MDDG has identified eight critical elements that are required to achieve commercialization success. The elements are incorporated into the company’s proprietary project management framework called Strategic Parallel Implementation™ (SPI™). They include:
1. Business – startup business planning, project management, product economics, efficiency improvements, turnarounds, fractional executives, collaboration
2. Marketing – market intelligence and analysis, marketing plans, product introduction, marketing materials, website development
3. Compliance – establish Quality Compliance Systems, regulatory affairs and post-market compliance for global markets, including US, EU, Asia, SA, CAN, etc; establish and improve WMS
4. Human Factors – determine "Ideal Final Results," user studies, industrial engineering, human factors compliance, design optimization, high impact design features
5. Supply Chain – supplier selection, logistics planning, operations management, rationalization, global sourcing
6. Technology – DFMAT, product development, visualization and simulation, rapid prototyping: implants, mechanicals, electronics, software, robotics, drug delivery, nanotechology
7. Risk Management – hazard analysis, risk mitigation, project and regulatory risk management, FMEA, ISO 14971
8. Legal – Involvement of a strong legal team is essential for providing IP review and opinions, IP and liability strategy, portfolio execution and IP protection; MDDG works with our third-party resources or yours; we are not attorneys
Commercialization