Gyder Surgical is developing a novel medical device to assist surgeons achieve more reliable and consistent hip replacement surgery outcomes. In partnering with Hydrix, it is taking advantage of having R&D, regulatory and quality systems skills on-call, and under the one roof.
Hip replacement is big business
Hip replacement is one of the most common inpatient procedures in developed economies. More than 1.7 million operations are performed around the world annually with growth at a steady 3% p/a. This makes for a substantial market given in 2014, US health insurance companies and Medicare paid out an estimated $40 billion on hip replacement procedures.
A critical part of the hip replacement procedure is ensuring that the artificial hip socket (acetabular cup) is positioned accurately in the pelvis. Currently, many surgeons perform this ‘navigation’ freehand, which leads to an average of only 50% alignments being correct. The consequence of this is an estimated and avoidable annual cost of $1.3 billion to $2 billion in the US alone for revised hip surgeries. A barrier to more technical solutions to alignment can be cost, with robotic or computer-assisted surgical navigation systems costing up to $1 million.
Hydrix is currently partnering with Gyder Surgical on the development of the GYDER™, a non-invasive, intra-operative surgical navigation tool that assists surgeons to accurately position the acetabular cup during hip replacement surgery.
The benefits of the GYDER technology include:
Simple to use - minimal training required
Non-invasive – other solutions can require fixtures to be pinned to a patient's pelvis or femur
Low cost compared with competitor solutions
Suitable for use in Minimally Invasive Surgery (MIS)
Core to the technology of this electro-mechanical device is the use of an innovative system that provides spatial positioning feedback. This proprietary technology enables the surgeon to rapidly determine the correct alignment for positioning the acetabular cup into the pelvis prior to final engagement (impacting the cup into place). Accurate alignment is crucial in ensuring a successful hip replacement, reducing the risk of post-operative complications, dislocations and longer-term issues for the patient.
The immediate value of co-location
As a medical device start-up, Gyder Surgical co-located with Hydrix to enable immediate access to an experienced and comprehensive medical device development team. This decision has allowed Gyder Surgical to rapidly mature its technology and prepare for market launch through having services on demand including:
User Experience design (UX), human factors engineering (HFE) and industrial design
Quality and Regulatory (regulatory strategy and development of an ISO 13485 accredited Quality Management System)
In sharing his insights on this co-location strategy, Bill Hill, Director of Gyder Surgical said: “Partnering with Hydrix has made perfect sense for Gyder Surgical. Their combined offering of design engineering capability, coupled with quality and regulatory specialists, has enabled Gyder Surgical to access all the skills that a start-up needs in the development phase, without the overhead and challenges of hiring additional staff or managing multiple independent consultants.”