Lightening Workshop: Exploring the Intended Use Statement's Impact on Regulatory and Marketing Strategies

Welcome to the Biomedevice Boston Presentation Store. Here you can view and download conference presentations before, during, and after the event, as well as free content from the Center Stage. If you’re looking for a presentation from a specific session, go to that session, and if we have the presentation to share, you’ll see the file below the session description. If you are unable to find it here, it’s likely because the presenter has not provided permission for external use or has not yet shared their presentation with us. Please check back after the event for a more complete catalogue of available presentations.

All Sessions Speakers My Schedule

Lightening Workshop: Exploring the Intended Use Statement's Impact on Regulatory and Marketing Strategies

Eri Hirumi (Regulatory Affairs Specialist, Microvention)

Location: Biomed Room 1

Date: Thursday, September 17

Time: 3:00pm - 4:30pm

Track: Track C: Surviving the Changing Regulatory Environment & Rising Costs

Vault Recording: TBD

A key challenge for obtaining market authorization for any new Medical Device is the crafting of the intended use statement. It must be similar enough to other products already available to qualify for substantial equivalence evaluation but provide unique features to allow for innovative marketing statements. Balancing the needs of these two polar concepts is a critical skill for the development of a novel medical device.

This workshop will:

Explore impacts of the intended use statement on reimbursement, regulatory and market strategy, including label design
Discuss product and process validation plans
Provide opportunities to practice developing intended use statements to understand the impacts upon getting products to market

Biomedevice Boston 2020 Presentation Store

Lightening Workshop: Exploring the Intended Use Statement's Impact on Regulatory and Marketing Strategies