In the age of IoT and AI, many are now wondering if the standards that govern innovative industries, such as the technology and medical device industries, are stifling innovation. According to a 2017 study, The Impact of Standards and Regulation on Innovation in Uncertain Markets, in markets with both low and high uncertainty, businesses that experience problems with standards have to spend a larger amount of resources to be innovative. Many manufacturers, however, don't end up marketing their products because they cannot pass compliance with regulatory bodies and do not possess the resources to re-test and redesign products. This poses a significant threat to the global economy as well as to technological evolution.
As discussed in our previous article, the medical device industry’s fierce regulatory environment has resulted in a reduction of innovative products and high-risk technologies entering the market. The perpetual introduction of innovative medical technology to the market has proven to save lives, improve the healthcare system, and enhance physical and emotional wellbeing in patients. For example, Smart Inhalers were recently introduced as a solution to the misuse of conventional inhalers. According to Tonya A. Winders, president and chief executive officer of the Allergy & Asthma Network, inhalers work for 90 percent of patients who use them correctly. Up to 94 percent of patients, however, do not use their inhalers correctly. One inhaler is to be used daily to reduce inflammation and another inhaler is to be used during an asthma attack. The Smart Inhaler, which will be introduced to the market in 2020, will use Bluetooth to pair to the patient's phone and remind them to use their inhaler. In addition, it will rate how well a patient inhales their medicine, effectively determining whether or not the patient is using the inhaler correctly.
While regulations are necessary for the safety of consumers there are sometimes specific rules with which devices simply cannot comply. Luckily, for such devices, the responsible party can submit a request for a waiver. Waivers are excellent tools to combat the strict regulations that many feel are stifling their innovation.
During the TCBC Fall 2019 Workshop this week, FCC leaders explained how responsible parties can request waivers in order to reduce the number of devices not making it to market. For Part 15 waivers, requests must demonstrate good cause for waiving the requirement. If the request is accepted, a review will be performed to determine whether or not the waiver will be granted. If the party does receive a waiver for its device, a copy of this waiver must accompany the device's certification application. Due to the FCC's waiver process, various medical devices have entered the market. Following is a list of medical devices and their accompanying waivers:
Zoll Medical / Kyma Medical Tech uCor: medical device that monitors congestive heart failure; required waivers for Sections 15.31, 15.503, 15.513, and 15.521.
Sensible Medical Innovations, LTD ReDS System: device that records lung fluid measurements in patients with congestive heart failure; required waivers for Sections 15.31, 15.503, 15.513, 15.521, and 15.525.
MIT WiTrack: monitors mobility, breathing, and other physiological signals in patients without the use of body-worn sensors; required waives for Sections 15.503, 15.31, and 15.521.
Other devices that recently required Part 15 waivers include Google Soli; 32 Technologies, LLC Tracking Dog Collar; Evolv Edge; Proceq; and Wavesense. If you have a device that does not comply with a particular Part 15 rule and would like to request a waiver, you can find more information on the FCC's website. And if you have a device that needs testing to Part 15, contact Rhein Tech today or request a quote online.