Mark Tunkel, global category director, Services at Nemera, explores the factors that should be considered when developing a device strategy in the current technology landscape, and how a holistic approach can lead to better and more long-term decision making.
Key insights:
- It is critical to fully understand the patient journey as well any related clinical processes at the earliest stages of establishing the functional requirements and user needs for a new device application.
- The selected device and drug should be appropriate, safe and effective for the target population - optimising the patient experience to create competitive differentiation,.
- Clinical risks must be identified through conducting formative and summative usability testing for all aspects of the device and supporting assets.
An increasingly complex landscape for combination products