Regulatory Challenges in Biomaterials: Focus on Medical Devices - Biomaterials Science: An Integrated Clinical and Engineering Approach - page 263

in the pharmaceutical field. These papers advocated for more transparency
in the way that members of these committees are elected, pointing out that
many of these members, who are in charge of deciding whether a product
will be approved or not, have important positions in the biomedical indus-
try. The effects of such influence are seen in how regulatory barriers become
less rigorous than they should be and products of unclear quality might be
allowed to enter the market. This is clearly shown in medical devices (many
of them using biomaterials), where it seems to be a growing concern regard-
ing their assessment, particularly in the quality of medical device clinical
trials. For example, a recent meta-analysis has shown that several premarket
approvals submitted to the FDA between 2000 and 2007 lacked the mini-
mum methodological requirements to be considered reliable, claiming that
only 27% of the studies supporting premarket approvals were randomized
and only 17% of them were blind, and 88% of all end points were surrogate
(surrogate end points are indirect forms for assessing the effectiveness of
a treatment, as opposed to more reliable direct end points) [26]. This is of
particular concern since it would be expected that medical devices would be
submitted to a more rigorous assessment than drugs, because, as opposed
to a drug that could be “washed out” from the body, once a medical device
is implanted, any failure such as malfunctioning, contamination, electri-
cal breakdown, heating, degradation, and corrosion could have profound
and catastrophic consequences in a patient. In addition, the FDA has more
recently started to deal with medical device regulation (from 1976 to date)
than with drugs (from 1906 to date), which ideally should make the regula-
tory process for biomaterial-medical devices much more stringent. Finally, it
is obvious that from an industrial standpoint, a less rigorous FDA approval
for medical devices would imply faster translation to the market of biomate-
rial medical-device developments.
The issue of potential conflict of interest within FDA brought about the
advent of independent committee assessment groups that would collabo-
rate with FDA experts in monitoring medical device technology by per-
forming critical reviews of clinical studies in order to assess the strength
of evidence necessary to launch a product to the market without being
under any economic influence. Among these groups, we can mention the
Institute of Medicine (IOM), Medicare and professional associations, and
the California Technology Assessment Forum (CATF). The last has been
assessing medical devices including capsule endoscopy (a biomaterial-
based capsule that is ingested and allows the visualizing of the gastroin-
testinal tract) and mammography. This organization works by performing
evidence-based reports based on reviews from medical databases such as
the Cochrane Library and Pub Med. These reports made by CAFT consul-
tants are later discussed with a multidisciplinary panel composed of sci-
entists, manufacturers, and consumers and subjected to a general vote. In
this way, strong evidence is used to assess the safety of medical technology
beyond FDA [25, 87-89].