Evolving Your SaMD with Ongoing Releases: Webinar

It takes a lot of work to prepare Software as a Medical Device (SaMD) for an initial launch – so much work that planning for subsequent releases can go overlooked, leaving companies to face significant technical, quality and regulatory debt when starting work on their product’s post-launch evolution. How do you take a forward-looking approach to developing SaMD that lays the groundwork for both short- and long-term success?

Join Orthogonal for a webinar on April 30th, 2024 at 11 AM CDT as we review best practices for developing SaMD under design controls with an eye towards ongoing releases. We’ll discuss ways to take advantage of software’s ability to evolve faster than hardware that allow you to rapidly expand your SaMD’s capabilities and improve both patient outcomes and your bottom line. Among other topics, we will look at how manufacturers and regulators are partnering around Predetermined Change Control Plans (PCCP) to promote and enable a future-forward mindset and device development stance.

You’ll leave this webinar with:

• An understanding of the challenges of designing SaMD that is intended to be continually improved and regularly updated.
• A high-level knowledge of best practices for working on SaMD under design controls with future evolution in mind and that can be immediately implemented into your product strategy.
• Real world examples of SaMD manufacturers that have faced these challenges and leveraged these best practices.

Speakers

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.

Melissa Gill, Senior Delivery Manager, Orthogonal

Melissa has 10 years of experience in Agile Project/Product Management and four years of experience in QA. She has worked in enterprise, security, pharma and SaMD industries on web, mobile and cross-platform projects. Melissa brings her experience implementing Jira/Confluence and Agile processes at numerous organizations to Orthogonal, where she also implements eQMS tooling and process improvements.

Moderator

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).