A medical device OEM’s internal engineering and production systems were challenged to iterate design and prototyping of a next-generation catheter fast enough to support the rapid move to final design freeze and the volume builds required to support DVT. Ametek EMC was already a vertically integrated supplier of 12 of the catheter’s most complex part numbers, totaling 86 discreet components and sub-assemblies in this next-generation catheter. Ametek EMC had developed the manufacturing and assembly processes that would be leveraged to execute rapid design iterations and would be instrumental to a successful DVT build. The OEM engaged the Medical Precision Components Division of Ametek EMC to:
- Complete an aggressive Design Verification Testing (DVT) schedule
- Create a validated manufacturing process on its next generation diagnostic electrophysiology catheter
The Medical Precision Components Division brought its robust and responsive engineering systems to tackle the OEM constraints faced in the development of this next-generation catheter. Having developed a collaborative partnership over many years, the OEM decided to rely heavily on Ametek to manage and perform a successful DVT on a very aggressive schedule.
Ametek assembled a dedicated cross-functional engineering team to serve as an extension of the OEM customer’s development team and participated in OEM project team meetings as an additional engineering resource.Ametek led twice weekly conference calls with OEM project team to uncover customer needs, identify and understand issues, target rapid resolution of issues/rapid completion of actions. Ametek actively managed the project plan with OEM project team. Ametek supported 12 major design iterations over a 14-month period and built 442 units to support the design feasibility phase path to design verification.
In the final 6 months of the project,Ametek EMC:
- Validated all manufacturing and assembly processes for this next-gen diagnostic electrophysiology catheter.
- Created inspection procedures for 46 additional outsourced catheter part numbers and qualified OEM-selected suppliers of these 46 part numbers per first article inspection protocols.
- Installed production-ready assembly lines in a dedicated clean room environment.
- Optimized this line with single piece flow techniques to minimize labor content and support volume quantities and pricing.
- Trained a dedicated team of direct labor, quality auditors, manufacturing engineering technicians, and process engineers to keep up with manufacturing demand of the customer.
The Ametek team delivered to the client a DVT build ahead of the client’s schedule. Within the build, 156 catheters passed OEM customer’s DVT with 98% yield and the laser welded 2F mapping electrode assembly experienced only 1 failure among the 7,680 electrode assemblies in this 156 catheter DVT build (0.01%). The manufacturing and assembly processes were validated and production-ready including the clean room environment, trained/certified team of labor, auditors, and technicians
Ametek’s engineering and manufacturing expertise working in close partnership with OEM project team, allowed the customer to rapidly iterate and trial/test many design concepts all in an effort to realize the next generation catheter and submit its 510K regulatory filing on time. This partnership continues as we work with the OEM on a new generation catheter utilizing similar technology.