Design Changes in MedTech: Adopt a Quality-First Approach

In 2017, a global medical device company’s implantable cardiac defibrillator (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) were recalled. The devices were used to treat patients with life-threatening heart arrhythmias. These medical devices are implanted into patients and deliver electrical shocks or pacing to correct abnormal heart rhythms. The products had to be recalled due to a defect in the lithium batteries used in these devices. In fact, in some cases, the battery had failed, resulting in fatal incidents.  

It was discovered that the formation of lithium deposits created short circuits in the battery leading to premature depletion without enough warning to the patients or healthcare professionals about the failure. This resulted in some devices not delivering life-saving electrical shocks when needed.

A root cause analysis revealed that the premature depletion was happening due to changes made in the battery’s design and manufacturing process without adequately assessing the downstream impact of this change on the device's performance over time.

From the quality management standpoint, the problem was at the supplier’s end. At the supplier’s end, a change was made, and this change impacted the final medical device. The big questions here are:

• What is the process needed here to ensure any change is evaluated for upstream and downstream implications?
• How can we ensure a change made by a supplier does not cause a quality issue in the final device?

The short answer is that we need a “connected” process and workflow for quality management across the product lifecycle. This includes design quality, product risk, supplier quality, and, of course, quality management across the manufacturing and distribution phases.

Building a robust change control process

This case is just one example of how inadequately assessed design changes can lead to product recalls or malfunctions. Any change introduced at any stage of the product lifecycle impacts not only design and manufacturing but also the supply chain and product performance. Therefore, organizations must adopt a proactive approach by following these fundamental principles:

Risk Assessment

Changes to design or manufacturing processes must undergo rigorous risk assessments to identify their potential impact. In the case of the implanted device, the lack of a thorough evaluation of the battery manufacturing process led to unintended downstream effects that endangered patient lives.

Change Control

A robust Quality Management System (QMS) with effective change control mechanisms helps mitigate such risks. All process changes should be evaluated not only for immediate benefits but also for long-term impacts on product functionality and patient safety. If there’s a change at a supplier’s end, one needs to have in place a supplier quality system to ensure that there are no quality issues resulting from that change.

Upstream and Downstream Evaluation

Every design or process change must be evaluated across the entire product lifecycle—from sourcing raw materials (upstream) to the product’s clinical performance (downstream).

Change is inevitable in product development, driven by various factors such as:

• Market Trends: Disruptive products, economic shifts, or environmental factors can alter market dynamics, even as product designs are being finalized.
• Customer Preferences: As technologies evolve, customer needs and usage patterns change, necessitating updates to product design.
• Raw Materials Availability: Supply chain challenges or the discovery of better alternatives may require material substitutions.
• Process Innovations: Advancements in digitalization and technology may lead to process changes that impact the product lifecycle.

The point is that change is inevitable in the process of bringing to market an innovative medical device product - or any product for that matter. However, it is critical to have a robust design controls process, with automated change management and product risk evaluation at the core of it.

Leveraging Technology for Design Control

Product Lifecycle Management (PLM) is evolving rapidly as new tools augment the efficiency of various stages of product design and development. Technologies such as Modern CAD, VR, and 3D printing are changing how design and engineering are done. These digital solutions shorten time-to-market, helping drive innovation into the product development lifecycle.

However, in some cases, these design tools are used standalone – and this lack of integration creates data silos, where changes made in one part of the process may not reflect across upstream or downstream functions.

To address these challenges, manufacturers need a unified platform that ensures real-time visibility into change actions and impact. This may require cross-departmental collaboration but with access to reliable data at the core of all communication.

CQ Design Control Solution with Integrated Change Management

ComplianceQuest’s Design Control Solution is a cloud-based platform designed to provide comprehensive visibility into the product design process, facilitating collaboration, compliance, and document management across teams.

Key Benefits of ComplianceQuest’s Design Control Solution include:

Real-Time Collaboration Across Teams

Traditional systems often rely on spreadsheets, making it challenging to track design changes and assign tasks effectively. With ComplianceQuest, design files are stored centrally with permission-based access, allowing teams to collaborate seamlessly. Integrated tools such as Chatter and Design Review Management ensure real-time communication and task tracking. CAD Tools/Software is also seamlessly integrated with the PLM Software.

Data Visibility

ComplianceQuest unifies data from across the organization—including requirements, deliverables, and changes—ensuring that teams remain aligned throughout the product lifecycle. With complete document stacks at their fingertips, quality and engineering teams can make data-driven decisions about product innovation, changes, and quality improvements.

End-to-End Tracking of Changes and Deliverables

The platform offers advanced project tracking tools, such as Gantt charts and list views, allowing teams to monitor progress on actions, deliverables, and timelines from any location. This ensures that every component and process receives the attention it needs at each stage of the design lifecycle.

Up-to-Date DHF and DMR Management

ComplianceQuest’s solution automates maintaining Design History Files (DHF) and Device Master Records (DMR) with the latest approved documents and design files. Teams can search, access, and share documents effortlessly, ensuring everyone works with the most recent information. This provides critical input for design review meetings and ensures all departments are aligned on key decisions.

Increased Change Visibility and Risk Mitigation

Integrated with a change management system, ComplianceQuest tracks the impact of all change actions in real time, providing visibility across all levels of the organization. Impacted teams can plan accordingly and ensure that all necessary approvals are obtained before changes go into effect. This structured process reduces risks by ensuring that post-production changes are validated thoroughly, preventing unexpected performance issues or non-conformances.