Services

Engineering / Product Development – Work as liaison between the management team and a contracted engineering partner through the development process of the medical device. Critical elements of this function include:

• Develop and maintain Critical Success Factors definition by entire management team
• Depending on the company’s exit strategy, select manufacturing partner and engage them throughout the product development process
• Develop and maintain Product Requirement in conjunction with the contracted engineering partner
• Work through prototype phase and proof of concept
• Develop and maintain Design Input/Output Matrix (DIOM)
• Develop risk management plan with contracted engineering partner
• Complete FMEA (Design and Process) with inputs from the management team and the contracted engineering partner
• Develop final product
• Complete biocompatibility studies
• Complete package design and testing
• Complete product validation activities
• Select sterilization method (if required) and conduct sterilization validation
• Complete shelf life studies, if needed, both in accelerated mode and real-time
• Manage and/or maintain the Design History File and Device Master Record

Project Management Support – Develop and maintain detailed Gantt charts to track and control schedule and budget for the entire management team. The project plan will include not only the engineering / product development activities, but also those for marketing, regulatory, clinical (if required), and fund raising (planned tranches and tranche milestones). Contingency plans will be developed as needed, proactively.

Marketing Support

• Prototype development
• Support initial focus group studies to define final product requirements
• Clinical builds and support for clinical studies, if required
• Support final focus group studies to validate final design of product

Regulatory Support

• Prepare significant portions of 510(k) applications as well as Tech Files
• Prepare for and guide management team through internal, third party, and notified body audits for approval of the Tech File and CE mark

Quality Management System

• Prepare QMS procedures and forms
• Implement QMS within the management team, guide training and provide documentation support as needed

Production Start-Up

• Coordinate technology transfer from engineering partner to final manufacturer (if this is required as part of the exit strategy)
• Manage raw materials and finished goods inventories
• Manage the entire supply chain to meet the strategic goals of the management team

Intellectual Property

• Guide product design to incorporate IP claims
• Work within a Freedom to Operate, if available
• Evaluate competitor IP for infringement, or work around in product development
• Work with IP attorneys to develop additional claims for utility or design patents

phone: (616) 990-0060          email: dirk.schipper@glexel.com