Digital health is dramatically transforming patient care and revolutionizing the physician experience, with telemedicine, remote monitoring, and AI-powered diagnostic tools leading the way. Its impact is also being felt in the field of ophthalmology, where emerging digital technologies are reshaping the way eye care is delivered.
At 52, Anya experienced frequent episodes of blurred vision. Her ophthalmologist suspected that her vision problems might be due to refractive error, which is a common condition that causes blurry vision and is often correctable with glasses or contact lenses. Since Anya's busy work schedule made it challenging for her to visit her ophthalmologist regularly, her ophthalmologist recommended a telemedicine consultation using a mobile app that had a digital imaging tool. This allowed Anya to capture and share images of her eyes with her doctor. Built-in technology, like Software as a medical device (SaMD) and AI algorithms, helped detect subtle changes in her retina, providing crucial information about her eye health and potential risks. This allowed her doctor to quickly develop an effective plan to correct her vision. Anya now uses the app to monitor her eye health, make adjustments to her contact lenses, and catch complications earlier, leading to better vision control.
Such success stories are driving patients' interest in remote, technology-enabled health management platforms such as Luna, Eyecare Live, Advanced Ophthalmic Systems, and Optos. Today, roughly about 40% and 60% of consumers are interested in virtual health solutions,1 presenting innumerable growth opportunities for companies, which are as follows:
Therefore, it is not a surprise that the SaMD market is estimated to grow at an annual growth rate of 22% by 2027.2 This, in turn, will attract more players, and the competition among emerging ophthalmology startups and established players, as well as strategic partnerships and collaborations, will only continue to intensify.
What do companies need to stay ahead? To capitalize on the opportunities presented by digital health in ophthalmology, it is important for business leaders to stay on top of best practices. We highlight a few critical ones below.
As life sciences companies strive to lead the digital health race in ophthalmology, it is crucial for them to stay on top of the varying regulatory policies surrounding SaMDs. In addition, companies must pay attention to important design, coding standards, and cybersecurity considerations to protect sensitive patient information. We briefly discuss this below.
A brief overview of SaMD regulatory policies in the United States
The US Food and Drug Administration (FDA) has outlined the requirements for clinical evaluation and software validation of SaMDs. To promote seamless integration with other medical devices and health IT systems, the FDA recommends that SaMDs be designed to be interoperable.
SaMD manufacturers must also comply with US privacy and data protection laws, such as the Health Insurance Portability and Accountability Act (HIPAA), to ensure that their products are secure and any Personal Identifiable Information (PII) is protected.
Furthermore, the FDA has issued guidelines on cybersecurity considerations for SaMDs, which include recommendations for secure coding practices, vulnerability testing, and risk management.3,4
A brief overview of SaMD regulatory policies in the European Union
SaMD products are subject to strict regulations under the Medical Device Regulation (MDR). Before they can be marketed, these products must undergo a thorough conformity assessment to ensure that they meet safety and performance requirements, as well as other requirements such as clinical evaluation and post-market surveillance.
Manufacturers must also comply with the General Data Protection Regulation (GDPR) and other relevant data protection laws to protect patient data.
In addition, coding standards for SaMD are considered an essential requirement of the MDR, and must comply with relevant harmonized standards. The MDR framework requires manufacturers to document their use of coding standards in the technical documentation for their product and assess their suitability for a given SaMD.3,4
To effectively track and stay on top of these changes, companies can take the following steps:
Combining multiple Go-to-Market (GTM) strategies, such as B2B2C/e-commerce, and partnership, can provide significant benefits to companies in terms of reach, revenue, and customer acquisition.
B2B2C/e-commerce strategies involve selling directly to businesses (B2B) that then sell the products to end consumers (B2C) through online platforms. This strategy can help companies reach a large customer base by leveraging the customer network of their partner businesses. Companies can also leverage their partner's resources and expertise. Take ecommerce for instance. E-commerce platforms enable convenience and seamless customer experiences, leading to higher customer satisfaction and repeat business.
For example: A digital health company that provides telemedicine services and medical devices for ophthalmology could partner with an e-commerce platform to reach new customers and provide a seamless online buying experience. Additionally, the company could partner with ophthalmology clinics and hospitals to expand its network of providers and further penetrate the market. This way, the company can leverage both online and offline channels to reach and serve its customers better
Collaboration and strategic partnerships can provide significant market advantages for companies offering remote eye care services. By joining forces with other companies that have complementary technologies, expertise, or customer bases, companies can create synergies that allow them to offer more comprehensive and compelling solutions.
In the case of remote eye care, companies that offer both platforms and applications with integrated AI technologies can be particularly competitive. These companies can leverage AI to streamline the diagnostic process, enabling more efficient and accurate assessments of eye health. They can also offer a more seamless user experience by integrating their platform with their application, allowing patients to easily access their eye care information and communicate with their healthcare provider conveniently.
Promoting SaMDs in the ophthalmology space can be challenging, as there are often multiple stakeholders involved in the decision-making process, including physicians, patients, and payers. However, there are several best practices that companies can adopt to succeed:
As the field of digital health continues to evolve, the potential benefits for patients, healthcare providers, and companies are enormous. However, the competition is increasing, and companies must continue to innovate and stay on top of best practices to remain competitive. A combination of GTM strategies, an effective regulatory compliance framework, and strategic partnerships can help companies stay ahead of the competition in this rapidly growing field. It is an exciting time to be involved in the digital health ophthalmology space, and companies that can adopt these best practices and techniques are well positioned for success.