Safety is an important consideration while designing and developing the next generation of medical devices as they are becoming more complex. Ensuring the safe use of medical devices and digital health solutions for patients and caregivers is a critical task for designers and manufacturers to avoid adverse situations. There are many approaches to address such tasks.
Experts from the medical device industry join us as panel members to share their experiences, approaches, lessons learned, and best practices while developing the next generation of medical devices within the context of safety and compliance.
There is a question-and-answer period at the end of the session.
About the Presenter
Lane Desborough – CEO, Nudge BG For the past decade, Lane has been focused on medical devices including automated insulin delivery (AID) systems for people with type 1 diabetes such as his son. Lane worked as a chief Engineer at Medtronic Diabetes and later at Bigfoot Biomedical. In 2020 he founded Nudge BG, a professional services firm for simulating, designing, developing, coding, implementing, verifying, and validating AID systems, including Nudge, which intends to be the world’s first commercial, regulated, full closed loop AID algorithm. Prior to working on AID systems, Lane worked as a control engineer, he was responsible for implementing and remotely monitoring commercial grade products and services in life-critical/safety-critical domains spanning oil refineries, power plants, mines, paper mills, and chemical plants at Honeywell and General Electric.
Emily Luvison – Principal Lead Cybersecurity Compliance, Digital Health Technologies – Genentech (A member of Roche Group) Emily Luvison is the Cybersecurity Compliance Lead for Genentech’s Digital Health Technologies (DHT) organization, where she leads the strategic development and execution of a cybersecurity compliance framework for digital health products and solutions in line with healthcare industry standards and regulations. Prior to this role, Emily has led cybersecurity and privacy teams to meet their compliance objectives for digital products and brings rich experience from her career in security consulting and auditing in the healthcare and technology sectors.
Nicolas Chbat – CEO of Quadrus Medical Technologies, NY, and adjunct Professor of Biomedical & Mechanical Engineering at Columbia University, NY Dr. Nicolas W. Chbat is the founder of Quadrus Medical Technologies. Nick has 23 years of Industrial R&D experience (GE, Mayo Clinic, Philips). He is the recipient of numerous technical and professional awards. He holds 50+ issued and filed US patents, 40+ publications, and 1 book. Nick is an adjunct professor of Biomedical and Mechanical Engineering at Columbia University, and chair of the cardiopulmonary systems engineering technical committee at IEEE-EMBS. His expertise is in mathematical modeling, controls, physiology, and estimation.
Recorded July 27, 2021
