Importance of Design Controls in Medical Device Product Development Lifecycle and Beyond
Blog | November 24th, 2022

Importance of Design Controls in Medical Device Product Development Lifecycle and Beyond

Recently, ComplianceQuest published a nuanced whitepaper on “Integrating Quality Compliance into the Product Design and Development Process using CQ’s Design Control Solution”. The paper focuses on –

  • The challenges faced by engineering and quality leaders when it comes to compliant design controls
  • How using a cloud-based, next-generation platform to automate design controls can improve efficiency and productivity

In this blog, we focus on the growing importance of design controls in the medical device industry and the role it plays in the product development lifecycle. We also discuss if automation will help resolve some of the key challenges businesses face while developing a product.

Product Development Lifecycle Without Automated Design Controls

Design and development of medical devices or MedTech products is a complex process. It requires deep collaboration between three critical teams:

  • The R&D team that figures out the underlying engineering behind the product
  • The product team that brings in a clear understanding of what the customer/user needs are
  • The business team that brings in competitor analysis, pricing strategies, budget allocation, etc.

The product development lifecycle is a multi-step process including brainstorming product requirements, developing the product prototype, collecting design feedback, product testing, and successfully transferring the product to production.

Given the sensitive nature of its use, medical devices also come with their own set of risks that need careful monitoring. A medical device manufacturer must ensure the product is effective and safe to use.

This is where design controls come into play. Except lowest-risk medical devices, the Food and Drug Administration (FDA) mandates manufacturers to develop their medical device under design controls.

Without an automated solution to manage design controls, the whole process becomes very challenging and difficult to track.

A product without design controls will be susceptible to

  • Undefined design elements
  • Product value gap
  • Regulatory nonconformance
  • Improper documentation of the design process

6 Key Benefits of Design Controls

The Food and Drug Administration1 (21CFR 820.30) defines design controls as:

“a set/framework of quality practices and procedures incorporated into the design and development process of a medical device product to assure that device specifications meet user needs and intended use(s)”.

Design controls enable integrating a systemic approach to design during the product development lifecycle to:

  • Proactively identify gaps in design input requirements (as early in the lifecycle as possible)
  • Recognize discrepancies between the proposed designs and requirements

Broadly, using design controls during the product development lifecycle offers the following six benefits —

  • Improve risk management by implementing appropriate controls to make the product more robust and improve its quality and safety
  • In an agile or concurrent development model, design control becomes crucial as the design enters the development stage before being completed
  • Design controls are a part of the quality system and come into play from the time of developing and approving design inputs to the design of the device and its production
  • Increase design conformance to user needs while improving collaboration and coordination between the different stakeholders
  • Meet all performance, quality, and regulatory requirements of the product
  • With early correction of designs, product rework can be minimized, and costs are kept under control while improving resource allocation.

Automation of Design Controls – Saves Time & Improves Quality

Today’s medical device industry is continuously growing. As businesses scale, it becomes difficult to rely on paper-based systems to document the design process or a digital file to track design changes. Similarly, the Safe Medical Device Act introduced Design Controls to regulate the design process for certain classes of medical devices in a better way. Compliance with regulatory standards and the complexity of the design process need robust software.

The design and development of medical devices is a complex process, with the chances of incurring high costs and wastage of resources being high. This has made digitizing and automating essential to improve efficiency, lower costs, and optimize resources.

ComplianceQuest’s Design Controls Solution gives you complete visibility over your product design process, making it easy for your teams to collaborate and design high quality products, while guaranteeing compliant and comprehensive documentation.

The solution ensures that the medical device developed is compliant with user needs, its intended use, and other specific requirements and prevents unexpected problems. Designed to align with regulatory requirements, the ComplianceQuest’s Product Design Management Solution helps businesses improve product quality, lower the cost of quality (CoQ), and maintain regulatory compliance – across the design lifecycle of medical devices.

Built on the Salesforce platform, the solution is integrated with the ComplianceQuest EQMS, thus offering instant access to risk management and documentation solutions, among others.

The key features of the CQ Design Controls Software include:

  • Project Management
  • Design History File
  • Design Review Meeting Management
  • Complete Product Design Files
  • Deliverables Tracking
  • Collaboration

Our Design Controls Solution along with our Requirements Traceability and Product Risk Management Solution can be true game changer for engineering, product, quality and business teams in the MedTech sector.

To see our product in action, request a demo here:

Watch a 6-min demo video here:

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