Virtual Reality as a Medical Device

by Madison Green | Jan 24, 2020 | FDA, Medical Devices, Regulatory, Requirements

Augmented and virtual reality first saw its boom in the consumer sector but has recently piqued the interest of the medical device community. Extended reality (or XR, the umbrella term for augmented or virtual reality) can have many uses across the medical device and healthcare space. With a wide variety of applications and features, many med device firms are turning to it with the aim of advancing the industry.

Many medical device firms are utilizing XR as the basis for their medical device. Intuitive Surgical was granted FDA clearance last year for its product IRIS, which is used by surgeons to view 3D images of patient anatomy during procedures. There are also startups like Limbix which uses a VR headset to treat mental illnesses such as panic disorders.¹Many companies are also turning to XR to assist with at home medical devices (which you can read more about here) in terms of training and patient instructions. Since medical device instructions can sometimes be hard to interpret based on a variety of factors, at home medical device firms are using XR to simulate hands-on training scenarios for customers.²

But how is XR regulated as a medical device? Since it’s such a novel field, the FDA is still actively working with medical device firms to effectively regulate the technology and allow for safer innovation. For now, most XR medical device firms are going the De Novo route, as the whole field is still new in the medical space and there aren’t a lot of predicate devices on the market. In March, the FDA is hosting a public workshop on medical extended reality, where it will host speakers from a variety of sectors and companies to discuss best evaluation practices for the technology.³ The agency is requesting comments from start-up companies and the public to help guide the conversation. With all of the emerging opportunities that XR medical devices could provide advancement in, the FDA wants to quickly figure out the most effective way to evaluate the products while still keeping consumers safe.

Much like 3D printed medical devices, XR medical devices are the new wave of the industry. The technology could potentially provide advancements to both health care providers and consumers alike that wouldn’t be possible without otherwise. If you are a medical device developer that is looking to utilize innovative technology such as XR, contact EMMA International at info@emmainternational.com or call (248) 987-4497 to see how we can help you navigate the regulatory pathway.

¹Limbix (n.d.) Prescription Digital Therapeutics retrieved on 01/21/2020 from: https://www.limbix.com/pipeline

²DiGiulio, NBC News (August 2017) 3 Ways Virtual Reality Is Transforming Medical Care retrieved on 01/21/2020 from: https://www.nbcnews.com/mach/science/3-ways-virtual-reality-transforming-medical-care-ncna794871

³FDA (n.d.) Public Workshop – Medical Extended Reality: Toward Best Evaluation Practices for Virtual and Augmented Reality in Medicine retrieved on 01/22/2020 from: https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/public-workshop-medical-extended-reality-toward-best-evaluation-practices-virtual-and-augmented

Madison Green

Director of Technical Operations - Mrs. Green serves as EMMA International’s Director of Technical Operations. She has experience in technical writing, nonconforming product management, issue evaluations, and implementing corrective and preventative actions in the pharmaceuticals and medical device industries. She has experience cross-functionally between R&D, lean manufacturing operations, and RA compliance. Mrs. Green also has academic and work experience with human health-risk engineering controls, physiological biophysics, and clinical research. Mrs. Green holds a Bachelor of Science in Biosystems Engineering with a concentration in Biomedical Engineering from Michigan State University. She is also a Certified Quality Auditor (CQA), and is currently pursuing her M.S. in Quality Management.