Archives: Agenda

Medical device companies are faced with countless legal and regulatory obligations that require them to disclose their plans for the future. Whether they’re sharing details regarding inventions they seek to patent, clinical trials to demonstrate the value of new devices, investor presentations for public companies, or regulatory filings to gain approval before launch, all of this information can provide invaluable insights into your competitors and customers plans for the future. In this session we will explore:

• Types of information publicly available regarding future development of medical devices
• Systematic approaches to use these resources to identify opportunities and anticipate competitive threats
• Case studies on the use of patent filings, clinical trial registries, and other resources

• Balancing cost alongside other considerations when selecting vendors
• Choosing large vs small vendors: advantages and disadvantages
• Working with international partners: additional challenges and how to overcome them

• Discussing how clinical strategy aligns with critical claims, regulatory strategy, and agency review pathways
• Understanding category and division-specific clinical data expectations for medical device approval
• Showcasing an innovative case study on Magnetic Surgery to illustrate key clinical program strategies

• Which stakeholders influence design?
• Does language influence design?
• How can we design devices to age with our patients?
• Best practices and lessons learned

During the roundtable discussion session, the conference hall will be divided into two ‘zones’. Delegates can choose which zone they would like to join. Each zone will be led by a table moderator and will focus on a different challenge within clinical operations in oncology trials. After 30 minutes, delegates will have the opportunity to swap and choose a different table, and each roundtable will run twice.

ROUNDTABLE 1
Bridging the gap between developers and end users to create more effective devices
Sarah Mische, Director, Clinical Affairs, Avivomed

ROUNDTABLE 2
Strategic leadership in MedTech clinical development: creating agile, high-impact trial strategies
Hatice Bilgic Lim, Director Clinical Innovation, Philips

• Solving a personal challenge to create a solution for thousands
• Marketing effectively through advocacy and community engagement
• Building credibility with clinical trials and provider partnerships
• Developing and refining software to enhance user experience and outcomes
• Navigating the regulatory environment for digital health technologies