WILL YOU BE READY FOR THE EU MEDICAL DEVICES REGULATION?

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1 WILL YOU BE READY FOR THE EU MEDICAL DEVICES REGULATION? OPINION PIECE Delivering Transformation. Together.

2 The clock is ticking on the new EU Medical Devices Regulation coming into law on 26 May Compliance isn t just a regulatory requirement; it s a business survival necessity. The 26 May 2020 deadline for compliance to the new EU Medical Device Regulation (MDR) 2017/745 might still seem a distant prospect for many in the industry. Yet, in reality, the changes to process, culture and data-specific technologies (e.g. capture, ingesting, analytics, monitoring) will be significant for the majority of companies, and fundamentally change their approach to data. Thus, if you haven t started your MDR compliance journey yet, you need to galvanise your business before it s too late. This too late warning isn t simply scaremongering. Non-compliance is a genuine risk to a company s bottom line. Why? Because if you are unable to provide the appropriate level of clinical evidence to get products to market and keep existing ones there, you simply won t be able to sell them. 2

3 Turning compliance into an opportunity While compliance will require considerable effort and, in many cases, resources, it also represents a major business opportunity. Companies will inevitably get a much richer data-set around their products, enabling them to make more informed decisions about future product development direction and requirements. For example, greater requirements for post-market surveillance will force companies to track usage, spot any problems and take remedial action to improve the devices patients depend on. In another potential change, the need to provide additional reporting as part of product classification may lead to the decision to withdraw a product from the market. This offers the opportunity to rationalise product portfolios, better understanding the value of different product lines to the business and remove those elements that are unviable. Then, of course, there are the much-reported benefits of an increased awareness of product performance in terms of patient safety and successful outcomes. This also reduces a firm s exposure to litigation and reputational damage. Thus, companies who better understand their products may find that they have a competitive advantage in the marketplace. MDR 2017/745: key changes Companies will have to provide more clinical evidence to get products to market and keep them there Re-label products with unique device IDs Greater data transparency data around trials, etc. will have to be made publicly available Greater requirements for postmarket surveillance and performance assessment for most devices Tighter vigilance reporting timelines reduced from 30 days to 15 days Classification of products may change and many may now require additional reporting/ surveillance to previous classification 3

4 Removing the barriers With such clear benefits, what s currently standing in the way of organisations realising the true value of their product performance data? None of the following will come as a surprise to professionals working in this industry. A key obstacle is the diverse data sources, structured and unstructured, that are both internal and external to the business. There is often a complete lack of master data for product lines and, with multiple systems, there is typically no single view, and no central portal to display the information. The lack of visibility on available data increases response times and limits an organisation s ability to make informed decisions. Further, in a hugely competitive marketplace, it can prevent sales teams gaining access to better and earlier information that can identify highperforming products and enable more focused sales activities. 4

5 Adding up the cost There s no avoiding the fact that complying with the regulatory changes will come at a price. And, as the amount of data increases, expectations around speed and access to it rise, alongside an escalating cost of searching for and analysing the data. But with no option in terms of the requirement to comply, businesses must bite the bullet and overcome their capital budget constraints. So, what are the key costs that need to be built into your MDA compliance programme? Firstly, it s highly likely that current IT systems will not be up to scratch, meaning that other options will need to be investigated. Typically, product lifecycle management (PLM) systems are not designed to capture and manage the data required. Second, the evidence-gathering and market surveillance activity is already hugely labourintensive, undertaken by expensive and rare resources. The teams currently carrying out the post-market surveillance, searching out reports/ studies, etc., will need to be greatly expanded in the new regulatory landscape. This may require new people to be trained, which will add to the cost and time to upskill these business-critical teams. Third, there will be a cost associated with managing the increased activity. Much of what these teams do is judgement-based and now the data they re working with needs to be easily shared for peer review and harmonisation of results. This demands new tools, but there is often a poor understanding of what s needed by the business to access the right information, at the right time and to provide an audit trail for all activities. 5

6 Taking a smarter approach to your data The level of spending on these three areas alone (there will be others) will vary enormously from organisation to organisation. However, Sopra Steria firmly believes that it can be significantly minimised by getting ahead of the game and investigating what smart new technology, such as artificial intelligence (AI) and robotics, can do for you. For example, the average most companies base their business decisions on just 10-20% of available data. Further, it s recognised that up to 80% of employees time is spent just locating the data. The smart use of technology could enable you to aggregate, ingest and analyse data based on your individual requirements. The time savings alone make a compelling business case. In a recent project, Sopra Steria helped a client achieve a 95% reduction in time spent searching for and retrieving information. AI tools are available that could help your evidence-gathering teams recognise patterns across siloed product data (clinical, PMS, regulatory, risk management, sales, marketing, R&D). These might be patterns that you re currently not picking up, for example in a single component that s shared across a number of different devices being developed, manufactured, or already on the market. Visualising product performance information in a single place can become much smarter with the use of a central data platform capable of ingesting and tagging structured and unstructured data. Add to this a smart interface underpinned by machine learning, so that it can learn from your experts and become better over time at classifying and flagging important information. The power of new, smart technology becomes increasingly clear. 6

7 Becoming an evidence-led organisation At Sopra Steria, we re already working with some extraordinary technology capable of gathering and centralising performance data from across multiple internal and external sources. The ability to search, find, consolidate and analyse structured and unstructured data (scraping web-published content), and pull relevant data into a data hub, with significantly reduced manual overhead is phenomenal. The result? The management information needed to ensure compliance, manage business risk, and assure product efficacy with minimal human effort. This is especially important for organisations in heavily regulated industries, such as financial services, utilities, pharma and, of course, medical devices. Our experience in data and analytics is being brought to bear in organisations seeking solutions to their evolving regulatory challenges. In 2016, for example, we took on the task of delivering a new, cloud based digital regulatory market data processing platform for the UK s Financial Conduct Authority. Taking a smart approach to utilising evidence is key to winning in the current and evolving regulatory environment. It supports the drive to become best-in-class in terms of identifying and processing clinical insights to substantiate product safety, performance and claims. Products with substantiated superiority and value propositions will shine. Regulatory compliance becomes a win-win situation all round: healthcare providers have confidence in the efficacy of the medical devices they procure; patients trust that the devices they depend on are safe and robust; and manufacturers gain the customer and product insight they need to differentiate and protect their brand reputation. 7

8 About Sopra Steria Sopra Steria, European leader in digital transformation, provides one of the most comprehensive portfolios of end to end service offerings in the market: Consulting, Systems Integration, Software Development and Business Process Services. Sopra Steria is trusted by leading private and public organisations to deliver successful transformation programmes that address their most complex and critical business challenges. Combining high quality and performance services, added-value and innovation, Sopra Steria enables its clients to make the best use of information technology. Contact me to find out more about how we could help you to prepare for the new regulation and make the most from your data. Tej Sembi Business Development Phone: +44 (0) LinkedIn: SOPRA STERIA Three Cherry Trees Lane, Hemel Hempstead, HP2 7AH +44 (0) info.uk@soprasteria.com PB060V01