Grappling with Recalls and Market Delays in the Medical Device Industry? It’s time to evaluate your Design Controls Process

Introduction: The Cost of Rushing the Design Phase

A leading MedTech company recently had to recall a Class II device weeks after launch due to a design oversight: the battery placement caused intermittent device failures. Internally, the issue wasn’t caught during verification because multiple design inputs were undocumented and loosely linked to user requirements.

The result? A market delay of over six months, a hit to brand credibility, and millions lost in remediation, repackaging, and reputational costs.

This is just one of many examples of how poor design quality, caused by inconsistent or immature design controls, can derail product timelines and trigger avoidable recalls. In an era where speed-to-market is critical, rushing through or loosely managing design phases can cause exactly the opposite effect.

Recalls and Delays: Often A Direct Outcome of Poor Design Quality

Let’s break this down:

a) Product Recalls from Design Quality Failures

• Devices hit the market with latent design flaws that only become apparent post-deployment.
• These are not always dramatic failures; often, there are usability oversights, compatibility gaps, or performance deviations that escape early validation.

b) Delays Due to Rework and Regulatory Pushback

• If design inputs/outputs aren’t properly mapped, teams spend cycles backtracking during reviews or audits.
• Missing verification evidence or inadequate traceability slows down submissions, and regulators demand more data before approvals.

A Few Examples of Design Quality Issues from the MedTech Industry

Let’s explore three types of design quality failures that lead to recalls or delays, and how strategic design controls can prevent them:

Example 1: Inadequate User Need Translation

A wearable medical device was recalled after patients complained of skin irritation caused by prolonged contact with a material that hadn’t undergone full user validation.

Root Cause:

Design inputs didn’t fully translate user needs related to material safety and comfort.

Prevented By:

• Tighter traceability between user requirements, material specs, and test protocols
• Early-stage usability validation and risk assessment

Example 2: Missing Verification for a Key Output

An infusion pump’s flow rate regulator performed inconsistently in hospital environments. A design update was made mid-development but wasn’t re-verified.

Root Cause:

Verification steps were not updated after design changes. Documentation gaps in the design history file (DHF).

Prevented By:

• Closed-loop design change management
• Automated linking of changes to verification activities
• System-generated DHF updates

Example 3: Component Incompatibility Discovered Too Late

A diagnostics device launched with firmware that conflicted with an approved hardware revision. Post-launch software updates failed to resolve the issue, resulting in a recall.

Root Cause:

Lack of integration between design teams working on hardware and software components.

Prevented By:

• Integrated design reviews across disciplines
• BOM (Bill of Materials) and CAD integration within PLM
• Cross-functional collaboration during change control

How Strategic Design Controls Improve Design Quality

Strategic design controls are not just regulatory checkboxes. When implemented with intent and supported by technology, they:

• Embed risk thinking early into design processes
• Ensure full traceability from user need → input → output → verification
• Enable change impact analysis across components and documents
• Automate documentation to keep the DHF always audit-ready
• Promote collaboration across engineering, quality, and regulatory teams

What CQ ProductQuest Brings to the Table

ComplianceQuest’s ProductQuest is purpose-built to elevate design quality through smarter PLM and embedded design controls. Features include:

• Unified platform for design, quality, and regulatory teams
• Integrated platform of PLM, design controls, product risk, and design traceability
• End-to-end traceability with automated gap alerts
• Seamless CAD and ERP integration
• Configurable workflows for design reviews and approvals
• Real-time dashboard for design risk, verification, and DHF status

Design Quality Matters: In Fact, It Holds the Key!

Design issues don’t usually surface all at once. They slip through cracks created by disconnected processes, documentation gaps, and misaligned teams. And the cost of discovering these issues after market entry is always higher.

Design quality is your first line of defense.

With strategic design controls in place, supported by a modern PLM like ProductQuest, you can reduce the risk of recalls, cut time-to-market, and deliver better, safer products.

Frequently Asked Questions (FAQs)