Interscope Receives EU and FDA Approval for Patented Endoscopy Device

The Back Story

Research firm Visiongain projects that demand for gastrointestinal endoscopy devices will grow globally from $6.6 billion in 2017 to $11 billion in 2023. To advance care in this area, two healthcare executives founded medical devices company Interscope, Inc. to remove mucosal lesions (i.e., polyps) and Barrett’s esophagus more effectively than existing products. Although a majority of mucosal disease is benign, the American Cancer Society states that patients with polyps and/or Barrett’s have an increased risk for cancer.

The Strategy

Interscope required product development expertise to help commercialize its single resection tool, the EndoRotor System. The Worcester-based start-up received support from the Massachusetts Manufacturing Extension Partnership (MassMEP). As part of the national Manufacturing Extension Partnership program, MassMEP provides resources to help Massachusetts companies succeed and to support economic growth in the Commonwealth.

Interscope then selected Boston Engineering as its product development partner, and key activities included:

  • Feasibility and Analysis:  After conducting research and feasibility analysis on the nascent concept, Boston Engineering translated this concept into a reliable, cost-effective product.
  • Engineering and Rapid Prototyping:  Boston Engineering met an aggressive deadline to develop an early functional prototype for animal lab testing. The testing enabled Boston Engineering to optimize and specify key product performance parameters that were critical to ensuring device safety.
  • Industrial Design:  Boston Engineering improved the usability of its early design by incorporating ergonomics and human factors insights that it gathered during functional prototype testing.
  • Quality Management System Development:  Boston Engineering leveraged its ISO expertise to ensure that the company’s design history file met regulatory requirements.
  • Regulatory Submission Support:  Boston Engineering provided the documentation required for Interscope’s FDA 510(k) submission in the United States as well as for European Union CE Mark approval.

The Impact

With support from MassMEP and Boston Engineering, Interscope quickly reached critical product milestones including:

  • Received FDA Clearance for its EndoRotor endoscopic resection tool
  • Received the CE Mark, which is regulatory approval to market the device across the European Union
  • Secured five U.S. patents to protect the company’s intellectual property (IP). The patents are a result of close collaboration between Boston Engineering and Interscope senior management

Boston Engineering continues to collaborate with Interscope to support product transition to manufacturing.

© 2016 Boston Engineering Corporation. All rights reserved. Boston Engineering is a trademark of Boston Engineering Corporation. Interscope, Inc.; Interscope; the Interscope logo; and the wordmark “EndoRotor” are registered trademarks of Interscope, Inc. All other brand or product names are trademarks or registered trademarks of their respective owners.