With rapid changes in clinical workflows and frugal approaches undertaken, medical device manufacturers are now required to find unique ways to improve their innovations therefore approaches of innovation-driven development are changing. Our contextual research methodologies help clients to understand and unveil distinct need gaps and value drivers.
As a medical device manufacturer, you would also have to navigate through a complex landscape of regulatory requirements before your devices can be marketed in different geographies. We offer full guidance to manufacturers to bring their products into the market and also support manufacturers during the commercial phase and post-market activities.
Some of our selective service offerings include :
- Understanding rational and emotional unmet needs of end user segments
- Articulating and positioning product ideas and improvements
- Understanding motivators and barriers to purchase/adoption of new technology solution/product
- Streamline clinical and other workflow related needs
- Test new product idea (Opinions and utility)
- Generating value proposition statements
- Understand value drivers and motivators of a customer segment
- Competitor due diligence
- Customer engagement and satisfaction tracking
- Distribution assessment including channel partner due diligence
The new Medical Devices Regulation (EU MDR) includes a series of critical improvements in regulations to modernize the current system and prioritizes the safety of medical devices. The new regulations apply to all medical device manufacturers who want to market their products in the European market and demands more robust clinical evidence, post-market surveillance, and information transparency.
Thus it is critical now for companies to swiftly go around devising new regulatory strategies in order to move forward efficiently and in time. We can support in navigating the transition from MDD to MDR by providing services related to gap assessment, post-market surveillance, technical documentation including Design History File (DHF), and Risk Management File (RMF) preparation.
Find out more about how you can maximize impact through our services and solutions.