Medical Device Product Development: Design Control Simplification
by Nate Palmer
The FDA requires that Medical Device companies use a formal design control process to develop and update medical devices. But not all product development projects are the same, and using a universal approach geared for complex developments can be burdensome, especially for smaller development efforts. Projects requiring some form of design control include full development of new products, software changes, component changes or obsolescence, process changes, facility changes, and documentation updates. Requiring that all project types pass through a common design control process, however, can be inefficient for an organization, leading to organizational debate about appropriate requirements, excess documentation, and slow execution of changes.
To ensure an appropriate balance of design control rigor and speed to market, Accel Management Group recommends the use of Design Control Pathways, specifically suited to various types of design, process, facility, or documentation changes. In each case, the requirements for risk assessment, V&V, phase gate reviews, and other aspects of the design control process are scaled appropriately to provide guidance to staff who are responsible for carrying out these projects.
For companies that traditionally send all projects through a singular design control process, typically developed to support full product development efforts, the savings in time and effort can be substantial. Estimates for time savings range from 10% – 60% with projects such as process changes, component obsolescence, and documentation changes seeing the greatest benefit through the implementation of more streamlined pathways.
In summary, while a design control process and documentation of that process are needed, providing staff with appropriate design control pathways to meet the scope and risk of the project is critical to ensuring compliance while also maximizing efficiency and speed to market.
About the Author
L. Nate Palmer has 25 years of consulting and business leadership experience within life sciences and high-technology companies. His focus includes process design and project team leadership for product development, operations, customer service and support, and information systems programs. Before joining Accel Management Group, Nate held positions as Vice President of Professional Services at RiverOne, Principal at PRTM, and Manufacturing Engineer at Raytheon. Mr. Palmer earned his BSME from the University of Massachusetts, Amherst, and MBA from the Anderson School at UCLA. He is CPIM certified.
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