We recently introduced Michael Mocker from our Advanced Surgical Business Unit as part of our ‘Meet the Experts’ series. In this piece, Michael shares some reflections on how his background in the highest risk category of medical device, Class III, is shaping his approach to Class IIb projects.
After years of working in Class III medical device manufacturing, where the margin for error is essentially zero, I recently made the move to Elos Medtech, where we primarily operate in the Class IIB space. While the regulatory classifications differ, the mindset for excellence shouldn’t.
One of the most important lessons I’ve carried with me is the power of a risk-based approach. Whether you’re developing a vascular implant or a surgical tool, the principles remain the same…
Risk isn’t just about product design – it touches everything
From incoming inspections of raw materials to process validations and final visual controls, every step in the chain has potential to affect the outcome. And every step deserves the same disciplined attention.
Drawings don’t always match reality
One of the most underestimated challenges is translating 2D plans into 3D reality. Measurements can differ based on angle, equipment, or environment, even when you and your customer think you’re assessing the same point. This is where a strong foundation in dimensional control and validation becomes vital. A good relationship and a trustful partnership with the customer is key, finding sustainable solutions and control procedures.
Let the experts lead
Too often, projects are slowed down when multiple voices try to direct the manufacturing path. Customers bring unmatched knowledge of the clinical need and regulatory pathway, but they don’t need to carry the burden of process engineering, too. That’s our expertise. We lead manufacturing so they can focus on market success, as well as market challenges, market needs and notified body (e.g. FDA) requirements.
Documentation, traceability, and data-driven processes make the difference
Reliable commercial production isn’t a result of good luck, it’s the outcome of deliberate, statistically-supported process development. With traceability, clear validation, and robust process controls, we deliver products that meet both performance expectations and compliance requirements.
Having a strong and reliable supplier is one big and important puzzle piece for being successful with NPI (new product introduction).
For me, moving from a Class III to a Class IIb environment hasn’t meant lowering standards. Instead, it has reinforced the importance of maintaining a rigorous, quality-driven mindset, regardless of classification. At Elos Medtech, I’ve joined a team that shares this commitment, where trust, precision, and expert leadership guide everything we do to deliver real value.