AI Is Here—But Great Leadership Still Matters More Than Ever

Executive Leaders: Want to incorporate AI into your business model but don’t know where to start? 

You’re not alone. AI is rapidly transforming manufacturing—especially in regulated industries like medical devices. Yet despite the hype, 95% of generative AI business integrations are currently failing to deliver measurable ROI, even after billions of dollars in investment. Why?

Because AI alone isn’t the answer. It’s a tool—powerful, yes—but it still requires clear strategy, human oversight, and strong leadership to unlock its value.

The Reality:

• 🔹 Only 29% of manufacturers have formalized AI in their corporate strategy

• 🔹 Just 32% feel prepared to implement it effectively

• 🔹 Major blockers: data infrastructure, talent gaps, and scalability

In a recent leadership conversation, Ian, Scott, and Manfred explored how AI is reshaping medical manufacturing—from improving CAPA systems and compliance to enabling smarter decisions on the shop floor.

But one insight stood out:

AI won’t replace leadership. It will depend on it.

AI can help analyze data, find root causes, and predict issues—but it still takes a human to act, interpret, and lead teams through change.

Manfred’s story—from building electronics as a teen in Germany to leading AI innovation in executive roles—shows us what leadership in the AI age looks like: vision, adaptability, and human-centered decision-making.

🔍 Key Takeaways:

• AI strengthens CAPA & compliance—but needs leadership to scale

• AI offers real-time insights—but leaders turn them into action

• People still want direction from people—not machines

• Innovation thrives when leadership embraces change, not fears it