Fogarty Innovation was humming during the first quarter of 2025, as the education team orchestrated a series of engaging presentations on topics that ranged from AI in medicine to practical lessons on design control, FDA human factors, and valuation. Looking ahead, the second quarter promises to be equally as compelling, with talks on market research, building confidence, managing risk, and “from the trenches” stories on commercialization.
Here are some highlights from recent events:
AI in Medicine
In January, Maame Yaa “Maya” A. B. Yiadom, MD, and Gabrielle Bunney, MD, MBA from the Stanford University Department of Emergency Medicine led a Lunch & Learn session on AI in medicine. Yiadom and Bunney launched the information-packed hour with an overview of AI in medicine, highlighting the use of AI in computer vision, natural language processing, and predictive analytics. For aspiring innovators, they discussed the importance of clearly defining the type of AI being used, the business model, and whether the goal is to make clinical or non-clinical claims. They also explored some of the challenges associated with AI in medtech, including healthcare’s inherently conservative culture, the need to build trust and demonstrate value, and the complexities of technical integration and regulatory approval.
Next Yiadom and Bunney shared their own work in this space as a case study. As Stanford Biodesign Faculty Fellows, they explored the use of AI to improve heart attack detection in the ED. The problem they set out to solve is critical; time is of the essence in heart attack identification and treatment, since delays of just 30 minutes can increase mortality risk by 7.5%. While all patients with potential heart attack symptoms are supposed to receive an ECG within 10 minutes of arrival, the reality is that it doesn’t always happen. To address this, Yiadom and Bunney developed SmartCare AI – an AI-powered system that integrates with the existing clinical workflow and data systems to flag high-risk patients and trigger the ECG test.
Design Control Fundamentals
Design Control is a fundamental part of a medical device company’s quality management system (QMS) and product development process—and getting it right can mean the difference between regulatory success and costly setbacks. In February, Jennifer Mascioli-Tudor presented on design control fundamentals and how to build a strong compliance foundation from the start. Key takeaways included:
- Engage Quality Early – Initiate design controls right after feasibility/proof-of-concept to set a strong foundation.
- Conduct Design Reviews at Every Phase – Design controls follow a phased approach, starting with user needs, defining design inputs, and progressing through the development process. Conducting a cross-functional design review at each phase is critical to identify gaps early, align teams, refine strategy, and prevent costly redesigns or project setbacks.
- Take a Risk-Based Approach from the Start – If you’re not integrating risk management in Phase 1 of Design Controls, you’re already behind. A proactive, risk-based strategy streamlines development, minimizes rework, and optimizes time, budget, and resources.
- Stay Ahead of Regulatory Changes – Medical device regulations are constantly evolving. By staying updated and proactively integrating regulatory changes, you can mitigate risks, maintain compliance, and streamline your path to market.
A Conversation with Todd Brinton, MD
Fogarty CEO Andrew Cleeland hosted an insightful conversation with Todd Brinton, MD, an interventional cardiologist, former director of the Stanford Mussallem Center for Biodesign Innovation Fellowship, co-founder of Shockwave Medical, and corporate VP and CSO at Edwards Lifesciences. Highlights from the discussion included:
- On Successful Innovation: “You have to work within the system we have, including understanding all the stakeholders, how they interact, and what they value. This includes working within the constraints of needing capital to develop your patient-centric solution.”
- On Mentorship: Todd credits influential mentors like Tony DeMaria, MD, Casey McGlynn, and Jay Watkins for his growth and success. He advises people seeking mentorship to be curious, talk to people, them what they do and build relationships rather than just pursuing individual goals
- On Failure: “Failure teaches more than success. If you are avoiding failing, you are avoiding learning.”
- On Career Decisions: “Do something that matters to you. For me, seeing something you created helping a patient is one of the most fulfilling feelings you can have.”
You can read a more in-depth summary of the conversation with Todd here.
FDA Human Factors
Denise Forkey, director, human factors strategy at ClariMed, Inc. is a popular speaker at Fogarty Innovation. In her most recent talk, she shared expert guidance on navigating the FDA human factors validation process.
Top tips shared include:
- The FDA is increasingly requiring human factors and usability studies even for devices without critical tasks that could lead to serious injury. They want to see validation that the device can be used safely.
- Submitting a pre-submission (pre-sub) or Q-sub to the FDA to get feedback on human factors protocols and plans is highly recommended to avoid issues during the final submission.
- Topics that can be discussed in a pre-sub include justification for not testing certain user groups, definition of user groups, use of surrogates, training strategies, and classification of critical tasks.
- When preparing for a pre-sub meeting, have a clear agenda, prioritize the key discussion topics, and ensure the appropriate experts are available to respond to the FDA’s questions.
Valuation
In March, Petra Loer, managing director, and Anna Vorontsova, investment analyst & business evaluation specialist at Andersen took the Fogarty stage for an in-depth look at the “Art and Science of Valuations for Early-Stage Startups,” with a focus on 409A valuations. Key insights included:
- A 409A valuation determines the fair market value of the company’s common stock and is required when issuing equity to employees. It also provide “safe harbor” if done by an outside appraiser.
- Ensure the valuation is done by a reputable firm, as it involves both art and science. Be prepared to discuss and potentially negotiate the valuation, but understand the appraiser also needs to protect their integrity.
- Be aware of the impact of financing structures like convertible notes, safe notes, and tranche financing on the 409A valuation and common stock value. These can significantly reduce the value of common shares.
- Work closely with tax advisors to take advantage of tax benefits like qualified small business stock (QSBS), which can shelter substantial gains from taxes if certain requirements are met.
To learn more and participate in Fogarty’s free educational programming, visit our website and sign up to be notified of upcoming programs.