Rethinking medical device regulation

Heneghan, Carl; Thompson, Marc

doi:10.1258/jrsm.2012.12k030

Cited by 19 publications

(19 citation statements)

References 9 publications

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“…For instance, debates were recently stimulated by the failure of EU regulation for metal-on-metal hip prostheses [30][31][32] and the case of implantable devices (e.g., cardioverterdefibrillator and breast implant), suggesting post-market surveillance failure due to poor reporting and analysis of adverse events [33][34][35]. The recent debates culminated with the scandal on breast implants marketed by the French company Poly Implant Prothèse [36].…”

Section: General Findings From the Literature Reviewmentioning

confidence: 99%

Generating appropriate clinical data for value assessment of medical devices: what role does regulation play?

Tarricone

Torbica

Ferrè

et al. 2014

Expert Review of Pharmacoeconomics & Outcomes Research

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Assessing the value of health technologies, through health technology assessment is critically dependent on the existence of relevant and robust clinical data on the efficacy, safety and ideally, effectiveness of the technologies concerned. However, in the case of medical devices, such clinical data may not always be available, because of the different nature of the regulatory requirements in different jurisdictions. Therefore, we conducted a systematic review of the regulatory requirements in seven major jurisdictions in order to identify current challenges and to suggest possible improvements. There are differences in the requirements across jurisdictions and in the balance between pre-market and post-market controls. Several improvements are required in order to generate adequate clinical data for health technology assessment.

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Section: General Findings From the Literature Reviewmentioning

confidence: 99%

Generating appropriate clinical data for value assessment of medical devices: what role does regulation play?

Tarricone

Torbica

Ferrè

et al. 2014

Expert Review of Pharmacoeconomics & Outcomes Research

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show abstract

“…Class I Medical Device without a measuring function and supplied in non-sterile condition does not require the involvement of a Notified Body. In accordance with the ‘Regulation of medical devices outside the European Union’, low-risk products may only require a supplier’s declaration of conformity (SDOC), where the manufacturer is responsible for ensuring that the product complies with the relevant requirement and then produces a written self-declaration statement [ 17 ].…”

Section: Methods and Resultsmentioning

confidence: 99%

The Vascular Factor Plays the Main Role in the Cause of Pain in Men with Chronic Prostatitis and Chronic Pelvic Pain Syndrome: The Results of Clinical Trial on Thermobalancing Therapy

Allen

2017

Diseases

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Chronic pain in patients with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), NIH category III is difficult to treat without understanding its cause. The main symptom of chronic prostatitis is pain. In this study, we would like to explain the origin of pain in men with CP/CPPS and its therapy. Forty-five patients with CP/CPPS have received thermobalancing therapy (TT) enabled by Dr Allen’s therapeutic device (DATD) for six months as mono-therapy. The control group comprised 45 men with CP/CPPS did not receive TT. Before and after six months the National Institute of Health Chronic Prostatitis Symptom Index (NIH-CPSI) scores, prostatic volume (PV) by ultrasound measurement and uroflowmetry (Qmax) were compared between the groups. Baseline characteristics have shown no difference. After TT, significant improvements in pain score (p < 0.001), quality of life index (QoL) (p < 0.001), decrease of PV (p < 0.001), and increase Qmax (p < 0.001) were determined. There were not noteworthy changes in the control group. Chronic pain due to CP/CPPS happens as a consequence and challenges at the capillary level, namely pathological capillary activity. In response to initial triggers—such as inflammation, cold, psychological and other factors—constriction and spontaneous expansion of capillaries follows, creating a continuous secondary trigger—i.e., the micro-focus of hypothermia—which in turn provokes expansion of capillaries. The additional tissue due to vascular changes into the prostate increases pressure on nociceptors causing pain. TT relieves chronic pelvic pain by eliminating the lasting focus of hypothermia in the affected prostate tissue.

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“…The system of approval based on substantial equivalence (e.g. the US 510(k) approval process) has already been recommended to be replaced with an integrated pre‐market and post‐market regulatory framework that effectively provides a reasonable assurance of safety and effectiveness throughout the device life cycle (Heneghan and Thompson, ; Sorenson and Drummond, ). A potential collaborative model of future device regulation is the MaRS Excellence in Clinical Technology Evaluation (EXCITE) programme currently operating in Ontario (MaRS, ).…”

Section: Discussionmentioning

confidence: 99%

Linking the Regulatory and Reimbursement Processes for Medical Devices: The Need for Integrated Assessments

et al. 2017

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Much criticism has been directed at the licencing requirements for medical devices (MDs) as they often result in a lack of robust evidence to inform health technology assessment (HTA) decisions. To better understand the current international decisional framework on MD technologies, we undertook three linked research studies: a review of the device regulatory procedures, a survey of current HTA practices and an empirical comparison of HTA reports of drugs versus MDs. Our review confirms that current device regulatory processes across the globe are substantially less stringent than drugs. As a result, international HTA agencies report that they face a number of challenges when assessing MDs, including reliance on suboptimal data to make clinical and cost-effectiveness decisions. Whilst many HTA agencies have adapted their processes and procedures to handle MD technology submissions, in our comparison of HTA reports we found little evidence of the application of methodologies that take account of device-specific issues, such as incremental development. Overall, our research reinforces the need for better linkage between licencing and HTA and the development and application of innovative HTA methodologies with the objective of securing faster patient access for those technologies that can be shown to represent good value for money.

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Rethinking medical device regulation

Cited by 19 publications

References 9 publications

Generating appropriate clinical data for value assessment of medical devices: what role does regulation play?

Generating appropriate clinical data for value assessment of medical devices: what role does regulation play?

The Vascular Factor Plays the Main Role in the Cause of Pain in Men with Chronic Prostatitis and Chronic Pelvic Pain Syndrome: The Results of Clinical Trial on Thermobalancing Therapy

Linking the Regulatory and Reimbursement Processes for Medical Devices: The Need for Integrated Assessments

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