Concept Ideation
•Develop design requirements based on key user, marketing, operation & business inputs
•Identify and assess existing technologies
•Ideation – brainstorm new concepts and/or improvements to an existing concept/product
•Assess and rank the merits of each concept; select concept(s) for further development
•Prototype leading concept(s)
•Select preferred concept (aided by key criteria matrix) & complete concept refinement
Product Development
•Detailed design (computer 3D solid models & detailed 2D engineering drawings)
•Engineering analysis, including Finite Element Analysis (FEA), injection mold flow & dimensional tolerance analysis
•Material selection recommendations for ISO-10993
•Production-equivalent product samples for evaluation (e.g. bench testing, validation, clinical studies), including equipment sourcing (e.g. molds and automation) from our preferred supplier network
•Product qualification – methodology development, including custom test fixture design/fabrication & MSA’s, testing, summary reports
•User/Human Factor studies to assess design merits (formative and summative)
Device Design Control Compliance
Prepare Design Control documentation throughout the product development process (Quality System Regulations, 21 CFR Part 820):
•DDP & Design Input documentation
•Design Verification & Validation plans, protocols & reports
•Design Outputs including detailed product drawings & Product Specification(s)
•Risk Assessment documents, e.g. FMEAs, ISO 14971
•Design Reviews & Design History File (DHF)
Clinical & Human Factors Evaluation
•Human Factors & usability evaluation (formative & summative validation)
Manufacturing / Commercialization
•Strategy, Approach, Implementation – pilot production through full-scale automated line, including design, build & cost analysis
•DFM – Design for Manufacturing
•Manufacturing equipment FAT, SAT, IQ/OQ/PQ validations and 1st Article Inspections (FAI)
•Unique Device Identifier (UDI) preparation and compliance
Marketing, Regulatory & IP Support
•Technical support for regulatory submission
•IP preparation assistance
•Sales & Marketing Support
•Preparation when seeking to license your technology to another company
•Quality System customized to your company and training needs
Conduct interactive client training for topics such as
•Medical product development overview, requirements & best practices
•Design controls & proper implementation
•Developing combination products & integrating cGMP and QSR requirements
Technical Advisor
•Provide technical experts in an advisory role
•Review product development programs, develop internal SOP’s
•Participate as independent auditors and advisors (e.g. product development process, Design Control, internal technical reviews)
Machine Shop & Prototyping Services
•Machine-shop services including 3D printing, model making, prototyping, test and/or assembly fixture/equipment fabrication, proof-of-design and/or manufacturing processes
Product Testing & Inspection
Product testing, product assembly for evaluation and qualification studies, as well as incoming inspection & QC