In the medical technology industry, 2016 has been an exciting year for R&D. From the development of naturally moving prosthetic limbs that are controlled by the brain to the use of a needle-free vaccine delivery device in Zika trials, medical devices are becoming a major focus in the advancement of human health.

In Alzheimer’s disease, a new clinical trial has begun that uses a device worn on the patient’s head, called transcranial electromagnetic treatment, or TEMT. The device breaks down proteins that scientists believe may trigger Alzheimer’s development, and stimulates mitochondrial function.

At Drexel University, researchers have taken on the challenge of improving treatment solutions for the millions of patients who suffer from slow-healing, chronic wounds. Backed by a $3 million grant from the NIH, the research team is testing the efficacy of a battery-powered applicator that uses low-frequency ultrasound to heal wounds.

Innovations in medical technology are fueling mergers, acquisitions and strategic partnerships, resulting in a restructured competitive field. A number of consolidations, including Medtronic and Covidien and Abbott and St. Jude’s Medical, have forced Johnson & Johnson from its long-held leadership position.

With the recently passed 21st Century Cures Act, the federal government has now created an environment that will likely accelerate expansion of this already growing market. In an era of big data, wearable technologies and the Internet of Things, the new policy will likely double the size of this $300 billion medical technology industry by 2020.

One of the most interesting provisions of the bill deregulates software that uses big data to support clinical decision-making. Except for software that collects patient data or has serious adverse effects, the FDA will no longer review these devices the way they review other interventions and diagnostics. Instead, the FDA will regulate accessories based on their intended use, instead of based upon the parent device with which the accessories are associated.

The new healthcare legislation has several provisions that are intended to improve the regulatory process for bringing medical devices to market. First, it establishes a Breakthrough Devices program that gives Priority Review for devices providing “more effective treatment or diagnosis of life threatening or irreversibly debilitating human disease or conditions.” Building on the FDA’s Expedited Access Pathway, the program will help bring technology to market for conditions with no cleared or approved alternatives.

Second, the bill expands the FDA’s Humanitarian Device Exemption program, which allows approval for devices that address rare diseases. The revised program will double the limit, allowing approval of devices for conditions that affect up to 8,000 people annually.

Other provisions of the bill include shortening certain types of rulings to 60 days, exempting some IVD tests from routine inspections and ensuring review panels have “adequate expertise” to assess the disease that the device is intended to cure, treat, mitigate, prevent or diagnose, as well as the device’s technology.

Although the jurisdiction of the new law only applies to the U.S., the impact of the legislation will be felt globally. Besides being the largest medical devices consumer, the U.S. leads the world in the production of medical devices. With the combination of innovation and supportive new policies, much of the world will benefit from both the development and commercialization of new medical technologies. 

Matthew Howes is executive vice president, Strategy & Growth for PALIO, an inVentiv Health company. A leader in digital strategy, he has provided the fuel for digital businesses visited by more than 100 million people every month. Email matthew.howes@inventivhealth.com.

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