Christmas holidays 2010/11 - Jamie set us the challenge of designing a 'better device' to assist him in his pioneering work in the development of the 'Direct Anterior Approach' to Minimally Invasive Hip Replacement Surgery - given his general dissatisfaction with the currently available equipment.
Deliberately rejecting his offer to see some surgery and evaluate the existing equipment, we sat him down and extracted from him what he really wanted the device to do;
- What it MUST do
- What he'd LIKE it to do
- What he wishes were POSSIBLE
We then set about brainstorming possible concepts and developing a product specification.
We initially came up with 5 quite different concepts, but quickly rejected 2 of these as unfeasible.
The remaining 3 concepts were developed into 3D CAD 'sketches' and then evaluated with a ranking and weighting exercise against our product specification - leaving us with one preferred concept.
Only then did we see some surgery and investigate the currently available (competing) devices, to make sure we hadn't missed something important.
Interestingly, both of the device concepts we rejected at this stage are actually currently available on the market - but we stand by our reasons for rejection.
February-May 2011 - we completed the design development stage of the preferred concept and then produced the design output - drawings and data - to enable costing and manufacturing process investigation
June-July 2011 - prototype component manufacture and modification. We assembled the fully working prototype at the end of July 2011
August 2011 - we spent preparing the patent specification so that we could file our initial patent application in early September 2011
September 2011 - we delivered the first prototype to Jamie's hospital for initial evaluation, operator training and field trials. Subject to minor modifications FLOTE has been in use for Anterior Hip Surgery ever since.
In parallel we had FLOTE independently evaluated for 'CE marking'. It is clearly a Class 1 device and we have now made all the necessary design/engineering changes required for compliance.
May 2012 - we took the propotype to Paris to show to several groups of surgeons, at the request of a number of implant companies; we ended=up completing 10 hip replacements in 2 days with a surgeon who had never seen it before!
July 2012 - we started to receive orders for the first production units - contingent on supplying production units to the SOFCOT congress in Paris in November the same year.
November 2012 - we completed the first 'pre-production' batch of 5 units and then trialled the first production FLOTE at the Wrexham Maelor hospital and started shipping production units to our french customers
January 2013 - we completed the pilot production lot of 30 FLOTEs - we are now in full series production.
March 2013 - we completed our first surgical trials in the USA and exhibited at AAOS in Chicago.
Currenltly we have 2 FLOTE devices in the USA permanently available for surgical trials, cadaver labs and demonstration.