DIY is still in… Meet the DIY Pancreas

The signal: A few weeks ago, as the world was starting to take COVID-19 seriously, we wrote about DIY medical devices. At the time, it would have been difficult to predict where we are now -- a place where millions of people are making their own masks, while open-source ventilator projects are surfacing everywhere (Exhibit A, B, C… the list goes on).

Biotech is top of mind for many people. Last week, ARCH Venture Partners raised $1.46B, while firms like ElevateBio, RemeGen, and Affinia Therapeutics also raised massive rounds. Their success is a reminder that not everything -- even in the medical field -- requires billions in funding.

In fact, there’s been evidence for over a decade that crowd-sourced, DIY-esque solutions can be even more effective. A 2007 study, for example, showed that one-third of scientific problems that were unsolvable by internal teams were overcome through the collective research of large groups of independent scientists, similar to the open-source model.

DIY medical devices aren’t completely new. With most medical systems designed to limit any harm done (instead of maximizing good, net of harm), people have decided to take their health into their own hands… and perhaps amidst a worldwide pandemic, we can learn a thing or two. Introducing the DIY pancreas.

A long and costly FDA approval process means that insulin pumps typically take years to make it to market. When they do, they’re riddled with outdated software and expensive upkeep costs. So, in 2015, a team of tech savvy type 1’s decided to take back their livelihoods from the medical industry, creating the world’s first artificial pancreas system.

Since then, the popular artificial pancreas Loop has emerged as a leader.

Here’s how it works: The system involves an iPhone app that hooks up directly to an FDA approved insulin pump, automatically adjusting blood sugar levels. The only other piece of equipment required is a Bluetooth component called the RileyLink.

An FDA-approved insulin pump capable of adjusting glucose levels can cost $6k to $8k, with ~$1.5k of additional supplies needed every year. The Loop system costs just $163 for the RileyLink, and another $99 a year for the app. The most expensive component is the pump, which retails for about $600 (like this Omnipod System).

But some patients illegally source secondhand medical devices or have developed resources on how to 3D print their own insulin pump for ~$100. In fact, there’s even a black market for such products (we don’t promote this activity).

But the open-source medical movement doesn’t end with Loop. A few more examples:

1. OpenAPS is an open-source artificial pancreas known for being the best-in-class at predicting future blood sugar levels.
   
   
2. The NIH hosts a 3d printed prosthetics exchange which allows users to upload custom-made blueprints for prosthetic limbs.
   
   
3. CoEpi is an open-source community that plans on building an app to track the spread of epidemics.
   
   
4. Healthy Pi is a DIY portable ECG kit.
   
   
5. There are a number of open-source Github projects, which use EEG data to predict seizures, with devices costing as little as $99.

The Opportunity:

It’s illegal to buy and sell medical devices without the proper licensing, but there are still a wealth of avenues to participate legally:

• Cases...

Pump cases: Despite insulin pumps often being used outside of the home, very few products serve this use case. This is particularly relevant for the OpenAPS rigs, which are comprised of a number of small parts. For example, "insulin pump case" has 480 monthly searches on Google, alongside other keywords like "insulin travel case" (1.3k). Meanwhile, on JungleScout, these queries get 196 and 758 searches, respectively, but very few products serve these queries.

Phone cases: Users of the Loop system (remember, over 20k!) often wish to put their RileyLinks inside their phone cases, but there’s currently no product solving for this.

• Pre-Prepared Hardware Kits...

Combination hardware kits: A number of studies have begun using ECG data alongside other tools to predict seizures. With the surge of at-home testing kits, an ECG and EEG testing kit sounds like a no-brainer.

OpenAPS users require a number of hardware options that vary depending on their lifestyle needs. Pre-made hardware kits could provide the convenience many search for as they’re building their own electronic organs. For now, they’re dependent on these how-to guides.

• Optimize with AI:

Artificial pancreases are far from perfect at predicting your blood sugar levels. With the surge of AI into biotech (like this program), there’s opportunity to produce and sell AI-based software to FDA-approved artificial pancreas manufacturers or to participate in other medical avenues like drug discovery.

• Start a Not-For-Profit or Community:

Medical device regulation differs worldwide, and in many 3rd-world countries, people are desperate for devices that they may not be able to afford. DIU kits could provide a scalable solution. At the same time, there’s an opportunity to create a vibrant community for people looking to participate in open-source medical advancement.