The Phases of Product Development – The SPI Methodology

Phase 1: Concept Confirmation
The project management flow begins with this vital step, which includes creation of a business case, market assessment, risk benefit analysis and development and review of the prototype. At the completion of this stage, the developer and team have the information needed to confirm project viability.

Design Input
The next stage is targeted to obtaining design approval. Technology feasibility is determined, along with strategies for risk management, intellectual property, supply chain, reimbursement and regulatory.

Design Lock
As the project moves closer to realization, the third stage focuses on finalizing plans and strategies. In addition to steps involved with business planning, marketing and legal, the project moves closer to clinical trial. Important feedback from users is processed and used to fine-tune the product design.

Clinical Approval
While clinical trials are a critical element in obtaining regulatory approval, the pre-clinical stage offers an important time for finalizing manufacturing, marketing, regulatory and risk management plans. Each element of the SPI is reviewed and moved forward.

Launch Approval
With the conclusion of clinical trials comes final approval for launch. At this stage all elements have been fine-tuned and are in place, materials are in stock and ready to ship, prepared for a successful product rollout.

Post-Launch
The SPI methodology does not end with the launch. In order to ensure long-term success and broad adoption, marketing, training, service, manufacturing and IP support must all be in order.