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.