Digital health solutions and SaMD: key learnings for successful development and launch
Matt Norton, VP of Marketing & Commercial Development, spoke about ‘Digital health solutions and SaMD: key learnings for successful development and launch’ at Digital Health Advances Conference 2021.
For companies looking to build digital health solutions, Software as a Medical Device (SaMD) is now an essential distinction to be aware of. Not all digital health solutions are classified as SaMD, so it’s important to be clear on the influencing factors and the implications of going down this path.
- Why SaMD is important for digital health, the capabilities required, and the best approach when developing solutions
- Assessing the medical device classification of solutions and how this impacts on your business strategy, development plan, and regulatory roadmap
- Choosing the best region for launch and how it will determine the level of evidence and validation required, and what reimbursement models are available