Devices vs. Prescriptions: Why Do Machines Come So Slowly?
Over the past few decades, the Food and Drug Administration (FDA) has worked hard to streamline the approval process for new and innovative prescription drug treatments. This means that new drugs are getting on the market and into doctor’s offices sooner, treating illnesses more effectively. Yet medicine is not the only treatment for illness; mechanical devices often work alongside medicine, or replace medicine entirely, to assist with patient care and treatment. Imagine a world without inhalers for patients with asthma, or functional limbs for amputees—medical devices and treatment go hand-in-hand. However, the FDA simply has not sped along the process for getting new medical devices approved and on the market. What truly is the time difference, and how does that affect the elderly?
…apply to the FDA for approval and undergo rigorous testing procedures which take significant time and resources.
In a working paper from Harvard’s Business School, Ariel Dora Stern shows that small companies, which often fuel innovation in the sciences, cannot afford the difference in cost that it takes to wait for FDA approval for medical devices. It works like this: a company develops a new model or better design (or an entirely new product) to fill a medical need. They must apply to the FDA for approval and undergo rigorous testing procedures which take significant time and resources. This application is detailed and important; a miscategorization of a device could be the end of an application and mean taking even more time to process a new one. The longer approval takes, the more money the company loses in sales to insurance companies, doctors’ offices, hospitals, and consumers. This means that many companies simply cannot afford to waste time on the approval process, and so do not invest in creating innovative machines for treatment.
Losing innovation in machines means that existing devices are rapidly falling behind the times. If resources were unlimited and companies could innovate freely, we would see more machines that work better to treat patients. So this time cost, in essence, is costing us better treatment.
Lack of Resources
Treatments of some kind exist for nearly anything these days, but having less-than-ideal treatment can hurt more than one might think. Innovative products often either build where previous products failed or redesign products completely to be more effective. Think of it this way: why give a military veteran amputee a wooden leg when there are modern designs which function well enough to let some amputees run marathons? The approval process and its slower pace for machines mean that your senior could be working with a model that is less effective or less safe than a new product.
Machines not approved by the FDA are not covered under insurance. This means that elderly people who may have access to an untested machine are faced with a huge decision: get the machine at huge financial cost, go untreated, or use an inferior older model that has been outdated by new research and innovation. As many seniors live on a fixed budget and rely upon Medicare for their healthcare needs, this decision is an unfortunate rock-and-a-hard-place conundrum that could mean seniors without significant personal wealth could be left with substandard, non-innovative treatment.
The FDA’s job is to ensure that the products reaching patients are safe and effective, meaning that review of research, retesting, and scrutiny by experts are important.
There is a reason for an approval process by the FDA, however, and there is an argument in favor of taking time with approving treatments and being thorough in that process. The FDA’s job is to ensure that the products reaching patients are safe and effective, meaning that review of research, retesting, and scrutiny by experts are important. Without this, drugs and/or medical devices could be unsafe, claim to treat things they do not treat, or have hidden side effects that put patients at risk.
The question comes down to balance. How do we balance the needs of safety and effectiveness with getting innovative products into the hands of patients quickly? That is in the hands of the FDA.
Blanding, Michael. (August 10, 2015). New Medical Devices Get to Patients Too Slowly. Harvard Business School, Working Knowledge. Available at http://hbswk.hbs.edu/item/new-medical-devices-get-to-patients-too-slowly. Retrieved on March 3, 2015.
FDA.gov. How to Study and Market Your Device. (September 16, 2015). U.S. Food and Drug Administration. Available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/. Retrieved on March 3, 2015.
FDA.gov. What does it mean when FDA “clears” or “approves” a medical device? U.S. Food and Drug Administrations. Available at http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194460.htm. Retrieved on March 3, 2015.
Stern, Ariel Dora. (2015). Innovation under Regulatory Uncertainty: Evidence from Medical Technology. Harvard Business School, working paper 16-005. Available at http://www.hbs.edu/faculty/Publication%20Files/16-005_bbf7d434-a9e6-4190-b260-e2869cd36347.pdf. Retrieved on March 3, 2015.