During the last few years, we have witnessed an unprecedented acceleration of technological advances for people with diabetes, a condition that affects nearly 30 million Americans. New systems are promising patients less hassle, less pain, fewer injections and finger pokes, less mental math, and less worry about managing their condition. These advances provide more accurate and real-time information on blood sugar (glucose) through wireless technology, apps, built-in clinical decision support algorithms, and automated insulin delivery systems that can reduce diabetes burden and complications. Even Apple (AAPL) has reportedly hired biomedical engineers to develop a sensor that detects blood sugar, sparking talk of the company potentially embedding the sensors into a wearable watch that could become a “must have” for people with diabetes. But it will be a long time before it’s actually on the market.
There have been some recent successes: Continuous glucose monitoring (CGM) systems, such as the Dexcom G5 Mobile CGM system, use a sensor through a tiny catheter slipped under the skin that reads glucose every five minutes. This sensor wirelessly transmits information to a stand-alone receiver or smartphone to alert patients of upward or downward trends in their glucose so they can take preemptive action.
Large strides toward an “artificial pancreas” were taken in 2016 when the Food and Drug Administration (FDA) approved the Medtronic MiniMed 670G, which is the first device to uses CGM data to automatically adjust background insulin doses, which are then delivered through an insulin pump. IBM (IBM) Watson Health is developing a unique cognitive app that finds patterns in a patient’s blood glucose data and offers individual guidance for changes in management.
While patients have long clamored for innovations, the FDA-required testing and regulatory requirements may result in waiting years for a marketed product. A report from the U.S. Government Accountability Office (GAO) in 2012 estimated that the average time to approval of a new, low-risk device was 161 days vs. 627 days for a high-risk device. The stakes are high for products marketed to diabetes patients who must obtain accurate blood glucose readings and who require insulin to maintain their blood glucose within normal range to avoid serious health consequences. In addition, medical insurance companies typically are only willing to pay for products that have been properly tested for safety and effectiveness.
A number of regulatory hoops must be jumped through before a medical device is approved for marketing. Since the FDA has statutory authority for establishing requirements for medical devices, manufacturers must adhere to FDA regulations before gaining approval to market their devices. The most critical first step requires the FDA and device manufacturer to properly classify a device based on risk to the patient, guided by the Code of Federal Regulations. The amount of data that must be collected to demonstrate safe and effective use will depend on the risk associated with the device. In the area of general health and wellness apps that pose little risk to users, such as the Fitbit (FIT), the FDA has decided not to enforce regulatory requirements. However, with medical devices such as the Medtronic MiniMed 670G, risks to patients are higher, and regulatory requirements would apply.
Next, the manufacturer must register the device with the FDA. The device must be manufactured in accordance with Good Manufacturing Practices (GMP), which may substantially slow the availability of the device for testing. Clinical (human) studies are usually conducted to collect safety and effectiveness data after an Investigational Device Exemption (IDE) is filed, though the number of studies and patients varies widely.
These studies are conducted at various clinical research sites, and must be reviewed and approved by an ethics board (Institutional Review Board) to assure that human subjects rights are protected and risks to subjects have been minimized relative to potential medical benefit. Recruiting patients into studies may be challenging and may contribute to delays in obtaining the necessary data to submit to the FDA.
Most medical devices are marketed through an abbreviated pathway called 501(k) that is faster than the drug approval process and allows manufacturers to demonstrate that a new device is essentially equivalent to a currently available device. Although the FDA has made efforts to streamline its processes while safeguarding patients, some experts have stated that the FDA has increased hurdles for new devices. This may be due to concern regarding device failure and the high number of medical device recalls in general.
How can patients and others anxiously awaiting these devices know when they will be approved? While there is no definite answer, one thing is sure: Everyone will want to know that they have been thoroughly tested to be safe and to work as intended. The FDA’s stance on device regulations will undoubtedly evolve as patients, prescribers, and device manufacturers continue to advance the frontiers of medical innovation. But until then, you will have to wait for that Apple watch.
June Felice Johnson is a professor of pharmacy practice at Drake University’s College of Pharmacy & Health Sciences.
