Case Study: Smith+Nephew X-Wing™, Partnering on Design

Background

As many will be familiar, Smith+Nephew is one of the oldest and largest medical equipment manufacturers. Established in 1856, the company has since grown into an internationally renowned producer of medical and surgical products in areas like arthroscopy, endoscopy, advanced wound management, orthopaedic reconstruction, trauma and clinical therapy. Now boasting distribution to over 100 countries, the demand for Smith+Nephew products is such that the company leans on partners to help develop and deliver new products in each region. One such partner is Enztec.

The opportunity and search for a development partner

Smith+Nephew identified a gap in their sports medicine portfolio. They saw that single-tendon grafts could benefit from a specifically designed preparation system — one that allowed for the preparation and tensioning of the graft and prepared it for fixation with the appropriate Smith+Nephew implant.

With the opportunity defined, what were the criteria for Smith+Nephew when finding the right organisation with which to partner in the development of the graft preparation system?

1. Trusted, collaborative partnership: Smith+Nephew reviewed partners they had worked with closely before. They considered partners that applied an agile, collaborative approach and that could deliver.
2. Experience in the market: A partner was needed that specialized in orthopedic instruments and that could offer unique insights and experience.
3. Complete service offering: Smith+Nephew needed a partner with the ability to provide an end-to-end solution from design, verification and validation, regulatory compliance, manufacturing and delivery. A partner that had the capability to adapt and bring on different resources quickly as the project developed.
4. Ability to scale globally: While the product was initially deployed in Australia and New Zealand, there was an opportunity across Smith+Nephew globally, so a partner that could grow and scale to the needs of the project was valuable.

Enztec selected as the development partner

Smith+Nephew chose Enztec, a supplier based in their Australia and New Zealand market.

Smith+Nephew had worked closely with Enztec on previous projects. Enztec has more than 30 years of experience in orthopedic instrument design, engineering, manufacturing and regulatory compliance. Orthopedic instruments are all that they do.

“Collaboration is so important in orthopedics and Enztec is a trusted partner that I go to for collaborative development on orthopedic instruments. They bring our insights into the marketplace, allowing us to solve complex design challenges.”

- Smith+Nephew Global Marketing Manager

What happened?

Enztec’s experience came to the fore in the creation of the X-WING◊ Graft Preparation System, driving it forward with speed and attention to detail.

During the design phase, Enztec collaborated closely with Smith+Nephew to refine key product requirements: the new product’s capabilities, its design constraints and how it would differ from the currently available alternatives. The product began to take shape after all of the relevant factors were considered.

In terms of verification and validation, extensive testing was carried out by Enztec to ensure the mechanisms and material couplings selected for this high-load tensioning application were suitable. Enztec also managed the clinical evaluation in New Zealand, allowing the designers to get feedback firsthand, which sped up the evaluation cycle.

Enztec created and openly shared all technical documentation, which allowed Smith+Nephew to adopt the new product easily and seamlessly into their system. Enztec and Smith+Nephew then co-developed a surgical technique to support the procedure.

As the manufacturer of record for X-WING◊, Enztec is responsible for delivering high-quality products that are designed to observe U.S. FDA, Australian TGA and EU MDR regulations.

Since its official release, Enztec has worked collaboratively with the Smith+Nephew team to match manufacturing capacity with demand. Forecasting from Smith+Nephew allows Enztec to be responsive in manufacturing and has helped to greatly reduce lead times.

X-WING◊ was initially deployed in Australia and New Zealand, where it helped Smith+Nephew differentiate itself from competitors and gain market share. The product soon became globally recognized and has since been released in a number of key international markets.

The result

By partnering with Enztec to deliver X-WING◊, Smith+Nephew saved themselves time and complexity. Now a part of Smith+Nephew’s UltraTRAC◊ QUAD ACL Reconstruction Technique, X-WING◊ continues to gain market share.

Importantly, the greatest gains are felt by surgeons and their patients, who are reaping the rewards of this partnership.

See X-WING in action here.

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