A disruptive market of $410 billion until 2023, changes dramatically with the entrance of small and medium size players, many of them rising up from the startup community. Software plays a big part in this shift as a differentiator in medical devices as well as the manufacturing of portable devices used by the end user. Devices like blood glucose monitors, heart rate monitors, pulse oximeters and some others less widely used, like Alzheimer test applications and pacemakers with embedded WiFi capabilities may be in an everyday frequency by companies that some years ago were unknown to the wide population. A lot of people may have heard of Abbott Laboratories, Johnson & Johnson and Philips, but how many know Neurometrix and Sonova. In addition, companies coming from the lifestyle market like Apple and Fitbit try to gain a big portion of the market, using design and a bucket full of attractive features.
In an ever-changing healthcare landscape, FDA seeks a new procedure that will let the market continue to develop but also offer a safe environment for the users. “The De Novo pathway for novel medical devices allows the FDA to conduct a rigorous review of new technologies so that patients have timely access to safe and effective medical devices to improve their health,” said FDA Commissioner Scott Gottlieb. The move comes shortly after the FDA announced plans to modernize the medical device 510(k) clearance pathway.
In this frame, some days ago the U.S. Food and Drug Administration published the De Novo Classification Proposed Rule, which, if finalized, would establish procedures and criteria for the De Novo classification process and become part of the Medical Device Classification Procedures (21 CFR Part 860). The De Novo Classification Proposed Rule builds on FDA’s earlier work to provide structure, clarity, and transparency to the De Novo classification pathway. In 1997, through the Food and Drug Administration Modernization Act (FDAMA), the FDA was first able to classify novel, low to moderate risk devices without a predicate as a class I or class II device through De Novo Classification.
The proposed rules would set a 120-day review period for De Novo classification requests. The new FDA proposed rule follows the agency’s setting of substantial user fees for De Novo requests in 2017 as well as performance goals for assessing such requests. Providing clarification and greater detail regarding De Novo device classification requests should help market applicants better determine whether to utilize this registration pathway given its significant cost.
According to Dr. Ioannis Tarnanas, Founder and Chief Science Officer at Altoida, who has entered the market with a Class II medical device to screen and monitor cognitive outcomes, the new De Novo is more appealing compared to its 510(k) counterpart and it will build a better environment for companies to classify medical devices. Asking him about the cost, he told us that the starting fees are not the problem for most of the companies. More important are the expenses that a company has to assume, in order to keep the device in compliance with the certification framework. Minor adjustments such as the replacement of a sensor, a chip or even a button in the application interface,must not affect its efficacy. Employing consistent quality standards can be a real hassle for both the quality department of the manufacturer and the company that delivers the device to the market given that Asian suppliers may switch anything from materials to assembly lines in a flash.