UDI compliance: Achieving end-to-end medical device traceability

UDI compliance: Achieving end-to-end medical device traceability

Compared to the safety measures and compliance hoops faced by pharma companies for human medicinal products and their ingredients, the collection, standardization and monitoring of medical device data has been relatively rudimentary up to now.

But that must change if medical device or combination product manufacturers and their component suppliers are to stay the right side of the authorities. Continuing to track products using spreadsheets is unsustainable, and is preventing a clear line of sight across component sourcing, and device production and distribution. This is both risky to patient safety, and inefficient operationally.

Pharma companies with a medical device portfolio may have focused so heavily on drug-related regulatory information management that they’ve neglected to apply equivalent systematic rigor to handling medical device product data. As new waves of international Unique Device Identification (UDI) mandates hit, and as the respective authorities look to extend the scope to component manufacture, it’s time to rebalance attention and budgets.

UDI: A Global Initiative

Around the world, starting with the most safety-sensitive medical devices, regulators are gradually phasing in a Unique Device Identification (UDI) system. This is designed to provide single, globally harmonized positive identification of medical devices across their distribution and use. The goal is to ensure that any piece of medical ‘equipment’ – whether an implant, wearable device, syringe, or MRI scanner – can be traced back to its source for safety and accountability reasons. Worldwide, requirements across more device Class types are becoming mandatory and manufacturers without UDI risk being refused market access, and may be subject to legal and financial penalties.

UDI Compliance: Traceability is empowering

From the side of the public, a major benefit of UDI is its ability to enable a swift response to quality issues for efficient, targeted, and timely product recalls. From the manufacturer side, systematic device identification and information tracking paves the way for improved inventory management and supply chain efficiency, helping healthcare providers and manufacturers track the movement of devices, minimize errors in distribution, and optimize inventory levels.

The great thing about UDI is that it promotes the standardization of data related to medical devices, making it easier to integrate and exchange information across different healthcare systems and databases. The US FDA categorizes these slightly differently than the EU, and several other regions or countries each have their own guidelines. (Click here for overriding international guidance.) But once manufacturers across the world are all using an agreed system for identifying devices, and indeed for recording and reporting adverse events, it will become easier for healthcare systems to communicate and share associated information across borders.

Technology & Data Decisions

Technologically, there are a number of considerations as Life Sciences companies look to bring their medical device identification and end-to-end regulatory information management (RIM) up to scratch. Generally, this starts with the selection of a suitable RIM platform or system; then it’s about creating the right data fields, and flowing in reliable and robust device information in a compliant, standardized, and readily-exchangeable format.

Strategic decisions include whether to choose a single-vendor software platform. This may make it easier to integrate with manufacturing/SAP systems to ensure data consistency and accuracy, as well as process efficiency, across and between functions as part of companies’ broader digital transformation initiatives. Another option is whether to settle on a best-of-breed RIM solution, which stays within its lane and does pure regulatory information management very well.

Work will be needed to assess where relevant data already exists in spreadsheets and other information silos, the state and format of that data and to prepare it for migration into the new target system. To complete the end-to-end system, manufacturing and shipping processes will need to be adapted to ensure that devices are identified and tracked consistently and systematically across the entire product lifecycle, from component manufacture (e.g. all the parts that go into a pacemaker) to post-market surveillance.

In some cases, manufacturers may decide to cease production of one device, replacing it with another so they can start with a clean sheet. But even then there will be base data from the older-generation device that will need to be migrated into the new system to save completely reinventing the wheel.

fme is your Best Partner for UDI Compliance Initiatives

As Life Science and content lifecycle experts, we can help with all of the above. Our business consultants and technical teams are deeply experienced in Life Sciences data-based system projects and end-to-end services; most of our core data team having been RIM system developers for many years.

Crucially, in addition to this vital industry inside knowledge, we are vendor independent. We provide holistic solutions that focus on your unique needs, ensuring you maximize the ROI of your technology budget. We can perform gap assessments, provide regulatory timeline updates, and advise on the optimal roadmap based on the size and complexity of your current medical device portfolio and the structure of your current associated data. fme’s experienced team guides you from beginning to end with comprehensive data migration planning, expedited execution with our proprietary tools and methodologies, plus validation and ongoing support.

To discuss a particular requirement with our business or technical consultants, or discover more about our full range of services, contact us. We’d love to learn your challenges and provide an independent perspective designed to maximize your business success.

Pre-plan Your Regulatory Transformation Projects for 2024

Pre-plan Your Regulatory Transformation Projects for 2024

From building a realistic AI roadmap to making better choices about technology partners and broadening the impact of RIM systems, fme’s consulting approach and specialist data services can help pharma, biotech, and medical devices companies maximize investment into their digital transformation journey – both now and in the future.

It can be hard to effectively prioritize an ambitious digital transformation journey when external requirements and technology-based systems keep evolving. In a Life Sciences Regulatory context, those moveable parameters include changes dictated by compliance with IDMP data standards, or unique device identification (UDI) in the case of medical device manufacturers. Other influences might take the form of company mergers or acquisitions that require system consolidation or data harmonization, taking advantage of the continuous changes in evolving technology, or new opportunities to transform processes linked to the Regulatory functionality.

To successfully prioritize next steps and set realistic budgets that align with business goals, it’s important to consider the overall digitalization and transformation company roadmap.

We suggest reviewing these 3 considerations in particular when firming up plans for 2024.

Your roadmap for AI

Everyone is talking about artificial intelligence (AI) and machine learning (ML) as the technology becomes more advanced and accessible for mainstream day to day use. Certainly, it carries enormous potential to save time and drive new process efficiency, consistency, and repeatability. But there are use cases that lend themselves to AI/ML-based transformation, and others that do not, and it’s important to have a clear understanding of both the opportunities and the potential risks.

For instance, Generative AI (assistants like ChatGPT) could be ideal for drawing up job descriptions, summarizing recent achievements for a report or blog article, and/or improving communication across your organization (e.g. keeping everybody up to speed with the progress of a Regulatory Information Management implementation project). But such tools could incur substantial risk if used to generate patient information leaflets.

fme’s technology and content specialists can help you develop an appropriate strategy for your AI journey. Also, we can help you evaluate the current technology landscape – e.g. Regulatory Information Management (RIM) providers or other content management providers.

Get more out of your RIM system

Investing in a RIM system is a strategic move for organizations, with its significance extending beyond the immediate regulatory function. The true value of RIM platforms emerges when they transcend mere content collation and agency submission management.

The potency and transformative impact of a RIM platform become apparent when it delivers rich and comprehensive knowledge, making it accessible across the entire organization. When Regulatory, Quality, and Safety information is holistically stored and managed, strategic teams gain the ability to construct a nuanced understanding of market trends, identify adverse events, and pinpoint gaps in market coverage.

Elevating visibility beyond individual silos is a game-changer, providing C-level executives with a holistic view of organizational dynamics. This comprehensive perspective empowers executives to make informed decisions swiftly, expediting the process of bringing products to market.

Realizing the broader benefits of a RIM platform necessitates the formulation of a clear yet flexible digitization roadmap. Building on a sound data ‘bedrock’ is critical, establishing the right infrastructure and software platform to support smart, digitized information use and process efficiency. This foundation enables strategic compliance with evolving regulations and creates room for targeted adoption of AI and other technological advancements, ensuring the system’s relevance and value for at least the next five years.

Whether the strategic goal involves improved high-level decision support or leveraging Generative AI for routine, low-risk content creation, trust is paramount. Professionals must have confidence in the validity, quality, currency, completeness, and consistency of the information harnessed from the RIM system to effectively drive organizational goals.

Understand what you need from your RIM system and technology partner

Every RIM and content management solution, and technology partner, has its own features and benefits, and selecting the right fit will depend on the size and complexity of your organization as well as your future business goals.

Consider the following: As a pharma company, you don’t produce all the chemicals and machinery that go into the production of a drug. You select and assemble the best components to produce and deliver your product in the most cost-effective way. It’s the same for your technology solutions and partners. Should you expect a single vendor to provide a complete end-to-end solution that amazingly fits your unique needs when procuring a technology platform? No. It’s far more effective to define your requirements, and find technology and partners with their own capabilities, strengths, and experience that aligns with your needs, and all the vendors to concentrate on delivering a solution that is compliant with all regulatory requirements. Your technology vendor shouldn’t have to provide data assessment and migration services, a unique set of skills that are available from skilled specialists.

It’s critical to evaluate potential new technology and partners and understand what qualities you need in the full scope of the project including initial business process and data analysis, implementation and integration, data migration, and post-implementation support. Many decision-makers are swayed by a vendor that appears to offer a full end-to-end solution and services that seem to be packaged with all the associated services. But if those services are all designed around that company’s own product, how can they be sure they’re getting unbiased advice for a futureproof investment? That is an exceptional level of trust for such a large and business critical investment.

Instead of choosing a platform provider based on the promise of an end-to-end service, strategic companies choose knowledgeable and certified technology partners that are 100% focused on their unique business challenges and vision.

As an independent service provider, fme doesn’t have a vested interest in recommending any particular RIM or content management vendor or platform. fme’s consultative approach, specialist data services, and proven tools are designed to optimize the selection, delivery, and output of the system of choice. With proven strategies, fme helps companies navigate the complex minefield of vendors and technology options. Not only do we clarify and define your unique requirements, we have extensive experience with all the leading RIM platforms, along with deep insights into where these fit best relative to the type and size of the organization and its specific priorities. We help companies select and implement solutions that fit their needs in the short- and long-term, solving today’s challenges, manage and maintain those solutions as they grow, and establish a pathway for continual improvement as technology evolves.

Conclusion

Whatever your digitization objectives, fme’s business, technology, and content experts can help you assess and maximize the ROI of your plans. Whether you are planning a stand-alone project or incorporating an initiative within the context of other ongoing projects, fme can help you align your business strategy, technology, and priorities with your available resources, as well as platform vendors’ respective product roadmaps.

To discuss or analyze a current RIM project or transformation requirement, contact us. We’d love to learn your challenges and provide an independent perspective designed to amplify your business success.

Structured content authoring is transforming drug approvals processes

Structured content authoring is transforming drug approvals processes

Guest post by fme partner Maarten van Vulpen, Customer Success Manager, Fonto

In this dynamic, digital era – and in the context of expedited drug approvals processes, post pandemic – continued reliance on static, single-use Word documents to capture and publish or exchange critical information with Regulatory agencies makes no sense. It is hampering productivity, efficiency, compliance and visibility. Fortunately, there is a better way. Structured content authoring is already transforming drug approvals processes in Life Sciences.

In other industries, including the precision engineering and manufacturing-based automotive and aerospace industries, the automatic re-use of approved, structured content assets (fragments of approved text) is well established. Automatically generating onward documentation from a single source of approved content truth is the key to accuracy, reliability, and traceability as well as process efficiency.

And now Life Sciences, as it undergoes digital transformation, is beginning to recognize and reap equivalent benefits of structured content authoring (SCA) and automated content re-use, with a powerful impact on internal process efficiency.

There’s a practical imperative to this, too. In a bid to accelerate the approval of important drugs and make their own processes more efficient, health agencies are become more digital and dynamic in their information management and exchanges – an expectation they are passing on to drug manufacturers and license holders.

Yet, as long as these companies persist with Word/Excel/PDF based information and content management, they will only be creating more work for themselves in their efforts to keep up with those changing demands.

Driving new value from existing information with structured content

Pharma companies are already rich in regulated product information. The challenge is that much of this exists within single-purpose documents, dotted around different systems across the organization. This means that for each new purpose, teams have to go through protracted and laborious processes to locate, piece together, and seek approval for each new document use case – whether they’re generating a study report, submitting a new marketing authorization application, registering a product change, or updating labelling.

Structured content authoring tools like Fonto Editor strike right at the heart of this situation, transforming the way pharma subject matter experts (eg Clinical Trials, Regulatory, Quality or Safety teams) collate, publish, and manage vital drug information right across the product development, registration, and marketing lifecycle. Crucially, they are able to do this without having to brief out the content creation to technical writers, then check and approve their output. That’s because the SCA solution is intuitive for users, offering them a very familiar, Word-like experience, while building from content dynamic, reusable digital content assets.

Although there isn’t yet a single, agreed standard or schema for how documents should be constructed across Life Sciences globally, this will come in time and companies will be able to adapt to this relatively easily. That’s as long as they have got to grips with structured content authoring – and the immense scope for more reliable, efficient, and repeatable use of regulated information across a wide range of applications.

Transformation from the core

An obvious place to start in the adoption of SCA in pharma is the core data sheet, a key document representing the pharmaceutical company’s position on – and the definitive, correct, and current truth about – a product.

Once the core data sheet’s contents have been structured and stored as a series of digital content fragments, they can be flowed into a whole host of other documents including submission applications, reports, labels, and clinician/patient information, without risk of manual error – or the need for new rounds of internal content checks.

One of the top 5 pharma companies globally has already seen a 15% increase in productivity in processes linked to drug approvals, since adopting Fonto Editor to more automatically generate content that sails through internal checks.

By combining both Fonto and fme’s knowledge and experience with advanced ECM solutions, pharma professionals get several benefits. First, Fonto shields them from having to understand the ins and outs of XML formatting – a substantial win and time saver. Second, teams from across the drug lifecycle can gain seamless access to SCA capabilities from within their existing regulatory information management (RIM) platforms as a natural extension of their everyday work.

fme & Fonto: a formidable SCA partnership in Life Sciences

fme and Fonto share a strong pedigree in transforming Life Sciences content and data management, working together to integrate and embed SCA within companies’ Veeva, OpenText Documentum, or Generis CARA, or other systems. This means that relevant functional teams can shift to structured content management and authoring without having to learn to use new, separate tools.

For more details on structured content, Fonto has presented, and continues to present courses on the potential for structured content in Life Sciences via the Drug Information Association (DIA) – here’s a link to a recent session.

 

 

As the Life Sciences industry grows more serious about digital process transformation, fme has been highlighting the potential of SCA, too. In this post from fme’s Manuela Bernhardt, she explain that “Data is the heart of the business, whereas documents are the ‘packaging’ to create context”.

 

 

A dynamic pharma future needs structure

Over time, the opportunities for transforming content management processes through re-use of approved digital assets with at least some degree of automation will only grow. The regulators, as well as competitive market pressures, will demand it; meanwhile technology vendors like Veeva will continue to pave the way for powerful content re-use, as long as this is planned properly (for instance, with the support of RIM vendors like Veeva delivered through specialist Life Sciences partners like fme and Fonto).

To find out more about the potential for structured content authoring and management in your own organization, download this data sheet covering fme and Fonto offerings.

Click here to learn more about Fonto’s partnership with fme.

Or contact us to start the discussion today!

About the author

Maarten van Vulpen is customer success manager at Fonto, the leading solution in structured content authoring. This role gives Maarten the opportunity to discuss structured content authoring, its advantages and innovation with customers and potential customers from multiple industries, including life sciences. 

Join fme in Boston at the Veeva Summit: R&D and Quality

Join fme in Boston at the Veeva Summit: R&D and Quality

fme has been selected as a Gold Sponsor for the Veeva Summit: R&D and Quality for Boston this September, and we are looking forward to sharing our experience and strategies with the Veeva community. We enjoyed June’s European summit in Madrid, and are honored to be recognized in an elite group of certified partners invited to participate in the North American event.

We’d love for you to join us to explore how to leverage the power of the Veeva platform to achieve your business goals.

Join fme at the Veeva Summit!

fme specializes in the end-to-end implementation, integration, and support of the Veeva platform. At the summit our team of experts will be answering questions, discussing our capabilities, and proving how our partnership can guide organizations to new heights of efficiency and productivity. We will also be highlighting our newest offerings that deliver exceptional benefit to our Veeva clients:

  • fme PlatformAssist™ – A comprehensive set of modular building blocks that provide you with the unique end-to-end services needed for carefree post go-live management of your Veeva platform.
  • dqMan for Veeva Vault – Modeled after our popular dqMan for Documentum, our new version is focused on the specific requirements of Veeva clients, eliminating time-consuming and repetitive tasks and making admin and data management easy.
    If you are attending the summit, contact us and let’s set up a time to meet so you can get the most value from the summit.

If you are attending the summit, contact us and let’s set up a time to meet so you can get the most value while we’re there together.

Contact us to learn more

fme delivers the end-to-end knowledge and support you need to maximize the value of the Veeva platform. We’d love the opportunity to share our experience on how to best configure, utilize, and support Veeva for the unique challenges of your organization.

Contact us to schedule a personalized presentation aligned with your unique challenges. To schedule a discovery meeting with fme’s Veeva experts, reach out to our Global Sales Director René Rosenberg at r.rosenberg@fme-us.com.

Key topics for Life Science companies considering SaaS solutions

Key topics for Life Science companies considering SaaS solutions

Even in highly-regulated industries like Life Sciences, accessing key systems via the cloud, on a software-as-a-service (SaaS) basis, is rapidly becoming the default as consumer-based habits around everyday application use extend to the workplace. But what are the key considerations, and how do you choose a provider? Here are 5 common topics to focus on.

Businesses used to view cloud-based software and data hosting, along with subscription-based delivery (e.g., Software-as-a-Service, or SaaS, delivery models) with considerable caution. Concerns about risk to business continuity in the case of network or data center downtime; fears of supplier lock-in or security breaches; and questions about long-term cost of ownership seemed to undermine the promise of simplified IT management; improved speed of deployment; and more flexible access to systems and data beyond the office.
Today, cloud and SaaS-based system delivery is not only proven; it is fast becoming the norm. And this extends to strictly-regulated industries too, including Life Sciences.

The technology has matured considerably; networks/connections and backup provision are altogether more robust; service provider offerings have become incredibly sophisticated to appeal to corporate buyers; and the pace of technology advancement has accelerated to the point that the alternative – buying software and running and managing it on premise – no longer makes business sense in the majority of use cases.

As digital-native generations enter the workforce, and as employees generally become familiar and comfortable with using the cloud to store photos and documents in their personal lives via their smartphones and other devices, the appetite for cloud-based application access is growing too. The perception of risk associated with externally-hosted applications has greatly decreased, especially as built-in cloud security becomes increasingly sophisticated.

Despite users’ increasing comfort level when it comes to relying on hosted solutions in their day-to-day lives, there are some important considerations when deciding to move a business process to a cloud/SaaS platform.

Below are some of the considerations for business functions when making decisions related to cloud-based SaaS deployment:

1. Integration options

Although there is a general belief that cloud-based software makes it easier to connect and exchange data between applications, this isn’t a given. While it is possible to connect platforms through application programming interface (API) calls (a message sent to a server asking for information), those applications may not have an intensive library of calls, depending on the level of development investment the supplier is willing to make. Additionally, there can be barriers to implementing integrations like sharing security protocols or opening firewall ports where multiple suppliers are required to coordinate/cooperate with each other to enable the requested functionality.

2. Validation

In regulated industries like Life Sciences, software must be shown to be reliable in delivering what’s expected and to support patient safety, product quality, and data integrity. That means conducting risk-based testing and compiling as well as maintaining documentation proving that the software functions as designed and required.

In a cloud-deployed SaaS context, many software providers will include access to their validation package, even if there is a modest associated fee to access the associated scripts and documentation. In this context, the challenge of cloud-SaaS is the software functionality is subject to regular updates throughout the year, with customers largely at their mercy. Each update will require an impact assessment to identify any changes that will need to be made to existing configurations, as well as understanding new configurations that the business may wish to implement. Along with these changes, some level of validation will be needed, which requires involvement from internal teams.

The advice here is to:

  • Refrain from too much customization. Stay close to the out-of-the-box functionality, wherever possible. Choosing the best fit initially will help considerably here.
  • Check out the validation provisions ahead of time to avoid resourcing issues later.

It’s worth looking into associated documentation and training, too, as this can help users get up and running quickly and confidently using the new software. Best-case scenarios can be within a couple of months compared to 12-18 months for an on-premise deployment.

3. The risk appetite of the relevant business function

With so much security and trust built into cloud/SaaS services now, decisions about whether to embrace externally-hosted/subscription-based software access comes down largely to the risk appetite of the given business function. Often, the advantages substantially outweigh any negatives–reduced reliance on internal IT help and support, and faster access to the latest technology features are among the bigger pluses of choosing the cloud/SaaS route. Again, it is vital to perform an assessment of the preferred SaaS provider. It’s also a good idea to check whether your peers are among their customers, as this will provide useful clues to the supplier’s credentials in your sector.

4. Licensing/pricing and scalability models

One of the great appeals of accessing software through a SaaS model is the ability to spread costs, and to scale capacity with the needs of the business. But it’s important to examine the overall cost of ownership over time. Be sure to check the terms and conditions around price increases and clauses related to scaled demand. Many SaaS models offer tiered pricing depending on the role, where a read-only account has a different cost compared to an account that can create and edit content. So be sure to plan for the number of users you will need as well as the specific roles each user would require.

5. Ongoing support

This is something we’ll cover in a separate blog, but it’s important to at least mention here the importance of assessing what is provided for in the way of post ‘go-live’ support. Also, what that might look like in reality if you actually have to use it (something you can’t know in advance).
Direct vendor support might be fairly rudimentary, but there may be a certified partner that can bridge any gaps and provide a more tailored service that fulfils the business’s requirements.

Learn more

To find out about fme’s comprehensive SaaS consulting, implementation and support services, including our platform-assist offering, please contact us and and we’ll schedule a time to discuss your specific requirements.

Whitepaper: Essential Steps to a Successful Data Migration

Whitepaper: Essential Steps to a Successful Data Migration

As companies undergo significant changes and upgrade their core systems, ensuring the quality and usability of the data being migrated is paramount to unlocking the full potential of new technologies. We are excited to share practical tips and insights gained from decades of project experience in complex data migrations to help you achieve a smooth and successful transition. Read our Essential Steps to a Successful Data Migration whitepaper to gain invaluable knowledge to support your digital transformation journey.

In this paper we cover:

  • Realistic Scope of Data Migrations: One of the most common barriers to a successful data migration is failure to realistically and independently plan the time required to classify, migrate, and verify the data.
  • Effective Migration Project Phases: It is critical to break the data migration into logical phases that are aligned with the wider digital transformation initiative.
  • The Importance of Validation: Validating the migration is essential to ensure data can be recalled and relied upon as part of business processes, and requirements should be agreed upon from the outset.

Don’t wait – get this paper before your project starts!

In the rapidly evolving digital landscape, it is critical to get the most ROI from your technology investment. This paper outlines invaluable steps to ensure you achieve the full potential of your digital transformation by providing insights and practical strategies to navigate the complexities of data migration. Gain access to expert knowledge that will empower your organization to scope your project properly, craft an effective migration strategy, and plan for critical data validation after your migration. Download our whitepaper today and ensure the first step to unlocking the full potential of your digital transformation journey is successful.