Catheter Manufacturing

Our international customer was a startup developing a unique, differentiated, and somewhat complex product for a structural heart application. The customer was entering DV & clinical trials and their volumes were deemed too small for their current CMO who could not continue to support their needs. The customer required a solid, reliable and safe solution that would collaborate with them with the required urgency.

ICS Medical Devices reviewed and quickly understood the specification. We responded with a plan and quotation to secure a new supply chain and initiated process development and capability testing on key bonds and requirements for the product.

ICS Medical Devices successfully improved key processes, including elimination of adhesive bonds in favour of thermal bonds and improving robustness of all bonds. We proposed and executed changes to components specification and tolerances to further optimise the final device dimensional capability. ICS Medical Devices tackled some historical process challenges the product had by treating the customer as a priority, allowing ICS to focus on the product and its processes and develop solutions to safeguard the quality and the supply of the part even in its current low volume status.

All engineering and testing was completed with data supplied to customer to rationalise and support each change ICS implemented. Upon successful completion of development and supply chain qualification, ICS implemented full quality and control systems, training, inspections, testing and product release procedures to supply the product to the customer.

ICS currently supply this valued customer an improved quality product. The customer now has a product supply route for a quality product that is reliable, repeatable, flexible and meets their quality expectations. The customer can now implement additional design improvements, ongoing supply and scale their demand with us.

Our customer was in a challenging situation as they pursued design freeze and clinical trial milestones crucially required to secure future investment in their company. At the same time our customer realised their current design had a cost of goods that was too high to be successful in the market. They had ideas on how to improve but were running out of time to implement in the current design cycle.

After approach and review with the customer, we proposed a plan to design and build new components – reengineered and simplified to eliminate much of the materials cost but still satisfying the product requirement.

After successful build at ICS and testing by the customer, ICS Medical Devices progressed to installation of systems and methods to facilitate the build of 1000 assembly components required to support the customer DV program. Within three weeks of starting, ICS supplied the first 250 pieces and followed up with an additional 250 pieces every three days to satisfy the customer build into the final assembly. We are now working with this customer in ongoing clinical trials.

Our customer was an early stage start-up with a novel approach for a new therapy in the structural heart space. They were tasked with a key feasibility trial in order to meet a key project milestone and satisfy their investor expectations. Based on our experience in product development and manufacturing, and our deep understanding of what is required for development and manufacturing, ICS Medical Devices was asked to support some key assemblies for their product feasibility trial.

ICS took control of the material specification and process specification. We secured raw materials to specification; completed development on critical laser welds, thermal bonds, jacketing pouch seal and packaging processes; set up process methods, quality systems and controls, build traceability, training and inspections to support the feasibility build.

ICS completed the feasibility builds within the customer schedule, facilitating that customer to get to a successful trial. The customer achieved their milestone, successfully demonstrating product efficacy and this was presented to investors and ultimately helped to secure our customer’s next round of investment to advance the project.