Reflecting on 2020: RIM process challenges highlighted

2020 was the year that saw unprecedented changes in the pharma industry. Here are some of the key insights we gained from it.

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From producing ventilators, to personal protective equipment for healthcare professionals and home care staff, to COVID-19 testing kits, 2020 was a busy year. 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 manufacturers’ readiness to make products outside of their normal remit.

In the meantime, as medical centers and hospitals put routine operations and clinics 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 discouraged from presenting in person, boosting reliance on smart devices and digital patient support based on readings from wearable devices or portable monitoring kits.

All of these changes, and their suddenness, exposed any 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 responses to them.

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.

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 (e.g., 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.

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.

Published on    Last updated on 14/01/2021

#Life Sciences

About the author

With more than 25 years of experience in the Life Sciences industry, David Gwyn is a seasoned executive with extensive experience. As a Vice President for AMPLEXOR Life Sciences, David’s main focus is aligning customer needs with the capabilities of the company’s Life Sciences Suite to ensure that the solution meets the needs of the customer.

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