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SaMD Product Definition & Sizing: Putting You in the Driver’s Seat for Successful Development
You’ve got an idea for a new Software as a Medical Device (SaMD) that has the potential to move the needle on patient outcomes and be commercially successful. But we all know that MedTech device development projects sit at the intersection of technology, regulatory and business innovation and can go off the rails very quickly. De-risking your projects up front and making sure you’re in the driver’s seat on big decisions and tradeoffs from the very beginning are key to ensuring a successful development effort that creates a safe and effective device, on-time and on-budget.

SaMD Product Definition and Sizing is a critical first step before launching development, acting as a compass and guiding you to your goals while avoiding endless rework and analysis paralysis in your pre-planning. You need to proactively identify key roadblocks and risks in bringing your device to market. From there, you will generate essential deliverables that help align the development process with your needs without accruing quality, regulatory or technical debt. Planning tools such as a project roadmap, user needs analysis and regulatory strategic plan can help you get your ducks in a row quickly and cost-efficiently, enabling you to jumpstart your development effort when ready and ensure you build the right device and build the device right.

In this webinar, you’ll:
- Understand how to set up new device development projects for success, avoiding the accrual of technical, quality, regulatory and commercialization debt.
- Learn about the key early project deliverables that prepare you and your entire team for success by identifying and addressing key risks and challenges before you begin writing any software code.
- See how an initial investment in de-risking your project pays dividends over the full product development lifecycle.

Apr 19, 2023 11:00 AM in Central Time (US and Canada)

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David Feygin, PhD, MBA
CEO & Founder @AnavoDx
David Feygin is an experienced healthcare executive with a strong background in digital and data healthcare leadership. He has guided startups and enterprises, built digital technology solutions, and enhanced patient care on a global scale. As Chief Digital Health & Data Officer and VP at Boston Scientific, David led the enterprise digital and data efforts and drove the enterprise toward digitalization. David holds an MBA from Harvard University, a PhD in Mechanical Engineering from the University of California, Berkeley, and a bachelor's degree in Mechanical Engineering from The Cooper Union for the Advancement of Science and Art. He is a thought leader and influencer in his space, working with industry-shaping institutions such as MDIC Digital Health, Sheba Medical Center Future of Health Community, and is the Chair of the Executive Council of Brigham and Women’s Center for Patient Safety Research and Practice.
Randy Horton
Chief Solutions Officer @Orthogonal
Randy Horton is Chief Solutions Officer at Orthogonal, a software consulting firm that improves patient outcomes faster by helping MedTech firms accelerate their development pipelines for Software as a Medical Device (SaMD), digital therapeutics (DTx) and connected medical device systems. Orthogonal makes that acceleration happen by fusing modern software engineering and product management tools and techniques (e.g., Agile, Lean Startup, User-Centered Design and Systems Thinking) with the regulated focus on device safety and effectiveness that is at the heart of MedTech. Horton serves as Co-Chair for AAMI’s Cloud Computing Working Group, as well as AAMI CR:510(2021) and the in-process Technical Information Report #115, all of which address how to safely move medical device computing functions into the cloud. He is a frequent speaker at conferences and webinars, including events hosted by AdvaMed, AAMI, HLTH, RAPS and the Human Factors and Ergonomics Society (HFES).
Bernhard Kappe
CEO and Founder @Orthogonal
Bernhard Kappe is the Founder and CEO of Orthogonal. For over a decade, Bernhard has provided thought leadership and innovation in the fields of Software as a Medical Device (SaMD), Digital Therapeutics (DTx) and connected medical device systems. As a leader in the MedTech industry, Bernhard has a passion for launching successful medical device software that makes a difference for providers and patients, as well as helping companies deliver more from their innovation pipelines. He’s the author of the eBook Agile in an FDA Regulated Environment and a co-author of the AAMI Consensus Report on cloud computing for medical devices. Bernhard was the founder of the Chicago Product Management Association (ChiPMA) and the Chicago Lean Startup Challenge. He earned a Bachelor’s and Masters in Mathematics from the University of Pennsylvania, and a Bachelor’s of Science and Economics from the Wharton School of Business.