Accelerating Clinical Trials for a Vascular Care Medical Device Company
Synopsis
A vascular care medical device company was facing a 22-week lead time that threatened its clinical trial timeline. Global Interconnect (Gii) knew the objective was clear: deliver a high-quality assembly faster, while reducing costs, offering a one-stop scalability solution, and keeping its groundbreaking vascular technology on track.
The Result: A 10-week reduction in lead time, $20–$30 in cost savings per assembly, and clinical trials that stayed on schedule.
Background
A medical device company specializing in therapeutic ultrasound solutions for vascular care required a manufacturing partner capable of delivering a high-quality, reliable assembly within an aggressive clinical timeline.
Its existing supplier presented delayed lead times, creating a significant risk to the program's critical path; jeopardizing essential clinical trials, product performance, and potential investments.
Recognizing the urgency of the situation, the company partnered with Gii to develop a faster, more scalable manufacturing solution.
Engineering the Solution
The company was seeking a contract manufacturing partner to produce a complete generator-to-handpiece assembly, including the cable assembly, male locking connector, cable, and printed circuit board assembly (PCBA). The project was executed through a highly collaborative development process focused on the customer's clinical priorities and aggressive production schedule. Engineering and manufacturing teams worked closely to refine product requirements, optimize the design to accommodate downstream assembly operations, and accelerate production.
Prototype assemblies were developed and validated in time for pivotal trials. Product qualification included:
- Flex testing
- Pull-force testing
- Electrical testing
- Connector reliability testing
Frequent communication between both teams enabled rapid decision-making and design refinements, ensuring the program remained aligned with critical clinical milestones.
The Gii Advantage
Leveraging its engineering expertise and vertically integrated manufacturing capabilities, Gii developed a strategy that met the customer's aggressive timeline without compromising quality or reliability. Through value engineering, rapid manufacturing, and supply chain optimization, Gii delivered a scalable solution that supported both immediate clinical needs and future production growth.
Key outcomes included:
- Reduced initial assembly lead time by 45% (22 weeks to 12 weeks)
- Lowered assembly costs by $20–$30 per unit
- Electromechanical assembly manufactured with a custom extruded cable assembly, injection molded components, and PCB assemblies.
- Introduced a custom connector solution that improved manufacturability while reducing costs.
- Developed a custom cable to replace the prototype cable that was previously used for benchmark functional trails – Took OTS coax with heatshrink outer jacket to complete vertically produced custom extruded cable that met all functional requirements.
- Provided DFM and design support for optimization of overmolded grommet to interface with customer’s clamshell handpiece.
- Improved supply chain efficiency to support future production demands.
- Kept the customer's clinical development timeline on schedule with no impact to the critical path.
- Successfully supported pivotal clinical trials that were essential to commercialization and future funding.
- Most importantly, the customer was able to place its product into physicians' hands on schedule.
Customer Perspective
Working with GII has been a great experience. Their team is highly responsive and always provides thoughtful, knowledgeable feedback. They've consistently collaborated with us to refine our product design and specifications, ensuring everything aligns with our evolving requirements.