We're driven by a few things as a team, one of them to create a product that is simple, affordable and accessible so that we can save the most number of lives as soon as possible. Another thing is to encourage medical device entrepreneurship in general - since we believe that there are too many pressing problems out there to solve that get too little attention because too many brilliant people are either intimidated by, or unaware of, the promise of potential of health entrepreneurship.
So we decided to provide a quick inside look at our process to do what's called a clinical validation study, or Phase 0, using our technology. Because intellectual property (IP) is a key driver of value in health, and medical device, entrepreneurship, we're going to have to speak in general terms - but we hope this post is helpful for aspiring health entrepreneurs none-the-less.
The first thing an aspiring health entrepreneur should know is that everything she does from the point she decides her device or technology is on a validation path (that is, once she decides to prove it works) needs to be clearly catalogued and recorded. That means developing a whole set of design and product protocols for which there are clear rules and regulations you can find better described on the MaRS site here.
This really kicks into gear when you prepare for a clinical validation study, and have to write up your visit protocol - and sign and file it - before even heading into the clinic. Now, we have it relatively easy: our device is non-invasive, does not touch or interact with the patient, and even more lucky is that we don't even change the standard of care (the way the doctor conducts the exam we're seeking to enhance). As you can see in the image above, our first variation of the technology just clips onto the back of an existing colposcope, using the colposcope itself to gather the data we need to provide additional data to the physician.
But even though we have it much easier than, say, a cardiology startup, when you go into the clinic everything can go wrong...and usually does. For example, we mistakenly assumed that the colposcope had a certain focal length because we forgot to measure one of the pieces in our preparation run. This meant that we went in to the clinic with a device that we built that simply could not acquire a picture in its first iteration.
In other words, we were facing an 'unknown unknown,' and had one hour to find a solution so that the trial could continue as planned.
Luckily, we had heard great advice going into the preparations - and that's the advice we'd like to share with you today. The advice is simple: develop multiple hypotheses, and course of action based on success or failure for each hypothesis of high priority.
For example, our hypothesis was that our device was going to be able to image at a micron resolution. When we realized our hypothesis was disproven (and our test failed), we had a secondary hypothesis, that our device using a set of lenses at a range of distances, could image at a a micron resolution, When that test succeeded, and our hypothesis was proven true, we had to ensure we properly documented the distances and requirements of this new system. Which required a set of assumptions and tests as well.
In other words, a protocol for initial visits should include a decision tree. If one succeeds, you move on along that path to the next junction. If it fails, you progress to the next junction along a separate path. And if you hit an unknown unknown, you jump to another high priority test so you can make sure you come out of the visit with data that can enable you to regroup and reset your tests.
The wrong thing to do is to go into a trial thinking your technology can't fail, and without playing out different scenarios as to what could go wrong to make your test fail.
Since a working technology is the foundation for every other trial you will conduct in the future, the more robust this process, the more prepared you'll be for future trials.
So...how did we fare? After dealing with a few failures and correcting for a few incorrect assumptions, we're doing great, thank you. Our device can now image at a micron resolution and enables a clinician to focus in with the colposcope while still benefitting from our technology's increased specificity. Very cool. Now it's time to push ahead to the next stage...and we'll keep you updated.
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