HOW TO: Realise ROI from your UDI ProjectIn this exclusive interview Dawn Fowler, Senior Manager, Labeling & Documentation Endologix, speaks to Andrea Charles from Pharma IQ about the benefits of UDI implementation beyond compliance and why it is important to ensure ROI from your UDI project. Fowler shares key lessons learnt from trying to realise return on investment from a UDI project and how to manage and utilise the new volumes of data created by UDI implementation.
Exclusive Interview with Simon Richards from Alere
Ahead of the UDIs and Traceability for Medical Devices Forum 2014, Simon Richards, VP for Regulatory Affairs, EME at Alere, spoke with us about:
- The benefits of a well-built unique device identification (UDI) system
- Developing a strategy for implementation
- Future perspectives for medical device manufacturers
Balancing Act: Taking a Harmonised Approach to Medical Device Label InteroperabilityIn this exclusive interview Melissa Finocchio, Director, Product Labeling and Documentation BioMerieux, speaks to Andrea Charles about:
- Changing trends in product labelling and documentation for medical devices
- Overcoming barriers to standardisation and BioMerieux's top 3 priorities now that the FDA Final Rule on UDIs for medical devices is out
Medical Device UDIs: What You Need to KnowIn this Pharma IQ interview, Regina Au from BioMarketing Insight shares her insights on the current UDIs for medical devices landscape and the impact of the FDA’s final rule on UDIs on the medical device industry, both in the US and on a global scale. Au also reveals the 5 key business benefits for medical device manufacturers.
Filling The Gaps In Your UDI Strategy
Following the demand for increased accountability and traceability with medical devices to safeguard patient safety, manufacturers must meet the expectation to bring printing, labelling technologies and master data management up to compliance standards. This will involve developing a UDI corporate strategy and policy for all business units and departments.
On the road to meeting compliance deadlines and executing a UDI project one key step will be pinpointing any gaps between existing supply chain systems to UDI requirements. This will involve analysing the supply chain process, transit issues, the mechanics of recalls and reporting on a UDI compliant product and whether the expected benefits are achieved. Then redesigning and integrating management of product labelling and packaging to enable regulatory compliance. With this large task in mind, we spoke to a couple of experts on the subject of filling the gaps within a UDI strategy.
Updated for 2015 - The UDI Final Rule Interactive Compliance CalendarView this one-page compliance calendar to help you understand what impact the September 2013 FDA Final Rule on unique device identification will have on your business.
UDIs for Medical Devices The European LandscapeWhile the US advances with its coverage of medical device classes within the U.S. Food and Drug Administration (FDA) Unique Device Identification regime, other countries around the globe are progressing their own track and trace strategies for medical devices. Through the collaboration of the world’s regulatory agencies it is hoped that a synchronized approach to medical device identification will be achieved on an international level, amidst their efforts to tackle counterfeiting, increase accountability and enable safety corrective measures. (2)
In early 2013, the European Commission released a recommendation upon a proposed structure for the UDI requirements system in the EU.
Now, the current trilogue negotiation between the three EU institutions – the European Parliament, Council and Commission, is expected to produce the adopted final regulatory text within 2016. Market analysts have forecasted that after this text is agreed and adopted, the industry is likely to be given three years until the regulation will come into force. (5)
As the industry awaits the finalized regulations from the EU, some have looked at the FDA and predicted that the EU is likely to mirror the preferences of the US body.
Resource Booklet: UDIs for Medical DevicesPharma IQ has compiled this resource booklet containing presentations held at the 2015 Medical Device UDIs and Traceability conference on the following subjects:
- GUDID – The Data Gathering and Maintenance Challenges
- Re-thinking Your Labelling Processes and Getting the Buy-in from All Stakeholders
- Evaluating and Determining the Key Components, Planning and Execution of a UDI Project
The Hospital Perspective: Lessons on UDI Implementation at the Point of CareThe task of realising advantages from deploying UDIs for medical devices stands as a vast project, with the practical challenges of efficient and compliant implementation looming large.
Some of the implementation roadblocks that confront and hinder today’s hospitals include:
- Bar codes not being well printed
- Unreliable bar codes
- Superfluous labels on a device, mostly intended for the manufacturer’s use that drown out the label of interest for the hospital.
Data Complexities with the EU UDI RegimeA selection of experts have highlighted one key hurdle the market should brace for: data management with the EU UDI regime. Due to this area being expected to differ from the FDA’s GUDID process quite sharply in some places. With the MDR due to come into effect in a few years time, Pharma IQ gains insight on the forecasted data complexities attached to the EU’s UDI gameplan.
Download the agenda for a look at the speaker panel and full topic sessions.