Integrating Design Controls and the Product Development Process for Effective and Compliant Medical Device Development

Most medical devices are subject to design controls requirements defined by a global set of regulations, standards, and guidance to ensure the safety and effectiveness of these products. Design controls alone, however, are not sufficient to address all of the needs of a medical device development program. To address this gap, organizations employ some variation on a product development process to integrate design controls requirements with more general program management needs.

This seminar provides an overview of design controls requirements and proposes two models for incorporating these requirements into a more comprehensive product development process. The first proposal assumes a serialized “V-model” approach to product development and steps the attendee through the combination of design controls and other program activities in a stage gate process. The second proposal assumes an iterative model (e.g. Agile Scrum, SAFe) and applies variations of stage gate processes depending on the degree of iteration required and the complexity of the program.

The seminar will recommend both compliance and program management tools to move organizations through each stage gate. There will also be a discussion of the Quality Management System, as a subset of a Business Management System, which will provide clarity regarding those activities crucial to safety, efficacy, and compliance, as contrasted with important program activities that go beyond the scope of quality and regulatory compliance.

The primary goal of the seminar is to propose a model that integrates safety and efficacy with compliance and more general program management needs. A secondary goal is to ensure elements of the product development process that are normally within the scope of a regulatory audit or inspection are distinct from elements that might not be of primary interest to regulators and notified bodies.

Learning Objectives:

• Be aware of existing regulatory literature as applied to design controls globally
• Understand design controls activities required by existing regulations, standards, and guidance
• Understand the elements of a Quality Management System as distinct from a Business Management System
• Understand the key elements of a product development process and how it goes beyond design controls
• Apply product development process stage gates to both serialized and iterative development models
• Effectively defend design controls in an audit or inspection without pulling out-of-scope product development activities into the discussion

Areas Covered :

• An overview of existing regulatory literature as applied to design controls
• A detailed walkthrough of design controls activities and deliverables required by existing regulations, standards, and guidance
• The components of a Quality Management System and a Business Management System
• The structure of a stage gate product development process
• Mechanisms to advancing through stage gates
• Application of a product development process to a serialized or v-model development approach
• Application of a product development process to an iterative (e.g. Agile scrum, SAFe) development approach
• Adapting the product development process to change management and post-production maintenance
• Defending design controls when embedded in a product development process