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Realizing Safe, Intuitive User Interfaces: Key Considerations for Regulated Medical Devices

Tuesday, January 17, 2023 (11:00 AM - 12:00 PM) (EST)


Realizing Safe, Intuitive User Interfaces: Key Considerations for Regulated Medical Devices

January 17th | 11:00 AM - 12:00 PM

Regulatory focus on Human Factors and Usability Engineering provides an opportunity for device OEMs to improve the usability and safety of their products/devices. Despite the common view that regulation is only a burden, human factors analysis (HFA) can yield tangible benefits beyond the realization of safe, intuitive user interfaces that meet today’s regulatory standards. By adopting the best practices from this guidance, device OEMS can improve their development processes, avoid costly rework and delays, and ultimately deliver value to their customers.

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Margaux Boyaval
Director of UX Digital Health
Teva Pharmaceuticals

Margaux enhances the experience of patients as the digital product UX/UI director at Teva Pharmaceuticals. She heads the design team responsible for the launch of Digihaler: an integrated inhaler system for asthma management.

Margaux led Amgen’s Commercial Innovation oncology and Global Customer Experience teams to develop the first in-house self-injection system for a range of Amgen biologics.

Prior to her work in pharmaceuticals, at Ximedica, she directed client programs with internal innovation teams from initial product conceptualization through realization.

In her 20+ year career, she has built and led design teams that are able to meet patient needs and business goals. She has been awarded over 30 design & functional patents.

Margaux earned her BFA in Industrial Design from Rochester Institute of Technology and has a Project Management Professional (PMP) Certification.

Mary McNamara-Cullinane
Vice President, Regulatory Affairs

ClearPoint Neuro  

Mary McNamara-Cullinane has over 25 years of regulatory experience in the medical device, diagnostics and biotech industries. She has successfully authored over 175 510(k)s/responses, multiple PMAs, De Novo submissions, Breakthrough device designations and has been responsible for several clinical trials. In addition, she has strong regulatory knowledge of global regulatory practices and registrations in Europe, Korea, and Australia having work on many technical files and CERs. Most recently, Mary was Senior Vice President of Regulatory at Alira Health responsible for management of all medical device/combination product strategies, submissions and FDA meetings.  Prior to that position, Mary was responsible for US regulatory strategy at Intrinsic Therapeutics, VP of Regulatory and Clinical Affairs at Echo Therapeutics, Director of Regulatory Affairs at Z-Medica, and Director of Regulatory Affairs and Quality Assurance at Molecular Biometrics. Prior to Molecular Biometrics, Mary was in regulatory consulting for 17 years at Medical Device Consultants, Inc.

Michelle Wu
Fractional COO and Medical Device Development Consultant
Wu Consulting

Michelle Wu is a senior leader with 20 years of experience in the medical device and life sciences industries with roles in executive leadership, product and process development, manufacturing, and quality.  Michelle has a history of successful medical device product development, strategic planning and execution, building teams, process evolution, and managing organizational change.  She values a collaborative and diverse, equitable, and inclusive environment, believing that diverse perspectives lead to the best ideas, more cohesive teams, and better results.  As a Fractional COO and Medical Device Development Consultant at Wu Consulting, LLC, she is designed to help start-ups bring their medical device innovation to life; leading them through various stages of business, organizational, and product development; bringing clarity, alignment, and calm to the chaotic and unknown.  Her passions include Women’s Health and supporting women leaders.

Bruce Johnston, PhD
Lead Solution Architect

Dr. Johnston has 25+ years' experience designing and developing complex software system and 15+ years' experience working in regulated medical software development. Much of this experience has been focused on UI design and Human Factors aspects of Class II and Class III medical device programs. Most recently Bruce has been providing strategic insight to a variety of clients on the intersection of modern software development methodologies, including HF/Usability and Agile practices, and the regulated medical environment.

Tuesday, January 17, 2023 (11:00 AM - 12:00 PM) (EST)
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