DHSC: Medical Technology - Product Information Management Data Platform - Alpha phase

Description

Summary of work "The MedTech Data and Analysis Team within the Department of Health and Social Care have concluded an inhouse Discovery Phase for the Product Information Management (PIM) database. The next stage of the project is an Alpha Phase. During this phase we aim to explore and prototype solutions to our riskiest assumptions. These assumptions include ingesting an existing dataset, encouraging use of the solution as a single source of the truth, manufacturers taking responsibility for their data to correct errors and maintain data quality, and to explore options for the long term development and maintenance of the prototyped solution. We expect this solution to help make data sharing between manufacturers and NHS trusts less time consuming and to encourage the maintenance and use of consistent and accurate data. The solution should be able to ingest, process, clean, and make available the existing dataset of medical products that will be provided to prototype. Users should be able to use this solution to view the data, search for records, apply filters, export the information, and flag any information that they believe to be wrong. This solution aims to act as a reference point for core information on medical products for health system users. The problem that we aim to solve is the currently inefficient data sharing process between manufacturers and trusts and the lack of accessible, consistent data on products. Currently the data on MedTech products is often of poor quality and is dispersed throughout the healthcare system. Products have a range of characteristics which can make comparisons difficult and as there are over three million medical products registered for use in the UK and about 10,000 registered manufacturers, data fragmentation can lead to significant inefficiencies for NHS Trusts who often make multiple and repeated requests to companies for information. Having a national, unified solution should help to provide accurate, clean product data that is aligned to data standards. " Where the supplied staff will work No specific location (for example they can work remotely) Who the organisation using the products or services is Department of Health and Social Care Why the work is being done This work is being done to improve the accessibility and quality of medical product data that is dispersed throughout the healthcare system in the UK. This is one of the aims of the Department of Health and Social Care's Medical Technology Strategy (https://www.gov.uk/government/publications/medical-technology-strategy) and particularly of Priority 3 (Enabling Infrastructure). The need for this work has been emphasised repeatedly in our discussions with relevant stakeholders such as NHS Trusts, the MHRA, NHS England, and the wider MedTech industry. A shared reference system for exchanging product data will help support the supply chain, patient safety and inventory management needs of NHS Trusts. Making high quality, trusted, key medical product information more widely available will also support the healthcare system to meet other initiatives. For example, the upcoming NHS England Medical Device Outcome Registry initiative that aims to more comprehensively track devices that are implanted into patients. Similarly, this work will help Trusts meet NHS information standards like DAPB4004 (https://digital.nhs.uk/data-and-information/information-standards/information-standards-and-data-collections-including-extractions/publications-and-notifications/standards-and-collections/dapb4004-global-medical-device-nomenclature-gmdn). The work also aligns with the 'collect once, use often' approach to data as recommended by the Independent Medicines and Medical Devices Safety Review (https://www.immdsreview.org.uk/Report.html) and will help bring the UK MedTech system in line with international efforts, as both the USA (https://accessgudid.nlm.nih.gov/) and the EU (https://ec.europa.eu/tools/eudamed/#/screen/search-device) have launched similar solutions. A further description of how PIM aligns with wider government priorities can be found in the attached discovery report. The business problem Currently, the approach for sharing information about medical products in the health system is inefficient and leads to poor quality data. NHS Trusts often collect this information individually at a local level and MedTech manufacturers have to respond to multiple requests for the same information. It is dispersed throughout the system. This information is often shared manually (e.g. emailing Excel files) which means it can easily become wrong, out-of-date, or inconsistent with other sources. This means that there is no standardised way of referring to a product or the category it belongs in as different users in the health system often refer to the same products in different ways. Overall, it is a burden for the health system to provide, manage, and use medical product information. The inaccurate and incomplete data collected poses a risk to patient safety and effective procurement and administrative processes There is a risk that manufacturers will not correct or verify the quality of their data which would restrict the usefulness of the proposed solution as trusts would have limited reason to trust and use the data. The people who will use the product or service User type: Manufacturer of medical devices in the UK Definition: As a manufacturer of medical devices in the UK, I need to share information about my products so that NHS Trusts have the correct information to procure them User type: Data systems lead in an NHS Trust Definition: As a data systems lead in an NHS Trust, I need to have accurate product information that updates automatically so that I can use this information in other systems (e.g. finance, electronic patient record). User type: Procurement lead in an NHS Trust Definition: As a procurement lead in an NHS Trust, I need to be able to understand the characteristics of different products so that I can understand what I am buying and can identify alternatives. User type: Patient safety lead in an NHS Trust Definition: As a patient safety lead in an NHS Trust, I need to know about the products being used in my Trust so that I can track product recalls, meet national initiatives like Scan4Safety, and my patients can have confidence in the products being used. User type: Analyst in a national body like NHS England/MHRA/DHSC Definition: As an analyst in a national body like NHS England/MHRA/DHSC, I need to have accurate product information that can be easily exported so that I can join product information with other datasets, analyse the market, and understand patient safety trends. User type: A patient Definition: As a patient, I need to be confident that the information about key products used on me is correct so that I can remain safe. For example, I may want to check whether a device that has been implanted in me is safe for if I have an MRI. Any pre-market engagement done As part of our discovery phase, we have spoken to external stakeholders who have been involved in developing and maintaining similar product information systems. This was to understand the steps taken, potential challenges, and likely costs. This engagement has helped to refine the scope and requirements for the alpha phase. Work done so far We have completed an in-house discovery phase which involved speaking with over 25 stakeholders from across the health system to better understand user characteristics, needs, and journeys. This included representatives from NHS Trusts (patient safety, procurement, and clinical engineering teams), MHRA, NHS Scan4Safety, NHS Supply Chain, NHS England Medical Device Outcome Registry, NHS Digital, devolved governments and health bodies, manufacturers, and medical device data bodies. This has involved a mix of interviews, focus group sessions, site visits, calls for information, and resource sharing. The key question asked during discovery is ""How can we make basic information about medical products more available and of better quality?"" Key findings: 1. Multiple stakeholders have already collected a range of data about medical products. The discovery phase showed that it would be more efficient to use and clean an existing dataset as opposed to trying to start from scratch. We expect this existing dataset that will be used to contain about three to four million records, with this increasing over time. 2. The importance of having a focused scope. While there are many data fields that would be useful for users, the focus should be on the most important core pieces of information (about 15 data fields - more detail found in the discovery report). Most of these are static pieces of information (they should not change over time) which is preferred compared to including dynamic information (e.g. a product's price) as this would significantly increase the complexity and risk of any system. 3. The importance of having an automated transfer of data and for any solution to be integrated into other systems. This is to ensure that the information becomes a shared reference point and is widely used. Part of this is about using open and accessible data standards so that a range of stakeholders can effectively use any future system. Several existing systems have struggled to share data effectively due to a lack of open standards and siloed legacy systems. 4. Data quality is key. Without a clear process for validating and improving the quality of information, users will not engage with any solution and it risks repeating the existing inefficient approach. Many stakeholders have also emphasised the importance of a 'collaborative curation' approach to data quality. This involves users being able to notify the system of potential data issues, which can then be fixed at source. This compares to the current approach where improvements are made in one dataset but not elsewhere, thereby creating greater inconsistencies. Constraints: 1. Legacy technology being used by several external stakeholders means that the ability to efficiently and automatically share existing data is limited. As these systems are currently being upgraded (separate to this work), there is a changing technological context for this work which means there is uncertainty in the most suitable approach to take. One of the key alpha requirements will be to identify the most suitable short- and long-term approach for linking with other data systems. 2. The current process for cleaning and updating data is manual, inefficient and repeated unnecessarily by different users. One of the main benefits of developing a national system is for improvements to be made once and for all users to benefit from them. A requirement of this alpha work will be to understand the data model, data flows and data mastery and identify suitable ways to minimise this constraint so that improving the quality of existing data is as easy as possible. The following additional documents are attached: 1. Discovery report - provides additional detail of the findings from our discovery work to complement the material included in the advert. It describes the problem, aims of our proposed solution, our view of long term success, outputs we expect from alpha, user stories and learnings from others. 2. Intro to PIM slides - these are slides historically used for onward sharing to new and interested stakeholders to briefly summarise the key features of the proposed PIM including reference to the data fields. Which phase the project is in Alpha Existing team The existing DHSC team consists of a strategic lead, stakeholder manager, and data analyst. The existing DHSC team will put the supplier in contact with subject matter experts and key stakeholders from across health system. This includes colleagues from the MHRA who will be closely involved, particularly in areas including understanding data flows and providing architecture assurance. This alpha phase does not involve working with another supplier. Address where the work will be done Work can be undertaken remotely. The DHSC team is based at 39 Victoria Street, Westminster, London, SW1H 0EU. Working arrangements The supplier's staff will be expected to be available during the typical working hours of Monday to Friday (9.00am to 5.00pm) to maximise collaboration and knowledge sharing. We require the supplier to conduct the usual agile ceremonies, weekly updates, 'show and tell' workshops, and any additional sessions as required. A supplier that can help develop the internal teams project delivery is also preferred. This will include producing resources and documentation of work undertaken to provide a clear record of what has been done and decisions made. There will be clear and continual communication between the supplier and the DHSC team to ensure a joined-up approach is taken. Sessions will take place remotely unless otherwise agreed. The supplier can ask to meet the DHSC team in person if they require, at their own expense. Security and vetting requirements Baseline Personnel Security Standard (BPSS) Latest start date 1 April 2024 Expected contract length Contract length: 0 years 2 months 0 days Optional extension: 0 years 1 months 0 days Special terms and conditions special term or condition: All expenses must be pre-agreed between the parties and must comply with the Cabinet Office (CO) Travel and Subsistence (T&S) Policy. DHSC reserves the right to terminate the agreement where the supplier has not met the deliverables set out in the agreed statement of works. DHSC will retain ownership of the intellectual property rights created during the contract. Budget Indicative maximum: £400000 Indicative minimum: The contract value is not specified by the buyer Further information: The maximum budget is for the Alpha deliverables only. Contracted out service or supply of resource? Contracted out service: the off-payroll rules do not apply Terms and acronyms Term or acronym: MedTech Definition: Medical technology (e.g. products used in healthcare, such as pacemakers, syringes, MRI machines) Term or acronym: MHRA Definition: Medicines & Healthcare products Regulatory Agency Term or acronym: DHSC Definition: Department of Health and Social Care Term or acronym: NHSSC Definition: NHS Supply Chain Term or acronym: PIM Definition: Product Information Management Term or acronym: UDI Definition: Unique device identifier (applied to a medical product) Term or acronym: GMDN Definition: Global Medical Device Nomenclature Term or acronym: NETIS Definition: National Equipment Tracking Information System Term or acronym: MDOR Definition: Medical Device Outcome Registry Term or acronym: ABHI Definition: Association of British HealthTech Industries Term or acronym: PQP Definition: Price per quality point (PQP) is an evaluation technique designed to fairly compare bids of varying quality and price. PQP is calculated for each bid by - determining the quality score for each bid, expressed as a whole number rather than as a percentage - dividing the bid price by the quality score to give an output price per quality point. We will be using PQP to evaluate submissions at Stage 2 rather than the 50%/20%/10%/20% split that the DOS forms force us to select. More information will be supplied at next stage