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Medical Devices and Clinical Trials: Exploring a N

Medical Device Trials Posted on: 13 Dec 02


As the medical device field becomes more advanced the need for clinical trials will grow. With less experience of global clinical trials than those in the pharmaceutical sector, medical device compani
An important area within healthcare is the medical devices industry. Given the high media profile of the pharmaceutical industry, new drug development sometimes overshadows progress in the medical devices industry. However, medical devices are making important contributions to advances in healthcare and the sector is characterised by a high level of innovation and intense competition. One of the interesting aspects of R&D within the medical devices field is the coupling of diverse biomedical and engineering disciplines. The medical devices industry involves the input of companies within the microelectronics, software, advanced materials, telecommunications and biopharmaceutical fields. Estimates of the value of the global market depend on the interpretation of the term “medical device” as it can be applied to a wide range of products. It has been suggested that the global market comprises of about 8,000 types of medical devices, ranging from items such as orthopaedic appliances and prosthetics to diagnostic equipment. Although estimates of the market value differ, it is agreed that the largest market is that of the USA, followed by Japan and then Europe.
Clinical trials Although they are often talked of in conjunction with pharmaceuticals, the process of getting a new medical device product to market can differ considerably. This is because the intended action of a medical device is generally through a physical means and requires different types of evaluations as a result (1). A drug, on the other hand, will generally rely on a pharmacological, immunological or metabolic action (1). Interestingly, the use of clinical trials in getting a new medical device to market is a relatively recent development (1). Like pharmaceuticals, the move towards using carefully controlled and internationally standardised clinical trials has been driven by regulatory concerns, following some well-publicised medical device failures in the past decade.
Regulations Public concern over the safety of medical devices has led to a number of regulatory changes. Marketed medical devices in Europe require the CE-mark (1). There are four main classes of medical device, with Class I representing the lowest risk devices and class III devices representing the highest risk devices (1, 2):
  • Class I devices are subject to the least regulatory control and are of minimal potential harm to the user. As such, they are unlikely to require a large volume of clinical trial data to achieve a CE-mark.
  • Class IIa devices are low-to-medium risk products e.g. hearing aids and ultrasonic diagnostic equipment.
  • Class IIb devices are medium-to-high risk products e.g. ventilators.
  • Class III devices are high risk products e.g. balloon catheters. Clinical evaluation would be required prior to obtaining a CE-mark.
Towards harmonisation As with pharmaceuticals, there have been efforts to harmonise international regulations concerning medical devices. The Global Harmonization Task Force (GHTF), which is a voluntary group made up of representatives from national regulator agencies and from industry, has been very active in promoting harmonisation (3). It is hoped that the harmonisation of medical device regulations at an international level will boost the competitiveness of companies involved in this market and will improve the access of patients to the latest technologies. The GHTF also acts a knowledge forum, allowing members to exchange information on international regulatory practice.
The need for trials As the medical device field becomes more advanced the need for clinical trials will grow. With less experience of global clinical trials than those in the pharmaceutical sector, medical device companies can benefit from organisations whose specialist expertise lies in clinical evaluation. Contract research organisations now carry out an increasing amount of clinical evaluation work for companies in the medical devices sector. As well as advising these companies on how best to plan and structure their trials, CROs can offer valuable advice on regulatory strategies. By using CROs in this manner, medical device companies can control finances, benefit from external expertise and thus improve the odds of getting their product to market via a timely and cost-effective route.

Dr Faiz Kermani and Jeff Kingston

Last updated on: 27/08/2010 11:40:18

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