Pro-Nata Yorkshire Obstetric Forceps
Globally 10 – 15% of births are assisted vaginal deliveries (AVD) using either the forceps or vacuum devices.
The forceps device has a higher success rate for AVD but has major drawbacks; the risk of trauma to the perineum of the mother and baby due to use of excessive traction force, the device is made of steel; its success is dependent on the operator’s skill and experience. Whilst the vacuum device been improved over time, there have been no innovative improvements to the forceps devices on the market.
The new obstetric forceps have been designed with an in-built safety device to regulate the amount of traction force that can be applied to achieve a vaginal delivery. The operator is simultaneously able to see the amount of force being applied and get additional auditory and tactile feedback once the maximum traction force is exceeded. This removes individual variations in the maximum amount of force used and the risk of use excessive traction force. The new device is intended to be single use and made of lightweight, recyclable, non-steel materials. This has environmental benefits and in low-resourced countries reduces the risk of cross-infection and the cost of sterilisation.
Medipex impact on project
Having determined that there were gaps in both the IP landscape and the market, Medipex helped the clinician apply for a grant so that a working prototype based on his idea could be developed. A 150 clinician market research study was carried out at this phase to gather views from other clinicians on the use of obstetric forceps and to determine what features they would like to see improved about the device.
The data gathered supported the need for the suggested device and was used to help prepare a design brief. A local design and prototyping company was engaged to turn the concept and information into a product which would be capable of manufacture at scale and to produce a series of initial prototypes.
These were tested on birthing simulators to check that they worked as desired and a patent application was filed around the novel features of the device.
Feedback from other clinicians was then garnered which helped to further refine the device. The design was then frozen and a piece of work carried out to confirm that the product could be made and sold for the target price.
The IPR relating to this device has recently been out-licensed to a UK SME - Surgical Dynamics - for commercial exploitation (Medipex negotiated and prepared the licensing agreement on behalf of Hull and East Yorkshire NHS Trust) and we were successful in applying with the company for a SMART award to support some of the costs associated with taking the product through to market.
In June 2016, Surgical Dynamics announced the launch of Pro-Nata, an innovative device that marks a new era in obstetric forceps design.