A successful Medical Device development approach for both adhesives and polymers includes a roadmap for product design. Although there are numerous ways to bond materials, often the designer is faced with bonding dissimilar materials and a difficult design where only an adhesive is the right bonding solution.  Without a proven methodology to follow, product teams find themselves in a failure loop, without a methodology to resolve bonding challenges and to prevent downstream problems.  With unsolved failures, often the product team, or company, faces a “shut down” situation.  The steps for adhesive/polymer bond success include design evaluation, an understanding of adhesive fundamentals, chemical compatibility, joint design principles, regulatory issues, testing, and processing.  A case study of a Medical Device moving from single-use to multi-use requirements will be provided.  This design approach includes key factors for success and a roadmap to aid in project management and risk mitigation.

JoAnne Moody, MS

President, Zeta Scientific LLC