Meeting Product Design Challenges in MedTech Sector with Design Controls, Requirements Traceability, and Product Risk Management
Blog | February 15th, 2023

Meeting Product Design Challenges in MedTech Sector with Design Controls, Requirements Traceability, and Product Risk Management

Technological development and breakthroughs in medical research have enabled medical technology companies to develop pioneering therapies and treatments for several diseases. The blurring of lines between hardware and software also makes many of these solutions compact and portable, increasing the ease of use for patients and caregivers.

But, these developments have also given rise to other, newer challenges. On the one hand, regulations have become more stringent to protect patients and their privacy. On the other hand, MedTech companies are also grappling with issues such as rising costs, time to market, increasing competition, and quality control.

Design Controls and Traceability for Improved Product Quality

Regulatory requirements make design controls, requirements traceability, and product risk management mandatory. This is to ensure that the product meets the specifications and fulfills its purpose while ensuring patient safety. Businesses minimize the chances of receiving warning letters or product recalls by complying with Food and Drug Administration’s Sec. 820.30 regulations and other similar standards and regulations. These regulations cover the entire aspect of design and development from planning up to the point of transferring the design to manufacturing.

The regulations require the design to be reviewed at every stage from the time of planning the design of the device to input gathering and to the final output. This ensures that the design still conforms to the initial plan and purpose even after the changes it undergoes at different stages of the design lifecycle. The changes must be documented and approved and all references stored in a design history file for easy traceability and to demonstrate conformance to requirements.

Sec. 820.65 Traceability of FDA specifies the need for manufacturers to establish and maintain procedures that enable the identification of implants and similar devices with a control number for each unit, lot, or batch of finished devices, and appropriate components where required. This is to enable corrective action and the identification should also be documented in the design history file.

While these improve patient safety and product quality, they also make the process more complex for manufacturers.

Common Product Design Challenges MedTech Companies Face

The MedTech companies have their plates full with a plethora of challenges including:

  • Global Supply Chains and Product Quality: In today’s world of global manufacturing, MedTech companies source design from one location, components from another, and outsource manufacturing to a third location. Managing these different suppliers and complying with regulatory requirements can be very difficult. Ultimately, the onus lies with them to ensure the design is as per the requirements and the final product conforms to the specifications.
  • Demonstrating Compliance: The medical devices must be certified before they are allowed to be released in the market. The MedTech company must demonstrate compliance as well as prove that the quality management system it uses meets the statutory requirements and that the product is safe and as per the design. Any deviation and non-conformance can lead to the product having to be reworked or scrapped.
  • Documentation: Documentation is a regulatory requirement as well as essential for traceability. It is also essential for taking corrective and preventive action, if required, quickly and effectively. Updates and enhancements can also be accelerated with proper documentation.
  • Risk Management: Risk management is a critical aspect of product development, mandated by regulations. It helps manufacturers be proactive in identifying, prioritizing, and mitigating risks, improving product quality, and ensuring patient safety. Based on the severity and frequency of risk, manufacturers can implement appropriate controls to minimize or eliminate the risk.
  • Continuous Improvement: Medtech manufacturers also need to constantly improve the design process to make it more efficient and effective. The feedback from the market must be sent to the design team so that the design can be improved to meet customer requirements and expectations.

In a manual design controls process, keeping track of the many aspects that go into the design and development of the product can be difficult. Documentation and tracking can be a drain on resources and the lack of visibility can lead to errors being introduced unwittingly. Gathering relevant information and leveraging it effectively for continuous improvement may also not be possible.

Automating Design Controls and Traceability with CQ

Using a quality management system such as ComplianceQuest can help manage the design controls workflow end-to-end, providing visibility and facilitating proper documentation. The Product solution from CQ enables the automatic creation and updation of DHF and DMR with the latest approved documents and design files.

It can help teams connect and collaborate in real-time, enabling better change management and document sharing to minimize deviations and errors. Reviews and revisions can also be speeded up and made more accurate, reducing non-conformance.

All stakeholders can access centralized data sources and a unified repository for all design documentation including requirements, deliverables, and changes. It can also be integrated with product data from other sources such as ERP and Jira, thereby providing a holistic view of all documents with appropriate access controls.

The CQ platform also improves project management, which allows tracking of actions, deliverables, and timelines for improved productivity and compliance.

CQ Product facilitates requirements traceability and product risk management by allowing the teams to track and manage the design lifecycle including design inputs, outputs, validations, and verifications along with integrated management of product risks. This can help improve product quality, and meet regulatory requirements while ensuring patient safety.

To know more about ComplianceQuests Product Solution, watch this demo video:

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