Current Approaches and Challenges in Evaluating Health Technologies for Medical Devices: Insights from OPS/WHO

Navigating the Complex Evaluation of medical Device Technologies: A PAHO Webinar

Register now: devices. Check local time. The webinar will be offered in English and Spanish, with simultaneous interpretation available in Portuguese.

Unlike pharmaceutical evaluations, assessing the value of medical devices presents distinct hurdles.Generating robust clinical evidence is frequently enough difficult, especially with limitations in randomization and blinding – especially for implantable devices. Finding appropriate comparative technologies for analysis further complicates the process.

This webinar aims to provide guidance on adapting Health Technology Assessment (HTA) methodologies to effectively evaluate medical devices, recognizing their specific characteristics. The discussion will focus on the potential benefits of methodologies like rapid HTAs, multi-criteria decision analysis, adaptive HTAs, and the utilization of Real-World Evidence (RWE) for countries in the region. These approaches can facilitate timely and contextualized evaluations.

A Tribute to Adriana Velázquez

The webinar will also serve as a special tribute to Adriana Velázquez, a key figure at the world Health Organization (WHO) who is retiring. Her significant contributions to strengthening medical device management will be celebrated,recognizing her lasting legacy and inspiration to the field.

Featured Speakers:

Adriana Velázquez – WHO
Blanca Novella – Sermas-rets, spain
* Victoria Hurtado – Redeetsa working group on medical devices, Chile

Following the presentations, an open forum will be dedicated to questions and comments from attendees. This webinar is a vital chance for healthcare professionals, policymakers, and researchers involved in medical device evaluation to share insights and advance best practices.

How does OPS/WHO support the integration of real-world evidence into medical device evaluations within the Americas?

The Evolving Landscape of Medical Device Evaluation

The rapid innovation in medical device technology presents both incredible opportunities and notable challenges for healthcare systems globally. Effective health technology assessment (HTA) is crucial for ensuring these devices are safe, effective, and offer value for money. Organizations like the Pan American Health Organization (OPS/WHO) play a vital role in guiding these evaluations, especially within the Americas. Mexico, as a representative democratic republic with a complex healthcare infrastructure (as noted by OPS/WHO), exemplifies the nuances involved in adopting and assessing new technologies.

Core Approaches to Medical Device HTA

Several key approaches are currently employed in evaluating medical devices:

Clinical Evidence Review: This remains the cornerstone of HTA. It involves a systematic review of randomized controlled trials (RCTs), observational studies, and real-world evidence (RWE) to assess clinical efficacy and safety.

cost-Effectiveness analysis (CEA): Determining the incremental cost per quality-adjusted life year (QALY) gained is a standard practice. This helps policymakers understand the economic implications of adopting a new device.

Budget Impact Analysis (BIA): BIA projects the financial impact of a new technology on a healthcare budget, considering factors like adoption rates and patient volume.

Multi-Criteria Decision Analysis (MCDA): MCDA incorporates a broader range of criteria beyond cost and clinical effectiveness, including ethical considerations, patient preferences, and societal impact.

Early Signals Detection: Proactive monitoring of post-market surveillance data to identify potential safety concerns or performance issues early on. This is increasingly significant with the rise of connected medical devices.

OPS/WHO’s Role in Harmonizing HTA

The OPS/WHO actively promotes the harmonization of HTA methodologies across the Americas. this includes:

Developing Regional Guidelines: Creating standardized frameworks for evaluating specific types of medical devices.

Capacity Building: Training healthcare professionals and policymakers in HTA principles and methods.

Facilitating Collaboration: Encouraging details sharing and joint assessments among countries.

Promoting the Use of Essential Lists: Supporting the development and implementation of national lists of essential medical devices, prioritizing those with the greatest public health impact.

Key Challenges in Medical Device Evaluation

Despite advancements in HTA methodologies, several challenges persist:

Rapid Technological Change: The pace of innovation often outstrips the ability of HTA systems to keep up. Digital health technologies and artificial intelligence (AI) in medical devices pose unique evaluation challenges.

data Scarcity & Quality: High-quality clinical data, particularly RWE, can be limited, especially for novel devices or those used in specific populations.

Complexity of Devices: Many modern medical devices are complex systems, making it arduous to isolate the impact of the technology itself.

Regulatory Hurdles: Navigating different regulatory pathways and requirements across countries can be time-consuming and costly.

Equity Considerations: Ensuring that the benefits of new technologies are accessible to all populations, regardless of socioeconomic status or geographic location, is a critical challenge.

Post-Market Surveillance: Effectively monitoring the long-term safety and performance of medical devices after they have been approved for use.

Specific Considerations for Emerging Technologies

Medical device cybersecurity is a growing concern. Evaluations must now include assessments of a device’s vulnerability to cyberattacks and the potential impact on patient safety. Similarly, the ethical implications of AI-powered medical devices – including bias in algorithms and data privacy – require careful consideration.

Benefits of Robust HTA Systems

Investing in robust HTA systems yields significant benefits:

Improved Patient Outcomes: By ensuring that only safe and effective devices are adopted.

optimized Resource Allocation: Directing healthcare funding towards technologies that offer the greatest value.

Enhanced Healthcare System Efficiency: Reducing waste and improving the overall performance of the healthcare system.

Increased Public Trust: Demonstrating a commitment to evidence-based decision-making.

Practical Tips for Manufacturers & Healthcare Providers

Manufacturers: Invest in generating robust clinical evidence, including RWE, to support your device’s value proposition. Engage with HTA agencies early in the development process.

Healthcare Providers: Stay informed about the latest HTA guidelines and recommendations. Participate in clinical trials and contribute to RWE initiatives.

Policymakers: Prioritize investments in HTA capacity building and data infrastructure. Foster collaboration among countries to share best practices.

Real-World Example: Telemedicine Device Evaluation in Mexico

The expansion of telemedicine in Mexico, particularly in rural areas, has highlighted the need for tailored HTA approaches. OPS/WHO has supported initiatives to evaluate the cost-effectiveness of telemedicine devices and their impact on access to care.These evaluations have considered factors such as internet connectivity,digital literacy,and the availability of local healthcare providers. This demonstrates the importance of adapting HTA methodologies to the specific context of each country.