Design optimization to increase industrial capacity
Joint interview with Didier Morin, Industrial Director, and Xavier Perin, Head of Development and Industrialization
- What specific challenges does the industrial manufacturing of ZENEO® present?
Before addressing the challenges, it is important to highlight a key industrial advantage of ZENEO®. Our needle-free auto-injector is a common platform across all medications developed by CROSSJECT; it is the injector’s configuration that differentiates each indication.
That said, the manufacturing of ZENEO® must meet a dual requirement. In addition to the constraints inherent to medical devices, production must comply with the very stringent rules governing the handling of energetic materials classified as powders and explosives.
To ensure collective adherence to these rules, our quality approach is based on a clear principle: we document what we do and strictly apply what is written. In the case of powders and explosives, an additional rule applies — anything that is not written is prohibited.
Beyond regulatory requirements, we also impose our own standards, all aimed at guaranteeing the stability, reliability, and ergonomics of the auto-injector.
ZENEO® consists of more than 20 components supplied by around fifteen companies. These requirements are shared with our suppliers, and each batch of components is subject to inspection, sometimes with dimensional tolerances down to one hundredth of a millimeter.
Manufacturing is carried out internally and is subject not only to ISO 13485 standards, but also to strict qualification requirements — both for equipment, to ensure process repeatability, and for personnel. In the case of the pyrotechnic components, staff qualifications are reassessed on a quarterly basis.
- Scaling up capacity while complying with Good Manufacturing Practices is a challenge. What principles guide CROSSJECT’s industrial approach?
ZENEO® entered a fully industrial phase more than ten years ago. Over this period, we have accumulated expertise at every stage of manufacturing and progressively eliminated bottlenecks.
Today, more than twelve months elapse between the initial component order and final delivery of the finished product. Our objective is to halve this lead time. To achieve this, we are acting on several levers: improving the efficiency of each machine, optimizing flows between manufacturing stages, and integrating more effective tools and industrial practices.
- How do design evolutions of ZENEO® contribute to continuous production improvement? What tangible results have already been achieved?
The industrialization of ZENEO® has been marked by continuous progress.
For example, on the component side, we have reduced the number of operations required to manufacture the injector body in zamak, a zinc alloy, from five to three. This was achieved through close collaboration with our supplier, from initial concept through final validation. As a result, manufacturing lead time for this component was reduced by a factor of three, from six weeks to two.
Another example within CROSSJECT involves optimization of the depyrogenation cycle. Our objective is to reduce its duration by half without compromising the expected outcome or tube quality. Achieving this would effectively double production capacity for this critical operation — a strategically significant result.
- Part of the production process is outsourced upstream (components) and downstream (filling). How would you assess supplier commitment?
The vast majority of our suppliers are long-standing partners who have worked alongside CROSSJECT from the very beginning. This long-term collaboration facilitates a deeper understanding of the role each component plays and encourages process optimization initiatives.
We learn together, in a relationship built on mutual benefit. Our partners believe in CROSSJECT’s potential and share the effort required to support its growth. In some cases, this involves significant adaptation on their part, including dedicated production lines and the integration of pharmaceutical best practices.
- What are the next steps in optimizing your industrial strategy?
When considering “routine capacity” — that is, without pushing equipment to maximum performance and while maintaining shift patterns of 3×8 to 5×8 as flexibility levers — the current bottleneck in our process allows for approximately 300,000 units per year.
We are now working on a master plan aimed at harmonizing routine capacity across the entire process to reach 500,000 units per year.