David Gwyn, Amplexor

Lessons from the Global Health Crisis: How to Get Product Information Management Right

By David Gwyn
David Gwyn, Amplexor

The pandemic has revealed some inadequacies in the way medical device suppliers manage regulated product information. The following is a look back on a challenging year and suggestions for practical improvements to cope with continued uncertainty in 2021.

2020 was the year that saw manufacturers in different industries turn their production lines over to medical equipment—from producing ventilators to PPE for healthcare professionals and homecare staff to COVID-19 testing kits. For those commissioning and overseeing the products, as well as those doing the fabrication, administrative efficiency and the ability to accelerate testing and safety approvals became as critical as a manufacturer’s readiness to make products outside of their normal remit.

In the meantime, as medical centers and hospitals put routine operations on hold, demand for standard medical equipment dropped away, forcing rapid reviews of production and of stock backing up in supply chains. These moves also placed new pressure on remote monitoring devices at home and in communities, as patients were encouraged to participate in virtual visits, boosted reliance on smart devices and digital patient support, some of which was based on readings from wearable devices or portable monitoring kits.

This rapid change exposed gaps in the medical device industry’s ability to manage product information in real time, in all its forms, in a unified way—so that companies could keep pace with alterations in demand and keep regulators up to speed with new or diverted activities.

The Best-laid Plans

Certainly, if life sciences organizations had been more proactive in their plans for unified product information management, they might have fared better in managing the disruption caused by the pandemic. Systemic, unified information management based on pooled, authoritative master data about products and their current regulatory or market status would have helped enormously in enabling companies to track and get ahead of emerging situations and their subsequent responses.

Surprisingly, though, many related IT projects already given the green light—and assigned budget—stalled in 2020. Plans to update information management capabilities gave way to patchworks of tactical measures. This is a shame: If companies had pressed on with digital transformation initiatives, they could have been in completely new territory by now—benefiting from industry best practices, using a largely out-of-the-box unified information management solution, implemented and delivered via the cloud, entirely remotely.

Now, and for the foreseeable future, everyone is working differently—with no sign of an end to the disruption caused by the pandemic. Regulatory/quality/safety teams have no choice but connect remotely, following the sun, and cooperating more closely than ever with distant partners to address supply issues and changes to product demand. If alternative sources of raw materials or manufacturing capacity become necessary, companies need a way to manage all of this from a quality/safety and marketing approval perspective.

In situations like these, a unified global product information platform would keep everyone in the loop, effortlessly. Meanwhile change requests and alerts to emerging issues could be issued automatically, triggering early action. Disruption to team members’ locations, meanwhile, would prove no barrier to progressing work, particularly with a cloud-based regulatory information platform. In fact, with a web-based solution, the IT implementation—even the business change management and team workshops—could be managed entirely remotely.

Managing Long-term Uncertainty

As 2020 gives way to 2021, much uncertainty remains, which means it is more important than ever that medical device companies take stock of where they are, what is not working well, and what needs to happen to turn that situation around.

Remote working can be expected to remain the norm now. Collaborative authoring is just one of the advanced ways remote teams can boost their output. When all of the latest product/market/regulatory information is readily accessible as a “corporate knowledge asset”, and team members can work on it in parallel, sharing their edits and comments as they go, this drives much faster task completion (eg., planning and creation of new or updated marketing authorization submissions). That’s compared to traditional methods of circulating documents for feedback, with the author having to painstakingly absorb all of the suggested changes.

Keeping Pace with Market Changes

The other crucial benefit to a more coordinated and holistic approach to product information management is the opportunity to gain a 360-degree perspective of regulatory activity and product/market status globally. The ability to spot untapped market opportunities or potential red flags as licenses come up for renewal or safety updates are due, is almost impossible to quantify—but it is significant.

Whether companies are bringing to market equipment that is central to addressing COVID-19 care or personal protection, or simply trying to rebalance supply chains to adapt to disrupted healthcare services, a unified global information management platform would help identify and highlight markets where demand is particularly strong, or where products are not currently being sold—so that the teams responsible can swing into action, targeting resources and accelerating formal safety approvals.

With change really the only constant now, there is no time like the present for medical device companies to get their global operations in order. The information management challenges that existed before COVID-19 haven’t gone away; if anything they have been magnified by the disruption of the pandemic. To maximize market opportunities, companies need to be able to navigate and manage change in ever more effective and efficient ways—and a unified, global information platform offers the best means to do this.

About The Author

David Gwyn, Amplexor