Medical Futures Lab

Now that our class is coming to a close, and given the amazing presentations and responses at our final critique last night, I thought this article in the Boston Globe was particularly appropriate.

Entrepreneural spirit just a start to “disrupt” health care – http://www.bostonglobe.com/business/2014/04/25/more-than-entrepreneurial-eagerness-needed-disrupt-health-care/POSS7fv6mBZQPGfhojuO7I/story.html

The article talks about the recent boom in hackathons, accelerators, and showcases specifically relating to health and medicine. There are tons of new startups and products that are coming out with the potential to change medicine, but they are all running into the same problem.

Once you’ve built an app, or built a device, in order to validate it you need to do some sort of pilot study. But it turns out, health startups are finding it extremely hard to find doctors and hospitals willing to work with them on a pilot-study.

The reason isn’t that doctors don’t want change, but it’s because they are already extremely busy people. In almost every field there are dozens of apps claiming and trying to do the same thing. So in an extremely limited time resources setting it becomes very hard for doctors to decide whose product they should pilot.

Not only that but hospital systems are extremely bureaucratic, institutional review board approvals can be hard to come by, and clinical trials can often costs startups easily between 50 – 100k!

All of that made me realize how lucky we are in our medicine in media class to have problem owners who are so invested in the products and teams. We don’t have to struggle to find a physician partner, because we already have an in-built one.

Creating a medical product is far from an easy pathway, but since all of us are lucky to have one of the biggest obstacles in our path cleared, I hope to see several of our innovations in the real world in the near future.

As a pre-medical student and a future doctor I’m well aware of the fact that it will be a number of years before I become a practicing physician. I’m also very well aware of the fact that the medical environment and community that I will be practicing in could be very much different than the medical environment of today.

That’s neither a good thing nor a bad thing, hopefully it’s good, but for now it’s just a fact. So I always do my best to keep an eye out for information that could help me understand the direction medicine is going so I can envision what medicine will eventually look like.

One thing I hear a lot about is this effort to hold doctors accountable and to empower patients to use data to select the most appropriate healthcare. I think the goal behind that mission is absolutely wonderful. Doctors are supposed to first and foremost help their patients, and patients deserve the opportunity to be able to learn and decide for themselves where they want to obtain their care.

The only concern I have though, is that the metrics and data being provided to patients to make their decision are not always truly indicative of good care. For example, one thing I’ve heard about is both paying and judging surgeons based on their rates of complications. Seems like a decently fair strategy. But what happens if you’re an amazing surgeon, but you decided you wanted to help a lower income population. Isn’t very much possible that the environment your patients are in after they leave the surgery could affect the degree to which they have complications? That doesn’t necessarily make you a worse doctor does it?

Just the other day I came across a phenomenal article about this subject from Lisa Rosenbaum MD, from the New Yorker titled “What Big Data Can’t Tell Us About Healthcare”.  In this article she talks about a recent release of Medicare payments that was made available to the public. In this release anyone, including patients, can look up the amount doctors are billing and how they rank amongst their peers.

The basic idea is that transparency can help patients make informed decisions.  And the implied message is that doctors who are billing higher are misusing the system and ripping you off.

“The hope is that members of the public will be empowered by their access to payments data, and will use this information to identify doctors who are behaving badly, helping to end fraud and profit-driven overuse.”

But that’s extremely missing. Just knowing how many Medicare specific treatments your doctor does , how much he or she bills for them, and what their total overall billing is does not provide nearly the whole picture. You don’t know what the doctor’s costs are; maybe the area they are in requires higher costs? You don’t know the exact breakdown of the doctors billing system within their practice. Often times a single doctor bills the entire practice’s procedures.

And there is an overall dilemma between doctor judgement and what’s deemed as necessary that  this also highlights. Is a test unnecessary just because it doesn’t return positive results?

How do we define quality care and how do we provide patients with a data set that is truly reflective of that? That’s still a challenge that is yet to be answered.

http://www.newyorker.com/online/blogs/currency/2014/04/the-medicare-data-dump-and-the-cost-of-care.html

For anyone that has any experience trying to create and commercialize a medical device one of the most challenging, frustrating, and intimidating obstacles is obtaining FDA approval. It’s complicated, it’s expensive and more than anything it’s LONG.

There are currently a number of different ways that someone can obtain FDA approval. The two most common are the 510(k) pathway and the Premarket Approval (PMA) pathway.

The 510(k) is a pathway that can only be followed by devices that can prove they are substantially similar to a pre-existing device on the market. In doing so, devices that pass by FDA approval through the 510(k) do not have to undergo clinical trial for approval. (Although for more complicated devices trials are also necessary to show validation to the market). Most Class I and Class II devices are approved using this pathway.

However, for inventors and companies with groundbreaking technology that is not similar the PMA pathway is often the only option. This is an extremely stringent and time consuming process that is often an enormous barrier to entry for startups.

An expedited pathway to approval called the FDA Fast Track Development Program has existed for a few years in the pharmaceutical industry that can accelerate approval time  to only 60 days. Drugs that offer solutions to unmet needs are appropriate for this program like novel cancer drugs.

But for some reason no such equivalent has existed for medical devices. Well hopefully the wait is over.

Just yesterday the FDA announced proposed the Expedited Access Premarket Approval Application, a program for medical devices that will help new and novel technology that is needed by patients and the medical community to obtain faster FDA approval.

Technology has been growing at an incredibly rapid pace, and technological marvels are all around you. Unfortunately, the medical environment has been resistant to change and slow to evolve. Part of that has always been the huge obstacle associated with FDA approval.

Hopefully, this new process will make things a little bit easier. 

http://www.reuters.com/article/2014/04/22/us-fda-medicaldevice-idUSBREA3L10120140422

Many of the applications that are being developed as part of this class have run into the same dilemma: how can we have doctors communicate with patients in a HIPAA compliant and secure environment? There are secure doctor networks like Doximity, and in my last post I mentioned an idea for a secure patient doctor portal based on Doximity.

Well here’s another option. Cyber Dust.

Cyber Dust (http://cyberdust.com/) is a Mark Cuban backed startup that is described as “Whatsapp meets Snapchat”. The mobile application allows members to communicate with one another in a secure environment in which all messages are automatically and permanently erased after 30 seconds.

The impetus for this technology has absolutely nothing to do with medicine. Cuban talks about situations like Alex Rodriguez’s incriminating text messages that were part of the case leading to his history making MLB ban; private discussions he wanted to have with investors without worrying about the SEC prying; and confidential discussions between clients and lawyers.

With current text messaging however that just isn’t a reality; cyber dust allows individuals to communicate without leaving a digital footprint.

The common denominator here is that all of these conversations were supposed to be confidential, which is exactly what communication between doctors and patients is supposed to be. So then could Cyber Dust be modified in a way that facilitates secure patient doctor communication?

I see a lot of promise in the idea. But there is also a risk. Without a digital footprint it could be hard to hold doctors accountable.

I guess the real question for patients, doctors, Cyber Dust, and Mr. Cuban is do the benefits outweigh the risks? 

I have had an idea for a while, but I’m still not sure whether it is something that people need, desire, or would find beneficial. So I’ve decided I’m going to publicly share it on this forum, and see what kind of feedback I can get.

Throughout the semester in class we’ve touched on the subject of authenticity over the internet. It can be very difficult to assess a person’s credibility and authenticity on the web. This is a problem with the internet in general, but it’s an even bigger concern in medicine where information related to health is being shared. How can I be sure this individual’s advice is credible? How do I know this isn’t some company trying to scam me, or an individual who enjoys trolling the internet? It can be hard.

Completely unrelated to that we’ve talked about the disparity between the number of individuals who own smartphones or the number who have internet access and the number of individuals who are actively engaged in their health.

But maybe these two things aren’t unrelated? I have a feeling that there is a relatively large segment of the population that might not be active because they don’t feel safe and secure with both the information they are sharing and the information they are receiving.

So that’s the problem – here’s the idea.

If you are familiar with Doximity (https://www.doximity.com/about) you know they have done an excellent job verifying the credentials of physicians and giving them a portal that they feel secure communicating in. For patients, there are online portals like PatientsLikeMe which are fairly popular, but they don’t have nearly the kind of security that a site like Doximity does.

But what if we combined the two?

Doctors are very familiar with their patients. If we create a patient centered portal that works with Doximity we could use doctors to verify the credentials of patients as true patients.

Here’s how it would work. Suppose I have diabetes; in order to gain access to the secure diabetes portal I would send my doctor the equivalent of a friend request on Facebook asking for permission to access the portal. My doctor would then verify that I am a diabetes patient, and only then would I be able to access the information and share my information over the portal.

While this may seem unnecessary or cumbersome it adds value by creating a portal where each patient knows that the individuals they are communicating with are truly patients concerned about one another, not companies and not trolls. It could also potentially provide doctors with a more secure and private place to communicate broadly with disease communities.

The technology and software for this is easy. But are there people out there that could use this? That’s the tough question. Thoughts?