For the sake of patient safety, the ability to track and trace medical devices at a global level is paramount. However there are some key considerations to be aware of when implementing UDI.
Download our useful guide to discover the benefits of UDI, discover how it is tracked, who it is relevant to and more: http://www.prisymid.com/resources/blog/399-the-useful-guide-to-unique-device-identification.
Craig Jones is the Vice President of Enterprise Sales Engineering for PRISYM ID with responsibility for understanding customer needs and industry challenges to drive solutions to improve efficiency, minimise risk, address regulatory requirements and provide new approaches to business systems and processes. Craig has 14 years of experience delivering validated label lifecycle management solutions to life science and healthcare industries including medical device, pharmaceutical and clinical trial organisations. His experience includes roles as an industry consultant, in IT management and as a senior manager for global technical support and professional services.
1. Why did you decide to do a webinar with Business Review Webinars?
As a company we have worked with Business Review Webinars before and have found them to be very professional and helpful in promoting our webinar to companies within our industry.
It is the perfect platform for PRISYM ID to interact and engage with its audience and show a snapshot of our capabilities with our latest-technology global label lifecycle management software.
With this being a live event, it gives the audience the opportunity to ask on the spot questions which we can answer there and then. It saves time and money for all those involved with a watch-back session provided afterwards.
2. What are you looking forward to explaining to the audience?
I’m looking forward to introducing the audience to the output of the PACT project (Project Authoring For Clinical Trials) and how it addresses the common industry labelling requirements for language management, regulatory content management, ‘just in time’ labelling and label postponement.
3. What do you most enjoy about your role?
I enjoy working with our customers to overcome industry challenges that are presented, and to make real and measurable improvements to current systems and processes. This is only achievable by working closely with a highly-experienced team who really understand these challenges and how to overcome the problems.
4. What would someone be surprised to know about you?
One of the things that many customers would not know is that I’ve worked on the majority of PRISYM ID’s software implementations. Before moving to head up Pre-Sales in 2013, I headed up the technical support Helpdesk and Professional Services teams for 6 years.
5. What do you do in your leisure time to relax?
My favourite pastime is spending time with my family. When I manage to get some time off, I love to jump on the road bike or head up to the local kick boxing club. Although with a 2 year old child, there really isn’t much time to relax!
For many years, validating labeling processes has felt like an impossible mission for global medical device manufacturers, and has in some ways become a major barrier to the deployment of new systems for the fear of lengthy testing cycles and spiraling costs. Yet Label Lifecycle Management (LLM) is a mission critical ‘must have’ for life sciences organization that need to streamline processes, reduce labeling errors and mitigate risk.
It’s understandable that companies are cautious of change. The medical market is risk adverse in its very nature, no one can afford mistakes that threaten patient safety. Yet the move to newer labeling processes and methodologies offers real business gain that would mitigate such risks. So it shouldn’t be if LLM should be implemented, but how.
GAMP V (Good Automated Manufacturing Practice) sets out five key concepts to help medical device companies reduce the escalating costs of validation and improve compliance whilst bringing greater efficiency. These key concepts are:
The latter concept, which encourages companies to take full advantage of supplier capabilities, is perhaps key. The guide advises that regulated companies should ‘maximize supplier involvement throughout the system lifecycle in order to leverage knowledge, experience and documentation, subject to satisfactory supplier investment’. It argues that suppliers could be well placed to help with requirements gathering, risk assessments and the creation of functional specifications, as well as system configuration, testing, support and maintenance.
The long-standing notion of ‘validation pain’ need no longer present a barrier to the introduction of LLM innovation. With the right supplier, validation is no longer an impossible mission, you too can transform your validation cycle to drive progress, productivity and profitability.
To discover more tips on how to make the validation process simpler, why not register for our webinar and download our free whitepaper ‘Validation Pain to Real Business Gain’
Warren is responsible for leading and driving results from the global sales team. He has a detailed knowledge of the auto-ID industry with particular emphasis on label lifecycle management and production techniques.
Warren is passionate in identifying and securing new business opportunities, whilst building business within our existing global client base to create year on year revenue growth.
We know from talking with clients and prospects alike that many are facing increasing challenges with FDA/EU regulatory compliance in their labeling operations. Combined with the continued drive for improving supply chain efficiency, this means current labeling systems are often not sufficient. Implementing a new labeling system can often seem a complex task so we wanted to highlight ways to reduce the impact of this, and ensure it’s done in the most efficient way.
Hopefully we’ll be able to show the audience how they can reduce the perceived validation pain of implementing a labeling lifecycle management solution, ensuring they are compliant with all relevant regulations, but also making the labeling process more efficient – reduce risk, reduce process costs and improve compliance!
There have been many! I think one of the best would be helping a medical device client realize savings of around $8M through supporting their move to print-on-demand. This meant they could dramatically reduce the amount of paper wastage by printing country specific IFU’s. It saved them around 175 tonnes of paper wastage, which has to be good for the environment too!
Sri Lanka…. Great people, good culture and cricket!!
Increasing operational efficiency is an aim for all medical device manufacturers and is a driver for change for many organizations. But the question is how without affecting every day operations?
Many proactive medical device companies are already beginning to take a more strategic approach to the management of data and are implementing single, fully integrated, end-to-end label lifecycle management systems that capture, store and disseminate data safely, quickly and accurately for increased label integrity. The deployment of such validated systems can improve efficiency by reducing the number of unnecessary manual checks, improve quality control throughout the lifecycle and accelerate product to market.
Moreover, the use of centralized data creates a robust platform for a ‘single version of the truth’ that can be used to generate and print labels ‘just in time’ – ensuring that the right information goes on the right product at the right time, every time. The obvious implications of product recalls are significant and costly; efficiency and productivity take a major hit, whilst the potential damage to brand reputation and patient safety are equally severe.
Through the implementation of a more flexible, transparent and accessible system for version control, medical device organizations can save money as well as increase operational efficiency by managing product labels centrally – irrespective of country , language or regulatory requirements. By implanting secure, web based solutions they can also allow and manage correct access levels to third party manufacturing, packaging and labeling operations, again aiding efficiency objectives.
The industry can undoubtedly benefit from implementing standardized mechanisms to control data globally and, as a consequence, mitigate the expensive risk of mislabeling. If companies are able to manage and structure data correctly, then all the downstream benefits will emerge for free; label creation, workflow processes, inspection capabilities and audit control all flow from ensuring the right data is available to the right people at the right time. And, the efficiency gains are a natural and welcome byproduct.
Keep your Labeling System ahead of the curve by joining our webinar on the 9th June. Find out more by clicking here.