So you have a great idea for an app. Not so fast: it took two years and over half a million dollars to get ours cleared for marketing by the US Food and Drug Administration (FDA).
Our app, DANA uses a mobile phone to records peoples’ reaction time during game-like tests. It also provides questionnaires that help clinicians evaluate brain health. Commissioned from AnthroTronix by the Department of Defense, the app will help diagnose concussion, depression and Post-Traumatic Stress Disorder (PTSD).
For something so important, a serious investment of time and money for clearance may not sound extravagant, but few small companies can afford a two-year go-to-market delay, not to mention the significant investment and heartache that goes with it. And although the FDA has tried to facilitate regulation by providing guides like the Mobile Medical Applications Guidance Document and the Mobile Medical Applications website, the regulatory process remains confusing.
Here are five simple lessons from our own experience that will help other entrepreneurs to do the right thing and engage with the FDA:Continue reading…
Injury to the brain continues to be a unique thing in medicine. These injuries are scary and unfamiliar to many health care providers. There is a finality to them. Their consequences are hidden a little bit; the asystole is easy to figure in the emergency room but the suppression and brain death isn’t something so easily recognized.
They’re what you might imagine, along with polytrauma, as poster child conditions for tertiarization and transfer to a higher level of care.
In truly catastrophic injury to the brain however, I’m not sure that’s a good thing.
My institution has had a small discussion lately on just what ethics and the law requires of us as a place with full neuro specialty coverage.
I’ll make up an example:
A 61 year old man comes into a small community hospital’s emergency room. He was found down at home by his wife and last seen normal four hours previously. He wouldn’t wake up and he was breathing slowly and shallowly. The ambulance crew intubated him. In the emergency room his pupils are large and don’t react to light and he doesn’t do anything when the doctor hurts him. He’s in a very deep coma. If the physician working the emergency room felt comfortable doing a brain death exam, which he doesn’t, the patient might have some very primitive reflexes left but his condition is very serious.
An uninsured Seattle man has put out an ad offering to trade his 2006 Mustang GT for brain surgery. He provides an image from a MRI of his brain even. The poster doesn’t describe what symptoms he attributes to his arachnoid cyst but the relationship between arachnoid cysts and late symptoms is often difficult to establish.
Arachnoid cysts have been associated with headaches, nausea, seizures, vertigo and even in anecdotal cases with psychiatric symptoms or the onset of dementia. But the relationship is often hard to establish. Up to a third of people with chronic headaches have some sort of abnormality on there MRI, including arachnoid cysts. Relating the findings and the symptoms is often difficult; sometimes you have a finding on an MRI or a CT scan but it is a red herring as far as the symptoms are concerned.
Arachnoid cysts are collections of cerebrospinal fluid trapped between the brain and spinal cord and the arachnoid membrane. They’re primarily a congenital entity but can be associated with trauma, infection or be iatrogenic following surgery. The vast majority of cysts are discovered incidentally and associated with no major symptoms. While even asymptomatic cysts can progress to cause symptoms and they can be associated with post traumatic, or even spontaneous, hemorrhage the risk of such is low enough that in small asymptomatic cysts it is often more than reasonable to do nothing.
I’m a little bit dubious of the poster as he relates that he’s been thinking of trying to get to the cyst himself. However, if it’s an honest post I think the poster really needs to sit down with a neurosurgeon in consultation and go over the above in detail and discuss the best course of action.
I suppose health insurance is coming in 2014.
Colin Son, MD is a neurosurgical resident in Texas. He blogs regularly at Residency Notes, where this post originally appeared.