Design Controls Defined

Design Controls Defined 

by Charles Ventura, President 

Design Controls, do we really have to follow them? 

Design Control is a topic that medical device professionals seem to either love or hate. Many Engineers call Design Controls, “the paperwork” or “just the documentation”, and rarely seem to value them.  The thought of having to create the Design Control documentation can be daunting or unnecessarily tedious.  Often, these documents are not fully completed until products are about to be launched; this is dangerous and not the way Design Controls should be utilized! At Ventura Solutions, we believe the amount of rigor, analysis, and engineering expertise involved with creating the Design Control documentation is where the real engineering starts. Followed correctly, Design Controls can help you make world-class products that are also safe and effective! 

Why do we have to follow Design Controls? 

Design Controls are a quality system requirement mandated by the FDA, under the Code of Federal Regulation (CFR) Title 21 Part 820, subpart C. The FDA has put Design Controls in place to help manufactures design safe and effective products that meet their intended use.  In short, Design Control is a process that helps teams integrate all the various product requirements and risks mitigations into developing a safe and effective product!  At Ventura Solutions, when faced with developing a new product, we love and live the Design Control process method; we would even recommend following the process if it was not a regulatory requirement! So, embrace Design Controls, do it right, and at least try to have fun!   

Applicability

Design Controls are applicable to class II devices, class III devices and some class I devices. An excerpt from the Code of Federal Regulations can be seen below listing the applicability.  

Part 820 — Quality System Regulation  

When do we have to start following Design Controls? 

When manufacturers start a new project, they can be in the research phase for some time. During the research phase, manufacturers may analyze high-level marketing needs and go through many design iterations as they test the feasibility of various concepts. Early in this research part of the design phase, Design Controls are not required. However, when the manufacturer decides to move forward with a certain design, Design Controls should begin. The process usually begins with the initiation of a Design and Development Plan (DDP) and the Design History File (DHF). The Design and Development Plan amongst other sections will outline the project scope, resources, department interdependencies, project timelines, and project constraints. This plan signifies the intention to take a product from feasibility to development, formally.  

What are some of the details associated with Design Controls?  

The Design Control process is a sophisticated way to translate high-level user needs, marketing needs, manufacturing needs, and regulatory needs, along with other quality system needs, into safe and effective products that meet the customer’s intended use.  Manufacturers are encouraged to embrace this process as a way to keep track of all the various requirements and identified risks when developing a complex or simple medical device, yes even simple medical devices can benefit a lot from this process!  The figure below illustrates the traditional Design Control process waterfall diagram from the following highly recommended resource: FDA Design Control Guidance for Medical Manufacturers 

The Design Control process can be broken up into different phases, one such way is illustrated in the figure below. On Risk Management 

Although, risk is only mentioned once in CFR 820 Subpart C (Design Controls), specifically section 820.30 (g) for design validation, it is tightly integrated into the Design Control process. Companies are encouraged to start the risk management process as early in the design process as possible and follow ISO 14971. Often, it is common to start the risk management process concurrently with the creation of the design inputs. Similar to Design Control, the first step in risk management is the creation of a Risk Management Plan 

How to implement and where do I start 

The table below illustrates the typical phases of a Design Control process and the associated Design Control, Risk Management, and Regulatory deliverables, by phase. 

Phase  Phase Title  Phase Deliverables 
I  Concept 

  

  • Project Leader and Project Team Identified 
  • To establish defined User Needs Document (UND) 
  • Create a Design and Development Plan (DDP) 
  • Develop a Risk Management Plan (RMP) 
  • Initiate the Design History File (DHF)  
  • Create a Design History File Index 
  • Identify regulatory requirements and strategy for clearance/ approval, (i.e. Regulatory Strategy) 
  • Concept Selection  
  • Concept Phase Design Review 
II  Definition  
  • Translate the defined User Needs into Design Inputs 
  • To establish defined Design Inputs Document (DID) 
  • Creation of the Hazards Analysis (HA) 
  • Creation of Use FMEA, 
  • Definition Phase Design Review 

  

III  Development 
  • Translate the Design Inputs into detailed Design Output specifications. 
  • Creation of DFMEA and PFMEA  
  • Development Phase Design Review 

  

IV  Verification & Validation 
  • Complete Design Verification to verify that Design Outputs meet Design Inputs. 
  • Complete Verification of Risk Management activities, Risk Management Report (RMR). 
  • Ensure all training materials and labeling are released and ready for market release. 
  • Complete Design Validation to confirm that device specifications conform with User Needs and Intended Uses. 
  • Verification and Validation Phase Design Review 
V  Design Transfer  

  

  • Complete Design Transfer 
  • Design Transfer Design Review 

 

To fully implement a Design Control process for a medical device requires much more than detailed here; however, this article gives you an overview and broad framework of the Design Control process.  

Remember, Design Controls are an FDA requirement, so make the most of the process, use them to your competitive advantage, have fun, and develop safe and effective products! 

There is a lot more to know about the Design Control process and the various ways they can be implemented. Future posts will detail nuances from our experience and overviews of the various Design Control elements. We will also be discussing exciting tips and recommended industry practices. Stay tuned and join our newsletter to get the latest updates! 

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