Left to Your Own Devices
Getting an idea for a new medical device is only the beginning of a much larger process.
The field of otolaryngology is one that naturally lends itself to innovation. And often that innovation comes in the form of new devices that can change the way old procedures are done.
Anand Devaiah, MD, Professor of Otolaryngology – Head and Neck Surgery, Neurological Surgery, and Ophthalmology at the Boston University School of Medicine in Massachusetts, said the technology-heavy field of otolaryngology makes for fertile ground when it comes to device innovation.
“Whether you are approaching device innovation from the standpoint of developing a solution to a problem, fostering a deeper understanding of the ‘how’ and ‘why’ of development, or both, it allows for better application of future and existing technology in one’s practice,” Dr. Devaiah said.
Learning how to take that device idea from the drawing board to use in the field is the focus of Tuesday’s session, “Design It, Build It, Study It, Use It! A Crash Course and Guide to Device Innovation.” Dr. Devaiah said there are many steps physicians must go through in the process of bringing their device ideas to market.
“These include approaching development from a problem-solving standpoint,” he said. “Also, incorporating ‘lean’ methods and ergonomics into a device, and mapping out prototype validation and testing ahead of time to save time and resources.”
It also means involvement from the U.S. Food and Drug Administration (FDA), which provides regulation and guidelines on all new medical devices. Srinivas Nandkumar, PhD, Director of the FDA Division of Dental and ENT Devices, will discuss the regulatory processes and resources.
According to the FDA website, the first step in this process involves determining if the device is in fact a medical device. To do this, you must determine if it meets the definition of a medical device in the regulations and whether there is an appropriate product classification that exists for your product. These can be done via the FDA website and a searchable Product Classification Database.
From there, you must prepare a premarket submission and send it to the FDA for review, whereupon the agency will guide you through the review process. That process includes an administrative review where officials examine the premarket submission to determine if it is complete enough for a more substantive review. From there, it goes to an interactive review, in which FDA staff will communicate directly with applicants to move the review process along.
Dr. Devaiah said the principles discussed in the session will be applicable to a broad variety of devices, which will help provide physicians with a broad skill set when it comes to figuring out how to get those devices out into the working world.
“Whether you are starting on a new medical device, in the midst of development and deployment, looking to better inform your own practice choices, or simply interested in learning, we’ll have something for everyone,” he said.