Sizing up SaMD Projects for Success: Webinar

Randy Horton
Randy Horton
Orthogonal SaMD Product Definition and Sizing Webinar Apr 19 2023 without CTA

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, as it acts as a compass that guides you to your goals while avoiding endless rework and analysis paralysis in your pre-planning. By proactively identifying key roadblocks and risks to bring your device to market, you can align the development process with your needs without accruing quality, regulatory or technical debt. SaMD Product Definition and Sizing 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.

On April 19th, 2023, Orthogonal hosted a webinar in our Move Faster and Break Nothing Series, where we discussed the art and science of SaMD Product Definition and Sizing and the benefits to mapping out development goals before the project begins.

The recording includes the 50-minute roundtable discussion, followed by an additional Q&A session with the speakers. The webinar was moderated by Randy Horton, Chief Solutions Officer.

Key Takeaway Points

  1. Because it’s so easy to make changes to software, it’s hard to keep from ballooning the scope of the project – and inadvertently transforming a health app into a Class II or even Class III device. It’s critical to develop clear boundaries over what the software is and what it isn’t, and keep to those boundaries over the course of development, so you can effectively manage the risk and functionality of your product.
  2. If you want to define a product without falling into analysis paralysis, you should separate the “what” from the “how.” In the early stages of product discovery, set aside the exact details of how your product will work and hone in on what it will do and what a successful product will look like. That being said, there are certain things you have to decide early on because the whole product depends on it.
  3. The Lean Startup Method is highly recommended at the early stages of product development. Key to this method is rapid hypothesis testing on all elements of a potential business model, including product market fit, cost and revenue models, distribution channels, regulatory and reimbursement. This compliments the Agile practice of breaking work down into smaller pieces, where you can quickly iterate and deliver results that drive further iteration and even better results. By prioritizing what’s important and focusing on building only what’s necessary, you get rapid feedback that validates product features.

Webinar Recording


david feygin 011


David Feygin, PhD, MBA, Healthcare Digital Business Leader

David Feygin is a digital and data healthcare executive with extensive experience in corporate strategy, product, and commercial healthcare leadership, and a deep background in transformative technology. Through two decades of expanding healthcare industry leadership, David has guided startups and enterprises, led organizations to enhance patient care on a global scale, and built digital technology solutions and innovative businesses that have saved lives.

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. Prior to that, through evolving Director- and VP-level roles, David led enterprise strategic innovation efforts, established a Corporate Product Security Office, led structured multiple startup investments, and created an Information-Enabled Medication Management strategy that laid the foundation for the transformational acquisition of CareFusion.

Early in his career, David led the design, development, and global commercialization of a suite of Virtual Reality Medical Simulators for Laerdal Medical (formerly SimQuest). 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.

bernhard photo


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.

Bob Zimmerman Headshot square large


Bob Zimmerman, Founder, Getting Predictable – A Product Development Methodology

Bob Zimmerman is a software solutions architect with a focus on product development and related technology platforms. He is an accomplished leader with a successful track record of growing and empowering teams, leading them through organizational transformation while delivering results that drive revenue and efficiencies. He has experience working in both entrepreneurial and corporate IT environments, scaling Product Management and Application Development organizations.

Bob’s distinguished career is largely dedicated to common-sense best practices that innovate how technology organizations deliver business value. He is a specialist in creating alignment between IT and business objectives, and delivers his Getting Predictable mantra to raise the bar on collaboration. His uniquely practical approach to software development enables him to coach and mentor people at all levels.


Randy Horton


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).

SaMD Insights

White Paper

Software as Medical Devices (SaMD): What It Is & Why It Matters


Sizing up SaMD Projects for Success

White Paper

PCCP for Class II SaMD Beyond AI/ML


Climbing the Mountain of Regulatory Documentation for SaMD

developing successful samd at speed white paper ebook mockup

White Paper

Developing Successful Software as a Medical Device (SaMD) at Speed


Top 10 SaMD Communities, Organizations & Working Groups


3 Tools Your Need for SaMD App Development