Regulatory Challenges in Biomaterials: Focus on Medical Devices - Biomaterials Science: An Integrated Clinical and Engineering Approach - page 266

and better performance. As the trend to personalized medicine is expected
to impact drug therapies by applying pharmacogenetic and pharmacoge-
nomic tools, the same trend towards customization of medical devices tak-
ing into account special populations with particular needs will improve the
ways medical devices are adapted to the host, and will therefore improve the
effectiveness and safety of implantable devices.
However, the current status in medical device technology regulation
seems to favor technological improvements that are incremental in nature
(improvements of devices already existing in the market) rather than disrup-
tive technologies, and the reason is that breakthrough medical devices are
subjected to a much more comprehensive review process by the FDA. This
favors the development of conservative approaches that hinder any innova-
tion. Therefore, innovation in medical devices will be possible only by the
modernization of regulatory science. In order to achieve this goal, inter-
disciplinary groups working together at the FDA and at the manufacturer
worksite will enable a more dynamic regulatory process, bringing medical
devices in a faster and safer way to the population. Hopefully, in years to
come, programs such as the Critical Path Initiative will impact the regulatory
science and policy by adopting new approaches in clinical trials of medical
devices, incorporating new technologies such as computer simulations for
studying implantation performance and other advanced technological tools
now available. Furthermore, this amazing repertoire of techniques will pro-
vide the FDA personnel with more accurate information, thus decreasing the
risk of device failure and increasing the chances of success, and paving the
way to bring new disruptive medical device technologies to the patients in a
timely fashion without hindering safety performance.
From an ethical point of view and based on recent criticism made to the
FDA about potential conflicts of interest, the advent of independent com-
mittee assessment groups that would collaborate with FDA experts in
monitoring the strength of the evidence in clinical trials of medical device
technology will help make the regulatory process more transparent and less
prone to economic bias.
Acknowledgments
The author thanks Dr. Yitzhak Rosen for his invaluable comments, critiques,
and editing of this chapter and is grateful also to Dr. Orlando Auciello for
his continuous support during the writing of this chapter. The author would
also like to acknowledge the radiological pictures kindly provided by Dr.
Tim Hunter. The author also thanks María Victoria Gonzalez Eusevi for all
her technical support in the review of this manuscript.