Manufacturer of record is a phrase that shows up in contracts and regulatory filings, but it is worth being specific about what it actually means for a device company. It is the company that stands behind the finished product, the one whose name is on the line when a device has to meet its specifications, pass its testing, and satisfy its regulatory requirements.
For most device programs, that responsibility stops at the device itself. Packaging is handled separately, by a different company, under a different agreement, with no direct tie to the manufacturer of record. It is a split that has become so normal in the industry that few teams think to ask whether it needs to stay that way.
Why the Split Creates Extra Work
A sterile device does not exist as two separate products. It exists as one sealed unit, and the packaging is what keeps the device sterile, protected, and usable until the moment a clinician opens it. When the company responsible for the device and the company responsible for the packaging are not the same, every change to either side has to be communicated, translated, and reconciled between two organizations that were not part of each other’s process to begin with.
That coordination work falls back on the device company, even though the manufacturer of record is supposed to be the one absorbing that kind of complexity.
Bringing Packaging Inside the Manufacturer of Record
Through the combined ZIEN + Averra platform, a manufacturer of record relationship can now include packaging expertise from the start, rather than treating it as a downstream vendor problem. ZIEN’s manufacturing capabilities, spanning device categories from interventional radiology to general surgery, sit alongside Averra’s decades of experience as a thermoformed packaging manufacturer. That means a device company’s manufacturer of record is not just responsible for the instrument coming off the line. It can also carry responsibility for the tray, the seal, and the sterile barrier that ships with it, all under one quality system instead of two.
A Different Standard to Hold a Manufacturing Partner To
Device companies evaluating a manufacturer of record often focus on production capacity, quality certifications, and regulatory experience. Those still matter. But it is worth adding a question to that list: does this manufacturer of record understand packaging well enough to make good decisions about it, or does that responsibility get handed off the moment the device is finished? For a growing number of device programs, the answer needs to be that packaging stays inside the
relationship, not outside it.
Want to talk through what a combined manufacturer of record and packaging relationship could look like for your device program? Connect with our team to get started.