Biomedical Engineering Design and the Promotion of High Value Relationships with Clinical Medicine Robert Hitchcock

Background A highly regulated industry Collaborative development environment University resources and vision Utah BioDesign

Course Highlights Projects are initiated by clinicians Projects are initiated by clinicians Students interact with clinicians Students interact with clinicians Focus on FDA Quality System Regulation – Design Controls Focus on FDA Quality System Regulation – Design Controls Projects required to follow Standard Operating Procedures Projects required to follow Standard Operating Procedures

Regulatory Environment CSA EC IEC JCAHO ISO FDAUSPTO ISTA ASTM GHTF

Systematic Systematic Allows organizations to develop design processes that meet their needs.Allows organizations to develop design processes that meet their needs. Team based Team based Multidisciplinary teams are empowered to make decisions.Multidisciplinary teams are empowered to make decisions. Customer focused Customer focused Requirements play a key role in driving specifications and validation.Requirements play a key role in driving specifications and validation. Robust Robust Verification and validation ensure a higher quality design.Verification and validation ensure a higher quality design. Required by law Required by law Why Design Control?

Design Control SOPs Approach used by all medical device and pharmaceutical companies Approach used by all medical device and pharmaceutical companies Interprets FDA QSR for design course Interprets FDA QSR for design course Creates common ground for students Creates common ground for students Provides consistent guidelines for assessment Provides consistent guidelines for assessment “Audit" students as part of their assessment “Audit" students as part of their assessment

Design Control SOPs Document NameDoc. #DescriptionRegulatory Fulfillment Design Control PolicyDC 04 01Outline the procedures to follow to develop new, or modify existing products. 21 CFR (a) Design Input – Marketing Brief, Product Specification Considerations DC 04 04Provides a procedure to develop the items that must be considered and documented in the design input phase of device development. 21 CFR (c) Design and Development PlanningDC 04 12To indicate the factors that may be considered in the generation of a design and development plan (the Plan) for a new product, product improvement, or product modification, or components of products 21 CFR (b) Design ChangesDC 04 20To indicate the process to be followed when changing, or making additions to, approved documents that are included as part of Design History Files. 21 CFR (i) Design ReviewDC 04 16to indicate the process to be followed to conduct Design Reviews. 21 CFR (i) Design ValidationDC 04 28To indicate the general process to follow and the documentation required to establish a Design Validation Plan and perform Design Validations of new and revised designs (products). 21 CFR (g) Design VerificationDC 04 24To indicate the general process to follow and the documentation required to establish a Design Verification Plan and perform Design Verifications of new and revised designs (products). 21 CFR (f) Device Master RecordDC 04 16to indicate the contents of a Device Master Record (DMR). 21 CFR

Course Timeline – Spring / Fall

Projects Bone marrow aspiration device Bone marrow aspiration device Heart patch for stem cell delivery Heart patch for stem cell delivery Third heart sound monitor Third heart sound monitor Optically guided feeding tube Optically guided feeding tube Fiber optic respirometer Fiber optic respirometer