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The story behind our research and development bone screw project for surgeons

Over the years here at Kirkstall Precision Engineering, we have been approached by a wide range of companies to look at translating ideas into reality for new products into small scale prototype samples to be tested by a wide range of professionals.

Largely these ‘R&D Precision Engineering Projects’ are brought to us by major international and national medical OEM’s as well as universities and sometimes even surgeons themselves.

One such project is our bone screw for one of the world’s largest medical OEMs, which was used for spinal surgery to insert a medical implant into the spine.

The background to its development.

We were initially forwarded 3D files and PDF drawings from the customer after a detailed contract review in line with our ISO13485 regulatory requirements. We analyse the technical files to enable us to create the CAD programs for our machines and from there we finalise the proposed route of manufacture with a production plan detailing all the quality and trackability requirements. We purchase the raw materials and bought in components from our approved suppliers with full certification. During the manufacture of a product like this it is critical for synchronisation between all the manufacturing cells as there are multiple parts that will need assembling at the final stage.

Our highly skilled production engineers will look at all the various stages as these products go through production, so we can understand in more detail the processes involved and resource required if it were to evolve from a small-scale R&D project into a full-scale mass-produced order. This is obviously crucial for accurate quoting and estimating lead-time for meeting any larger orders.

Speaking about this, our CEO and Technical Support, Adam Thornton commented that: “A typical product like this can use our CNC Milling, CNC Turning, EDM, even some manual machining operation and we are proud that we still have all the required skill sets in-house at Kirkstall Precision. On completion of the machining processes the components then go on to our finishing team, which can involve such processes like bead blasting, electro polishing, laser welding and laser marking to add branding and any other required markings.”

The final stage is technical assembly of the complete instrument where all the machining tolerances, limits and fits are checked and verified, via our qualified QA team using the latest measuring technology.

Working closely with customers.

At the end of the manufacturing process, we don’t just dispatch the products to customers. Close collaboration is important, so we invite customers on-site and for a product like this, customers have been known to bring dry bone in with them to test out the final product at our facility.

This instrument was a replacement for three other instruments, a three in one solution was required as  It replaces an instrument to drive the screw, an instrument to insert the screw and an instrument to release the screw. Being able to easily operate this new device is crucial to its success and this is what the customer will want to test on-site with us.

From here the customer might ask for refinements, but as their end customer is a surgeon, it is usually sent out into the field for comments to see if it will add value to surgical procedures as initially thought and to see if it will instigate a new technique of implantation.

Regular R&D projects at Kirkstall Precision Engineering

Creating products as part of an R&D exploration for customers is not a rare thing to do here at Kirkstall Precision. We will undertake quite a few projects like this and recently we’ve been looking at creating an implantable staple, where we’ve created 12 variations of the product to be tested by the customer and surgeons to understand the right permutation to proceed for manufacture.

Speaking about this, our Managing Director Iqbal Bahia commented that: “What usually happens is that the customer comes to us with a concept. They’ll have no idea about the design for manufacture or the manufacturing processes. Our job is to turn that concept into reality, and this is where Kirkstall really comes into our own as a total solutions provider, taking the germs of an idea into something tangible that can be tested and analysed to see if the concept will change things for the better.”

It’s not just large companies that will come to Kirkstall Precision with concepts. In many cases we have individual surgeons and professors come to us with ideas and it’s our job to work out such specifics as tolerance levels as well as the best materials to manufacture in and the most efficient processes as well as producing CAD drawings of their concept.

Whatever your R&D needs, speak to the team at Kirkstall Precision Engineering.

The spinal bone screw highlighted in this article is just one of many R&D projects we take on for a wide range of sectors in the medical, veterinary, automotive, oil & gas plus many more. If you have an idea for a product or initial drawings and want to discuss a small batch run to manufacture to solidify your proof of concept, contact our Managing Director Iqbal Bahia at info@kirkstallprecision.co.uk