The Regulatory Landscape of Software as a Medical Device

So much of the medical world is about data, and as healthcare data continues to play an increasing role in the “big data” landscape, the challenge is figuring out how to use it properly within the healthcare ecosystem. A new class of medical software known as Software as a Medical Device (SaMD) is offering innovative ways to capture, optimize and analyze healthcare data with the goal of improving health by utilizing analytics to manage and optimize health outcomes. However, this rich field of technology is evolving more quickly than regulators can keep up.

The challenge is when a software is designated as SaMD, a string of regulatory requirements come into play, creating a maze of potential pathways and product development implications. In this webinar, the panelists will define what is considered a SaMD and explore key strategies to bring it to market successfully through regulatory strategy, clinical impact and considerations for patient engagement and participation.

Register for this webinar to learn about the regulatory pathways for software designated as a medical device.

Speakers

Vicki Gashwiler, Executive Director, Specialty Programs, Premier Research

Vicki brings over 20 years of healthcare experience and 15 years of experience in the medical device industry, both on the sponsor and CRO sides. Prior to her industry experience, Vicki began her career as a registered nurse in 2000, working on cardiac, critical care, and out-patient orthopedic surgical units. She started her industry career as a clinical research associate and had the opportunity to advance as a clinical trial manager, project manager, senior project manager, program director, associate director, and director of strategic development and market access. She supported global clinical trials spanning across Europe, Canada, Latin America, Australia, the US, and the Asia-Pacific.

Vicki has an extensive understanding of complex trial execution on a global scale, diverse team management, and global regulatory processes and timelines. She has experience in oncology and dermatologic devices, endocrinology, weight management, orthopedics, cardiac and vascular device trials.

Vicki brings a high-level understanding of market development and trends and a deep therapeutic knowledge of many disease processes and the clinical trials to intervene upon them.

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Nach Davé, RPh., MSc, Vice President, Development Strategy, Premier Research

Nach Davé provides strategic and commercial input for Premier Research’s business activities. He brings more than 20 years of experience in the pharmaceutical and contract research industries to the position. He previously served as the Vice President of Regulatory at Premier and has been in leadership positions at both CROs and sponsor companies.

In his current role, Mr. Davé brings innovative solutions and grows Premier’s footprint in the areas of medical device development, real-world evidence, and government relations. He is keen to explore how innovative technology like AI, ML and other developments can best support the growth of Premier’s business.

Mr. Davé holds a Master’s Degree in Drug Regulatory Affairs from Long Island University and a Bachelor’s Degree in Pharmacy from the University of Sciences-Philadelphia. He is a registered pharmacist.

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