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Case study: The Gannet Implant 2017-05-19T11:11:43+00:00

Case study: The Gannet Hip Fracture Implant

Femoral neck fractures are being called “the unsolved fracture” because of the bad results of internal fixation methods. Osteosynthesis by means of the Dynamic Hip Screw is leading to 10-12 per cent failure with nondisplaced fractures and around 35% failure with displaced fractures.

Baat Medical went from the whole process, from Market Mapping & Concept, development of the implant in five stages through supply chain management.

Four peer-reviewed article have been published and the fifth article is in preparation. The failure rate of osteosynthesis in femoral neck fractures decreases dramatically from 10-12 per cent in nondisplaced fractures to 4 per cent and from around 35% per cent in displaced fractures to 14 per cent, based on approximately 800 patients treated so far.

The results are not only improving patient’s life but are also reducing health care costs because of the reduced number of re-intervention surgeries.

The implant is now on the market and Baat Medical is still responsible for the supply chain management.

Gannet Implant Website

Market Mapping & Concept

Baat Medical carried out Market Mapping & Concept. The outcome was an original idea that could be patented. Subsequently, the implant (Dynamic Locking Blade Plate or ‘Gannet’) has been developed using the five stages method.

Stage 1: Explore

The main demands for the implant were: It should help to reduce the failure rate significantly, the operation technique should be very simple and straightforward and the system must be inserted over a K-wire, otherwise it will not be accepted in the market.

Having this user input in mind we first analysed possible causes of the high failure rate. In this case the surgeon had a very clear view about the particular issues of this fracture that are very different from other bone fractures. Using this knowledge the solution concept was not hard to find: A blade plate with minimal frontal area, having anchors that can be deployed in the femoral head to fixate the implant. Once we had a solution we defined a list of technical specifications for the new implant.

Stage 2: Design

At that moment the blade plate concept had many uncertainties: How much force is needed to tap the implant in? Can the anchors be deployed properly in the bone? What is the rotation stability of such a single implant?

We first designed the implant and managed to create a design that was able to meet the demands. Then the main issues were addressed. We built special test set ups to find out the behaviour of the anchors in practice. Using sawbones, we compared the rotational stability with conventional implants. Moreover, we tested the deployment of the anchors in real hipbone.

Beside the implant we also designed the key instrument for insertion of the implant. We managed to come up with a complete new concept.

Stage 3: Engineer

Once the key issues where solved, the design was finalized into detail. Sizes of the implant where defined and the set of instruments was completed. This phase did not only contain product development activities. Also setting up the production process was completed. Finally we have tested the complete procedure during saw bones sessions.

Stage 4: Validate

In this phase we validated the design. All mechanical tests according to the applicable standards where performed. Moreover, cleaning and sterilisation was carried out and in this case also a clinical trial of 35 patients was part of this phase. The results of the clinical evaluations showed a major reduce of the failure rate and with these results we could CE mark the product.

Stage 5: Transfer

Once the CE mark was obtained, the actual delivery of the product started. Our main role was to monitor the production of the first batches. We checked whether the quality procedures as developed in the previous phase were indeed effective and all traceability data was stored properly. Because when more surgeons started using the implant it was unavoidable that some issues appeared during use. During this project we had to solve issues with the insertion instrument and the drill. In that phase we addressed those issues and solved them appropriately.

Supply Chain Management

After completion of the development of the implant, Baat Medical takes responsibility for the supply chain management. This includes complaint handling and follow-up procedures.