What is a roadmap investigation?

Medical devices that are new or fall into the category of improved products that differ significantly from existing products must be subjected to clinical studies to demonstrate their efficacy and safety. Similarly, the launch of new medical services, such as telemedicine, requires an investigation of not only the marketability of the product but also trends related to competitors.

To assist companies planning to market a new medical device or service, SunFlare conducts a roadmap investigation aimed at achieving a successful market launch.

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Case study #1: Roadmap investigation for the launch of medical device

We investigate the following regulatory issues related to the relevant product to identify potential problems and devise measures for resolving them:

  • Comparative analysis of the product vs. conventional and similar devices
  • Endpoints of the pre-clinical and clinical studies for the product
  • Specific content of the pre-clinical studies, including animal testing
  • Expected scenarios for clinical studies
  • Outlook for regulatory affairs compliance after clinical development and market launch of the product
  • Overview of the roadmap and the expected timeframe for each stage

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Case study #2: Market investigation for the overseas launch of a medical device

We investigate the following issues to ascertain the products marketability and trends related to competitors.

  • Current market environment for the relevant product, service, or technology
  • Overview of global competitors and their respective services
  • Examples of rival products and services
  • Details of competitors’ business models
  • Overview of competitors’ clients and sales systems
  • Overview of regulations applicable to the product in each country (protection of personal data, regulations, etc.)
  • Latest trends and accident case studies for each country
  • Expected target clients and potential business partners in each country

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