Agentic AI for MedTech: From Requirements to Tested Software

Randy Horton
Randy Horton
Published on: August 11th, 2026

2026 Aug Webinar Banner

AI can help developers write code faster, but the greater opportunity for MedTech is connecting product intent to clear requirements, working software, and reliable testing to achieve 2-3x gains across the entire product development lifecycle.

Behavior-Driven Development (BDD) provides a practical structure for agentic workflows. Using testable acceptance criteria written in Gherkin, teams can define expected software behavior in a format that product, engineering, quality, and regulatory stakeholders can understand and review.

Join Orthogonal for an illustrative example of how an AI agent can help produce acceptance criteria, build software from them, and test whether the resulting behavior matches the original intent. We will also examine where product knowledge, risk decisions, validation, and human judgment must remain in control.

What You’ll Learn

  • Move Beyond AI Code Assist – See how agentic workflows can connect requirements, development, and testing.
  • Turn Product Intent into Testable Behavior – Use BDD and Gherkin to create clear, structured acceptance criteria.
  • Reduce Requirement Ambiguity – Improve alignment across product, engineering, quality, and regulatory teams.
  • Make AI-Generated Work Easier to Review – Review defined behaviors instead of large volumes of generated code.
  • Keep Human Judgment in Control – Identify the product, quality, and risk decisions that must remain with experienced people.
  • Consider Validation and Risk – Address the oversight and validation needed for agentic AI in regulated development.

Who Should Attend?

  • Executive & Business Leaders evaluating how AI can improve product delivery and create business value beyond individual productivity gains.
  • Product, Engineering & R&D Leaders responsible for turning product strategy into clear requirements, working software, and reliable tests.
  • Quality & Regulatory Leaders assessing how AI-supported development may affect requirement clarity, reviewability, validation, product quality, and risk.

If your organization is considering how agentic AI could fit into its MedTech software development process, this session offers a concrete starting point for connecting human decisions to AI-supported requirements, development, and testing.

Save Your Spot
Megan Graham Headshot (1)

VP, Regulatory & Quality, Orthogonal

Megan Graham

Megan Graham is the Vice President of Regulatory and Quality at Orthogonal. She brings more than 25 years of experience in software engineering, product development, quality systems, and regulatory strategy for medical devices, SaMD, and digital health. Megan has held leadership roles at Mayo Clinic, Medtronic, and digital health startups, supporting FDA clearance, notified body certification, and ISO 13485-certified quality systems. She is also an adjunct faculty member in the University of Minnesota’s Master of Science in Software Engineering program and an ISO 13485:2016 Lead Auditor.

Larkin Lowrey, Senior Director of Software Engineering for Digital Health, Tandem Diabetes

CTO, Orthogonal

Larkin Lowrey

Larkin Lowrey is a veteran software engineering leader with over 30 years of experience across IoT, medical devices, telecom, and e-commerce. He developed a telematics platform later acquired by Verizon and now leads cloud-native, analytics-driven software development for regulated medical technologies. He holds 26 U.S. patents and applies Agile principles to build high-performing teams.

Bernhard Kappe

CEO & Founder, Orthogonal

Bernhard Kappe

Bernhard is a MedTech leader with over a decade of experience in Software as a Medical Device, Digital Therapeutics, and connected medical device systems. He has led the launch of medical device software, authored Agile in an FDA Regulated Environment, co-authored the AAMI report on cloud computing for medical devices, and founded ChiPMA and the Chicago Lean Startup Challenge.

Randy Horton, VP of Solutions and Partnerships, Orthogonal

Chief Solutions Officer, Orthogonal

Randy Horton

Randy helps MedTech companies accelerate development of Software as a Medical Device, digital therapeutics, and connected device systems by applying modern software and product practices, including Agile and Lean.

Related Posts

Talk

MedTech Ecosystem Design Controls: Move Faster With the Right Level of Compliance

Talk

Injecting Compliance into Code: Automating Compliance with AI in the MedTech SDLC

Talk

Beyond the Device: Where Digital Ecosystems Are Creating Real Value in MedTech

Talk

Cloud-Native Architecture (What You Should Learn from Amazon, Google and Microsoft for MedTech)

Back to Insights
BSI ISO 13485 Logo
Terms of Use | Privacy Policy | Careers
All Rights Reserved © 2026 Orthogonal