Founded in 2012 by its current CEO and CTO, Calcivis offer what dentists consider the holy grail of tooth decay: real-time chair-side assessment of the condition. Crucially, the company’s CALCIVIS® Imaging System enables a preventative dentistry approach, supporting early decision making and better patient communication, ultimately improving patient outcomes.
A small start-up, Calcivis lacked in-house expertise in print, packaging and presenting products to market. They tasked us with helping address this issue for both of their products: the Imaging Device Kit itself, which is a one-off purchase, and also the ancillary Imaging System Kit, which enables twelve tests to be performed and which dentists buy on a repeat basis.
We supplied the cutter guide to an agency who designed the artwork, which we then used to print the boxes. A customer-specific Standard Operating Procedure was created, with all information recorded and kept within a Device History Record for five years.
The Imaging System Kits are kitted and despatched by us in bulk to the USA, where they are distributed by Calcivis. Using boxes and fitments which we designed, each kit contains 30 batch-controlled items including syringes, sterile wipes, IFU and glass vials of Diluent and Photoprotein. Again, a customer-specific Standard Operating Procedure was created, and all information contained in the kits is recorded and kept with a Device History Record for five years.
In 2023, the CALCIVIS® Imaging System became the first Scottish medical device to secure coveted pre-market approval (PMA) from the US Food and Drug Administration (FDA). This is official recognition of its all-round efficacy and integrity, only ever awarded after stringent scientific review. Crucially, it opens up the USA’s multi-billion-dollar dental market to our client.
MBM’s kitting process for the Imaging Kits was audited as part of this highly prestigious and commercially transformative accreditation.
