Starting with a product concept proposed by a physician, we led a project to develop a biliary stent from scratch. Our involvement has continued from development and obtaining Japanese marketing approval to post-approval improvements, change applications and coordination between the marketing authorization holder (MAH) and distribution partners.
Subject: Biliary-stent development and product expansion
Support provided: Leading development from a physician’s idea, practical support for approval and partial-change applications, and coordination between the MAH and distribution partners
Outcome: Marketing approval obtained, followed by product-series expansion through repeated post-approval partial-change application support
Connecting development and regulatory work
We organized the product characteristics and differences from approved devices, examined where existing materials could be used and identified areas requiring additional evaluation. While checking consistency between evaluation materials and the submission, we supported preparation of the application and supporting documents and responses to inquiries during review. The device obtained marketing approval.
After approval, we have supported repeated applications for partial changes to approved matters arising from product improvements. We have also been involved in expanding product series under the same approval and continue to coordinate the MAH and distribution partners.
Considering intellectual property from the idea stage
Across our company’s work, we also seek to secure intellectual property from the early stages of development. For ideas with potential for patent applications, we actively pursue joint filings with the relevant parties and have built experience in patent applications, including joint applications.
Returning value to academia as part of our mission
Protecting physicians’ and researchers’ ideas as intellectual property and connecting them to products used in clinical practice is part of our mission. We also consider returning the value of those achievements to academia part of that mission.
We lead projects that bring ideas from clinical practice and research into tangible form by connecting development, intellectual property, regulatory work and product expansion.
Related support
GI endoscopy and biliary-pancreatic device development and regulatory support
Submission preparation and inquiry-response support
Discuss development and submission support
Tell us about your product concept, current development stage and the support you need.