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Development Process Consulting


A clear and concise Product Development Process (PDP) is the foundation of successful product development. By incorporating industry and regulatory standards with your own best practices, the PDP becomes your foundation for effective product development with good outcomes.

Using a systems-engineering based development process as the starting point, S2insight will collaborate with your team to define a customized PDP for your business. Deliverables include a high-level Swim Lane diagram of the process , a phase-based Deliverable Dictionary, a concise Process Guide, and critical templates. The entire process is based on best-practices proven to work in the medical device space. In addition, we offer best practice-based templates for the major deliverables, and also develop custom templates, that offer teams the tools they need to document the design. Not only do these templates greatly accelerate process adoption, but they also help standardize high-quality work products. Finally, S2insight will help you plan and execute the deployment and training activities essential to putting the PDP into practice.

S2insight’s PDP services are a systematic and proven way to improve your product development capability.

Typical Engagement for the PDP Process:

  • Creating a PDP Process Guide that defines objectives, activities, deliverables, and reviews.

  • Clarifying cross-functional roles, responsibilities, and deliverables throughout the process.

  • Integrating regulatory requirements, industry standards, and current best practices.

  • Mapping current processes via a PDP Mapping Intensive session.

  • Creating professionally written and easy-to-read documentation.

  • Developing deployment plans and customized training.

Typical Engagement for the PDP Templates:

  • Defining template priorities, requirements, and content.

  • Utilizing web-sessions to minimize travel costs.

  • Creating draft versions in Microsoft Office® and reviewing with the team.

  • Following documentation standards that assure the template is easy to understand and utilize.

Duration: Varies

Delivery Format: On-site assessment and distributed

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