Consulting Services for Medical Device, Diagnostic & Pharmaceutical Companies

Lead Cross-Functional project teams to develop, commercialize, and support new product development programs

• Provide expertise and best practices in these product areas:
  • Medical Devices
  • Diagnostic Reagents & Test Systems
  • Pharmaceutical compounds
  • Pharmaceutical / Medical Device Combination Products
  • Companion Diagnostic Tests
• Provide project management and project coordination support to team leaders
• Develop organized, detailed project timelines with clear interdependencies
• Identify program risks and plan appropriate mitigations
• Determine resource needs and facilitate acquisition of key individuals
• Prepare project status updates and dashboards for leadership presentation and review
• Lead project sub-teams to accomplish deliverables

Provide interim Program Management Office leadership

• Provide mentoring and advice to program managers and team leaders
• Design custom phase-based product development and project management processes
• Prepare portfolio & product pipeline planning & summary charts
• Create project planning and development document templates

• Create product definition documents
• Create product requirement specifications
• Write Design & Development Plans
• Lead product risk analysis activities & document results in tracking charts
• Write Verification and Validation protocols and reports
• Create and maintain Trace Matrices to track Design Inputs, Design Outputs, and Risk Resolution
• Work with Software Engineers to develop User Interface and lead teams to test product software
• Establish and maintain Design History File

• Plan commercialization and marketing activities
• Lead teams to execute launch plans
• Manage external vendors to produce collateral and sales tools
• Manage development and implementation of Packaging & Labeling content & artwork
• Conduct customer service and product support staff training sessions
• Lead Sales Training and Product launch activities
• Provide project management leadership and coordination for re-branding efforts
• Lead development of iPad applications to provide marketing tools to sales force
• Lead digital marketing efforts & web-site content development
• Develop analytical tools for post-market research

• Develop content for product labeling, including IFUs, and PIs
• Conduct research to ensure comprehension of labeling for consumer use
• Coordinate work with vendors to translate content & produce artwork
• Organize components for multi-national launches
• Manage routing & approval of content through electronic document approval systems

• Help teams identify, plan, & implement Regulatory requirements
• Clarify requirements to comply with US & International regulations
• Plan and implement Design Control requirements
• Create and support FDA submission packets
• Lead teams to bring legacy products in line with current standards
• Assess Design History Files, identify gaps, and lead teams to update files
• Provide regulatory review for marketing, packaging, and labeling pieces

• Lead and manage Clinical Research Programs
• Create Clinical Study Documentation Forms
• Conduct Site visits and set up new study sites
• Follow up with study coordinators to conduct studies
• Ensure appropriate data management and data entry

• Lead and manage Contract Manufacturing Operation teams
• Assist in Manufacturing Site Selection
• Manage transfer of Operations to new manufacturing sites
• Develop tracking tools to analyze & report manufacturing yield rates & metrics
• Lead teams to assess and implement improved business processes