Stitching – Spec Build

In Need Of Some Heavy Lifting

Full spine and hips to ankles imaging can be difficult. Positioning the patients can be tricky and the exam times longer. Patient motion and image receptor perpendicularity are all points of concern for a radiographer. The process of care, patient safety and exam efficiencies are all primary concerns. In DR technology, when a single long format panel is used, the detector itself is bulky, heavy, and very expensive. Carestream Health, located in Rochester, NY, came to Reina Imaging with a challenge. They were going to launch a large format 17x51in. panel that had to be positioned upright, undertable and cross-table in the exam room and also to be mobile. They required cETLus certified detector positioners that would be stable, easy to move, safe, compact and able to handle the large format panel’s weight – all without the need for electricity. They came to the right place. This type of mechanical arrangement is one of Reina’s specialties.

The Reina Approach

Our quality system – guided by ISO13485-2016, IEC 60601, FDA and EU MDR requirements – lays a clear foundation for success. In this case, long bone and full-spine applications are right in the Reina Imaging new product design wheelhouse, so our team of engineers and project planners went straight to work. They first reviewed the customer’s product requirements – this initial step, sifting through the “must haves” versus the “would likes,” is critical to success. It’s key to charting the right product path, setting the design and development schedule, keeping the project on time and conforming to budgetary limits. Once the client signs off on the product requirements, we lean into our product development flow using a gated-review process where we communicate with our clients each step of the way: feasibility analysis, design plan, product development, design verification, design validation, design transfer and commercial release for sales.

When Quality Counts

RI is a bona fide medical device manufacturer. We adhere to the strictest global regulatory requirements when designing, manufacturing and supplying products. A high-level compliance and quality system is mandatory when demanding customers like Carestream evaluate potential suppliers. CSH is a global leader in the medical device arena and can only partner with qualified vendors that can supply products with demanding specifications and high volumes at a great price that provides a solid margin in the marketplace. 

The Results

After years of supplying these goods to Carestream Health, RI is proud to say we have had no returns, complaints, nonconformities nor any other quality issues, earning a 100% supplier score from CSH at every review. Consistent quality and strict manufacturing processes have made Reina the first choice of large OEMs for new accessory designs and we’re honored to have CSH as one of our valued accounts.