Managing the OEM-CM relationship is complicated, being influenced by the medical device’s complex production process, legal aspects (product copyrights, patents, and production & design technology rights), market fluctuations, production variations (scalability), vendor management, and the interpersonal aspects.
How does a medical device OEM find the right contract manufacturer and safeguard themself from falling into a relationship that results in a season of financial loss?
The following is a case study of a medical device OEM that went through an unpleasant experience with another contract manufacturer. Upon parting ways, the CM refused to cooperate in sharing crucial production information pertaining to their device. The OEM approached Quasar seeking to save their product with minimal information to work with. Let’s review the simple yet highly effective steps that resulted in the OEM standing strong today alongside a CM partner they can rely on.
The product: A laser catheter sensor tasked with providing precisely accurate navigation.
Quasar was tasked with designing a development process assembly without being provided the necessary or even minimal information on the product such as design instruction and documentation. Most contract manufacturers, do not welcome this sort of situation or challenge. Quasar, however, views such a scenario as a favorable opportunity to exercise the full extent of our capabilities in identifying critical steps to reduce production time as well as our engineering expertise to significantly improve the device functionality.
Our R&D and production engineering teams worked together with the client through every stage of the process development, to ensure that we truly understood their vision for both visibility and functionality of the product.
What was provided was a product sample. We reversed engineered the product sample to get the necessary design information. We finally split the laser catheter into two sections: the distal and the proximal. We used a separate production process for each of the sections. The proximal section is based on off-the-shelf machines while the distal section was produced by a machine that we at Quasar developed from scratch – this involved fiber optics: for which we built customized automation via self-learning of the production process.
We successfully produced four versions of the device, in four months, at a 50% reduction in production cost and time in comparison to the previous design. This is a direct result of Quasar’s vision for the future of the product that focused on a plan of action for when an increase in production quantity was required while also automating key stages early in the production process in order to lower future costs.
Quasar is an established expert in the field of Catheter design, development and production. Our thirty plus years of expertise spans the length and breadth of the various types of catheters, including micro-sized, embedded electronics, and laser catheter sensors for minimally invasive devices. At Quasar we know the value of trust and have diligently gained the trust of the largest medical device OEMs in the industry today.