Quality in the Boardroom™ Launches: Leading at the Edge of MedTech Innovation
Pictured left to right: Rajit Kamal, Kwame Ulmer and Michel Moravia
"Speed, compliance, quality, and patient safety are not trade-offs. If you think about them as trade-offs, you are starting with the wrong mindset." — Rajit Kamal, VP, MedTech Executive
MedTech Impact Partners is proud to announce the debut of a new series, Quality in the Boardroom™, in partnership with Quality Means Business.
In the premiere episode, Rajit Kamal shared powerful insights on how forward-thinking MedTech organizations are leveraging technology and Design Risk Management (DRM) to stay ahead of the curve.
A few key takeaways that every MedTech executive needs to consider:
Frontloading Risk: High-quality data at the pre-submission stage isn't an afterthought—it's built directly into the process. Utilizing robust frameworks ensures visibility long before a product ever reaches the market.
The Changing FDA Landscape: The FDA is actively building an AI/ML-expert workforce. As regulators evolve, industry leaders must align their engineering, quality, and regulatory talent to match that expertise.
Demystifying the "Black Box":AI shouldn't just do things on its own. It requires traceability, rigorous verification and validation (V&V), and leaders who are continuously learning so they can ask the right, auditable questions.
On the demands of AI-driven change management, Kwame Ulmer noted:
"I think of three things that we need to enable — it's safe, it's responsible, and it's transparent... with software and AI, how do we come about doing change management that's iterative and ensure patient safety?"
As the industry pivots heavily toward software-driven differentiation, holding onto a "quality-first" culture is what separates scalable operating systems from extreme compliance exposure.
Register to watch the full series and access these leadership insights at qualiverse.ai/qib.
The next episode of Quality in the Boardroom™, featuring Sean Boyd, will be released in two weeks on July 14, 2026.
At MIP, we believe powerful conversations spark meaningful change. Featuring leaders like Kwame helps illuminate the challenges and opportunities at the intersection of technology, healthcare, and capital.
We're proud to share this moment with our network. Stay tuned for more leadership spotlights and insights from the MedTech Impact Partners community.
Industry Conversations with Industry Leaders
Quality in the Boardroom convenes the operators, investors, regulators, and clinical leaders shaping MedTech. The conversation is editorial, on the record, and built for executives who do not have time for surface answers.
Presented by QMB, Inc. & MedTech Impact Partners | Sponsored by QMB, Inc. & QualityHub