Potential Impacts of Apple Vision Pro in Healthcare and on the Medical Device Industry

With the unveiling of its disruptive product, Apple Vision Pro, during WWDC 2023, Apple introduced a new era of mixed reality experiences. In this article, we explore the challenges and opportunities for Apple Vision Pro in healthcare and the potential impact of this new technology in the medical device industry. 

1. What is Apple Vision Pro

Apple Vision Pro is a groundbreaking spatial computer that represents a significant leap in the technnology, offering a seamless integration of digital content with the physical world while keeping users connected to their surroundings. Apple Vision Pro uses eye and hand tracking for navigation and interaction and boasts a fully three-dimensional user interface controlled intuitively through a user's eyes, hands, and voice. Powered by visionOS, the first ever spatial operating system, Vision Pro allows users to interact with digital content as if it were physically present in their space. 

Despite its promising potential and usability in a variety of scenarios and industries well beyond entertainment and gaming, the MedTech industry and healthcare sector included, there are some challenges that Apple Vision Pro must overcome to achieve widespread adoption. One significant concern is its high cost, currently $3,499, which could make it unaffordable for both individuals and institutions. Additionally, the device's weight of 1.5 kg may pose difficulties during extended usage, potentially limiting its practicality in certain situations. Moreover, the success of Apple Vision Pro in healthcare and elsewhere relies heavily on the availability and quality of apps and content that can fully utilize its spatial computing capabilities and provide genuine value to users. As a nascent technology, it might take time for the range of compatible applications to expand, and third-party developers will play a crucial role in enhancing its capabilities and features.

2. Apple Vision Pro in healthcare

Apple Vision Pro has the potential to significantly impact various industries, especially in the field of medical technology, healthcare, and digital health. 

From revolutionizing telemedicine and medical education and training to assisting surgeons in surgical planning and enhancing mental health treatments, the headset's immersive data visualization and accessibility features open up new horizons for both professionals and patients alike.

For example, the advanced sensors and hand-tracking capabilities of the headset can be harnessed for virtual rehabilitation and therapy applications. Providing patients with immersive environments for interactive exercises, monitoring their movements, and offering real-time feedback could greatly improve the effectiveness of rehabilitation programs and increase patient engagement.

3. Would Apple Vision Pro be a medical device? 

Apple's strong focus on accessibility features in its products suggests that Apple Vision Pro could introduce innovative visual aids or assistive technologies. These may include advanced magnification tools, object recognition, or navigation assistance, catering to individuals with visual impairments or other disabilities.

An ongoing online debate as to whether the headset may correct visual impairments and enable users to navigate their surroundings with improved vision, similar to traditional glasses, has already raised concerns about qualifying Apple Vision Pro as a medical device. However, as the manufacturer has not explicitly stated a medical purpose for the device, and prescription glasses users might still be able to use the headset with contact lenses or purchase custom-made prescription lenses, this scenario is unlikely. Apple has announced it is partnering with Zeiss to offer Zeiss Optical Inserts that can attach magnetically to the Apple Vision Pro and be customized to each person's vision prescription. 

Our opinion is that, by opening up applications for a developer’s kit and allowing selected developers to use the actual hardware to develop device-specific applications, Apple is opening up the way for Vision Pro to be used much as the iPhone or iPad are nowadays. Meaning, medical applications with a clear intended purpose and clinical indications will be developed and certified as medical devices by their developers to be then downloaded and used in conjunction with Apple Vision Pro. 

It is worth remembering that currently, digital therapeutics (DTx) are themselves in need of a more straightforward regulatory pathway as outlined in a recent paper. Their versatility in providing medical interventions for disease or disorder prevention, management, and treatment should be met with the corresponding level of care in ensuring accessibility appropriate for the user’s digital literacy (for example for elderly users with limited digital know-how) and proven effectiveness through systematic clinical trials in the case of evidence-based treatments. 

In this setup, Apple Vision Pro and the opportunities it offers in healthcare and the medical device field could either be an incentive to strengthen and simplify the regulatory requirements for digital therapeutics or a generator of further confusion in the field in the future. 

If you need support with establishing your regulatory strategy for software as medical devices, please contact us at: info@quaregia.com and check out our SAMD blog post  and medical device software presentation page for more details. We can support you by taking a proactive approach to the development and documentation of your medical devices including ML/AI algorithms with gap analyses, technical dossier audits, and custom SOPs tailored to meet the newest requirements and regulations.

Last updated 2023-07-31