in OEM contracts with world-leading pharmaceutical and diagnostic companies.

Continuous product innovation has been key to Owen Mumford’s business success, doubling turnover in the past six years to £30 million.

The company employs over 350 people with sites in Woodstock and Chipping Norton, Oxfordshire. Owen Mumford strives continually to bring innovative products to market in shorter timescales and fulfil the quality standards demanded by ISO 13485 and the FDA.

The company became aware that their existing paper and electronic systems were starting to constrain their improvement initiatives and engaged with In2grate Business Solutions to explore how PLM (Product Lifecycle Management) could improve their business processes.

In2grate Business Solutions performed a PLM Audit to identify the process issues and value of PLM in the context of the company’s business objectives. “ We were very impressed with the PLM Audit performed by In2grate Business Solutions. It identified 95% of our main issues and gave us confidence that PLM was the right approach for our business” says Adam Mumford, Managing Director. “The resulting report was then used as a discussion document to agree a joint venture and implementation plan for the PLM solution.”

The PLM system electronically manages product-related documents and data such as Specifications, Change Notes, SOP’s, 2D/3D CAD files etc. It provides revision and version control of these documents together with automated numbering and automatic data population of the documents where appropriate. Visibility of this information is made available over two sites, providing access to the latest and historical information together with visibility of any documents that are about to change. A solution was provided to streamline the creation of BOMs and Packing Specifications which had become complex and difficult to manage.

SmarTeam Workflow routes documents electronically around the company for approval and for information, and will be used to process map the business. The Workflow module will enable core processes to be controlled, enforced and monitored electronically. The solution included the functionality required by FDA regulations 21CFR part 11. The system also allowed several databases to be consolidated to remove duplication of data entry.

SmarTeam’s ability to link related information assists with ascertaining change impact, updating affected documents, and collating information into record files. Phase 2 will update their manufacturing system with data directly from SmarTeam (manufacturing BOM). Owen Mumford has decided to become early adopters of PLM in order to reap immediate benefits and ease the transition to the electronic centric environment needed to ensure the long term success of the business.