Harland Medical Systems and Tapemark (West St. Paul, MN) have joined forces to commercialize new innovations in medical coatings. The collaboration partnership will focus on applying medical coatings to high-volume medical devices such as glucose test strips, microfluidic diagnostic strips, introducer patches, wound management dressings, and other coated medical devices or components.
Combining capabilities from both companies provides the customer with a totally integrated solution from early R&D to high volume production. The collaboration provides support and direction in the early stages of product design and coating development through optimization of the coated materials into the final production and packaging of the medical device. As contract manufacturers, products produced for Harland/Tapemark customers may include finished medical devices, device components, and drug/device combination products.
Harland Medical Systems’ expertise is in evaluating and commercializing coating materials, in developing coating application processes, and in designing and building coating equipment. Tapemark brings 50+ years of expertise in medical and pharmaceutical contract manufacturing including substrates and in-line manufacturability, coating and dispensing, die-cutting, laminating, and packaging.
The companies will collaborate to take projects from feasibility through commercialization including development, DOE, OQ and PQ, and validated full-scale production. Products will be converted and packaged in Tapemark’s multiple clean room suites, which are cGMP-compliant, ISO 9001 and 13485 certified, and FDA-audited for both Drug and Device.
Andy Rensink, president and COO of Tapemark, notes, “With Harland’s strong foundation in the formulation and application of coatings to dimensional medical devices, combined with Tapemark’s background in coating and converting roll goods, we marry our expertise to bring the best of both worlds to our pharmaceutical and medical device customers.”
Jon Anderson, CEO of Harland, adds "Tapemark is recognized as best-in-class meeting the manufacturing needs of leading pharmaceutical and medical companies. This position makes them the ideal complement to Harland's proven capabilities in coating materials, coating process development and coating equipment design. The comprehensive integrated solution provided through this partnership allows our customers to quickly capitalize on exciting new innovations utilizing surface enhancement technologies.”
Both companies will be exhibiting at the upcoming MD&M East tradeshow in New York City, June 8-10, 2010. Harland Medical Systems will be in booth 1143 and Tapemark will be nearby in booth 1546.