Case Study

Transforming a High-Risk Supply Challenge into a Scalable Solution

Our international customer, a startup developing a complex structural heart device, faced challenges as their volumes were too small for their current CMO to support during DV and clinical trials. They needed a reliable partner who could respond with urgency.

ICS Medical Devices quickly reviewed the specifications and provided a plan and quotation to secure a new supply chain. We initiated process development and capability testing on critical bonds and requirements.

We improved key processes, replacing adhesive bonds with thermal bonds and enhancing overall robustness. Component specifications and tolerances were optimised to improve dimensional performance. By prioritising the customer and addressing historical process challenges, ICS ensured quality and supply reliability even at low volumes. All engineering and testing were completed with data provided to support each ICS change. Following successful development and supply chain qualification, ICS implemented full quality systems, training, inspections, testing, and product release procedures.

ICS now supplies the customer with a reliable, high-quality product. The customer has a secure supply route, enabling ongoing design improvements, scalable production, and consistent quality.

Pilot Manufacturing

Our customer faced a challenge as they pursued design freeze and clinical trial milestones essential for future investment while realizing their current design’s cost of goods was too high for market success. With limited time to act, they needed an efficient solution.

After reviewing the situation, we proposed designing and building new, reengineered components, simplified to reduce material costs while meeting all product requirements.

Following successful builds and customer testing, ICS Medical Devices implemented systems to produce 1,000 assembly components for the customer’s DV program. Within three weeks, we delivered the first 250 pieces, followed by 250 more every three days to support final assembly. We now continue to work with this customer on ongoing clinical trials.

Building to a Successful Feasibility Trial

Our customer, an early-stage start-up developing a novel therapy in the structural heart space, needed to complete a key feasibility trial to meet project milestones and investor expectations. Leveraging our product development and manufacturing expertise, ICS Medical Devices was asked to support critical assemblies for the trial.

ICS took ownership of material and process specifications, secured raw materials, and developed critical laser welds, thermal bonds, jacketing, pouch seal, and packaging processes. We established process methods, quality systems, traceability, training, and inspections to support the feasibility build.

ICS completed the builds on schedule, enabling the customer’s successful trial. The milestone demonstrated product efficacy, which was presented to investors and helped secure the next round of funding to advance the project.