Supporting your move to Electronic Instructions for Use (eIFU)
Digitise your product information to reduce operating costs, improve the interactions with your end users, optimise your supply chain, drive your sustainability agenda, and support safer and more progressive patient care.
The challenge
When it comes to improving end user safety and experience, Medical Device companies are increasingly embracing digital solutions, including Electronic Instructions for Use (eIFU).
For busy practitioners working with medical devices, often in sterile environments, searching through paper Instructions for Use is impractical, and at times, dangerous. They need fast, up-to-date information, in an easily searchable and accessible format, but the existing paper solutions are not only physically difficult to handle but can take up to 6 months to update (1) offering limited, flat information.
Regulators are starting to tackle the issue, moving to a position where it will be permissible for manufacturers to provide more digital information for all medical devices.
The most proactive manufacturers are already one step ahead of this regulatory trend, and the benefits they’re identifying by implementing eIFU go far beyond improving practitioner safety and experience. Those leading the way in the industry are seeing substantial cost savings in their Operations and Supply Chain functions as well as a real boost to their sustainability efforts.
The solution
Whilst the benefits of eIFU are clear, it can be a challenge to know where to start. Many Medical Device manufacturers operate on a business unit model, and it can be unclear how to drive and coordinate these changes in such an organisational construct. But wherever you are on your eIFU journey we are here to help and have strong experience of driving these programmes for our clients.
We offer a full end-to-end eIFU solution, with our services underpinned by Deloitte’s proprietary platform, helping to accelerate your transformation. From crafting a compelling business case, to reimagining your operating model and implementing your eIFU solution, we can work with you every step of the way.
Our Medical Device industry experts will work alongside you, providing guidance through the evolving regulatory landscape, identifying and unlocking sustainability opportunities, and leveraging deep sector knowledge to keep you ahead of the curve.
Benefits
Drive sustainability agenda
eIFU often starts as a sustainability topic but needs to driven in collaboration with the Operations and Supply Chain function to ensure all benefits are realised. With many existing IFU paper solutions taking the form of large booklets, a complete switch to eIFU could save larger companies over 6000 tons of paper per year (1) and dramatically reduce energy consumption during transportation. We work with you to harness all available opportunities to meet sustainability targets.
Long-term cost reduction
Reducing paper leaflets and moving to eIFU will ensure significant cost reductions by saving on printing and distributing. We will work with you to optimise your supply chain, helping you to manage your stock and the grouping of your products more effectively and have more control over the whole product lifecycle.
Accelerate transition to structured data
In order to have more than a simple PDF on a webpage, we use generative AI to transform any of your semi structured eIFU data or unstructured documents (e.g. pdf) into FHIR data (a structured, health data format) correctly aligned to industry systems. This is all controlled under Deloitte’s AI governance and risk management frameworks and accelerates transition to structured data, meeting FHIR specifications.
Fast implementation
We offer a suite of pre-built accelerators, ready for immediate deployment. We bring together leading technology organisations to build and deliver robust solutions that align to your strategic technology imperatives.
Access industry expertise
Our solutions are built by our Medical Device experts, and our regulatory experts will help you navigate the evolving regulatory landscape and stay up to date with all the latest requirements.
Better user experience
End users can access up-to-date information easily on their medical devices anytime, anywhere, and in any language they choose. We work with you to understand what additional information may be needed in a digital format, such as explainer videos, demonstrations, or service manuals to ensure the product is safely maintained.
Analytics and insights
Our data will show valuable insights into eIFU usage, such as sections viewed most, to improve content and products, and get a better understanding of how, where and when the device is used.
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How we can help
We offer a comprehensive end-to-end transformation service; however, we recognise that every business has unique requirements. We will collaborate with you to understand your specific needs and tailor our approach with flexible, modular options.
1. Strategy and business case
We collaborate with you to develop a compelling business case for adopting eIFU, outlining the advantages and value it brings to your organisation – either at the enterprise level, within an operating unit, or at the product level.
2. Prototype and concept work
We help you visualise the potential of eIFU for your specific needs. Through insightful analysis and demonstrations, we illustrate how eIFU can integrate seamlessly and effectively within your operational framework.
3. Operating model transformation
We create and design new or enhanced structures, capabilities, and operational processes, transforming the vision of eIFU into a tangible reality.
4. Implementation and scale
We provide comprehensive support for the Global Enterprise-wide implementation of eIFU solutions. Our services span detailed design, robust system development and integration, global roll-out, and associated training and mobilisation.
5. Migration
We manage the complex process of migrating your diverse global product information data – which can be tens of thousands of documents for larger manufacturers, to the FHIR standard, and ensure it generates eIFU to deliver your product information in the best way for the end user.
6. Running your eIFU solution ‘As a Service’
We can go beyond design and implementation and offer comprehensive management services for your eIFU solution, encompassing analytics, ongoing support, service and content updates, and QA services.
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