Product Development Process (PDP)

Any company's success depends on getting the right products to the market at the right time. It is a challenge to launch the right medical device in a timely manner when a big part of the process is consumed by FDA regulations which can induce unplanned changes in the development timeline. To overcome these inconsistencies, it is necessary to follow a structured process that instills a regulatory discipline into the process without sacrificing creativity. Such a structured process that contains all the actions necessary to take a process from conception to commercialization is called the Product Development Process (PDP).

A PDP consists of many phases, each of which indicates specific tasks or activities to be completed in that particular time. Early phases emphasize concept formation, product definition and project planning, while later phases focus on development, verification, rollout and maintenance of the defined product. A medical device PDP can consist of the following phases:

Phase 0 - Concept Development
Research and identify market needs, opportunities; evaluate and prioritize; identify a strategic fit; obtain management approval.

Phase 1 - Definition and Planning (21 CFR 820)
Involves design control activities (Refer to Design Contols post); define product and project plan; convert consumer needs to product requirement specifications; maintain a Device History File.

Phase 2 - Design and Development
Complete design process and develop a prototype for testing. Regulatory submissions - 510k. Plan verification, validation and manufacturing phases.

Phase 3 - Verification and Validation (21 CFR 820)
Verify and validate the product for compliance with design requirements, customer needs and regulatory requirements. Regulatory submissions - IDE, PMA. All regulatory approvals must be obtained by the end of this phase.

Phase 4 - Commercialization
Market launch; post-launch evaluation and comparison with competition.

A more detailed interaction of the development and business activities involved in the phases of the PDP can be seen in the figure below. The activities in purple represent design control-related activities and the activities in green are non-design control activities.
(Source: www.qualityprogress.com)