In our September webinar, Richard Adams, CEO, and Simon Jones, VP of Global Product at PRISYM ID discussed why continuing with international medical device manufacturing without the support of a true GLS, will create continual challenges, and why now is the time to take a different approach.
You can watch this webinar on-demand here; but for those on a time crunch or just wishing for an overview, here are PRISYM ID’s Marketing Executive - Sarah Hrycyk’s highlights:
Why market drivers are making a GLS a business imperative
The global medical device market is growing fast. We expect that at the end of the decade, it will grow to at least 50% greater than it is today, - approximately $100 billion according to research.
Companies are expanding their presence in existing markets, but they're also exploring new geographies, and of course, increasing the adoption of new technologies and new capabilities to better deliver solutions for patients.
Consequently, this means that there is an increased emphasis on the need for a highly competent global supply chain that is going to enable manufacturers to create a product and then to distribute. As such, having a modern GLS in place is critical to allowing these requirements to happen and to support the challenges of being able to operate in this fashion.
What a modern medical device GLS will need to offer a device manufacturer –
When regulatory bodies adjust their rules to meet market demands, it is critical for medical device manufacturers to respond in parallel with technological updates and advances to match.
Thus, as demands from the market are becoming more and more complex, such as the requirement of recording label content and templates for operational effectiveness, the maintenance of these demands fracture. Therefore, the core capability of a modern GLS is to support and manage these changes, which, as we all know is extremely difficult to live up to without the right tools in place.
The concept of a GLS for Medical Devices is nothing new, but…
Some industry comments suggest that global labeling systems are somewhat lagging in terms of evolution in meeting industry demands. The challenges caused by this is that companies are missing out on potential opportunities, such as manufacturing, capability and capacity opportunities.
We know that products and certainly their packaging and labeling must be localized for local markets: they must meet local certification requirements, the information and language needs and so on and so forth. It is suggested that most labeling systems are operating in a reactive and disparate fashion. This fragmented approach, however, only exacerbates risk.
It is vital, therefore, that the new generation of global labeling systems run in parallel with the broader supply chain capability for this to work, ultimately providing the opportunity for companies to not only optimize their business efficiencies but also manage their risk.
The complexity in Medical Device labeling
Medical device labeling is not easy, it is much more complicated than general production labeling found in other industries.
Both the design, the labels, and the content required are covered by requirements from regulators. It's not just production data, it’s the warning statements, precautionary statements, the use of symbology, etc., that are all critical; not just in terms of meeting regulations but also critical to the healthcare professionals and patients and their understanding of how to use the product correctly.
The Future Is on Our Doorstep
There is much more conversation needed around the adoption of using cloud technology as an enabler underpinning the implementation and deployment of global labeling systems. It can be suggested that due to the regulatory complexity within this industry, the sector lags behind some other industries in its adoption of cloud technology. But that's becoming something of the past. Organizations are starting to understand that there's a huge opportunity in running cloud-based solutions.
Whether you were able to watch our webinar or just came here for an overview, we hope these five key learnings were useful to you. To keep up to date on the latest industry topics and opinions, join the PRISYM ID community online.
About the author
Sarah Hrycyk, Marketing Executive, PRISYM ID
I’m Sarah, and as part of the marketing team here at PRISYM ID, I have a keen interest in staying up to date, researching and analyzing the key facts, figures and market trends within life science, pharma and medical device labeling. While this research is valuable to my everyday work, I want to start conversations with you (our readers) around the topics I share in our blogs. I would love to hear from you – you can connect with me on LinkedIn, here.