Road to recovery: Why manufacturers need to ensure their processes meet agreed protocols

Lucy Pamment, a supply chain technology specialist for Access Group, believes the recent Implant Files scandal will put further pressure on medical device manufacturers to build transparency into their processes.

It is only natural and right that major customers (like the NHS), healthcare professionals and patients are going to ask questions about the safety and effectiveness of medical devices – so what processes do you have in place to ensure compliance with legal and quality standards, such as ISO 13485 and GS1?

A scandal like the Implant Files shines a light on the importance of an electronic audit trail, allowing manufacturers to trace raw materials, components and products back to the source, and containing relevant documentation such as test results.

Many production managers already recognise the power of digital technology and are harnessing it to some extent. While digitalisation is not yet universal, I expect to see the pace of change accelerate as growing numbers of manufacturers adopt electronic data interchange (EDI) solutions to tackle challenges around traceability.

As reported in Medical Plastics News, we have reached the point where terms like ‘connected health’, ‘digital health’ and ‘disruptive technologies’ are fast becoming the norm. No longer just for the trailblazers, Tier One manufacturers and small-scale suppliers alike are already benefitting from access to real-time data, actionable insights and connected supply chains across factories and warehouses.

The question every supplier needs to ask is whether it wants to be the only one in a complex supply chain that has to search through multiple spreadsheets if a part or product is found to be defective? Or the one that continues to fax and post documents because there is no EDI software in place, running the risk of them being mislaid, inadvertently or even maliciously?

Making the case for digitalisation even stronger is the fact that it is now key to winning new and repeat contracts. By 2019/20, suppliers to NHS acute trusts must be GS1 compliant – a standard that has resulted in cost savings of more than £4,000,000 at Guy’s & St Thomas’ NHS Foundation Trust (GSTT). Using GS1 barcodes and Global Trade Item Numbers (GTINs), hospital teams can track and trace any product, scanning it to access key data such as the batch number.

The move towards barcode scanning and data sharing is not limited to the NHS, of course. As the Unique Device Identification (UDI) regulation come into force in both the US and EU, suppliers will be required to display an identifier – typically a barcode – that ensures full visibility for every device. As a result, defective or recalled products are removed easily before they adversely impact patients.

Ultimately, it must be possible to ‘uniquely identify, track and trace individual medical devices through the supply chain and, importantly, into a patient pathway’– something that can only be achieved through effective data sharing and by holding quality and compliance documents in a secure, central location.

In the wake of the Implant Files, manufacturers and distributers will have to work hard to restore confidence among professionals and the public. With the need for transparency becoming more urgent, it is only a matter of time before data exchange via the cloud is mandatory in all areas of healthcare procurement.

Developing IT infrastructure still seems like an insurmountable barrier – particularly for small and medium sized enterprises (SMEs), which account for 98 per cent of the 3,700 UK’s medical technology companies. Even so, a good software solution can be implemented with little or no downtime, is easy for staff to operate and can be scaled up according to production needs. At the very least, I would urge all manufacturers and distributors to have a digital strategy in place, which includes full data back-up and recovery services.

Far from making their work more onerous, compliance with internationally-recognised standards opens up new doors for suppliers with major healthcare providers like the NHS. To make the most of these opportunities, however, manufacturers will need to ensure their processes meet agreed protocols as soon as possible.