Digital health products (such as digital therapeutics, mobile health, telehealth, and personalized medicine) development has been on the rise in recent years, promising to transform healthcare delivery. However, the challenges faced in developing, commercializing, and marketing successful digital health products are significant, including market access and reimbursement; regulatory challenges due to lengthy and costly regulatory approval processes and the reality that ongoing compliance can be a burden even after approval; data privacy and security concerns; a highly competitive field; and reimbursement and revenue models. To minimize risks and maximize the chances of success, companies need to prioritize five key considerations discussed here: user expectations, digital environment, data, go-to-market strategy, and agility.
Key Considerations for Digital Health Product Development
The first consideration for developing successful digital health solutions is to prioritize the problems and challenges faced by users before offering solutions. In today’s healthcare landscape, patients expect personalized, data-driven solutions that can address their unique needs and concerns. By focusing on the problems faced by users and developing an in-depth understanding of their challenges and concerns, companies can design solutions that are tailored to their specific needs. This user-centered approach will guide the development and commercialization of digital health products and ultimately lead to more satisfied and loyal customers who have had their problems effectively solved. For example, there is no treatment available for adults with amblyopia, although research has shown that it is possible to develop a digital therapy.
What are digital health products?
DTx: A type of medical intervention that uses software as a medical device (SaMD) to deliver treatment.
mHealth: The practice of using wearable devices, mobile phones, and other tools to collect and share health data (such as adherence tracking).
Telehealth: The application of technology for managing patients remotely (such as monitoring, video calls, or remote clinical trials).
Personalized Medicine: Products that use data from genes, proteins, or other biomolecules to customize treatments or interventions for individual patients.
The second consideration is about making sure that our digital health product becomes an integral part of our users’ daily lives, without the need for them to adopt new apps or technology. We understand that people are often resistant to change, and thus it’s crucial that our product integrates seamlessly into their existing routines. To achieve this, we must ensure that our product is easily accessible, user-friendly, and engaging. We need to take into account the user’s behavior, needs, and preferences while designing our product (i.e., human factors). Extensive user research is necessary to develop an intimate understanding of our users. It is key to identify the most common technologies and devices that the users use, and optimize the experience for mobile use, to cater to their busy lifestyles. Additionally, developing interfaces that allow the product to integrate with other software and applications that users commonly use is an absolute must; for example, a product that integrates with personal assistant devices such as Google assistant to deliver notifications and reminders could be quite impactful. A critical step of the development is to validate the design with human factor studies. FDA’s guidance Applying Human Factors and Usability Engineering to Medical Devices describes validation activities to ensure safe, effective, and usable medical device design.
The third consideration is an end-to-end data strategy, which goes beyond mere handling of user data. While utmost care and transparency are necessary to protect user privacy and ensure compliance with data protection regulations such as the US Health Insurance Portability and Accountability Act (HIPAA) and the EU General Data Protection Regulation (GDPR), it is essential to go further. Data must be utilized to improve the product, healthcare outcomes, and the user experience. Companies should establish a data strategy that facilitates data collection, storage, analysis, and sharing, with a focus on generating insights that benefit users and stakeholders. This includes establishing clear protocols and guidelines for data usage, prioritizing user privacy, and ensuring transparent communication with users on how their data will be used. Furthermore, data must be shared back with users and stakeholders to build trust, improve transparency, and demonstrate the value of the digital health product. Sharing back data can take several forms, such as providing users with personalized insights, generating anonymized and aggregated data reports for stakeholders, and using data to facilitate collaborations between healthcare providers. For example, integration with “electronic medical record” and “electronic health record” (“EMR” and “EHR”) systems will help physicians and health practitioners improve patient care coordination. The verification and validation phases need to have specific test activities to ensure that the protection and the integrity of data is guaranteed and collected data is aligned with the intended use.
The fourth consideration is finding an effective go-to-market strategy, which involves more than just identifying the appropriate target audience. For example, companies must determine whether their digital health product is meant for prescription or over-the-counter use, which has a significant impact on the distribution channels. Companies must develop partnerships with healthcare providers, insurance companies, and other stakeholders to ensure reimbursement and coverage. Building strong relationships with these partners can also improve credibility and trust in the product. Effective marketing strategies are also necessary for promoting the product and driving sales. Companies should understand the unique needs of their target audience and tailor marketing campaigns accordingly. Ultimately, a robust sales strategy can help companies achieve profitability and widespread adoption. By considering factors like reimbursement, prescription versus over the counter, and partnering with key stakeholders, companies can establish a sales channel that aligns with the product’s goals and target audience.
The fifth consideration is the agility of a company operating in a young digital health industry. The digital health ecosystems and evolving FDA regulations demand a flexible and iterative approach to product development and commercialization. Companies should be willing to experiment and to pivot based on user feedback, emerging technologies, and changing regulatory requirements. The FDA has been undergoing a significant regulatory overhaul, which has led to changes in the way digital health products are reviewed and approved. Technology changes fast in every industry, so life science companies should explore the same new methods, such as iterative processes, agile development, or design thinking, that technology firms use. In this early stage of digital health, it is essential to remain focused on the goal of delivering positive health outcomes for users. By embracing agility, companies can navigate the challenges of the digital health industry and emerge as leaders in this rapidly evolving space.