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BLOG biotech : Sep 6, 2011

Developing Technologies for the Developed World

  • Zachary Russ
Cloud Nine or Ward Eight?
Aid to developing nations often conjures up ideas of faraway places, with thatched huts or corrugated tin roofs. Indeed, the Philippines was just featured because it was the aim of an MIT idea to provide light to shantytowns, using water bottles as skylights. Dubbed "A Liter of Light," the bottles substitute sunlight for electrical lighting.

Living in an apartment that makes extensive use of skylights, I have seen firsthand how much of a difference a bit of solar lighting can make. The packaging may have been a little different (PET bottles versus acrylic sheets), but the principle was just as relevant in Berkeley as it was in Manila.

But there's more that brings Manila a bit closer to home than one might think. For one, infant mortality, a good indicator of health: The latest figures put the Philippines' average at about 20 deaths per 1,000 births. The average in the U.S. is about 6/1,000, but in inner-city areas such as Ward 8 of Washington D.C., the rate goes up to about 20 deaths per 1,000 births.

As embarrassing as it is to have some of the worst public health problems in our nation's capital, these problems also bring up an interesting trend: The rest of the world is catching up, and they suffer from many of the same difficulties we do. The diversity of the U.S. also extends to living conditions—there are rural and poor communities without common amenities: 1.7 million people live without running water in the U.S.  What might be 0.5% of the U.S. is still enough to compose Washington D.C. proper with enough left over to fill Baltimore and Atlanta.

Places like Pakistan and Nigeria have two cellphones for every three people; imagine getting a text from someone with intermittent electricity. With summers heating up and high air-conditioner usage being the lead cause of rolling blackouts and brownouts, that similarity may find its home here as well.

Cutting-edge bioscience and medical research in the U.S. is often focused on designing for the ideal cases, producing ever-more-expensive and complicated equipment. But million-dollar MRIs and thousand-dollar thermocyclers are not sustainable in a world of budget cuts. Nor is this model compatible with increased access—schools can't demonstrate PCR, and medical care bankrupts people.

What Is Appropriate?
The solution is to take a different design approach, much like that used when academics hope to do good for the Third World. The style is called appropriate technology (often in conjunction with sustainable technology), and it focuses on a few tenets:
--limit dependence on the availability of local expertise, infrastructure, or resources
--reduce cost to produce and distribute
--maximize performance, subject to accessibility and usability of the device

These design tenets need not be limited to humanitarian projects. They are often called sustainable because they are just that.  Sustainability is not something to be avoided: every nation, industrialized or not, needs to find a sustainable balance.

Some technologies are inherently amenable to this model. The ELISA, for instance, has been powering 98% accuracy $7 pregnancy tests for years. It is now powering $15 20-minute HIV tests, and it could be applied as a binary test for practically any protein marker.  Up-and-coming technologies include small-volume reactions using hybridization or nucleic acid polymerization and automation.

It is no stretch of the imagination to consider a kiosk that offers voice-guidance in submitting and preparing samples and then does the test of the samples on the spot. Smartphones are finding their way into the hands of people who have not graduated middle school, and the internet is widespread, providing an opportunity for distributed use of technology. There are already cheap ultrasound devices that connect to smartphones, as well as microscopes, breathalyzers, and pulse oximeters.

These are friendly technologies, though. What about technologies that are more difficult to supply to the masses? These are still manageable.

DIYbio groups have come up with $70 thermocyclers when the list price is orders of magnitude higher; MIT's D-lab designed electricity-free incubators based on material that melts at 37°C; George Whitesides' group develops paper-based quantitative blood tests for pennies apiece; and researchers at Stanford came up with prepolarized MRI machines that cost $50,000 using off-the-shelf parts, and those machines are better than the million-dollar-models at imaging patients with metal implants. These cheap prepolarized MRI machines could find their way into podiatrists' offices, just as ultrasounds came to obstetricians.

However, while several of these devices have found their way into villages, they have not found their way into the mainstream here.  What has found its way into the mainstream is the practice of medical tourism—companies such as indUShealth ship patients overseas to receive treatment where they can still afford it.

Why So Expensive?
If we are implicitly and explicitly admitting that costs of healthcare and indeed biotech—from online pharmaceuticals to shared and used lab equipment—are too high, why hasn't something been done about it?  Why haven't we seen the same explosion of features, access, and decrease in cost that we did with computers and cell phones?

Part of the problem is mindset—the suggestion of cheaper equipment, of optimizing for cost and wider access is anathema to a heavily regulated system where anything less than the best is grounds for disapproval or malpractice.

Products designed for developing countries benefit from breezy acceptance. Because of the communities' immediate need and minimal regulatory structures, streamlined testing to prove a device reproducibly works as predicted is sufficient.

In the U.S. critical diseases such as HIV and cancer have provided more streamlined approval, but the regulatory burden is still much greater. It is often simpler just to start using the product overseas as a way to generate proof of safety and efficacy for the FDA.

Some of the design considerations do have counterparts in aspects of FDA approval: being granted a CLIA-waived status allows all labs (defined as any facility that tests humans for medical purposes, which can include a lone nurse or test van) to use a diagnostic test.  This is critical for achieving greater access to patients – the local doctor (CLIA-waived) may be five minutes away, while the nearest lab (CLIA-moderate or above) would require a referral and additional travel.

Similarly, over-the-counter approval grants a wider end-user base, though this requires additional design considerations as many people lack the skills to use and interpret these tests.

For instance, 36% of adults tested in the 2003 National Assessment of Adult Literacy had below-intermediate competence. An example of an intermediate-level challenge was identifying compounds that may cause a side-effect when combined with an OTC drug by reading the information on an OTC drug label. When one in three adults can't figure out when not to use a drug or test based on the label, a semi-supervised application may be ideal.

Speaking of ideal, the situation has developed as it has because those demanding the tech have been isolated from cost. Just as college tuition skyrocketed in response to increased grants and loans, doctors are shielded from the costs of the new machines.

Scientists can use grant money to buy the latest and greatest at any price. It's supply-and-demand, where the demand is supercharged by limitless funds.

Perhaps "was" is the better term: the debts incurred by this system are starting to come due. The budget market will become much more relevant as we find that third-world considerations are real-world considerations. Our institutions and regulations, which were built for an ideal world on idealized funding, are in for a very real surprise.