It takes a village to develop a new product:
Medical Device and Pharmaceutical/Biotech companies invest large portions of their total budget on discovery, being the first (most important) step in product development. While the R&D/Development team is charged with product development, the transition from R&D into the marketplace is the challenge many companies face.
Perfecting this transition is critical for your patients and business. Some companies use regulations to guide their process, whether following the FDA QSR/ISO standards or ICH Q8, Q9, and Q10 or a combination of the two. Other choose to use processes that were successful in the past. Real success comes by taking a cross-functional approach, involving the entire organization into Total Product Life-Cycle (TPLC) Management. Realizing that the product developed today needs full support once placed into the market.
At the start of the process, the team forms a charter with clear and defined deliverables providing goals as the product goes from Big R into Big D; allowing for Team and Management Reviews to access progress and provide decision making tools to continue funding for at risk projects.
Development projects, like snowflakes, vary from company to company and product to product. The diagram below provides a highly generic overview of a potential TPLC process, providing the integration of the organization leading to successful new products launches:
Example of Team Deliverables during the TPLC process
Having a defined process enhancing product development cycle-time, and more importantly provides a framework work to exceeding global regulatory requirements. We have over 35 years of experience in providing oversight for product development in the Pharma, Medical Device and Combination Product industries. Whether you need help defining your TPLC process or to enhance your current practice, Consult Wing can provide the services to help your organizational needs. Give us a call (760-690-3952) or email Info@consultwing.com: we are ready to help align, achieve and sustain your TPLC process.
