The HTA process for medical device evaluation
Health Technology Assessment (HTA) for medical devices is a comprehensive, systematic evaluation process that examines the medical, social, economic, and ethical implications of introducing and using a medical device. The goal of HTA is to gather and synthesise evidence to inform policy and decision-making in healthcare to ensure that new technologies provide value and are effectively integrated into health systems.
Defining the technology to be assessed, the purpose of the assessment, and the key questions to be addressed. The first step in HTA is identifying and defining the health technology to be assessed. This involves specifying the scope of the assessment, which includes:
- Defining the Technology: Clearly describing the health technology, including its intended use, target population, and mode of action.
- Determining the Purpose: Establishing the objectives of the HTA, such as evaluating the clinical effectiveness, cost-effectiveness, safety, or social impact of the technology.
- Setting the Boundaries: Outlining the scope of the assessment, including the key research questions, outcomes of interest, and the context in which the technology will be evaluated.
Collecting data from various sources, including systematic literature reviews, clinical investigations, economic models, and expert opinions.
The clinical effectiveness assessment evaluates the health technology’s impact on health outcomes. This includes:
- Efficacy vs. Effectiveness: Differentiating between the efficacy (performance under controlled conditions) and effectiveness (performance in real-world settings) of the technology.
- Comparative Effectiveness: Comparing the health technology with existing alternatives or standard care to determine its relative effectiveness.
- Meta-Analysis: Conducting meta-analyses to statistically combine results from multiple studies and derive pooled estimates of the technology’s effects.
Assessing the safety of the health technology is crucial to understanding its potential risks and adverse effects. This involves:
- Adverse Event Reporting: Reviewing data on adverse events, complications, and side effects associated with the technology.
- Risk-Benefit Analysis: Weighing the potential risks against the expected benefits to determine the overall safety profile of the technology.
- Post-Market Surveillance: Considering data from post-market surveillance studies and registries to capture long-term safety information.
Economic evaluation is a critical component of HTA, assessing the cost-effectiveness of the health technology. This includes:
- Cost Analysis: Estimating the direct and indirect costs associated with the technology, including acquisition costs, implementation costs, and ongoing maintenance costs.
- Cost-Effectiveness Analysis (CEA): Comparing the costs and health outcomes of the technology with those of alternative interventions, typically expressed as cost per quality-adjusted life year (QALY) gained.
- Budget Impact Analysis (BIA): Evaluating the financial impact of adopting the technology on the healthcare budget, considering factors such as patient population size and adoption rates.
- Sensitivity Analysis: Conducting sensitivity analyses to assess the robustness of the economic evaluation results to variations in key assumptions and parameters.
HTA also involves evaluating the social and ethical implications of the health technology. This includes:
- Social Impact: Assessing how the technology affects patients’ quality of life, access to care, and social inequalities.
- Ethical Analysis: Considering ethical issues related to the technology, such as informed consent, patient autonomy, and equity of access.
- Stakeholder Engagement: Engaging with patients, healthcare providers, policymakers, and other stakeholders to understand their perspectives and address their concerns.
Compiling the findings into a comprehensive report that includes recommendations for policymakers, healthcare providers, and other stakeholders.
- Conclusions and Recommendations: Formulating conclusions and recommendations based on the synthesised evidence, considering the overall benefits, risks, and costs of the technology.
- Transparency and Clarity: Ensuring that the report is transparent, clearly presenting the methods, results, and limitations of the assessment.
The final step in the HTA process is disseminating the findings and supporting their implementation. This includes:
- Publication and Communication: Publishing the HTA report in scientific journals, presenting findings at conferences, and communicating results to stakeholders.
- Guidelines and Policies: Using the HTA findings to inform clinical guidelines, healthcare policies, and reimbursement decisions.
- Monitoring and Evaluation: Monitoring the implementation of the HTA recommendations and evaluating their impact on healthcare practice and outcomes.
Review HTAs for applicability to a certain context:
- Clinical Effectiveness: Check the reported outcomes and measures of clinical effectiveness. Are they relevant and accurately presented?
- Economic Evaluation: Assess the cost-effectiveness analysis. Are the cost models and assumptions reasonable and well-explained?
- Safety and Risks: Evaluate the assessment of safety and potential risks. Are all possible risks adequately considered?
Check for Transparency:
- Clear Reporting: Ensure the HTA is transparent in its methods and findings. Can the study be replicated based on the provided information?
- Conflict of Interest: Review disclosures of any potential conflicts of interest among the authors or sponsors.
Check for Quality and Bias:
- Use Standard Quality Tools: For economic evaluations, utilise standard appraisal tools like the Quality Assessment of Diagnostic Accuracy Studies (QUADAS), the Cochrane Risk of Bias tool, or the Drummond checklist.
- Evaluate studies for overall risk of bias
Evaluate the Conclusions:
- Validity of Conclusions: Determine if the evidence presented supports the conclusions.
- Recommendations: Review any recommendations made. Are they practical, feasible, and based on solid evidence?
Context and Relevance:
- Applicability: Consider the relevance of the HTA to the current healthcare context and its applicability to the intended population.
- Policy Implications: Assess the potential impact of the HTA on policy and practice.
Peer Review and Expert Opinion:
- Seek Opinions: Get feedback from peers and experts in the field to ensure a comprehensive review.
- Compare Reviews: Compare the HTA with other similar assessments to check for consistency and robustness.
Resources
MedDev Central Academy:
MedDev Central Knowledge Hub:
- 2015 Global Survey on Health Technology Assessment by National Authorities
- Health technology assessment of medical devices, WHO medical devices technical series, 2011
Budget Impact Analysis (BIA): A financial assessment tool used to estimate the cost implications of adopting a new healthcare intervention within a specific budget context over a defined time period.
Clinical Context: The specific medical conditions, patient populations, and healthcare settings in which a device is intended to be used, influencing its design, functionality, and regulatory requirements.
Clinical Evaluation: A methodologically sound ongoing procedure to collect, appraise, and analyse clinical data about a medical device and to verify its safety and performance, including its clinical benefits. Also see Clinical Investigation.
Clinical Guideline: A systematically developed statement to assist healthcare practitioners and patients in making decisions about appropriate healthcare for specific clinical circumstances.
Cost-Effectiveness Analysis (CEA): A method of evaluating healthcare interventions by comparing their costs in relation to their health outcomes, typically measured in terms of cost per unit of health improvement gained.
Cost-Benefit Analysis (CBA): A technique for assessing the financial feasibility of interventions by comparing their costs and benefits, where benefits are expressed in monetary terms.
Cost-Utility Analysis: A type of economic evaluation that compares the costs of healthcare interventions to their outcomes in terms of quality-adjusted life years (QALYs) gained, providing a measure of health-related quality of life.
Economic Evaluation: The evaluation and analysis of the costs and consequences of using a medical device or intervention, often comparing different options to inform decision-making. This may also be called an Economic Assessment.
Healthcare Professional: An individual trained and licensed to provide medical care, treatment, and advice to patients, encompassing a range of roles such as physicians, nurses, pharmacists, and allied health professionals.
Healthcare Provider: An individual or organisation licensed or otherwise authorised to deliver medical, nursing, dental, or other healthcare services to patients or clients.
Health System: The organised network of institutions, resources, and people that deliver healthcare services to meet the health needs of a specific population.
Health Technology: The application of organised knowledge and skills in the form of devices, medicines, vaccines, procedures, and systems developed to solve a health problem and improve quality of lives (WHO definition).
Health Technology Assessment (HTA): A systematic evaluation of the properties, effects, and impacts of health technology, such as medical interventions, pharmaceuticals or medical devices, to inform healthcare decision-making.
Payer: An entity or organisation, such as an insurance company or government agency, responsible for reimbursing or funding healthcare expenses related to using health technologies.
Regulation: The rules, laws, standards, and requirements set by regulatory authorities to ensure the safety, efficacy, and quality of devices intended for medical use.
Reimbursement: The process of receiving payment from insurers, government health programs, or healthcare facilities for the use of medical devices in patient care.
Safety: The condition of being protected from or unlikely to cause danger, risk, or injury.
Sensitivity Analysis: The process of evaluating how the variation in the output of a model can be attributed to different variations in the input parameters.
Stakeholder: Any individual or group with an interest or influence in the delivery, outcomes, or policies of healthcare services.
Systematic Review: A structured and comprehensive synthesis of research studies that aims to identify, select, assess, and summarise the findings of all relevant individual studies on a particular topic.
Universal Health Coverage (UHC): Ensuring all individuals and communities receive the necessary health services without suffering financial hardship.
World Health Organisation (WHO): A specialised agency of the United Nations responsible for international public health.