igital 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 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.