Medical Futures Lab

Recently I had a brief meeting/discussion with a doctor from the Texas Medical Center who conducts research in the realm of public health. We met so that I could receive feedback on some health-related software that I had developed for a class. Among the many things I learned during the conversation, there was an intriguing observation that I perceived: software engineering methodologies for creating a solution are philosophically different than the techniques the doctor was employing, and the methods I was learning about in class.

Source: Wikipedia

In software development, one of the core principles is to operate continually, using an loop of building software and getting feedback. This is absolutely necessary in the world of software where goals, technologies, and requirements change at dizzifying rate. The answer to the speed of software was to use a set of adaptive and flexible methodologies, often referred to as “Agile” practices.

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The method on the other end of the spectrum is to engage in research that results in a deep understanding of users and the solution domain. Rather than prototype quickly and get feedback, the idea behind user-centered design is that users are sufficiently understood so that when it is time to design, prototype, and evaluate, time spent will be more efficient and effective because there is a solid understanding of the stakeholders and their environment. This is effective in most situations, because the assumptions are not changing even while one is prototyping.

In reality, the methods are not too far apart from each other, as they both operate in iterations that contain similar elements. However, there is an important philosophical difference; in the two figures, user centered design places the main elements in a circular loop while agile development reinforces the continual and parallel nature of the processes. This is only because of the ridiculous speed of the software industry. But in the end, each party at both ends of the spectrum could take notes from each other. A healthy balance of user-centered design combined with fast prototyping and quick iteration cycles would provide an approach that is both responsive and precise.

If I were to ask you to name someone in your life that is described by the word eccentric, who comes to mind? Everyone has someone in his or her life that blurs the line when it comes to sanity, and can be described, for a lack of better words, as a little bit “off their rocker.” For me, that person is my grandpa. A high spirited and extremely social old man, he is constantly calling me to talk to me about his garden, to rant about the latest University of Arkansas sporting event, or to remind me that I need to cover up the camera on my laptop because the government is using it to spy on me. While his slightly paranoid notions constantly amuse me, I’ve begun to see how some of today’s advances in science appear to be a bit out of this world. The constant innovation and development of new technology has provided tools for medicine that seem like they belong in a sci-fi book or the ranting’s of a conspiracy theorist.

One such example is a technology that has the possibility to revolutionize the way we approach medicine. In many of the projects presented in class, students brought up issues of patient adherence to treatment plans as obstacles in designing a solution. Teams provided examples of having no way to check or confirm if patients were taking their medication and if so were patients doing so consistently, at the right time, etc. So, what if we could eliminate this problem of adherence to a medication plan all together?

A group of researchers at MIT are trying to do just that.

This team has designed a microchip, about the size of a scrabble piece, that can be preloaded with medication and implanted into the body with the option of being programmed to administer drugs at a given time, interval, and dose. This allows patients freedom from the burdensome medication schedules they usually adhere to, and gives doctors the ability to theoretically adjust or stop medication dosage remotely. Proven to be safe and effective in a study done in 2012, the company, microCHIPS, hopes to continue to improve the chip in order to be able to have it turn on and off remotely and improve structure of that hopefully it could remain in the body and deliver medication for up to sixteen years.

What implications does this innovation have on the future of medicine? First and foremost it offers the possibility for major improvements in the treatment of chronic illness that require constant medication and treatment. Having a built in system that eliminates a lot of the human variable of adherence provides the opportunity for more consistent care and better health outcomes.

The microCHIPS also present a variety of possible resources in preventative medicine. For example, can implanting a chip in a person at a high risk for allergic reaction be beneficial and effective further down the line when an emergency ensues? The possibility of arming high-risk patients against future potential medical problems increases opportunities for improvements in preventative care.

As we move forward in our examination of this product we are left with a variety of questions:

What other implications or applications could microchip produce?

 Also, what possible complications, both medical and social, could arise from implanting a microCHIP with medication into the body?

Sources: http://www.cnn.com/interactive/2014/04/health/the-cnn-10-healing-the-future/?frame=1&hpt=he_c1

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