Health Technology Assessment Methods Guidelines for Medical Devices: How Can We Address the Gaps? The International Federation of Medical and Biological Engineering Perspective

Polisena, Julie; Castaldo, Rossana; Ciani, Oriana; Federici, Carlo; Borsci, Simone; Ritrovato, Matteo; Clark, Daniel; Pecchia, Leandro

doi:10.1017/s0266462318000314

Cited by 31 publications

(30 citation statements)

References 22 publications

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“…As opposed to pharmaceuticals, medical devices have a greater potential to indirectly impact an organization. Improvements, especially from an economic standpoint, can be gained by optimizing patient pathways or hospital workflows (26, 33, 34). Due to the learning curve, there may also be need for staff training, or the requirement for a sterilization process to be put in place for a reusable device.…”

Section: Issues Specific To Medical Devices Are Mainly Unresolved In mentioning

confidence: 99%

Critical Review of European Health-Economic Guidelines for the Health Technology Assessment of Medical Devices

et al. 2019

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Background: Health-technology assessment (HTA) is a recognized mechanism to determine the relative benefits of innovative medical technologies. One aspect is their health-economic impact. While the process and methodology for pharmaceuticals is well-established, guidance for medical devices is sparse.Aim: To provide an overview of the health-economic aspect in current European HTA guidelines concerning medical devices and identifying issues raised and potential improvements proposed in recent literature.Methodology: Available guidelines by European agencies were each reviewed and summarized. To complement this, a full systematic review of current literature concerning potential improvements to existing HTA practices for medical devices, from PubMed and EMBASE, was conducted; the focus was on health economics. Authors could only review documents in English, French, or German. The systematic review yielded 518 unique articles concerning HTA for medical devices, 32 of which were considered for full-text review after screening of all abstracts.Results: There is very limited consensus in—and mostly a complete lack of—guidance specific to medical devices in official HTA guidelines, for both clinical and economic analyses. Twenty two of 41 European countries had published official HTA guidance in English, French, or German. Among these only 4 (England, France, the Netherlands, and Sweden) dedicated a chapter or separate document to medical devices. In the literature, there is sufficient evidence to suggest medical devices need to be addressed separately from pharmaceuticals. However, mostly challenges are discussed rather than implementable solutions offered. We present the following set of frequently discussed issues and summarize any solutions that pertain to them: a weak evidence base, learning-curve effects, organizational impact, incremental innovation, diversity of devices, dynamic pricing, and transferability. We further combine reviewed information to suggest a set of possible best practices for health-economic assessment of medical devices.Conclusion: For greater efficiency in medical-device innovation, European agencies should look to (re-)address the specific requirements of medical devices in their HTA guidelines. When both the health-economic and data requirements for the HTA of medical devices are defined, the development of practical solutions will likely follow.

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Section: Issues Specific To Medical Devices Are Mainly Unresolved In mentioning

confidence: 99%

Critical Review of European Health-Economic Guidelines for the Health Technology Assessment of Medical Devices

et al. 2019

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“…For the latter, moving towards the paradigm of precision medicine can be even more critical. Medical devices effectiveness is dependent upon several factors including the environment in which are utilised (e.g., sterilised or not, temperature, humidity, dust), the experience of the operators, maintaining, servicing and preparing the medical device 9 . For instance, recent studies demonstrated that even the positioning of applied parts (e.g., probes, sensors) in a trial might affect the significance of the results 10 .…”

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confidence: 99%

Precision Medicine and Artificial Intelligence: A Pilot Study on Deep Learning for Hypoglycemic Events Detection based on ECG

Porumb

Stranges

Pescapè

et al. 2020

Sci Rep

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147

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Tracking the fluctuations in blood glucose levels is important for healthy subjects and crucial diabetic patients. Tight glucose monitoring reduces the risk of hypoglycemia, which can result in a series of complications, especially in diabetic patients, such as confusion, irritability, seizure and can even be fatal in specific conditions. Hypoglycemia affects the electrophysiology of the heart. However, due to strong inter-subject heterogeneity, previous studies based on a cohort of subjects failed to deploy electrocardiogram (ECG)-based hypoglycemic detection systems reliably. The current study used personalised medicine approach and Artificial Intelligence (AI) to automatically detect nocturnal hypoglycemia using a few heartbeats of raw ECG signal recorded with non-invasive, wearable devices, in healthy individuals, monitored 24 hours for 14 consecutive days. Additionally, we present a visualisation method enabling clinicians to visualise which part of the ECG signal (e.g., T-wave, ST-interval) is significantly associated with the hypoglycemic event in each subject, overcoming the intelligibility problem of deep-learning methods. These results advance the feasibility of a real-time, non-invasive hypoglycemia alarming system using short excerpts of ECG signal.Tracking the fluctuations in the blood glucose level is relevant for both healthy individuals and diabetic patients. High glucose levels (hyperglycemia) result in long-term complications and can damage the kidneys, nerves, blood vessels in the eye and can bring many other complications 14 . Low blood glucose levels (hypoglycemia) may result in acute short-term alterations of health status such as confusion, irritability, palpitations, feeling shaky and sweaty and can even result in severe loss of attention, coma or death 15 . In fact, hypoglycemia can be particularly dangerous during specific activities requiring great attention (e.g. while driving, performing complicated surgeries). Thus, technologies for non-invasive, continuous monitoring of glucose concentration aiming at early-detecting hypoglycemic events are highly required.The most diffuse methods for blood glucose testing consist of analysing a drop of blood resulted from a finger prick. However, this method does not allow continuous monitoring, is invasive, cumbersome, expensive, and it has been demonstrated that it affects patient compliance with the glucose measurements 16 . As an alternative, Continuous Glucose Monitoring Devices (CGMs) can infer the blood glucose levels in real-time based on the glucose in the interstitial fluid. These devices significantly empowered diabetic patients, but still, they present some limitations that make them unattractive for pre-diabetic patients and diabetics. Commercially available CGMs can be worn for a limited number of days, usually between 7 and 14 days. Most of the CGMs require finger prick calibration; some studies reported that the reliability of CGMs is limited 17-19 during low blood glucose level events and they sample from the interstitial fluid whi...

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“…For this, the information is structured according to the following fields: names of the authors, title of the article, methodologies (HTA or mini-HTA or any other unspecified methodology), multi-criteria techniques and main assessment criteria (health problems and use of technology, description and technical characteristics, safety, clinical effectiveness, costs and economic evaluation, ethical analysis, organizational / institutional aspects and human resources, patient and social aspects, legal aspects, among others). In addition, 14 guidelines and methodologies proposed by international HTA agencies were reviewed, allowing the conceptualization of methodologies used internationally [11,12,16,23,24,30,31,[33][34][35][36][37][38][39][40][41][42][43][44].…”

Section: Methodsmentioning

confidence: 99%

Multicriterial analysis for the prioritization of technological alternatives for POCT blood gas equipment procurement in a high-complexity healthcare institution

Perilla¹,

Melo²,

Villegas³

et al. 2020

DYNA

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This study proposes a multi-criteria analysis for the prioritization of alternatives for POCT blood gas analysis equipment procurement in a high-complexity healthcare institution through the Analytic Hierarchy Process (AHP). This work is presented as a tool for hospitals and is based on the Health Technology Assessment (HTA) model that supports the decision-making process in the acquisition of medical equipment. For this, criteria, sub-criteria and assessment instruments were identified based on the Core and mini-HTA models, review of scientific articles and healthcare institution requirements for high-complexity healthcare. The proposed approach was applied to the procurement process of POCT equipment in a healthcare institution in the city of Santiago de Cali-Colombia. As a result, the current procurement process was simplified by identifying five criteria and eleven sub-criteria that allowed the prioritization of POCT blood gas analysis equipment alternatives. Furthermore, three criteria with greater relevance were identified in the technological selection process.

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Health Technology Assessment Methods Guidelines for Medical Devices: How Can We Address the Gaps? The International Federation of Medical and Biological Engineering Perspective

Abstract: (2018) Health technology assessment methods guidelines for medical devices : how can we address the gaps? The

Cited by 31 publications

References 22 publications

Critical Review of European Health-Economic Guidelines for the Health Technology Assessment of Medical Devices

Critical Review of European Health-Economic Guidelines for the Health Technology Assessment of Medical Devices

Precision Medicine and Artificial Intelligence: A Pilot Study on Deep Learning for Hypoglycemic Events Detection based on ECG

Multicriterial analysis for the prioritization of technological alternatives for POCT blood gas equipment procurement in a high-complexity healthcare institution

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