Irish Medical Times: 16th Feb 2012
Developing Medical Device Innovations: The X-Bolt® for hip fractures.
Clinicians play a vital role in the development of medical technologies, writes Dr. Brian Thornes. Doctors and surgeons are often pivotal in defining the concept, as the genesis of an innovation usually starts with a problem that needs solving. Clinicians can also help shape improvements to the new technology, and play an important role for later clinical investigations and obtaining independent scientific evidence.
One current major orthopaedic problem is the burden of hip fractures, typically accounting for 30-40% of all trauma orthopaedic bed occupancy, and approximately €60M p.a. in acute health service costs. Complications of treatment in this elderly patient cohort greatly increase costs and average bed stay. The biggest single mechanical complication of hip fracture fixation is ‘cut-out’, mostly due to osteoporosis and poor bone quality that makes screw purchase difficult.
The inspiration for the X-Bolt® came whilst wall mounting a plasma screen TV using expanding bolts. The design adaptation has taken 3-4 years, beginning with filing patent applications, to sourcing manufacturers and testing prototypes in research institutions around Ireland. Once the concept was proven (the X-Bolt® has a 25% greater resistance to ‘cut-out’), much of the testing was to examine potential modes of failure, and to simplify end-user experience.
All manufacturing processes and test data are audited by a notified body (e.g. NSAI or BSI) to gain CE Mark regulatory approval in Europe, or by the FDA for the United States. Occasionally a clinical investigation is required to demonstrate safety and effectiveness. However, this was not necessary for the X-Bolt®, as predicate device data, coupled with our own biomechanical testing was sufficient for approval, and the X-Bolt® was awarded the CE Mark in September 2011.
The first surgical cases have recently been performed, allowing surgeons to familiarise themselves on the short learning curve, and allowing the design team to tweak minor instrumentation issues. The close interaction with clinician-users here has been very welcome, and is an area where the Irish clinical community can excel, alongside the vast number of indigenous and multinational medical device companies based in Ireland.
Savings are anticipated by reducing complication rates and thus the average acute hospital bed stay. Use of the X-Bolt® should provide estimated healthcare savings of €4M per annum in Ireland. An ethics-approved, randomised, controlled clinical study will commence in Ireland in the coming weeks, to scientifically document the device’s mechanical and economic benefits.
Dr. Brian Thornes, MCh, FRCSI, MBA, is the Founder & CEO of X-Bolt Orthopaedics (www.x-bolt.com), which has recently been shortlisted in The Irish Times Innovation Awards 2012. He also is the inventor of the ankle syndesmosis TightRope® (www.ankletightrope.com).