Device recalls have inherently been, and still are, a largely manual process, with manufacturers working from spreadsheets and Commercial teams visiting consignee locations to obtain responses from affected consignees.  With over 16 000 device Recalls in 2024 affecting more than 70 million devices worldwide, recalls have garnered more scrutiny and media attention in today’s consumer driven environment, notwithstanding regulatory body pressure.

The burden placed on existing service & commercial teams to execute a recall could mean loss in potential revenue and placing patient safety at risk. Additionally, with the recent advancements made in digital health and increasing pressures on MedTech supply chains globally, organisations face huge challenges in ensuring the safety & quality of their products.

So, what is a recall? A device recall typically occurs when an organisation is either mandated to or voluntarily withdraws a potentially harmful product from the market to protect patients and maintain brand integrity. A manufacturer can also recall a product for commercial purposes i.e. swopping out existing products in market for a new product with updated technology or a device has been manufactured using new and/or updated material.

In this blog post, we’ll explore the need for digital intervention and how this can mitigate for a poorly executed product Recall.

Product Recall areas in need of digitisation:

1. Recall Management Software: vendors such as IQVIA MedTech offer fully integrated & digital platforms which provide notification templates, response reconciliation & live reporting capabilities.
2. CRM systems: clean data is a critical aspect of executing a Recall effectively- and integration into Recall Management Software allows vendors like IQVIA MedTech to cleanse & validate your CRM data, providing clients with organized, clean data and a well-executed Recall.
3. Quality Management Systems (QMS): effective, digital capturing of quality events, such as CAPA’s and adverse events, allows manufacturers to easily identify & remediate quality issues before they impact patients.
4. ERP systems: a fully digitized and integrated ERP system into a vendors Recall Management System allows for effective inventory tracking & coordination with all teams to execute a product Recall flawlessly.
5. Consignee response mechanisms: vendors need to accommodate digital means of communication & dissemination when initiating a product Recall- for ease and quickness of response from the consignee as well as automated response reconciliations.

How digital tools can mitigate for a poorly executed product Recall:

1. Speed: quicker delivery of FSN’s and faster consignee responses allows consignees & hospitals to act quicker by removing defective devices faster.
2. Efficiency: tech based & easy to set up- no wasting time considering the urgency and risks to patient safety.
3. Transparency: consignees can respond immediately, with responses uploaded in real time.
4. Reporting: manufacturers can have almost real-time visibility of the progress of their recall, change strategy, if need be, and submit reports to regulatory bodies at the click of a button.

To support the need for digital tools and demonstrate their clear value, recent data from product recalls executed by IQVIA MedTech globally indicate an emerging trend and favourability in using digital tools when responding to or acknowledging a FSN or recall. Some data from recent projects (averaged) that can be attributed to this are as follows: