Topic Tag: Session I

2019 Device Development: Essential Concepts

2019 Diagnostic Devices Development

Lecture – Ian Meredith, MD, Boston Scientific

Ian Meredith, MD Exec VP and Global Chief Medical Officer, Boston Scientific Learning Objectives Understand the elements that contribute to technology adoption Learn about the importance of the unmet need, ease of use, and empowering patients Learn the importance of clinical evidence and digital technology Understand the importance of economics in technology adoption

Learning Objectives

Adoption of Technology

Lecture – Robert Byrne, MD, Heart Centre, Germany

Robert Byrne, MD, BCh, PhD German Heart Centre, Munich, Germany Learning Objectives Understand the European regulatory requirement Learn the European regulatory processes Understand the new legislation MDR 2017 Learn the medical device regulation 2017 Understand the risk-based classification Learn about the MDR 2017/745 clinical evaluation Learn about the clinical evaluation consultation procedure

Lecture – Chris Mullin, PhD, NAMSA

Chris Mullin, PhD Director, Product Development Strategy, NAMSA Learning Objectives Learn the statistical evaluation for diagnostics devices Understand the sensitivity, specificity, positive and negative values Learn about the importance of specific statistical evaluation for translational research Understand non-statistical components that affect statistics such as risk/benefit and others

Lecture – Renu Virmani, MD, CV Path Institute

Renu Virmani, MD President and Medical Director,CV Path Institute Learning Objectives Learn the difference among the animal models Learn the timeline of evaluation according to the device evaluated Understand the difference in anatomy among different animals and suitability for device evaluation Understand which devices to use in what animals

Lecture – Stan Rowe, Edward’s Lifesciences

Stanton Rowe Former Chief Scientific Officer, Edwards Lifesciences Learning Objectives Understand what qualifies as a good concept Learn how to choose the appropriate investors Understand the element of successful business planning Learn the importance of a product development team Learn about the source of fundraising

Lecture – James Inskeep, Patent Attorney

James Inskeep, Esq. Patent AttorneyINSKEEP Intellectual Property Group, California, USA Learning Objectives Understand the importance of intellectual property Learn how to protect your intellectual property Learn the do’s and don’ts of intellectual property Learn how and when to disclose an invention Learn how to collaborate with others during the process of innovation