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

Abstract

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.

Keywords::

• clinical evidence
• health technology assessment
• medical device
• regulation
• review

Acknowledgements

The authors wish to thank all respondents to our interview, namely the Office of Devices Authorisation Therapeutic Goods Administration (Australia), Medical Devices Bureau, Health Canada (Canada), China Food and Drug Administration (China), European Commission Directorate-General for Health and Consumers, Health Technology and Cosmetics unit (Belgium), Center for Devices and Radiological Health, US Food and Drugs Administration (USA) for their valuable inputs. Nevertheless, the authors are the only ones responsible for the contents of the present paper.

Financial & competing interests disclosure

The research leading to these results has received funding from the European Union Seventh Framework Programme under grant agreement HEALTH-F3-2012-305694 (Project MedtecHTA). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Key issues

• Evidential requirements are related to the level of patient risk associated with the use of different categories of devices. However, there are differences in the requirements across jurisdictions and in the balance between pre-market and post-market controls.

• Existing regulatory processes for medical devices generate less clinical evidence than the corresponding processes for pharmaceuticals. However, post-marketing surveillance is especially important in the case of devices, not just for safety monitoring, but also to assess effectiveness in regular use, given the device/user learning curve and the organizational impact of medical devices.

• Lack of clinical evidence generated to respond to regulatory requirements leads to difficulties in conducting health technology assessment (HTAs), which in some jurisdictions can create delays in funding and patient access.

• A challenge in all jurisdictions is in finding the appropriate balance between assessments of efficacy and safety on the one hand and allowing rapid access to patients on the other.

• In most of the jurisdictions studied, there are ongoing debates about the need to reform regulatory processes for medical devices. It is important, in the context of these discussions, to consider the need for improved clinical data for HTA, alongside other important needs such as safety and rapid patient access.

• There are innovative models of collaboration between regulators, reimbursement agencies and manufacturers taking place in some jurisdictions (e.g., Canada EXCITE program). These have the objective of speeding up the process of assessment, thereby securing faster patient access for those devices that can be shown to be cost-effective.

Notes