When an injectable device malfunctions, the moment doesn’t end with a patient reporting a complaint. In fact, that’s where a much larger process starts to begin.
Behind every reported misfire, incomplete dose, or device failure is a complex workflow involving patient safety, regulatory compliance, product investigation, and secure disposal. These processes are often invisible to patients, yet they play a critical role in maintaining trust, meeting regulatory obligations, and improving future product performance.
As injectable therapies like GLP-1 auto-injectors become more common in at-home care, understanding what happens after a complaint is more important than ever.
From Patient Experience to Regulatory Requirement
When a patient reports that an injection did not work as expected, pharmaceutical manufacturers must act quickly. Complaints may stem from device malfunctions, product stability concerns, or incorrect administration. In many cases, resolving the issue requires the physical return of the device for investigation.
Regulatory agencies such as the U.S. Food and Drug Administration require manufacturers to document, investigate, and resolve these complaints. The returned product becomes a critical data point, helping quality teams determine whether an issue was isolated or indicative of a broader risk.
However, without a structured return workflow, these investigations can stall. Incomplete returns, incorrect packaging, missing components, or delays in shipping can stretch resolution timelines from weeks into months, increasing regulatory risk and frustrating patients.
The Hidden Challenges of Product Returns
Across the pharmaceutical industry, complaint-related product returns are often more complex than they appear. While the goal is to retrieve a device for investigation, real-world execution introduces challenges that can slow investigations, increase costs, and elevate regulatory risk.
In one injectable-device complaint program jointly supported by a pharmaceutical manufacturer and PureWay Compliance, early performance data revealed significant friction. Fewer than half of initiated returns were completed, and many received kits were non-compliant. Patients frequently returned incorrect components, omitted required documentation, or packaged devices improperly, sometimes including used sharps.
These issues created downstream consequences. Investigations were delayed due to incomplete or unusable data; quality teams spent additional time correcting preventable errors, and patients experienced extended wait times for resolution or replacement therapy.
PureWay’s Role in Redesigning the Complaint Workflow
To address these challenges, the pharmaceutical company partnered with PureWay Compliance to redesign the return and disposal workflow with a focus on patient behavior, regulatory requirements, and operational visibility.
Rather than treating returns as a single shipment, PureWay helped restructure the process as a guided, end-to-end workflow. Clearer packaging instructions, standardized labeling, and instructional inserts reduced confusion around what materials should be returned and how they should be prepared. Automated communication, including shipment confirmations and reminders, helped set expectations and improve follow-through.
PureWay also enabled enhanced tracking and analytics, allowing the program to monitor return completion rates, turnaround times, and common points of failure. This data-driven approach created visibility that had previously been missing, supporting continuous improvement across the complaint-handling process.
Measurable Improvements Through PureWay’s Approach
With PureWay’s redesigned workflow in place, the program achieved measurable operational gains. Return completion rates increased significantly, while average investigation timelines were reduced by more than half. Non-compliant returns declined, lowering the need for rework and follow-up outreach.
Logistics and resupply waste were also reduced as excess kits and unnecessary shipments were eliminated. These improvements allowed quality control teams to identify potential product issues sooner, support faster corrective actions, and maintain stronger documentation for regulatory review.
For patients, the impact was equally meaningful: clearer instructions, faster resolution, and quicker access to replacement therapy when needed.
Integrating Secure Disposal into the Complaint Process
An often-overlooked aspect of complaint handling is what happens after the investigation concludes. Returned devices, used injection pens, and associated materials must be managed safely and compliantly to prevent sharps exposure, environmental risk, or documentation gaps.
PureWay’s role extended beyond returns to include secure, compliant disposal as part of the same workflow. By integrating disposal into the program, the manufacturer maintained full chain-of-custody documentation and ensured materials were processed in accordance with regulatory and safety requirements.
This closed-loop approach reduced handling risk, improved audit readiness, and eliminated gaps between investigation and final disposition.
From Regulatory Obligation to Strategic Advantage
Device malfunctions are often unavoidable in complex drug–device combination products. What differentiates organizations is how effectively they respond.
By partnering with PureWay Compliance, this pharmaceutical manufacturer transformed a fragmented complaint process into a data-driven workflow that supported faster investigations, stronger compliance, and better patient experience. Programs like this help manufacturers meet expectations from agencies such as the U.S. Food and Drug Administration while also reducing waste and operational burden.
As injectable therapies continue to expand in at-home care, complaint, return, and disposal workflows designed for real-world use are no longer optional. They are an important component of patient trust, regulatory readiness, and long-term program success.
About PureWay Compliance
PureWay Compliance partners with pharmaceutical and healthcare organizations to support compliant medical device returns and compliant sharps disposal. With patient centered design, PureWay helps manufacturers manage complaint programs more efficiently while reducing risk, waste, and operational complexity. To learn more or shop disposal system options, please visit www.pureway.com.
