The medical device industry produces a high variety of devices not only for therapeutic but also for diagnostic purposes, in comparison to pharmaceutical products that are usually therapeutic. These devices play a significant role in the lives of millions of people. From elastic bandages to trans-catheter aortic valves, medical devices nowadays can be either simple tools in the treatment process or actual lifesaving options when facing more critical health conditions.
Medical device research is as significant as pharmaceutical research. When it comes to clinical trials or clinical investigations, the pathways to approval vary and the challenges are often more complex compared to drugs. It is known that medical device research is subject to more regulatory reviews and often more obstacles which may affect novelty and delay processes.
There are three categories of medical devices (I, II & III) classified according to their risk by the Food & Drug Administration (FDA), therefore it is understandable that the regulatory requirements for each category vary. Class I devices are the ones that pose the lowest risk to the users and the regulations for this category are usually less controlled. On the class II & III devices require more demanding regulatory pathways before being introduced to the market.
When it comes to medical device clinical trials there are many challenges that need to be considered including:
Study design must meet the requirements of the Medical Device Directive/ Medical Device Regulation.
Studies cannot be blinded
Device companies usually have limited budgets, therefore strategies to expedite recruitment and run the studies are critical in order to get to market as quickly as possible.
Studies need only to generate endpoints to meet the essential requirements of the directive not already met by Clinical Evaluation, therefore studies do not have traditional endpoints.
The outputs of a single trial will be used to gain market access therefore if the device is to be launched in multiple markets, the study must meet multiple regulatory requirements. This factor makes nearly all medical device trials pivotal.
Patient population requirements can change from region to region, therefore careful site selection and inclusion/exclusion criteria are critical.
As the medical device industry is constantly growing, clinical research in this area is important in itself, as well as part of the overall pharmaceutical research. However, research in medical devices differs from pharmaceutical products in many aspects such as the regulatory pathway, the study duration or the statistical analysis.
TCTC Group has a wealth of practical experience in medical devices and is available to assist you with all your Medical Device trial needs and secure the most efficient and effective pathway, that meets the regulatory requirements, to get a CE marking and get your product to the market.
[Sources: www.clinicaltrials.gov/ct2/info/fdalinks, www.fda.gov]