OEM Medical Device & Contract Manufacturer Relationship

In the last two decades, there’s been a dynamic shift in the relationship between OEM medical devices and contract manufacturers. Not long ago, the norm was that OEMs instructed the contract manufacturers on what to produce and how. However, as contract manufacturers kept servicing more customers, their know-how increased, and they updated their value propositions. Having grown and evolved, they are nowadays able to provide comprehensive services from concept to development; specialized manufacturing; and even supply chain management. From the raw material vendors all the way to the final consumers.

Such is especially true when the contract manufacturer is involved as early as the design stage. This is when the contract manufacturer can influence the design of the manufacturing process to be of the highest quality, efficiency and adaptability to future product updates.

Understanding the significance of the impact to the bottom line, the medical device OEM’s strive to involve the contract manufacturer in even the more detailed decisions such as product material selection and production methods.  

However, despite this relationship shift, many characteristics still remain constant in the relationship between OEMs and contract manufacturers. In this article, we take a look at those relationship attributes, as well as the role of the contract manufacturer in enabling smooth cooperation.

OEM Medical Device

Initial Agreement & Market Projections

The basic factors that determine the nature of any OEM medical device collaboration, and are laid out in the initial conversations between the OEM and contract manufacturer. The most important one is sales projections, in terms of items required per year. However, the medical device OEM can set work expectations based on predictions that don’t always correspond with reality. 

Especially when entering a new market or launching a new product, it is very difficult to define exact numbers, and estimations far from reality can be made. Mainly because volatility is an intrinsic feature of any new project. That’s why the contract manufacturer needs to be flexible and able to correspond to such fluctuations, scaling production output up or down as required. This is where the manufacturer’s experience and know-how come into play, and can have a big impact in the OEM’s bottom line.

Meeting Market Expectations

Production output is not the only factor affecting the OEM medical device and contract manufacturer relationship. Far from it: raw materials price fluctuations, complications with suppliers, and medical device features updates, all factor into meeting market expectations. Dealing with those matters requires long-term relationships built on trust, between the contract manufacturer and their vendors. And when such issues arise, solving them effectively requires clear communication and know how from the contract manufacturer.

Meeting Quality Expectations

A big part of a medical device contract manufacturer is meeting their quality agreement’s contractual obligations. In the field of medical devices, this is an especially important factor, since to market said devices requires regulatory compliance. In this field, the expertise a contract manufacturer lends to the OEM is of critical importance, as it can influence time to market, customer satisfaction, and company liability.

Your Trusted Contract Manufacturing Partner

Quasar has supported medical device OEMs achieve their goals for over 30 years. Having amassed an enormous amount of experience and know how, coupled with our modern production facilities and specialized personnel, we can help you achieve your OEM medical device goals. Contact us to discover how Quasar can become your trusted contract manufacturing partner.

• OEM: What Original Equipment Manufacturer Means, With Examples
• Original equipment manufacturer – Wikipedia
• Contract manufacturer – Wikipedia

More useful resources:

• How to Conduct an OEM Audit for a Medical Contract Manufacturer
• China MAH Policy Changes and The massive Opportunity for Medical Device OEMs
• Medical Device Contract Manufacturing: How to Find the Right Partner for My Product?