Case Study: DAA Broach Handles, Bespoke Design and Manufacturing

Challenge

Enztec’s customer identified a gap in their hip portfolio for a Direct Anterior Approach (DAA) broach handle. More and more of their surgeons were adopting DAA and they recognized that there was a gap in their instrument portfolio that was causing surgeons to become frustrated.

The customer required a broach handle specifically tailored to their needs, that would be delivered quickly to ensure market share was retained, and that could meet the customers stringent internal quality requirements.

Having worked closely together before, and knowing Enztec’s experience with broach handles, this device company sought out Enztec to partner with. They knew that when speed to market mattered, Enztec’s agile approach could deliver to fill the gap in their DAA range.

Approach

The first step of this Bespoke product journey was to review the customers' extensive voice of customer research and translate that into key product requirements, while leaning on Enztec's extensive broach handle experience.  This ensured all KOL inputs were incorporated into the design, and a reliable solution was delivered that built on Enztec’s proven track record.

Enztec worked quickly to deliver this project, sharing images of the design, rapid prototypes, and CAD models.  This approach ensured the customer had a seamless experience and understood the design as it developed, which also allowed the customer to keep their KOLs engaged while the solution was being created. 

Throughout the process, Enztec created all technical documentation to enable CE marking and registration of the device with the FDA. Enztec’s commitment to transparency also allowed sharing information freely with the customer to ensure ready adoption of the product into their system. This open collaboration is key to providing customers with confidence in the end design, right down to technical details such as weld validation details. Enztec knows that delivering a product successfully means not just satisfying market needs, but that it also means meeting the needs of all stakeholders such as quality, regulatory and engineering teams.

Result

One of the key drivers of this project was getting a solution to market quickly. Enztec were able to supply the customer with a market-ready, CE certified and FDA compliant product within nine months of project kick-off. This product commenced deployment at a rate of 10 units per week, but based on the market success of the product it rapidly scaled to 25 units per week, allowing the customer to dynamically respond to the needs of their customers and maintain market share.

Since market release in March 2019, Enztec has delivered over 750 DAA Broach handles allowing surgeons in the USA, Europe and Australia to safely complete procedures using their technique of choice. The impact for the customer was immediate.

Following the first use of this DAA Broach Handle in the US, the customer reported:

“The surgeon provided very positive feedback on the handle, and the hospital is requesting additional supply as soon as possible, as other surgeon colleagues express their interest for this new instrument”

We are proud of our ability to understand each customer's individual needs, to leverage our extensive experience, and deliver products that make a difference for companies.  We remain committed to helping our clients meet market needs rapidly, while never compromising on quality.

To learn more about how we could make a difference to your company contact us today.