Within the next century, are physicians still going to be prescribing drugs for patients paralyzed with spinal injuries? Patient’s that now restricted to a wheelchair for their mobility.
Firstly, physician’s attitude needs to change from the drugs culture. However, changing the altitude of some physician’s, especially those for years that have administered drugs as a cure-all is going to be difficult.
There are still physicians out there, which perceive these new revolutionary implacable devices as ‘Science Fiction’ that has no place in healthcare services.
Changing altitude will not only be time-consuming, and costly, it’ll leave their patients still confined to wheelchairs. Attitudes need to change quickly; they need to come to terms, with this new scientific revolution, that’s taking place in human implantable technology.
University hospitals surgical teams need to take the lead in changing the attitudes of physician’s from one of a drugs culture. Implantable devices are here to stay and physician’s need to be made aware of the benefit to their patient’s paralyzed due spinal injuries.
Issue’s that are delaying the deployment of human implantable technology is the slowness of medical regulators to approve the devices. One particular concern is that device type approval is far too slow. In some cases, devices are not approved because regulatory agencies don’t employ the skills needed to understand the technology.
It is a critical time for reform of medical device regulation globally. In Europe, the European Commission is reviewing its process of medical device regulation—one that was established over 20 years ago and has not kept up with technological advances.
The Federal Drug Agency (FDA) commissioner has stated that the FDA’s “resources are outstripped by our responsibilities…there is a continuing need for expansion of investment”. Additionally, the safest and best way to speed review times—as the industry prefers because it would reduce costs associated with developing new technologies—is to increase funding for FDA to allow more review staff.
It’s critical that regulatory agencies have sufficient funding to search, find, and engage new staff. Staff capable of understanding the advanced technology used in these revolutionary implantable devices.
Scientists perform rigorous medical clinical trials, which demonstrate that their implant meat its designer specifications, it’s safe and that no side effects have been observing. All this evidence is handed over to the regulator for type approval before a licensing can be issued.
Assuming regulatory agencies can speed up type approval of these medical devices, safely. This would reduce the time it takes to deploy the devices to surgical teams for implantation. Thus allowing patients paralyzed, the opportunity to walk again.
Physicians need to relinquish their dependence on prescription drugs. They need to accept and embrace the groundbreaking advancement’s in implantable medical science.
For Harvard neurobiologist Jeff Lichtman, the question hasn’t been whether scientists will ever understand the brain, but how closely they’ll have to look before they do: ‘The answer, it turns out, is very, very close’.
The scientist is already beginning to see that the brain’s wiring diagram is organized in some interesting ways. It is not simply that nerve cells establish random contacts with nearby neurons, as was expected. There’s something purposeful going on here.
For Lichtman and his colleagues, the study is the culmination of years of effort, not only to understand the brain but also to develop systems for collecting precise images of how the brain is wired.
As Lichtman and his colleagues shed light on how the brain is wired, this will make possible for us to design sophisticated state-of-the-art implants. The types of implants that’ll help people with incapacitating illness like, schizophrenia (more than two million Americans have a diagnosis of schizophrenia) epilepsy, dementia, and Alzheimer’s.
Regulatory agencies need to quickly adapt to revolutionary new implacable devices. Adequate funding and political backing are essential so that global agencies. Such as the FDA and EU Notified Bodies can adequately assess medical device safety and efficacy prior to approval and monitor them in the post-marketing period.
Sales for medical devices are now projected to reach US$ 350 billion worldwide, isn’t it now time for government medical regulatory agencies to provide additional funding for their agencies? The funding into micro-devices research until now has been by university grants and generous donations by the public. But, additional investment is needed. Global businesses and Venture Capital Companies need to be persuaded to fund and assist researchers studying new microdevices.