On January 17, 2014 FDA CDRH released the Draft Guidance of the "Reporting of Computational Modeling Studies in Medical Device Submissions"
Computational Modeling Studies have been accepted by FDA for numerous applications. For example; verifying that a pacemaker will not change position, or worse dislodge, during a MRI, is something that computer modeling proved prior to subjecting a patient to what could have been both a painful and risky experience.
Yet, Computational Modeling Studies for Medical Device Submissions, and their use for the broader public health, is in the early stages of adoption and implementation. With virtual patient models of men, women, pregnant women, and children, medical device companies will have the ability to improve the assessment of risk, benefit, safety and effectiveness for FDA submissions. This has profound implications towards lowering costs, decreasing risks and improving health care.
"First in Man" studies: Innovative and cutting-edge devices that have great potential currently undergo a very expensive process to obtain approval before implanting into the first human being. To assess the risk versus the benefit of the medical device requires numerous animal studies. Not only does the anatomy and physiology of animals fail to reflect the human body, these studies are also expensive to run, and challenge the ethics of testing on animals. Instead, imagine medical devices tested on virtual patients to validate the risks and benefits relative to humans. The result: more accurate data on the impact to humans, less expensive studies, and reduced need for testing on animals win-win solutions.
Personalized Medicine: As patients, we reasonably expect that our health care providers can answer risk and benefit questions, relative to us. Yet patients are different, and providers are limited to their experience and research results. Imagine if the Electronic Medical Record systems were built with virtual patient models. Doctors and surgeons could assess the performance of a medical device in a patient prior to the actual implant, and improve communication with their patients.
The Draft Guidance is the first step towards this virtual future by creating uniformity in how industry will report to FDA and how reviews will be conducted by FDA staff. It is the standardization of reporting and reviews that will enable quality to lead the evolution of Computational Modeling Studies, and outcome tools that enable the right data for intelligent decisionsSM.
-- Vizma Carver, Founder and CEO, Carver Global Health Group