Unique Device Identification Webinar #7 - Global manufacturer UDI learnings, 22 March 2022

Michelle Van Wijk

Good morning, everybody. Thank you so much for joining us today for our seventh webinar on UDI. This is our first webinar for the year and we're very excited to be talking to you once again about UDI and the Australian implementation. Today, we have three items on our agenda. We're very delighted to have a specially invited guest speaker, Debbie Connors from Smith+Nephew, present to us, will be giving a TGA project update and will answer in that many of the questions that have been provided to us ahead of this morning's webinar.

And then we'll have some time at the end for questions and answers. And now I'd like to introduce our guest presenter, Debbie Connors. Debbie is the senior director from regulatory affairs from Smith+Nephew. She has extensive experience in the device industry and she's worked in a number of roles, including regulatory affairs and regulatory advocacy and policy. Debbie joined Smith+Nephew in 1995 and she works in the regulatory affairs organisation.

She's the global UDI programme manager and EUDAMED business readiness lead. She's currently focussing on implementing UDI regulations in the EU and globally. And what that includes is ensuring that Smith+Nephew have a UDI strategy that meets applicable regulations, strives for global alignment and meets the needs of the healthcare provider.

She's also the key interface support within the various impacted Smith+Nephew business teams to implement digital solutions for UDI master data management, business process development and organisational change adoption. Debbie has very kindly offered to spend some time with us this morning, talking through her experience, some of the lessons learnt, observations from a global UDI perspective.

Because we've had very strong feedback that hearing this information is really helpful to those in Australia who have the journey ahead, but also to other organisations who might be having to meet UDI requirements across multiple global markets. Thank you very much, Debbie, for your time. I will hand over to you.

Debbie Connors

There we go. Thank you, Michelle. And thank you for having me here to speak to everyone. Good morning. Good afternoon. Good evening. I'd like to start first by just giving you a brief introduction to Smith+Nephew, our business. We are a leading portfolio technology company. We have design development opportunities. We make technology that takes the limits off of living. Our company slogan motto is Life Unlimited.

And we strive to give that to every single one of our patients and surgeons who serve our customers. We have three global franchises. Our orthopaedics business, which is primarily reconstruction, trauma and robotics products. Our sports medicine and ENT franchises, a number of small joint and large joint implants for soft tissue repair, shaver systems, camera systems, everything that you would think about with arthroscopic surgery procedures.

And advanced wound management devices comprising biologics devices such as negative pressure wound therapy devices and bandaging and medicated bandages with medicinal components. We have about 18,000 employees worldwide. We are traded in the UK, in the London and New York stock exchanges and assets and revenue of $4.6 billion in 2020. Our global footprint in our customer base, we are a very well-balanced company with a global footprint in more than 100 countries around the world.

Smith+Nephew was founded in 1856 in the UK in a small city in northeast called Hull by Mr T.J. Smith. And he ran the company for about 40 years and it was succeeded around the turn of the century by his nephew, Horatio Smith. Thus our name, Mr Smith and his nephew, who're our founders. Our customers run, I think, the gamut of people we interact with obviously. And it's nurses, nurse specialists.

We have our healthcare systems and procurement groups, payers and administrators, retail consumers and patients, physicians and of course, surgeons primarily. To jump in a little bit now about our global UDI programme, we're going to go through a brief introduction of the landscape, what Smith+Nephew's global UDI strategy is, how we approach the problem, let's say, and the challenge. Where we're at as far as our compliance activities with global UDI and I think most importantly, we're always learning from these experiences.

We're going to look at a little bit about what our implementation challenges are. And of course, at the end, there'll be the Q&A session. This is a map that we work with quite frequently, both with internal and external stakeholders. It's the current global UDI landscape as we understand it and we've broken it into four different stages or phases of activity. Stage four being the most developed and stage one being the activities that are in the very early stages of evolution, I guess.

Stage four represents the countries that have live UDI systems. We currently have five markets in that space. We have the US FDA being the most mature. We have South Korea, China, Saudi Arabia and in Europe, the EUDAMED has released the device registration module for voluntary use. It's not yet mandatory, but manufacturers are encouraged to register their products, as the capability is now available.

We have several other markets at stage three who have guidelines and regulations published in place. They have their implementation schedules established. And they have timelines that are coming up starting later this year. Taiwan has its first registration date for its high-risk products coming up in late Q2, early Q3, I believe, of this year. And then more to follow with Singapore and Brazil. Stage two countries are the countries that are beyond exploration, but now they're getting into the process of really developing their guidelines.

They're seeking information, much like TGA is doing in these webinars series, to share information and understand what the environment is and how it impacts, not just manufacturers, but the healthcare sector as well. And then the very early talks are happening in the stage one countries. You can see it's quite a dynamic environment and it's happening very, very rapidly and it's a lot to keep our arms around.

When we speak a little bit about Smith+Nephew's approach to UDI strategy, we have to look at it as a holistic UDI compliance programme. There are many aspects to it and understanding all of these different aspects is really key to success in this global UDI environment. Across the different fields down the bottom here are the areas that we work across and within.

There's our data gathering activities, where we look to the regulation, we look to the different guidance documents and technical specifications to try to understand, what information is going to be necessary? What information is mandatory? What are the definitions around these different pieces of information? And what are the specifications of the database that these data will be in? And then how do we translate that into a solution that our companies can use to gather and manage this data from the lifetime of the product perspective?

We're also then looking at business process. As I was explaining Smith+Nephew to you, we have three different franchises. And those franchises represent seven different legal manufacturers with seven independent quality management systems. Then we also have manufacturing operations in other parts of the globe that we have to consider when we speak about the country-specific UDI requirements.

From a business process perspective, we have to try to take a solution and develop it to be flexible enough to meet the very different needs of our different business organisations, but still be compliant and still use the same tools that we provide for the same outcome around UDI compliance. We'll speak a little bit more about the challenges with business process development and adoption in one of the later slides.

Our digital solution roadmap… And it really is a roadmap because again, with the complexity of the environment, we've a lot of different digital solutions that are in place. Some of them are legacy, quite old. Some of them are investments that have been made more recently in digital solutions. And it's coming up with the right digital solution to manage all of the different aspects of control that we need, whether it's the data, whether it's supply chain, it's the integrations to our manufacturing environment.

And obviously, our product traceability once we have the product out the door and going to the customer. Product labelling and marking is another significantly impacted area when we talk about UDI compliance. I think most obviously is on the product label, is the implementation of the barcode, whether you use a GS1 barcode or a HIBCC barcode or an ICCBBA, it does have that aspect of getting the barcode on the label in the right format.

And making sure that it's readable, that you've got validated processes for applying and if you print it in line. And there's a lot of work that goes into even just structuring. Where does that sit on your product label to be sure that the customer has easy access to it? And our warehousing systems have easy access to it. Along with product labelling goes product marking. Direct part marking. There are requirements in the regulations.

And they all vary a little bit around direct part marking. When direct part marking is applicable, what types of direct part marks are required on reusable products, whether you can do a linear barcode or a 2D barcode? What type of information has to be embedded in that? And then also, the validations that go with the bar coding and assuring over time that that barcode is visible, it is scannable and it does maintain its integrity through the life of the product.

And then also, again, our supply chain. As we go through and we bring products into compliance with UDI, we want to make sure that we understand what we're shipping out to our customers. We have supply chain impact as far as distribution controls and we have supply chain impact just literally in cutting in the changes that we need to make in a timely fashion to meet all of the different compliance dates.

Overpinning all of these different functional areas, we have governance and lifecycle management. The concept of UDI and the compliance with UDI does have to be maintained throughout the lifecycle of the product. From its design inception and delivery to the very first customer, very first market, until that product gets obsoleted in sunset, somewhere later in life, however many years that takes.

With some products remaining in the market with shelf lives that are easily ten years or longer, capital equipment and instrumentation that can also last quite a bit longer than a decade. A lot of this has to be continuously monitored and processes in place to help manage those activities. And then we also have the regulatory advocacy and intelligence component. I can't speak enough to the value of having a strong advocacy intelligence component.

And really leveraging that opportunity. Take the opportunity to look at draft regulation. Take the opportunity to comment on the guidance and on regulation as it's coming out. Look to balance the requirements between the manufacturer, the regulators and the customer and keeping those different stakeholders in mind as we're laying out, what does a UDI regulation need to look like? What bits of data are critical to have versus nice to have? Those types of things.

And really being involved in shaping the regulation, when you have that opportunity, I think it's really critical and important for your businesses. I'm going to talk a little bit more about our approach here and more about some of our stakeholders and the structure and a little more detail about the key activities that happen in each of the areas. And then we'll also talk about what your budget should look like and what your budget should include.

From the regulatory intelligence perspective, we actually have a governance model as Smith+Nephew. It begins within our regulatory organisation and brings in the appropriate stakeholders at the appropriate time to get them involved in thinking about their country-specific UDI system and requirements. UDI compliance is not optional. It is a requirement of our different regulations. And we have to make sure that we have the appropriate, I think, support and funding to be successful in meeting that.

We do have a governance and an initiation process for all of our different UDI projects as new markets come on board with global UDI requirements. There's also the global UDI project and programme management organisation. As I was saying earlier, there's a lot of activity that fits in this one space. We do a lot of the development and understanding of the attribution. Not only do we understand it, but we have to make sure that it maps properly through our system.

As we're collecting information on these attributes, we have to look across the whole global environment of attributes to see where they overlap, where they're similar, where they're different. What impacts do those differences have? And how can we map that information we may perform in the background transformations on the data to get it into the right format? Because the question might just be tweaked slightly differently that a simple yes, no is not the right answer.

We may have to pick a different value and transform the information. There's a lot of activity that happens with this attribute mapping and laying out your attribution to look at, what attributes can be a global attribute that we can share across a number of markets? And then what attributes are very unique to each market? And thinking about that as you go through your development process of a UDI system. We have to determine screen layout requirements. We actually have to take a human factors' look at our user interfaces, our data entry screens, our data collection programmes. And think about the people that are asking to manage all this information and how does that work best? How can we make that user-friendly for them and straightforward? We also have reporting requirements. And again, it's very much the same thing.

Think about the utility of your reports and what those reports should look like to be the most user-friendly for the end group that has to read them, use data in them and manage some of that information maybe into other subsystems like complaints or into PSUR reports or clinical evidence reports, for example. We build out business cases. We have to obviously get capital expenditure funding when we're doing a digital compliance tool.

There's a whole business case and capital request process that goes with the UDI programme. A number of different work streams that feed into the programme. We've talked about some of those with operations, supply chain labelling, obviously our regulatory teams. And making sure that we have all of those players lined up to execute and bring us to a completely UDI-compliant solution. Like any business, any programme, any project, we have status reporting.

We do have regular governance meetings with the teams of stakeholders. We also do reporting both upstream and downstream from where we sit in the organisation, to reporting up to our executive levels. As well as down to the levels of people within the different business areas that may not necessarily be directly involved with our UDI programme, but do need to know what's going on. For Smith+Nephew, we do use GS1 as the barcode system that we follow.

And obviously, we have to be aware of and consider the GS1 requirements and ensure that we are compliant with those. We've talked quite a bit about our digital solution development. But we are also the testers. We also write the test scripts. We execute testing. We work with end users to help them support us in executing testing. We train them on the system. We are tied quite closely with our IT partners in developing the solution and in resolving defects.

All of that activity that go into validating a digital solution for managing our UDI data and moving it through our data ecosystem. We also have specific tools that have been developed, a different digital tool that we use to build out the capability to enter data directly into the tool for our data collection capacity, rather than trying to use Excel spreadsheets and stuff like that. We do have some tools that we've developed internally to help us manage the data.

Again, a fairly significant portfolio of product, close to, I think 100,000 SKUs. And it's a lot of data to manage when we start looking across the ecosystem. And with the inception of EUDAMED and the EU solution, there was a significant increase in the number of attributes that we have to manage. It's in the couple hundred range of attributes for each catalogue item number. Again, data collection tools, anything we can do to help organise the information and make it more user-friendly and minimise error.

And then again, business process support and integration. Integration is a significant challenge, I think, across any business to bring in something new like UDI. To bring it across several different legal manufacturers and countries concurrently is certainly quite time-consuming. And we have to be conscious of the fact that we have different challenges in different markets.

We have some countries and some markets and some business units that are far more comfortable working in a technology solution, entering their data, managing it, going through workflow approvals and things like that. And we have other country partners that we're working with that are very much less comfortable doing that. And we have to be conscious of those challenges. And look at each of these different business units and countries with a fresh set of eyes each time we're doing this to say, how can we bring them the right solution?

How can we make them comfortable with it and support their business needs? On the IT side, as I said, we have partners that we work with in the development of the system. We are looking at opportunities to set up… Again, I was speaking about the global attributes, the attributes that can be shared globally. And then we call them regulatory master tables. And then looking at a master table format and then cloning and modifying this master table element to capture the various unique elements in the system.

We do data loading, obviously requirements, developments for a digital solution that we have to tell the IT team what we're trying to accomplish so that they can build the solution. And obviously, extract reports so that we can pull the data out of those systems. On the operation side, we spoke to our labelling, our product marking and our supply chain controls a little bit. Again, other partners who we're working with on these areas.

The local markets, I just spoke to. And then oftentimes, on the commercial side, we're going to, dependent upon whether it's a UDI requirement… Or with the MDR¸ if the UDI requirements are bundled together with a very significant regulatory implementation, there may be a need to rationalise the portfolio. There may be products that you decide, because of either the cost and expense to either bring them into UDI compliance or to bring them into compliance with a regulation…

You may make a determination that these products really just aren't viable to bring forward. And there may be other alternates in your portfolio that will serve and you'll choose not to bring that product into a certain market. From a costing perspective, we break our costs into really three areas. There's two shown here, but there's a third area that I'd like to add. We have our global costs, which is the overall programme cost, the IT solution cost, the cost of bringing the operations activities into compliance, our labelling and our direct part marking.

Again, this takes time from a validation perspective, from drawing updates for prints, validations. And again, just cutting it into your work in progress through your operations facilities. Then there's also the local costs that are one-time setup fees that we may have to add on additional markets. You build your solution around, for example, the United States and EUDAMED. And as we extend it into different markets, there is a cost for setting up each of those individual markets.

One-time cost to get them their data set up, their solution integration done and their adoption. And sometimes licencing fees. And that goes into the cost that the individual markets bear in our strategy and model. And then there's also the sustaining costs. And I think what we don't capture here is what those longer term costs are to keep the products compliant. We have to continue to keep the data up to date.

We have to continue to submit updates to our UDI databases. And all of that takes manpower and effort and just management of a lot of activities that happen concurrently. Where Smith+Nephew is at, on the data side, we're in pretty decent shape. As a result of the US FDA and some work that we've done on GDSN over the last several years and our EU MDR efforts that are currently continuing in progress, we have collected 200-plus product attributes for a significant portion of our product portfolio.

What we're seeing is approximately 80% of the attributes collected are common across the different UDI geographies. They're what I would consider the global attributes. They are attributes that we're seeing, again, the pattern repeating, things like sterilisation methodology, MRI information, does the product contain latex? There are certain fields that we see consistently across the board. There are about 20% that are unique.

And the ones that tend to be market-specific unique tend to be around certain information such as the local registration numbers, I would say like your ARTG numbers in Australia, or they're around reimbursement information that may be required. Generally, we're seeing a few different tweaks here and there on some of the attributes as well. Something like phthalates, for example, we see hazardous substances are being implemented in a number of different ways.

And unfortunately, they're not very consistent. It's a little bit of a challenge. Those end up being more of a local attribute. From a product perspective, I would say we're at 98% or so of our products are physically UDI-compliant. Obviously, we are very heavily involved in the US market. With FDA coming up on their final compliance date in September of this year, we're seeing that most of our products and our portfolio are already compliant from a labelling and direct part marking perspective.

There are some outliers to that that we are currently working with for Europe, as well as China, South Korea and Saudi Arabia. There's also a very small portion of our portfolio that are aging and legacy devices. They predated the UDI requirements. And as such, we're not required by any of the current regulations to go all the way back in time and bring product back from the field and make it UDI-compliant.

When one of these products pop up, we do generally get a question from our customer and have to explain to them that this is an older legacy product that predated the UDI requirements. But in general, we are in pretty good shape for our physical compliance as well. I think our team, we're very fortunate to have a very strong team of UDI experts. It's a fairly small team. But I think what is really great about our team is we have expertise across a number of different areas.

And we're very complementary in our skillsets. We have people who are supply chain experts, people who have done digital solution implementation at very large-scale companies. We have regulatory expertise. We have expertise in database solutions. Across our group, again, like I say, I think the complementary nature of our talents is what makes us very, very strong and very successful as a global UDI team.

And I encourage, don't just think of UDI as being something that your regulatory team need to be the owners of and the managers of. There are a lot of different skillsets that are necessary to really, I think, be able to be agile and try to get it right the first time. Processes, again, global processes, we start at a very high level in our quality management system. We have global processes that speak to the high-level requirements of UDI, with specific subsections about country-specific requirements.

Those are then adopted and brought down within each legal manufacturer's quality management system at the site level. There may be some minor modifications to fit their business structures. But generally, the integrity of the global process is brought down. And of course, the compliance requirements are integrated into that site-level QMS.

And then the local markets such as China and Saudi and Singapore, etc., South Korea, we work with our local quality regulatory teams and make sure that they have their UDI registration procedures and requirements rolled out. We work with them to build those procedures and then make sure that they can implement it in their markets. It's a three-prong approach again. A global overview, a global high-level requirement site-level QMS integrated.

And then where you have your local companies' and countries' UDI requirements, integrating it into their quality management system. And then technology, we've spoken a little bit about this. We have a data collection utility that we use to collect the data efficiently. We have a solution vendor that we are working with and we've partnered with to build out this modular UDI component with the global data. And then the country-specific modules.

And then a self-serve product tool that we use to actually share the data downstream within our company. Within our company, we have the data collected and interfaced to a very large Informatica data pool. And overlaying that, we use Power BI as a tool to actually present that data to end users. And it's searchable. And with the interfaces, it's maintained in near real time. And lastly, again, always learning.

The US FDA implemented their regulation in 2013. We've had the benefit of several years now, seven, eight years, to learn about UDI. And with EUDAMED, we began working on EUDAMED about three and a half years ago. We've spent a lot of time studying the regulations, studying the requirements. And things we've learnt, this really is a programme. Global UDI is challenging. It's not just a regulatory activity.

It really is multifunctional. It's also multifaceted. You can't just focus on the data and the database activities. You have to take into consideration your labelling, your product, your attribution, your delivery methods, so on and so forth. It is required and it is necessary to maintain your UDI compliance through the lifecycle of the device. It's not a one-time activity. It's not one and done. It needs to be kept up to date.

And it's really important to set the tone from the beginning to make sure your business, including your commercial organisation, understand that UDI compliance isn't a nice-to-have. It has to be done. It's a direct impact for us. If we're non-compliant, there are implications both from a trading and from a company reputation perspective. We don't want our product being detained anywhere because we haven't supplied our database information or the label's not matching what we say is in the database.

It's really important to keep it up to date. And again, it helps our client partners in the healthcare sector as well. Subject matter expertise is very niche. The knowledge in regulatory affairs, supply chain, physical compliance, labelling, data management systems, you either have to have expertise in some of these areas. It's all learnable, trust me. I was not a data management person when I started working on global UDI and now it's pretty ingrained in my brain.

It's learnable. It's all learnable. But again, it's a very niche area, again, only being around for less than a decade at this point in time. Adoption of your business digital solution. How do you get your staff to come on board and understand everything you know? What's floating in your head? What my experience is, is that because UDI is usually approached as a programme, that the general knowledge within your company is probably not that strong.

There's a lot of questions about, why do we need to collect all of these attributes? Why do we need to maintain all of this information? There's a lot of education that needs to happen. As I said before, use of digital solutions is new to many people in your organisation. It will be. It is in ours. And making people comfortable with that has to happen. Trying to implement standardised processes and tools across multiple unique quality management systems. 00:38:27

It's the proverbial square peg in the round hole. How do you get that to happen? You have to be flexible. You have to work with people. You have to help them understand what the benefits are. A lot of times, I've learnt that if you can help them understand the benefits for them, including how it may make their job more efficient and easier longer term, they tend to listen to you and start working toward that solution with you as a partner.

Adoption's labour-intensive for the programme team and for the end user. We have to recognise that, that they have day jobs and they have to keep executing on those day jobs. And we have to work with them to make sure that we're fitting into their schedule. On the regulation side, the lack of regulatory harmonisation is a huge challenge for manufacturers implementing UDI solutions. And further, my concern is it dilutes the value of the global UDI.

It's critical to comment on proposed regulations and try to drive harmonisation back to the IMDRF standard and guideline as much as we can. Some of the things we see is different attributes by market. Europe, like I said, was probably the most significant, adding about 50 to 60 brand new attributes that had not been collected as part of US FDA UDI. Similar attributes with different definitions, it's giving you some examples where phthalates can come in many different flavours.

Trigger attributes. Trigger attributes are the attributes identified in the different regulations that require a new GTIN to be assigned to the product. A new GTIN is a new catalogue item number. And when you start diluting a catalogue item number because the triggers are different, you really lose the power and the value of UDI. Because now you have several different variants of the same product, but with different numbers that are not necessarily relatable.

You can't just simply link them together in the UDI databases to stitch together the story of a product. It's really, really important to try to keep the triggers to those that are obviously very critical, like changing something from sterile to non-sterile, changing something from non-latex to latex-containing. Things that are really significant changes within the product. And then inconsistent database rules for updating records.

What we're finding is that some databases will allow you to correct information in your records, fields that may have been a locked field, as they say. Other regulations require you to delete your entire record and start over. Anything we can do to try to look at the databases themselves and look at consistency in the rules for how records are kept up to date is really helpful. I think physical compliance, we talked quite a bit about the actual process of it.

But there also have to be considerations and exceptions for physical UDI compliance. Not all products are big enough to mark. It's not safe to mark all products. And some products, there may be a concern that marking the product could introduce risk and it could introduce, whether it's a stress rise or something like that. When you're marking a product with a physical laser mark UDI number, you don't want to do something that's going to damage your product and potentially harm a patient. And the lack of off-the-shelf solutions. There are not a lot of companies out here that are making good global UDI solutions. A lot of companies have taken a custom development approach for this modular approach that I've described that Smith+Nephew has implemented. And the solutions, especially if you're managing them yourself, can be very, very expensive and resource-intensive. And for both short term, your initial launch, and in your longer term development as databases get modified over time.

We do see that happening still with FDA that there are tweaks to the database now and then. And then one of the bigger challenges we have is the global UDI environment itself. The regulations are being established faster than manufacturers and solution providers can launch solutions. The environment's changing as quickly as we try to adjust to what we believe it is.

Every time we look over our shoulders, there's a new requirement or there's something that was delivered a little bit differently in our database than we expected based on the specifications. Those are some of the overall challenges that we see. And I think it is back to you, Michelle.

Michelle Van Wijk

Thank you so much for that, Debbie. That was really informative. And again, we appreciate your time. We're going to give you an update now on where we're up to from a TGA perspective. I'm going to cover some of those early questions that have been provided ahead of the webinar. And if we run out of time at the end for Q and A, if you'd like to send any additional questions to our email udi@health.gov.au, we'll follow up on those as well.

And if there's anything specifically for Debbie, then let us know and we will forward that on. In terms of where we're up to, Debbie did mention the challenge around the different triggers. Last year, we ran a working group to look at that perspective from a whole range from manufacturers, providers of data, through to healthcare use and registry and surgeon use, for example, and what that might look like. That's complete and we have a final report that was produced by that working group.

 

We have now implemented changes into our current systems for our Global Medical Device Nomenclature codes to be updated daily into the existing system. That was an issue for some sponsors in terms of applying for authorisation where our codes didn't quite match the GMDN. We are continuing to scope with Queensland Health and the commission, our early adopter project. It's likely that we might expand that to start to include mesh devices so that scoping of devices and hospitals is still occurring.

And we've started discussions with a second jurisdiction. Really, to look at how the UDI might be used from the perspective of a hospital or a public health system, to start to get some of that real-world experience that can then be fed back into our regulations, into our technical design and build. But also then to be shared across other hospitals, procurement organisations, all of those, to help inform other support and support other implementations for that early adoption.

One of the questions that we had and we always have is around the timing. We've actually gone a little bit faster. If you saw these time slides last year, you'll notice there's a change. As per last year, we are still planning to make a sandpit version of the Australian UDI database available in June. And that will be to allow users to provide data, to have a look at the look and feel, for hospitals to download into their catalogues, the surgeons to do device searches.

All of those things that we understand are those core needs, we've built. And this will be an opportunity for everyone to test them and to provide feedback to us on what we might need to do differently, what we might not have taken into account. We will have our support unit, and I'll talk about that in a minute, help everyone to understand and through our webinars and guidance, what that looks like, what the process is for indicating you'd like to join and how that will work.

We plan to put forward a third consultation paper in June to focus on some of those areas we haven't already covered to inform then voluntary compliance from January next year. The intent is we'll have the regulations in place before then. And we'll be focussing, like the other countries have, on those high-risk devices. For us, Class II, Class III and active implantable medical devices. We're still working out what the transition looks like and what the mandatory compliance will look like. But that's still, indicatively, July 2024. As you heard Debbie say, there's a lot of work that needs to happen from manufacturers, sponsors and the users of the data, their healthcare systems and the registries, to plan to put this in place. We need to make sure that we enable enough time for that, but also for anyone who's ready early. And that will depend on where and how much we vary from those already implemented countries, for example, that it is suitable there to go early.

And for anyone who's looking at the EU at the moment, we have a single system. We won't be based on releasing different modules. It will be one at the same time. We had strong feedback from what worked well in the US around providing that support capability. We now are building that. We're designing it and building that within the team to look at what phone support, what guidance, webinars, self-help we might enable.

Connection. For the machine-to-machine connections, which are new to health from system to system, how might we test those before we move into production to make sure that those systems talk to each other? That the right messages get to the right place and that we understand how the data is provided, updated, amended or deleted as needed through those systems? And that is both to provide the data, but then also to allow hospital and healthcare use of the data.

Because they might want to update on a regular basis and not want to actually have a manual process to do that. All of that connection, how that works, how the login will work, etc., will be part of this group. They'll look at our TGA resourcing for supply and demand. Are we going to get 1,000 people on day one? We need to make sure we cater for that. And we manage that so everybody gets the support they need.

And then also the technical support. I know there'll be policy-style questions and regulatory questions versus then those technical ones. And how do we make sure we cater for them both? In terms of looking forward, we have the June sandpit we just talked about and the development work we're doing. The third consultation, we've started a project to look at the alignment between the ARTG, our Australian Register of Therapeutic Goods, and UDI.

There are some data elements that are common to both, including method of sterilisation, size, a range of those. What we need to do is we need to look at how we're going to manage that from a TGA perspective, how the systems will align over time as the data changes and what we need to do there. We're planning to kick off that project shortly. We're just in the middle of scoping that. And we really appreciate the guest speakers.

We've had really good feedback in terms of the value. If you're interested or you want to nominate someone else for April or May that will be useful to hear about, please let us know and we'll plan those ahead of time as well. When we get to June, we'll probably start to talk more about the sandpit and provide some more detail around there. I want to share this slide with you. It's got a lot of information on it.

But what it really covers is, what will the sandpit be? It will provide functionality for sponsors and manufacturers, for early adopters, for public use and for TGA staff to also look at what they need to do around UDI to manage the data and those processes in place. And we've got here some high-level points around provision of data, scanning labels and barcodes, providing device data. And we've successfully integrated US UDID data to support projects where those devices are provided or supplied in Australia as well.

We're looking at how we test the bulk upload or the bulk change of UDI records, how we do the machine-to-machine. We're in the process of connecting to the National Product Catalogue, for example, because we know a number of manufacturers and sponsors already use in overseas the global device synchronisation network to provide regulatory data. We're also looking at that. These slides will be available.

I know someone questioned. The slides and the recorded webinar will be available on our website. For our development, focus is now really around the machine-to-machine and the connection and preparing for sandpit readiness. A lot of the core functionality is already there. We're just looking now at those particular areas to build so that we can have them ready for the sandpit. We have started a second working group, which is our technical working group.

And really, that is to focus on the technical design, interoperability and data exchange between systems. As I mentioned earlier, this isn't something that has been done in the TGA or in health before. We really need some information from all of the users who would use these functions to help us understand what the best source of design is, what the current standards or forms are being used, what's coming and what we need to do in terms of prioritising how we will build those, which ones we need to build and how they might work.

If you're interested, please let us know via our UDI email address and we'll make sure you receive an invitation to that. Our next meeting is Tuesday, next week, 10 AM. Just a couple more slides. And apologies, we won't get to the Q and A. But really, the third consultation is looking particularly at a number of focus areas, including impacts of accepting both US and EU labels and data. How might that work from a provision of data from a labelling perspective and then from the use in the healthcare system if we accept both as they are?

Again, to look at minimising the burden on manufacturers and sponsors for provision of that data. And what might our transition approach look like through voluntary compliance, through to mandatory compliance going forward? Really, that's going to be a key piece of work for us and we would encourage everybody to, as Debbie said, contribute to that. Share your thoughts with us. Send it to anybody who we may not have on our list.

But if you'd like notification, please send us your details if we don't already have them on the UDI stakeholder list. We're planning to use our consultation hub. That's an electronic survey tool that we've used for our second consultation. And we'll have a six-week consultation period, is what we're planning. Really, we have to finalise our consultation, prepare the regulations, get approval for them and have them through our processes to have them in effect by 1st January.

I can see I've got a minute left. I'll just go quickly. And this talks about the cleansing of the data. How do we align the data between our Register of Therapeutic Goods and UDI? We've discovered lots of challenges as we've looked at our UDI work. We know we have some old systems and they've constrained us a little bit. We have manual data entry as well. But there's some key focus areas we're working on.

And that project will be something that we will get up and running in the short to medium term. And that will require input from manufacturers and sponsors around the data. We could do it afterwards, but really, what we want to do is do it ahead of time so that we can support the UDI implementation in the way it needs to be supported to make it successful. We've got planning now. We'll do some analysis of what's in there and then we'll do some cleansing from July onwards.

That aligns very much with our UDI timeframe. We'll need support from sponsors. We'll have to look at data. We'll have to make changes to that data. We might look at the GMDN codes which are no longer managed by the GMDN agency. They've been made obsolete. For example, what do we do around those devices? Because a number of devices have been on the market for a long time. I'll pause there. Are there any questions?

We've got some more detail and I'll hand back control to our mediators today. But I think if there's any questions that we can have perhaps one minute for, happy to answer one if we can. We've had, please make the slides available. We will do that. I've got a question for Debbie. And what we might do is I'll read it out and then we will ask Debbie to respond via email afterwards, because I think we're right at the end.

Thank you to Debbie for the presentation. Are you able to perhaps share the level of full-time employment investment that you've dedicated or the organisation has dedicated to UDI? And how many are dedicated globally and how many in Australia and New Zealand? If you're happy to share that, I think that will help people in their planning. If you're happy to take that one on notice, then we can provide the data back, if that's okay with you?

Debbie Connors Yes, I can do that.

Michelle Van Wijk Thank you. I'd like to just hand back to our moderator. But thank you, everyone, so much for attending today. If you've got ideas for future topics, for future speakers, things that you'd like us to cover, we'd really appreciate your input. We will continue these on a monthly basis going forward. And as I said, as we get more closer to June, we'll talk a bit more about the sandpit and provide more information about that.