Introduction
Health Technology Assessment (HTA) is a multidisciplinary process that evaluates the clinical, economic, social, and organisational impacts of health technologies, including medical devices. While much attention is often given to clinical effectiveness and cost-effectiveness, the organisational aspects of medical devices are equally critical, especially for payers and health systems looking to adopt technologies that fit within existing infrastructures.
Why do organisational aspects matter?
Organisational aspects refer to the infrastructure, human resources, workflows, and training requirements to safely and effectively adopt a medical device into healthcare practice.
Healthcare providers may need to make changes to incorporate a new device, including:
- Changes in staffing, training or skill requirements
- Build or buy new facilities or equipment
- Clinical workflow adjustments or disruptions
- Adapt maintenance and supply chain logistics
- Integrate new IT systems or infrastructure
- Adjustments to healthcare delivery models or processes
Ignoring these factors can lead to underestimating the true cost (total cost of ownership) and feasibility of implementing a new device, potentially leading to poor adoption or inefficient use.
HTA frameworks addressing organisational aspects
Different HTA agencies and international collaborations highlight the need to address organisational factors in submissions:
EUnetHTA Core Model®
The European Network for HTA (EUnetHTA) Core Model includes Organisational Aspects as one of its nine domains. This domain evaluates:
- Training requirements for personnel
- Changes in care pathways
- Facility and technical infrastructure needs
- Implementation barriers and facilitators
This model is widely adopted across European HTA bodies and increasingly influences how manufacturers prepare their submissions.
National Institute for Health and Care Excellence (NICE) (UK)
The NICE Medical Technologies Evaluation Programme (MTEP) also considers organisational impact, especially where a device requires significant change to the way care is delivered. NICE may require:
- Real-world evidence on usability and integration
- Input from NHS staff on practical challenges
- Case studies of implementation across NHS Trusts
IQWiG (Germany) and HAS (France)
IQWiG in Germany and HAS in France have published guidance on the broader impacts of technology adoption, including staffing levels, delivery settings, and required training. In France, these elements can also influence tariff classification and reimbursement.
Engage early with HTA bodies: Some HTA bodies offer scientific advice or early dialogue opportunities. Engaging early can clarify the expected organisational evidence, enabling manufacturers to build the required studies into their overall evidence generation plans.
Types of evidence required
Demonstrating organisational aspects in HTA submissions requires a multi-source, multidisciplinary evidence base. Below are the key types of data and evidence manufacturers should prepare:
Process flowcharts or pathway diagrams illustrate how the device fits into or changes existing clinical workflows. These should include:
- Pre-use setup
- Point-of-care use
- Maintenance and disposal
- Staff roles and handovers
Including a “before and after” comparison can help demonstrate efficiencies or challenges introduced. These process maps are also useful for calculating Budget Impact Analyses, which may be economic evidence requested by an HTA authority.
Manufacturers are usually advised to follow the international standard IEC 62366-1, and the FDA guidance on Human Factors (for US-based organisations). This is almost always a regulatory requirement, but can also provide strong evidence of how the device supports clinical users. HTA reviewers often look for:
- Time to learn
- Error rates
- Training hours required
- Qualitative feedback from users
These studies provide quantitative and qualitative evidence to support real-world integration claims. Start Human Factors and Usability Studies early in development and build learnings into product iterations. Map the requirements driving regulatory and reimbursement decisions and design studies to gather evidence supporting both processes. This reduces costs and commercialisation timelines.
Deploying your device in pilot sites, test beds, or hospital innovation hubs can yield vital real-world data, including:
- Actual staffing required vs. anticipated
- Unforeseen operational challenges
- Workarounds used by clinicians
- Insights into hospital-level adoption barriers
Gather testimonies from clinicians and hospital administrators: These pilots aim to produce testimonials and case studies, both highly valued by HTA bodies. Anecdotal but structured feedback can contextualise data and make an HTA submission more compelling.
Documentation such as:
- Standard Operating Procedures (SOPs)
- Training curricula and completion rates
- Certification needs
- Time and resources required for onboarding
These materials help HTA agencies assess organisational or system readiness for widespread use.
Economic evaluation analyses should include:
- Training and implementation costs
- Infrastructure upgrades (e.g., space, power supply)
- Opportunity costs (e.g., time taken from other procedures)
- Maintenance, servicing, and replacement schedules
These contribute to the total cost of ownership (TCO) for an organisation to adopt a new technology. They are frequently neglected but can sway a reimbursement decision. Use sensitivity analyses to show the impact of different organisational scenarios (e.g. training or staffing assumptions) on cost-effectiveness.
Conclusion
Organisational aspects are an essential but often underdeveloped part of medical device HTA submissions. Failing to demonstrate feasibility, usability, and integration into healthcare settings can derail reimbursement and market access, even for clinically effective devices.
Manufacturers that proactively develop and present robust organisational evidence—not just clinical and economic data—can significantly improve their chances of a positive HTA outcome. Being transparent and honest in discussing implementation barriers and mitigation strategies builds credibility. By aligning with key standards like IEC 62366 and ISO 13485, and tapping into real-world user feedback, companies can meet the expectations of HTA bodies across Europe and beyond.
Resources
These links point to core HTA frameworks, evidence standards, or methodology guides addressing organisational impact.
- EUnetHTA Core Model v3.0 (PDF) — contains an entire domain on organisational aspects for medical devices and procedures.
- Medical Technologies Guidance (MTG) — organisational impact is considered in decision making.
- Evidence Standards Framework for Digital Health Technologies (PDF) — organisational fit, impact on workflow, training.
- Methodological Guide: Organisational Impact of Medical Devices (English version) — dedicated guidance on evaluating organisational aspects.
- General Methods — organisational impact part of medical device assessments under G-BA mandate.
- CADTH HTA Methods and Guidelines — includes organisational and implementation considerations in device assessments.
- MSAC Guidelines — organisational impact part of device and service HTA.
- AHRQ Technology Assessments — organisational aspects occasionally included in reports, but no dedicated guidance.
- Guidelines for Economic Evaluations in Healthcare — includes organisational factors in cost-effectiveness and reimbursement decisions.
- FIMEA HTA Model — organisational aspects considered in device appraisals (no dedicated English guidance link, but described in HTA model).
- HTA Process — organisational consequences are part of device assessment domains.
International Standards:
Benefit-Risk Analysis: The comparison of a medical device’s benefits to its associated risks, often used in regulatory decision-making.
CE Marking: A certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA).
Compliance: Adherence to regulations, standards, and guidelines set forth by regulatory authorities.
Equivalency: Demonstrating that a new device is as safe and effective as an already marketed device by comparing its technical and functional characteristics.
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.
International Medical Device Regulators Forum (IMDRF): A global regulatory collaboration focused on harmonising medical device regulations to facilitate patient access to safe and effective devices. This organisation was formerly the Global Harmonization Task Force (GHTF).
Labelling: The label on a medical device and all descriptive and informational literature associated with the device. Also see Instructions for Use (IFU)
Manufacturer: A legal entity that designs, produces, assembles, or labels a medical device with the intention of placing it on the market.
Notified Body (NB): An organisation designated by a country authority to assess the conformity of certain products before being placed on the market, ensuring they meet applicable regulatory requirements and standards.
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.
Regulatory Authority: An official body overseeing and enforcing laws, regulations, and standards within a specific industry or sector to ensure compliance and protect public interests. Also known as a Regulatory Authority. Also see Competent Authority and Notified Body.
Regulatory Submission: The formal process of submitting documentation and data to regulatory authorities for review and approval to market or sell the device within a specific jurisdiction.
Reimbursement: The process of receiving payment from insurers, government health programs, or healthcare facilities for the use of medical devices in patient care.
Risk Management (RM): The systematic application of management policies, procedures, and practices to the tasks of analysing, evaluating, controlling, and monitoring risk.
Safety: The condition of being protected from or unlikely to cause danger, risk, or injury.
Standard: A document that provides guidance, requirements, or specifications established by regulatory bodies, industry organisations, or international consensus groups.
Study Protocol: A document that describes the objectives, design, methodology, statistical considerations, and organisation of a clinical study.
Technical Documentation: All documents that demonstrate the design, manufacture, and performance of the device, essential for ensuring compliance with regulatory requirements. This is also known as the Technical File.
Traceability: The ability to verify an item’s history, location, or application by means of documented recorded identification.
User: Any individual who operates or interacts with a medical device, including healthcare professionals, patients, and caregivers.