ANALYSIS: Health Technology Assessment Tools
Written by Preetinder S. Gill
Many different definitions exist for health technology assessment (HTA). US Congress’s Office of Technology Assessment defines HTA as a structured analysis of a health technology, a set of related technologies, or a technology-related issue that is performed for the purpose of providing input to a policy decision. The European Observatory on Health Systems and Policies describes HTA a form of policy research that systematically examines the short and long term effects of a health technology or a set of related technologies. HTA can be initiated by any stakeholder of the healthcare system – policy makers, patients’ groups, providers, payers and health care managers in order to evaluate efficacy and effectiveness of 1) a new technology, 2) improvement to an existing technology or 3) change in the operating conditions of a technology. HTA can also encompass economic (cost-benefit) analysis. Additionally, HTA can assess concerns related to safety and ethics. Simply put HTA is decision making tool which systematically analyses effects of technology.
Despite the existence of many definitions of HTA there seems to be a consensus about two keywords: 1) requirements [of stakeholders] and 2) effects [of the technology(ies)]. There are two tools – quality function deployment and failure mode effect analysis – which are employed by product engineers that can be applied to these keywords.
Quality function deployment (QFD) is method widely used in product engineering. QFD is a methodology which is used to transform customer requirements into the design of a system. The QFD ensures that emerging functions of subsystems and components fulfill all the implicit and explicit requirements of the customer.
Failure mode effect analysis (FMEA) is a tool used to identify, rank and mitigate risks. Essentially FMEA involves assessing: 1) severity of a failure mode, 2) likelihood of occurrence of the causes of the failure mode give the preventive measure in place and 3) likelihood that a failure cause or the associated failure mode can be detected given the detection measures in place. This tool was first introduced by the US Military, standard # MIL-P-1629, back in late 1940s. This tool is currently used extensively in many industrial sectors. Joint Commission on Accreditation of Healthcare Organizations’ introduced standard Req. L.D. 5.2 for Health-FMEAs in July 2001.
It must be noted that both QFD and FMEA require teamwork between stakeholders with expertise in different fields. Hence, the importance of the role a team plays in the successful application of these tools cannot be emphasized enough. The QFD and FMEA can be combined in a novel way, described below, in order to supplement the HTA process.
Functional Analysis In HTA
Functional analysis (FA) in HTA must start with formation of a cross-functional team. Typically the core team could have 4 to 7 members who are facilitated by a neutral moderator. Besides the core team members specific subject-matter experts could be invited to meeting sessions, as needed. The four step FA process is described below:
1. The first step of the functional analysis involves collecting the requirements associated with the technology(ies) being assessed. The requirements come from four sources: 1) users/patients, 2) operators/staff, 3) internal guidelines and, 4) regulatory demands. The FA team can research various documents for example product brochures, existing research studies and historical data to identify these requirements. Additionally, the team can brainstorm to identify any requirements which were not found in the literature review. Regulatory demands pertaining to the three types of liabilities: manufacturing defect, design defect and a failure to warn/marketing defects must also be considered as requirements imposed on a technology(ies). The traditional HTAs involve evaluation of effectiveness, efficacy, safety and cost analysis. Hence, they only tend to cover the first two sources of requirements. The FA approach thus, could include additional requirements in the assessment process.
2. The second step involves decomposing the technology being assessed in sub-modules. To illustrate this step let’s consider a hypothetical glucose monitoring device. The overall assembly could be broken in following sub-modules: blood collecting unit, sensing unit, conversion unit, display unit, memory unit and communication unit. The display unit can be further broken down into the following components output port, input port and LED display among others.
3. In the third step the FA team lists the functions for the overall assembly (the technology being reviewed) and the sub modules and components involved. These functions then need to be connected in a means-purpose relationship. In other words relationships need to be defined between each function of sub-module/components and functions of the higher level assembly. The functions of the overall assembly then need to be connected to the requirements identified in step 1. Software such as APIS Informationstechnologien GmbH’s IQ-RM can be used to complete this kind of function analysis.
4. In the fourth step the team checks functional net associated with each requirement to assess whether or not every requirement is satisfied by the functions of the technology being reviewed. Further, the team can identify whether there are functions which don't seem to be associated with any requirement. This could in turn highlight any unintended effects of the technology being reviewed.
Team can quantify FA in terms of the Technology Assessment Score (TAS). TAS is a multiplicative product of three factors: importance, coverage and confidence. In order to calculate the TAS the team can assign each requirement an importance score on a scale of 1 to 10 where 10 is the highest importance. The coverage score of each requirement quantifies how well a particular requirement is fulfilled in terms of the functions of the overall assembly (the technology being reviewed). The team can assign the coverage score to each requirement on scale of 1 to 10 where 10 means perfectly covered requirement. The confidence score quantifies the level of understanding and comfort of the FA team with regards to the technical modalities of the various functions of the overall assembly (the technology being reviewed). In other words a new technology with novel functions will tend to have lower confidence scores whereas well tested and extensively understood functions will tend to have higher confidence scores.
Additionally, in assessing the confidence score the team must consider the underlying sub-functions. The confidence can be also be rated on the scale of 1 to 10 where 10 means absolute confidence. It must be noted while the importance and coverage scores are assigned to each requirement the confidence score is assigned to each function of the overall assembly (the technology being reviewed). The TAS for each requirement is calculated by simply multiplying its importance score, its coverage scores and the lowest confidence score associated with the specific requirement.
A novel technique adapted from well know product engineering tools - QFD and FMEA – is presented. The healthcare managers and policy makers can use the FA approach for HTA supplement to their decision making by leveraging their team’s expertise.
The FA approach also provides a readily available knowledge base which can be used for quantitatively comparing various technologies. The FA documents can also be used to educate new employees about the workings of components which constitute a specific technology. Lastly, the FA approach can be used as tool for continuous improvement where lessons learnt from one analysis cycle can be applied to next cycle.
Medical device companies: how to prepare for Brexit
Over the last decade, medical device businesses have been no strangers to regulatory changes and new compliance requirements. Companies with devices in the EU market have been working hard to achieve conformity with the requirements of the EU Medical Device Regulation 2017/745 (MDR) and In Vitro Diagnostic Regulation 2017/746 (IVDR), but the UK’s exit from the EU, effective as of 1st January 2021, demands yet another change: to comply with the new UK regulatory regime.
The Medicines and Medical Devices Act passed into law on 11 February 2021 does just that; it enables the UK to build its own regulatory system, although when this new framework will be fully in place is not yet known.
The transition to the UK’s new regulatory regime officially began on the 1st of January 2021, and with it a series of deadlines and phases that medical device manufacturers exporting to GB and Northern Ireland would do well to take close notice of. During the transition period, the UK Medical Devices Regulations (UK MDR) 2002, not to be confused with the EU MDR, will continue to apply in England, Scotland and Wales, whilst CE marked medical devices will still be accepted up to 30th June 2023.
The conformity assessment processes defined in the UK MDR 2002 (as amended) will require that medical devices carry the UKCA mark for entry in the GB market or the UKNI mark for entry in Northern Ireland (where the devices are not CE marked for the EU). In Northern Ireland, where the rules for placing a device on the market differ, the EU MDR and IVDR will apply in 2021 and 2022 respectively, in line with the EU’s implementation timeline.
This easing-in period of transition is valuable time that should be used productively by manufacturers to ensure that they get up to speed, keep up with relevant updates and prepare strategies and product portfolio for the next phase. To do this, businesses should make sure they consider the following areas as they assess their strategy for UK market access:
Potential Overlap with EU MDR and IVDR
Medical device manufacturers have been working to implement measures to ensure they comply with EU MDR and IVDR for quite some time. The experience, processes and objective evidence that they have gathered in these efforts are certain to be of use when applying for UKCA marking.
Product portfolios and new product pipelines should be evaluated against both overall compliance risk and commercial and strategic value. By identifying the regulatory compliance status for each product for the UK market and the efforts required to maintain that compliance, manufacturers can plan to use the grace period up to June 2023 to complete their activities. These plans should also be evaluated in consideration of the commercial importance of the individual products to help prioritise the workload. This may well result in the decision to discontinue certain products in the UK or to introduce new products on the UK market ahead of other markets.
Engage with Approved Bodies
This activity cannot take place too soon; as of the 1st of January 2021, UK organisations that were acting as EU Notified Bodies have become Approved Bodies in the UK, while EU Notified Bodies are no longer able to provide conformity assessments under the UK regulations. As there are currently only three UK Approved Bodies offering this service, there is a very real risk that latecomers will struggle to find a UK Approved Body to carry out the conformity assessment required to attain their UKCA mark in time.
Just as EU Notified Bodies are no longer relevant to pursuing UK certifications, UK-based Authorised Representatives are no longer valid when CE marking against the MDR or IVDR. Manufacturers using UK-based EU Authorised Representatives must switch to an EU-based Authorised Representative.
For the UK market, the role of the EU Authorised Representative is also no longer applicable. Non-UK manufacturers must have a UK-based Responsible Person (UKRP), which is equivalent to the EU Authorised Representative in terms of roles and responsibilities. Only one UKRP may be appointed, unlike EU Authorised Representatives, and they must have a registered place of business in the UK in order to register with the MHRA. Approved Bodies may be able to provide details of organisations acting as UKRPs and once this role has been assigned it will be critical for manufacturers to determine exact procedures for managing documentation and that clear communication channels are established.
Labelling and Import/Export
New UK regulations require that medical devices bear a UKCA mark in addition to the name and address of the UKRP for non-UK based manufacturers. Manufacturers who use the same products/packs for the EU and UK markets will need to consider the impact of adding more content to their labels in terms of usability for the supply chain and end-users.
While CE marking and certificates will continue to be recognised by the UK until June 2023, import/export administration is likely to change and become more burdensome. Manufacturers using separate products for GB (UKCA) and the EU and Northern Ireland (CE marked) will need to plan for how to ensure that the CE marked product is not shipped to GB post June 2023. Ensuring that processes and resources are in place to deal with developing situations will help manufacturers hit the ground running.
Many businesses will find that clinical investigations are carried out across multiple sites, some of which are outside the UK. In these instances, manufacturers will do well to have a plan for implementation and management of investigations, in compliance with local requirements. It is likely that the MHRA will also continue to update their requirements for clinical trials in the UK.
Data Protection and Standards
New tensions are emerging between the EU and the UK concerning UK data protection rules and the EU’s General Data Protection Regulation (GDPR), suggesting that maintaining ‘equivalency’ may involve a number of different phases.
Compliance with applicable standards also requires close attention; the list of designated standards for medical devices issued by the UK’s Department for Health and Social Care is based on the list of harmonised standards published in the Official Journal of the EU, which in turn are harmonised to the MDD, AIMDD and IVDD. More recently published standards, however, have not been harmonised to the latter European directives and are thus not in the UK’s designated list, despite being considered state of the art. It would be prudent for manufacturers to monitor the state-of-the-art standards and apply where applicable, rather than rely on superseded and outdated standards.
As the UK moves into a new regulatory regime, medical device manufacturers who have already invested time and resources to comply with EU MDR and IVDR can use this to attain their UKCA mark. However, a dynamic compliance environment combined with the new onus relating to export policies means that close attention needs to be paid on numerous fronts. Keeping pace with this changing environment will ensure that manufacturers face the future with confidence and do not lose important space on their markets.