Digital health solutions, and more specifically digital medicines and digital therapeutics (DTx), are increasingly recognized as potential solutions for areas of high unmet medical need. Rising expectations for these innovative solutions have put significant pressure on developers of digital medicines to bring them to market faster and to generate substantial revenue.
The regulatory environment for digital health products is highly complex and rapidly evolving. The FDA will continue to play a key role in the ongoing evolution of the market and is looking to partner with DTx manufacturers to navigate the regulatory pathways. The commercial environment also plays a key role in development of digital solutions, and a variety of go-to-market models have been used to successfully commercialize these innovative products. Clear strategic planning and agile response to changing conditions and competition are imperative for commercial success.
This webinar will provide key insights into opportunities to leverage the regulatory pathways and highlight factors that will ultimately determine the commercial success or failure of digital products currently in development.
Key Learning Objectives:
- Opportunities to navigate the potential regulatory pathways for digital medicines and digital therapeutics
- Identifying strategic planning components that will be required for commercial success
- Other key factors to consider when designing clinical studies and developing innovative digital health solutions
