Steve Donnigan

About Steve Donnigan

The path to medical device innovation is filled with obstacles - Technical Challenges Focused Resources The Relentless Pressure To Get To Market QuicklyThese obstacles can easily overshadow promising ideas, turning potential innovations into unrealized or delayed dreams. It\'s crucial to find the right expertise to bring your visionary ideas to fruition. But that can introduce even more uncertainty to an already challenging process.The solution? A skilled partner who can navigate this complex terrain. A65 Consulting offers that expertise, bridging the gap between your innovative concept and a market-ready medical device. We transform complex challenges into successful, cutting-edge solutions, ensuring your innovative idea transcends from concept to a viable product, while effectively navigating the industry\'s hurdles. You can rest assured that no matter how big or small your challenges are, A65 is more than equipped to handle them.Our services include: Mechanical Engineering System Engineering Manufacturing Engineering Project Management Interim Engineering Management Intellectual Property Review

Experience

1. Founder and Chief Engineer

   A65 Consulting, Llc

   Mar 2018 — Present · Denver, CO, US

   Founder of small boutique medical device consulting firm specializing in providing full-service engineering on unique, innovative, and challenging products. Engineering leadership and services provided to clients contributed to over $200M of projected new product revenue, multiple FDA 510k submissions, numerous new patent applications, reduced complaint rates, and on-time completion of mission critical projects.Areas of design include- Precision mechanisms - High volume disposables- Electromechanical systems- Complex robotic/automated systems Services include- Mechanical engineering o Concept brainstorming through detailed engineering and product launch o FEA and classical engineering analysis o Tolerance analysis o SolidWorks CAD modeling and drawing creation- Systems engineering o Requirements definition o Risk management o Voice of customer (VOC) surveys/interviews o Human factors engineering- Project/program management o Schedule development and tracking o Expense and resource estimation and tracking o Cross functional leadership and management- Manufacturing engineering o Design for Manufacturing/Assembly (DFM/DFA) o Supplier selection/management and COGS estimation o Fixture and tooling development (manual and automated) o Root cause analysis and investigation of production problems- Intellectual property review o Patent reviews o Patent disclosures o Infringement reviews

Education

• Colorado State University

  BSME, Mechanical Engineering

• Colorado State University

  MSME, Mechanical / Biomedical Engineering

Skills

• Product Development
• Solid Modeling
• Plastics
• Validation
• Biomedical Engineering
• Design of Experiments
• Manufacturing
• Pro Engineer
• R&D
• Gmp
• Injection Molding
• Medical Device Product Development
• Electro-Mechanical
• Root Cause Analysis
• Rapid Prototyping
• Mechanical Engineering
• Research and Development (R&D)
• Design Control
• Surgical Instruments
• Cross-Functional Team Leadership
• Minitab
• Product Launch
• Testing
• Engineering
• Finite Element Analysis
• Tolerance Analysis
• Design Engineering
• Solidworks
• Gd&T
• Medical Devices
• Product Design
• Design for Manufacturing
• Medical Imaging